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levetiracetam

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Description

Levetiracetam is an antiepileptic drug used to treat partial-onset seizures and myoclonic seizures in adults and children. It is a racemic mixture of two enantiomers, (S)-levetiracetam and (R)-levetiracetam, although only the (S)-enantiomer is pharmacologically active. Levetiracetam is thought to work by binding to a synaptic vesicle protein (SV2A) that is involved in the release of neurotransmitters, including GABA. This binding action may help to reduce the excessive neuronal activity that causes seizures. Levetiracetam is generally well-tolerated and has a relatively low risk of serious side effects. However, it can cause some common side effects such as dizziness, drowsiness, and fatigue. Levetiracetam is synthesized by a multi-step process that involves the reaction of a chiral amine with a chloroacetamide derivative. It has been studied extensively for its potential therapeutic benefits in various neurological disorders, including epilepsy, Alzheimer's disease, and Parkinson's disease. The compound has demonstrated promising results in clinical trials for the treatment of epilepsy, particularly in patients with partial-onset seizures and myoclonic seizures. It is widely prescribed as a first-line antiepileptic drug due to its efficacy, safety, and tolerability. '

Levetiracetam: A pyrrolidinone and acetamide derivative that is used primarily for the treatment of SEIZURES and some movement disorders, and as a nootropic agent. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

levetiracetam : A pyrrolidinone and carboxamide that is N-methylpyrrolidin-2-one in which one of the methyl hydrogens is replaced by an aminocarbonyl group, while another is replaced by an ethyl group (the S enantiomer). An anticonvulsant, it is used for the treatment of epilepsy in both human and veterinary medicine. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5284583
CHEMBL ID1286
CHEBI ID6437
SCHEMBL ID118843
MeSH IDM0374035

Synonyms (163)

Synonym
BIDD:GT0242
AC-1479
leviteracetam
ucb l059
AKOS015841981
1-pyrrolidineacetamide, alpha-ethyl-2-oxo-, (alphas)-
(-)-(s)-alpha-ethyl-2-oxo-1-pyrrolidineacetamide
keppra xr
levetiracetamum [inn-latin]
etiracetam levo-isomer
etiracetam, s-isomer
e keppra
1-pyrrolidineacetamide, alpha-ethyl-2-oxo-, (s)-
ucb-l059
ucb-l 059
torleva
(s)-alpha-ethyl-2-oxo-1-pyrrolidineacetamide
keppra
sib-s1
l-059
(2s)-2-(2-oxopyrrolidin-1-yl)butanamide
MLS001424069
102767-28-2
C07841
levetiracetam
MLS000759403
smr000466303
DB01202
levetiracetame
e keppra (tn)
levetiracetam (jan/usp/inn)
D00709
keppra (tn)
HMS2089L20
HMS2051D07
NCGC00186028-01
CHEMBL1286
ucb 22059
levetiracetam hospira
levetiracetam accord
levetiracetam sun
levetiracetam teva
agb-101
nsc-760119
elepsia
levetiracetam actavis
chebi:6437 ,
n03ax14
ucb-22059
A800616
(2s)-2-(2-oxopyrrolidin-1-yl)butanamide;levetiracetam
HMS3262H11
hsdb 7528
levetiracetamum
levetiracetam in sodium chloride
elepsia xr
matever
(s)-levetiracetam
44yrr34555 ,
spritam
unii-44yrr34555
levesam 500
levipil
levetiracetam [usan:usp:inn:ban]
levroxa
nsc 760119
(s)-2-(2-oxo-1-pyrrolidinyl)butyramide
L0234
nsc760119
pharmakon1600-01502265
HMS2235I18
CCG-100928
(s)-2-(2-oxopyrrolidin-1-yl)butanamide
(s)-(-)-alpha-ethyl-2-oxo-1-pyrrolidineacetamide
AM20070676
LP00835
levetiracetam actavis group
levetiracetam [ema epar]
levetiracetam [vandf]
levetiracetam [usp monograph]
levetiracetam [usan]
1-pyrrolidineacetamide, .alpha.-ethyl-2-oxo-, (.alpha.s)-
levetiracetam [orange book]
levetiracetam [mi]
levetiracetam [who-dd]
(-)-(s)-.alpha.-ethyl-2-oxo-1-pyrrolidineacetamide
levetiracetam ratiopharm
levetiracetam [usp-rs]
levetiracetam [ep monograph]
levetiracetam [ep impurity]
levetiracetam [hsdb]
levetiracetam [usp impurity]
levetiracetam [jan]
levetiracetam [mart.]
S1356
gtpl6826
bdbm50422542
CS-1854
HY-B0106
MLS006010215
SCHEMBL118843
NC00178
STL388027
KS-1176
(s)-2-(2-oxopyrrolidin-1-yl)butyramide
HPHUVLMMVZITSG-LURJTMIESA-N
AB00639945-06
NCGC00261520-01
tox21_500835
(s)-2-(2-oxopyrrolidin-1-yl) butyramide
Q-201292
(2s)-(2-oxopyrrolidin-1-yl)butyramide
(s)-2-(2-oxo-pyrrolidin-1-yl)-butyramide
AB00639945_07
AB00639945_08
mfcd03265610
DTXSID9023207 ,
levetiracetam, analytical standard
sr-01000759400
SR-01000759400-4
SR-01000759400-5
levetiracetam, united states pharmacopeia (usp) reference standard
levitiracetam, pharmaceutical secondary standard; certified reference material
levetiracetam, european pharmacopoeia (ep) reference standard
levetiracetam, >=98% (hplc)
levetiracetam 1.0 mg/ml in methanol
HMS3713P16
SW197558-3
BCP11856
SDCCGSBI-0633760.P001
NCGC00186028-13
HMS3884O11
s-isomer etiracetam
etiracetam, s isomer
(-)-(s)-alpha-ethyl-2-oxo-1-pyrrolidineacetamide (2s)-2-(2-oxo-pyrrolidin-1-yl)butanamide
EN300-244575
levetiracetam- bio-x
BL164623
Z1255435426
levetiracetam (usp monograph)
levetiracetam (usp impurity)
roweepra
levetiracetamlevetiracetam
(2s)-2-(2-oxopyrrolidine-1-yl)butyramide
elepsia xr 1000 mg
1-pyrrolidineacetamide, alpha-ethyl-2-oxo-,(s)-
levetiracetam (usan:usp:inn:ban)
levetiracetam (ep impurity)
elepsia xr 1500 mg
levetiracetam extended release
levetiracetamum (inn-latin)
levetiracetam injection
keppraxr
dtxcid503207
levertiracetam
etiracetam|levetiracetam
levetiracetam (ep monograph)
levetiracetam (mart.)
levetiracetamextended-release
levetiracetamer
levetiracetam er
levetiracetam (usp-rs)
levetiracetam, 1mg/ml in methanol

Research Excerpts

Overview

Levetiracetam is an anticonvulsant with a low side effect profile and favorable properties for individuals with bipolar I disorder during their manic phase. Levetiraceta is an anti-epileptic drug (AED) that sensitizes glioblastoma (GBM) to temozolomide (TMZ) chemotherapy by inhibiting O.

ExcerptReferenceRelevance
"Levetiracetam (LEV) is a broad-spectrum antiepileptic drug with neuroprotective properties and novel mechanisms of action. "( Levetiracetam promoted rat embryonic neurogenesis via NMDA receptor-mediated mechanism in vitro.
Alavi, MS; Ghorbani, A; Hosseini, A; Negah, SS; Sadeghnia, HR, 2021
)
3.51
"Levetiracetam is an antiepileptic drug that is primarily approved by the Food and Drug Administration for the treatment of focal and generalized seizures. "( Development and validation of a liquid chromatography-tandem mass spectrometry method with triple-stage fragmentation to determine levetiracetam in epileptic patient serum and its application in therapeutic drug monitoring.
Huang, J; Ji, Z; Jiang, Y; Li, Y; Lin, L; Liu, L; Yang, X; Yin, L, 2021
)
2.27
"Levetiracetam is an anticonvulsive drug increasingly used in paediatric populations. "( Levetiracetam pharmacokinetics and its covariates: proposal for optimal dosing in the paediatric population.
Pokorná, P; Šíma, M; Slanař, O; Švestková, N, 2023
)
3.8
"Levetiracetam (LEV) is a broad-spectrum and widely used antiepileptic drug that also has neuroprotective effects in different neurological conditions. "( Real-Time Monitoring of Levetiracetam Effect on the Electrophysiology of an Heterogenous Human iPSC-Derived Neuronal Cell Culture Using Microelectrode Array Technology.
Bonanni, L; Di Baldassarre, A; Di Credico, A; Ferri, L; Gaggi, G; Ghinassi, B; Iannetti, G; Izzicupo, P, 2021
)
2.37
"Levetiracetam is an anticonvulsant with a low side effect profile and favorable properties for individuals with bipolar I disorder during their manic phase. "( Levetiracetam as an Adjunctive Treatment for Mania: A Double-Blind, Randomized, Placebo-Controlled Trial.
Ahmadpanah, M; Brand, S; Brühl, AB; Jahangard, L; Keshavarzi, A; Sharifi, A; Soltanian, A, 2022
)
3.61
"Levetiracetam (LEV) is an anti-epileptic drug (AED) that sensitizes glioblastoma (GBM) to temozolomide (TMZ) chemotherapy by inhibiting O"( The effect of levetiracetam treatment on survival in patients with glioblastoma: a systematic review and meta-analysis.
Chen, ES; Chen, JS; Clarke, R; Haddad, AF; Lacroix, M; Sarkar, IN; Toms, SA; Wang, EJ; Zand, R, 2022
)
2.52
"Levetiracetam (LEV) is a newer antiepileptic drug that is commonly used to treat certain types of seizures."( Beneficial effects of levetiracetam in streptozotocin-induced rat model of Alzheimer's disease.
Alavi, MS; Fanoudi, S; Hosseini, M; Sadeghnia, HR, 2022
)
1.76
"Levetiracetam (LEV) is an antiseizure medication prescribed to women during childbearing age. "( Effect of levetiracetam on the gene expression of placental transporters in a murine model.
Blanco-Castañeda, R; Enríquez-Mendiola, D; Galaviz-Hernández, C; Lares-Asseff, I; Lazalde-Ramos, BP; Martínez, G; Sosa-Macías, M; Zapata-Vázquez, Y, 2022
)
2.57
"Levetiracetam (LEV) is an effective antiseizure medicine, but 10%-20% of people treated with LEV report psychiatric side-effects, and up to 1% may have psychotic episodes. "( A pharmacogenomic assessment of psychiatric adverse drug reactions to levetiracetam.
Berkovic, SF; Bobbili, D; Campbell, C; Cavalleri, GL; Cotter, D; Delanty, N; Depondt, C; Doherty, CP; Goldstein, DB; Heinzen, EL; Koeleman, BP; Krause, R; Kunz, WS; Lerche, H; McCormack, M; O'Brien, T; Patel, S; Sander, JW; Scheffer, IE; Sills, GJ; Sisodiya, SM; Stapleton, C; Stefansson, H; Stefansson, K; Striano, P; Zara, F, 2022
)
2.4
"Levetiracetam is a frequent treatment choice in these situations."( The safety of rapid infusion levetiracetam: A systematic review.
Douville, A; Jense, A; Weiss, A, 2022
)
1.73
"Levetiracetam (LEV) is a novel antiepileptic drug with a unique anticonvulsive mechanism of action. "( Effect of levetiracetam on nocturnal sleep in patients with epilepsy.
Chaneva, OG; Viteva, EI, 2022
)
2.57
"Levetiracetam (LEV) is an anti-seizure drug (ASD). "( Relationship between bone density and levetiracetam monotherapy in epilepsy patients.
Aydın, Z; Gözükızıl, ST; Yalçın, AD, 2022
)
2.44
"Levetiracetam (LEV) is a second-generation ASD with a novel SV2A protein target and is indicated for treating focal epilepsies."( Differential effects of levetiracetam on hippocampal CA1 synaptic plasticity and molecular changes in the dentate gyrus in epileptic rats.
Kutty, BM; Nair, KP; Salaka, RJ; Sasibhushana, RB; Shankaranarayana Rao, BS; Srikumar, BN; Udayakumar, D, 2022
)
1.75
"Levetiracetam (LEV) is an anti-seizure medication (ASM) known to have significant behavioral side effects in children with epilepsy. "( Vitamin B6 decreases the risk of levetiracetam discontinuation in children with epilepsy: A retrospective study.
Bartolini, L; Bassell-Hawkins, J; Lob, K; Nie, D; Patil, R, 2022
)
2.45
"Levetiracetam is a new generation antiseizure medication which binds to synaptic vesicle protein SV2A and inhibits the release of neurotransmitters. "( Levetiracetam-induced gingival hyperplasia.
Gafoor, VA; James, J; Jose, J,
)
3.02
"Levetiracetam is a new generation anticonvulsant used to treat both focal and generalized epilepsy."( Effects of levetiracetam on sleep architecture and daytime sleepiness.
Chaneva, O, 2021
)
1.73
"Levetiracetam is a newer second-generation anticonvulsant for the treatment of generalized and partial seizure disorders. "( Levetiracetam poisoning with acute kidney injury treated with hemodialysis: A case report.
Hirose, Y; Mizouchi, N; Sedogawa, H; Shimagaki, S; Watanabe, N; Yamaguchi, H, 2022
)
3.61
"Levetiracetam is a broad-spectrum antiseizure medication with known behavioral side effects. "( Pyridoxine for treatment of levetiracetam-induced behavioral adverse events: A randomized double-blind placebo-controlled trial.
Alizadeh-Navaei, R; Asghari, F; Cheraghmakani, H; Ghazaeian, M; Rezapour, M; Tabrizi, N, 2022
)
2.46
"Levetiracetam (LEV) is an antiseizure medication (ASM) whose mechanism of action involves the modulation of neurotransmitters release through binding to the synaptic vesicle glycoprotein 2A. "( Levetiracetam, from broad-spectrum use to precision prescription: A narrative review and expert opinion.
Aledo-Serrano, Á; Beltran-Corbellini, Á; Celdran de Castro, A; Garcia-Morales, I; Gil-Nagel, A; Nascimento, FA; Toledano, R, 2023
)
3.8
"Levetiracetam (Lev) is an antiepileptic drug that has been increasingly used in the epilepsy pediatric population in recent years, but its pharmacokinetic behavior in pediatric population needs to be characterized clearly. "( Development and Validation of Physiologically Based Pharmacokinetic Model of Levetiracetam to Predict Exposure and Dose Optimization in Pediatrics.
Geng, K; Shao, W; Shen, C; Sun, H; Wang, W; Wang, X; Xie, H, 2023
)
2.58
"Levetiracetam is an antiepileptic drug with anti-inflammatory and antioxidant effects."( Levetiracetam attenuates experimental ulcerative colitis through promoting Nrf2/HO-1 antioxidant and inhibiting NF-κB, proinflammatory cytokines and iNOS/NO pathways.
Amirshahrokhi, K; Imani, M, 2023
)
3.07
"Levetiracetam is a commonly used anti-seizure medication, with the development of neuropsychiatric symptoms being the most common side effect. "( Can Pyridoxine Successfully Reduce Behavioral Side Effects from Levetiracetam?: A Critically Appraised Topic.
Chhabra, N; Hoerth, MT; O'Carroll, CB; Sanchez, CV; Vanood, A, 2023
)
2.59
"Levetiracetam (LEV) is an anti-epileptic drug approved for use in various populations. "( Physiologically based pharmacokinetic modeling of levetiracetam to predict the exposure in hepatic and renal impairment and elderly populations.
Geng, K; Shao, W; Shen, C; Sun, H; Wang, W; Wang, X; Xie, H, 2023
)
2.61
"Levetiracetam appears to be a safe and effective medication for PTS prophylaxis in combat casualties. "( Use of Levetiracetam for Post-Traumatic Seizure Prophylaxis in Combat-Related Traumatic Brain Injury.
Atwood, R; Bradley, M; Elster, E; Walker, P; Walper, D, 2023
)
2.81
"Levetiracetam (LEV) is an anticonvulsant for epilepsy. "( Assessment of the toxic effects of levetiracetam on biochemical, functional, and redox parameters of salivary glands in male Wistar rats.
Antoniali, C; Chaves-Neto, AH; da Silva, LGL; de Freitas, RN; Dornelles, RCM; Fakhouri, WD; Ferreira, DSB; Fiais, GA; Kawaguchi, M; Nakamune, ACMS; Teixeira, GR; Veras, ASC, 2023
)
2.63
"Levetiracetam (LEV) is a first-line ASM with a stronger association with neuropsychiatric symptoms for PwID than other ASMs."( Rapid switching from levetiracetam to brivaracetam in pharmaco-resistant epilepsy in people with and without intellectual disabilities: a naturalistic case control study.
Allgar, V; Bright, C; Dunstall, H; Harding, K; John, K; Laugharne, R; Lawthom, C; McLean, B; Moon, S; Musicha, C; Pape, SE; Richings, C; Shankar, R; Thomas, RH; Watkins, LV; Winterhalder, R, 2023
)
1.95
"Levetiracetam is an antiepileptic drug with good tolerability that is used for focal and generalized epilepsy as well as acute treatment of status epilepticus; it is also a first-line antiepileptic drug for patients with concomitant medical conditions. "( Efficacy and safety of levetiracetam in Japanese epilepsy patients: A retrospective cohort study.
Rikitake, Y; Sekimoto, H, 2019
)
2.27
"Levetiracetam is a broad-spectrum antiseizure agent and one of the most commonly prescribed drugs for epilepsy. "( Biochemical and histological study on the effect of levetiracetam on the liver and kidney of pregnant albino rats.
Arafa, MAA; Hanafy, SM; Sabbah, WS, 2019
)
2.21
"Levetiracetam is an attractive choice of antiepileptic medication because of relatively fewer drug interactions and may be administered through the subcutaneous route."( Levetiracetam at the End of Life: A Case Report and Discussion.
Clark, K; Mohamudally, A, 2020
)
2.72
"Levetiracetam is a feasible option for preventing busulfan-induced seizures."( Comparison of clonazepam and levetiracetam in children for prevention of busulfan-induced seizure in hematopoietic stem cell transplantation.
Deguchi, T; Kato, M; Kiyotani, C; Matsumoto, K; Osumi, T; Shioda, Y; Shirai, R; Terashima, K; Tomizawa, D; Tsujimoto, SI; Uchiyama, T; Utano, T, 2020
)
1.57
"Levetiracetam is an effective therapy for females with PCDH19-GCE and should be considered early in the management of the highly refractory clusters of seizures that characterise this genetic disease."( Levetiracetam efficacy in PCDH19 Girls Clustering Epilepsy.
Dale, RC; Gecz, J; King, C; Kolc, KL; Mefford, HC; Sadleir, LG; Scheffer, IE, 2020
)
2.72
"Levetiracetam is a safe, effective and well tolerated antiseizure drug with good results in epileptic patients."( Oral levetiracetam for prevention of busulfan-induced seizures in adult hematopoietic cell transplant.
Aguilera-Jiménez, V; Chaguaceda, C; Gutierrez, G; Riu, G; Roura, J, 2020
)
1.79
"Levetiracetam (LEV) is an antiepileptic drug with a novel pharmacological mechanism. "( Alterations in intra- and internetwork functional connectivity associated with levetiracetam treatment in temporal lobe epilepsy.
Liang, XL; Liu, JP; Pang, XM; Zhang, Z; Zheng, JO; Zhou, X, 2020
)
2.23
"Levetiracetam (LEV) is a widely prescribed antiepileptic drug, but its actions on neuronal function are not fully characterized. "( Effects of levetiracetam on axon excitability and synaptic transmission at the crayfish neuromuscular junction.
Alshuaib, S; Lin, JW; Mosaddeghi, J, 2020
)
2.39
"Levetiracetam is an antiepileptic drug for the treatment of psychiatric patients. "( Determination of levetiracetam in human plasma by online heart-cutting liquid chromatography: Application to therapeutic drug monitoring.
Kul, A; Önal, C; Ozdemir, M; Sagirli, O, 2020
)
2.34
"Levetiracetam is a relatively newer AED with favorable pharmacokinetics and could be an effective and safer option for the treatment of convulsive status epilepticus (CSE)."( Efficacy and safety profile of intravenous levetiracetam versus phenytoin in convulsive status epilepticus and acute repetitive seizures in children.
Besli, GE; Yilmaz, S; Yuksel Karatoprak, E, 2020
)
1.54
"Levetiracetam (LEV) is a newer anti-epileptic drug with neuroprotective property and has been used in adults and pediatric patient but its use in neonates have very limited experience."( Efficacy of Levetiracetam in neonatal seizures: a systematic review.
Hussain, AM; Sharma, D; Sharma, SS, 2022
)
1.82
"Levetiracetam (LEV) is a second-generation antiepileptic drug with high efficacy and tolerability in children and adults with epilepsy. "( Levetiracetam monotherapy in children with epilepsy: Experience from a tertiary pediatric neurology center.
Akıncı Göktaş, Ö; Bektaş, Ö; Şahin, S; Tıraş Teber, S; Yıldırım, M; Yüksel, MF, 2021
)
3.51
"Levetiracetam is a relatively new-generation antiseizure drug approved for the treatment of focal and generalized seizures. "( Amelioration of Levetiracetam-Induced Behavioral Side Effects by Pyridoxine. A Randomized Double Blind Controlled Study.
Al Enazi, S; Al Otaibi, A; Al Wadei, A; Benini, R; Jad, L; Lubbad, N; Mahmoud, A; Tabassum, S, 2021
)
2.41
"Levetiracetam is a broad-spectrum antiepileptic drug that exhibits high interindividual variability in serum concentrations in children. "( Predictive Performance of Population Pharmacokinetic Models of Levetiracetam in Children and Evaluation of Dosing Regimen.
Benaboud, S; Billette de Villemeur, T; Bouazza, N; Boujaafar, S; Chemaly, N; Chenevier-Gobeaux, C; Desguerre, I; Freihuber, C; Gana, I; Hirt, D; Lui, G; Nabbout, R; Tauzin, M; Tréluyer, JM; Zheng, Y, 2021
)
2.3
"Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs."( Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy.
Carbone, EQ; Cardoso, RA; Herrera, R; Kowacs, PA; Lacerda, GCB; Lin, K; Manreza, MLG; Morais, DC; Nakano, FN; Palmini, ALF; Pan, TA; Souza, AMMH; Vattimo, ACA; Yacubian, EMT; Zung, S, 2021
)
1.65
"Levetiracetam (LEV) is an urgent control antiepileptic medication that offers relative lack of adverse effects and ease of monitoring."( Rapid administration of undiluted intravenous levetiracetam.
Bonnin, S; Haller, JT; Radosevich, J, 2021
)
1.6
"Levetiracetam (LEV) is a second-generation antiseizure medicine (ASM) with broad-spectrum efficacy and tolerability. "( Initial levetiracetam versus valproate monotherapy in antiseizure medicine (ASM)-naïve pediatric patients with idiopathic generalized epilepsy with tonic-clonic seizures.
Abdelmesih, SK; Elkhateeb, N; Girgis, MY; Zakaria, M, 2021
)
2.5
"Levetiracetam is an increasingly used new non-aromatic antiepileptic drug and reported to have a better safety profile in daily practice. "( Anaphylaxis to levetiracetam in an adolescent: a very rare occurence.
Arhan, E; Bakırtaş, A; Değermenci, Ş; Ertoy-Karagöl, Hİ; Güleryüz, OD; Kahraman, Ş; Menderes, D; Oktay, MA, 2021
)
2.42
"Levetiracetam (LEV) is an antiepileptic recommended during pregnancy. "( Levetiracetam exposure during prenatal and postnatal period induces cognitive decline in rat offsprings, not completely prevented by
Blossom, V; Devadasa Acharya, S; Noushida, N; Parida, A; Ullal, SD, 2022
)
3.61
"Levetiracetam is a broad-spectrum antiepileptic drug (AED) with a unique mechanism of action. "( Levetiracetam Clinical Pharmacokinetic Monitoring in Pediatric Patients with Epilepsy.
Ensom, MHH; Levine, M; Paquette, V; Tan, J, 2017
)
3.34
"Levetiracetam (LEV) is an antiepileptic drug commonly used in the treatment of epilepsy because of its excellent safety profile in all age groups. "( Reproductive toxicity after levetiracetam administration in male rats: Evidence for role of hormonal status and oxidative stress.
Atli, O; Baysal, M; Ilgin, S; Kilic, G; Kilic, V; Ucarcan, S, 2017
)
2.19
"Levetiracetam (LEV) is a novel anticonvulsant effective against varied seizures."( Intravenous levetiracetam vs phenytoin for status epilepticus and cluster seizures: A prospective, randomized study.
Al-Amrani, K; Al-Asmi, A; Al-Hashim, A; Ganguly, SS; Gujjar, AR; Jacob, PC; Nandhagopal, R, 2017
)
1.56
"Levetiracetam is an active, water-soluble S-enantiomer of racemic pyrrolidine acetamide which exerts its antiepileptic action by binding to the synaptic vesicle protein within the brain. "( A Review on Pharmacokinetics of Levetiracetam in Neonates.
Agrawal, A; Banergee, A, 2017
)
2.18
"Levetiracetam is an antiepileptic drug that has been used both as adjunctive therapy and monotherapy in pediatric patients with epilepsy. "( Can High-Dose Levetiracetam Be Safe? A Case Report of Prolonged Accidental High-Dose Levetiracetam Administration and Review of the Literature.
Kartal, A,
)
1.93
"Levetiracetam (LVT) is a relatively novel antiepileptic drug (AED) known to act through binding with the synaptic vesicular 2A (SV2A) protein, thus modulating the presynaptic neurotransmitter release. "( The Antiepileptic Drug Levetiracetam Protects Against Quinolinic Acid-Induced Toxicity in the Rat Striatum.
Aguilera, G; Colín-González, AL; Dircio-Bautista, M; Galván-Arzate, S; García, E; Maya-López, M; Santamaría, A; Túnez, I; Villeda-Hernández, J, 2018
)
2.23
"Levetiracetam (LEV) is a newer AED not approved for neonates."( A Systematic Review of the Efficacy of Levetiracetam in Neonatal Seizures.
Lancaster, S; Manganas, LN; McHugh, DC, 2018
)
1.47
"Levetiracetam (LEV) is a second-generation antiepileptic drug approved for the treatment of several types of epilepsy. "( B cell aplasia and hypogammaglobulinemia associated with levetiracetam.
Akdemir, G; Artac, H; Caliskaner, AZ; Karabagli, H; Ozdemir, H; Sumer, S,
)
1.82
"Levetiracetam (LEV) is a second generation AED, widely used in patients with epilepsy because of its favorable safety and efficacy profiles."( Efficacy and tolerability of perampanel and levetiracetam as first add-on therapy in patients with epilepsy: A retrospective single center study.
D'Elia, A; Fabio, P; Izzi, F; Liguori, C; Manfredi, N; Mari, L; Mercuri, NB, 2018
)
1.46
"Levetiracetam (LEV) is a recognized first-line AED with good seizure outcomes but recognized with PBSEs."( Eslicarbazepine acetate as a replacement for levetiracetam in people with epilepsy developing behavioral adverse events.
Ahmed, A; Henley, W; Jalihal, V; McLean, BN; Parrett, M; Sander, JW; Shankar, R; Tittensor, P, 2018
)
1.46
"Levetiracetam is a broad-spectrum anti-epileptic drug that is effective against both focal and generalized epilepsies. "( Levetiracetam monotherapy for the treatment of infants with epilepsy.
Arican, P; Cavusoglu, D; Gencpinar, P; Olgac Dundar, N, 2018
)
3.37
"Levetiracetam (LEV) is a novel anticonvulsant with proven antinociceptive properties. "( Antinociceptive and pronociceptive effect of levetiracetam in tonic pain model.
Alfaro-Rodriguez, A; Bandala, C; Bonilla-Jaime, H; Carrillo-Mora, P; Cortes-Altamirano, JL; Olmos-Hernández, A; Reyes-Long, S, 2018
)
2.18
"Levetiracetam (LEV) is an antiepileptic drug which has good safety and efficacy in neonatal seizure (NS), a common incident in neonates with weight <1500 g. "( Determination of plasma Levetiracetam level by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS-MS) and its application in pharmacokinetics studies in neonates.
Horsuwan, S; Jenjirattithigarn, N; Khongkhatithum, C; Prempunpong, C; Prommas, S; Puangpetch, A; Sukasem, C; Thampratankul, L; Visudtibhan, A; Worachat, N, 2018
)
2.23
"Levetiracetam (LEV) is a relatively new and wide spectrum anti-seizure medication with favorable pharmacokinetics and safety profile."( Efficacy of levetiracetam for neonatal seizures in preterm infants.
Han, JY; Lee, IG; Moon, CJ; Sung, IK; Youn, YA, 2018
)
1.58
"Levetiracetam is an antiepileptic drug that has the potential to be beneficial for migraine prophylaxis."( Efficacy and safety of levetiracetam for migraine prophylaxis: A systematic review.
Brown, JN; Gee, ME; Watkins, AK, 2018
)
1.51
"Levetiracetam (LEV) is a second-generation antiepileptic drug extensively used in therapeutics. "( Influence of Sex, Age, and Weight on Levetiracetam Pharmacokinetics.
Aldaz, A; Alzueta, N; Ortega, A, 2018
)
2.2
"Levetiracetam (LEV) is a broad spectrum antiepileptic drug (AED) that has a more favorable side effect profile compared to older AEDs. "( Therapeutic Drug Monitoring of Levetiracetam in Select Populations.
Jarvie, D; Mahmoud, SH,
)
1.86
"Levetiracetam (LEV) is a broad spectrum AED with a possible anti-inflammatory effect."( The effect of serum levetiracetam concentrations on therapeutic response and IL1-beta concentration in patients with epilepsy.
Gulcebi, MI; Kendirli, T; Onat Yilmaz, F; Patsalos, PN; Turgan, ZA, 2018
)
1.53
"Levetiracetam (LEV) is an anti-epileptic drug with demonstrated efficacy against generalized seizures. "( Levetiracetam inhibits endocytosis and augments short-term depression.
, 2018
)
3.37
"Levetiracetam (LEV) is a pyrrolidine derivative antiepileptic medication used for the treatment of seizures in pediatric and adult patients. "( A Rare Case of Levetiracetam and Drug-Induced Idiopathic Aseptic Meningitis in a Pediatric Patient.
McDonald, D; Siu, A; Sultan, R; Viswanathan, A, 2019
)
2.31
"Levetiracetam (LEV) is an emerging and promising antiepileptic drug (AED)."( Levetiracetam optimal dose-finding as first-line treatment for neonatal seizures occurring in the context of hypoxic-ischaemic encephalopathy (LEVNEONAT-1): study protocol of a phase II trial.
Boivin, E; Favrais, G; Jullien, V; Mouchel, C; Saliba, E; Ursino, M; Zohar, S, 2019
)
2.68
"Levetiracetam (LEV) is an AED that is neuroprotective in various neurologic disorders."( Levetiracetam administration is correlated with lower mortality in patients with mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes: a retrospective study.
Bao, XH; Wang, ZX; Xiong, H; Yuan, Y; Zhang, X; Zhang, Z; Zhao, DH; Zhao, XT, 2019
)
2.68
"Levetiracetam is a commonly used antiepileptic drug, yet psychiatric adverse effects are common and may lead to treatment discontinuation."( Prediction Tools for Psychiatric Adverse Effects After Levetiracetam Prescription.
Agha-Khani, Y; Engbers, JDT; Federico, P; Jette, N; Josephson, CB; Mackie, A; Macrodimitris, S; Marshall, D; McLane, B; Patten, SB; Pillay, N; Sajobi, TT; Sharma, R; Singh, S; Wiebe, S, 2019
)
2.2
"Levetiracetam is an antiepileptic agent that is used for partial and generalized epilepsy. "( Levetiracetam-Related Mania-Like Symptoms: An Adolescent Case.
Direk, MÇ; Ekinci, N; Ekinci, Ö; Güneş, S; Kalinli, M; Okuyaz, Ç,
)
3.02
"Levetiracetam (LEV) is an antiepileptic drug used widely in patients with a favorable safety profile. "( Safety and Tolerability of Rapid Administration Undiluted Levetiracetam.
Medenwald, B; Morgan, O, 2020
)
2.25
"Levetiracetam (LEV) is a second-generation AED widely used in elderly patients with epilepsy while lacosamide (LCM), which has been recently approved in European Union (EU) as monotherapy for the treatment of focal onset seizures, is affected by a scarcity of data in such frail population."( Long-term efficacy and safety of lacosamide and levetiracetam monotherapy in elderly patients with focal epilepsy: A retrospective study.
Del Bianco, C; Izzi, F; Liguori, C; Mari, L; Mercuri, NB; Ornello, R; Pisani, A; Placidi, F; Ulivi, M, 2019
)
1.49
"Levetiracetam is a broad-spectrum anti-seizure drug that has been suggested to be effective in reducing adult migraine episodes."( Levetiracetam for prophylactic treatment of pediatric migraine: A randomized double-blind placebo-controlled trial.
Agah, E; Amanat, M; Ashrafi, MR; Badv, RS; Dehghani, M; Heidari, M; Hosseini, SA; Mohammadi, M; Montazerlotfelahi, H; Salehi, M; Sander, JW; Tavasoli, AR; Zamani, GR, 2019
)
2.68
"Levetiracetam is a commonly used broad-spectrum anticonvulsant efficacious in both partial and generalized seizures. "( Asymptomatic elevation of liver enzymes due to levetiracetam: a case report.
Arsura, E; Cukierwar, F; Sethi, NK; Sethi, PK; Torgovnick, J, 2013
)
2.09
"Levetiracetam (LEV) is a newer type of antiepileptic drug."( Effects of levetiracetam on μ rhythm in persons with epilepsy.
Chen, CW; Hwang, JC; Ju, MS; Lin, CC; Tsai, JJ, 2013
)
1.5
"Levetiracetam (LEV) is an alternative; however, no published data validate comparable efficacy."( Changing trends in the use of seizure prophylaxis after traumatic brain injury: a shift from phenytoin to levetiracetam.
Goodwin, H; Harris, LH; Haut, ER; Kornbluth, J; Kruer, RM; Slater, LA; Thomas, KP, 2013
)
1.32
"Levetiracetam is a second-generation anticonvulsant that was approved by the Federal Drug Administration in 1999 for the treatment of epilepsy. "( Levetiracetam: an unusual cause of delirium.
Hwang, ES; Patel, R; Sen, S; Siemianowski, LA,
)
3.02
"  Levetiracetam [E Keppra(®)] is a second generation antiepileptic drug for different types of epilepsy in adults and children ≥1 month. "( Development of an integrated population pharmacokinetic model for oral levetiracetam in populations of various ages and ethnicities.
Lacroix, BD; Toublanc, N; Yamamoto, J, 2014
)
1.36
"Levetiracetam is a novel anticonvulsant with antihyperalgesic efficacy in inflammatory pain. "( Levetiracetam interacts synergistically with nonsteroidal analgesics and caffeine to produce antihyperalgesia in rats.
Micov, AM; Stepanović-Petrović, RM; Tomić, MA, 2013
)
3.28
"Levetiracetam (LEV) is an antiepileptic drug with a unique but as yet not fully resolved mechanism of action. "( Inhibition of excitatory synaptic transmission in hippocampal neurons by levetiracetam involves Zn²⁺-dependent GABA type A receptor-mediated presynaptic modulation.
Akaike, N; Kogure, K; Kotani, N; Wakita, M, 2014
)
2.08
"Levetiracetam is a reasonable alternative to (fos)phenytoin for prophylaxis of early posthemorrhagic seizures. "( Levetiracetam versus (fos)phenytoin for seizure prophylaxis in pediatric patients with intracranial hemorrhage.
Bansal, S; Blalock, D; Carpenter, JL; Dean, NP; Kebede, T, 2014
)
3.29
"Levetiracetam is a new-generation antiepileptic drug that has begun to be used in the treatment of epilepsy."( Neuroprotective effect of levetiracetam on hypoxic ischemic brain injury in neonatal rats.
Balci, S; Beydagi, H; Celik, Y; Erdogan, S; Komur, M; Okuyaz, C; Polat, A; Resitoglu, B; Tamer, L, 2014
)
1.42
"Levetiracetam is a frequently used drug in the therapy of partial onset, myoclonic and generalized tonic-clonic seizures. "( A missed opportunity - consequences of unknown levetiracepam pharmacokinetics in a peritoneal dialysis patient.
Bahte, SK; Hiss, M; Kielstein, JT; Lichtinghagen, R, 2014
)
1.85
"Levetiracetam is an antiepileptic medication that has been reported to be both well-tolerated and effective in treating generalized tonic-clonic, myoclonic, and partial-onset seizures. "( Levetiracetam as a possible contributor to acute kidney injury.
Hohler, AD; Montouris, GD; Spengler, DC, 2014
)
3.29
"Levetiracetam is a widely used drug that has been reported to be generally tolerable and effective; however, it has the potential to negatively affect renal function. "( Levetiracetam as a possible contributor to acute kidney injury.
Hohler, AD; Montouris, GD; Spengler, DC, 2014
)
3.29
"Levetiracetam is an antiepileptic medication that has an unknown mechanism of action."( Rare Red Rashes: A Case Report of Levetiracetam-Induced Cutaneous Reaction and Review of the Literature.
Evans, W; Jones, RT; Kavanaugh, K; Mersfelder, TL,
)
1.13
"Levetiracetam is a new anticonvulsant, which works to block high-voltage-activated Ca(++) channels in children, for partial-onset seizures. "( An 11-year review of levetiracetam ingestions in children less than 6 years of age.
Albertson, TE; Lewis, JC; Walsh, MJ, 2014
)
2.16
"Levetiracetam (LEV) is a relatively newer antiepileptic drug with novel mechanism of action. "( Levetiracetam induced acute reversible psychosis in a patient with uncontrolled seizures.
Chakraborty, A; Chandran, S; Kumar, N; Swaroop, HS,
)
3.02
"Levetiracetam (Lev) is a new antiepileptic drugs, proved to be effective and tolerance in regulatory trials, but these controlled trials do not always predict how useful a drug will be in day to day clinical practice, Retention rates can provide a better indication of efficacy and tolerability in everyday use."( Retention rates of levetiraceram in Chinese children and adolescents with epilepsy.
Chen, YX; Feng, XF; Liu, L; Xiao, N, 2015
)
1.86
"Levetiracetam is a new-generation antiepileptic drug initially approved as an adjunctive treatment for patients with refractory partial seizures and is now also used as a monotherapy. "( Genotoxic effects of prenatal exposure to levetiracetam during pregnancy on rat offsprings.
Elbistan, M; Kara, N; Karakuş, N; Ozyurek, H; Tekcan, A; Tural, S,
)
1.84
"Levetiracetam is an antiepileptic drug with analgesic efficacy shown in pain models and small clinical trials. "( The effects of levetiracetam, sumatriptan, and caffeine in a rat model of trigeminal pain: interactions in 2-component combinations.
Micov, AM; Pecikoza, UB; Popović, BV; Stepanović-Petrović, RM; Tomić, MA, 2015
)
2.21
"Levetiracetam (LEV) is a common add-on antiepileptic drug (AED) in dogs with refractory seizures. "( Effect of chronic administration of phenobarbital, or bromide, on pharmacokinetics of levetiracetam in dogs with epilepsy.
Muñana, KR; Nettifee-Osborne, JA; Papich, MG,
)
1.8
"Levetiracetam is a broad spectrum antiepileptic drug (AED) with proven efficacy when used as adjunctive therapy against myoclonic seizures. "( Paradoxical exacerbation of myoclonic-astatic seizures by levetiracetam in myoclonic astatic epilepsy.
Beydoun, A; Fawaz, A; Hmaimess, G; Makke, Y; Nasreddine, W, 2015
)
2.1
"Levetiracetam (LEV) is a unique, effective, relatively safe antiepileptic drug that preferentially interacts with synaptic vesicle protein 2A (SV2A). "( Omega 3 polyunsaturated fatty acids enhance the protective effect of levetiracetam against seizures, cognitive impairment and hippocampal oxidative DNA damage in young kindled rats.
Abdel-Wahab, BA; Habeeb, SM; Khateeb, MM; Shaikh, IA, 2015
)
2.09
"Levetiracetam is a first-line therapy for seizures in critically ill patients because of its clinical efficacy, minimal drug interactions, and wide therapeutic window. "( Levetiracetam Pharmacokinetics in a Patient Receiving Continuous Venovenous Hemofiltration and Venoarterial Extracorporeal Membrane Oxygenation.
Frazee, EN; Kashani, KB; Nei, SD; Wittwer, ED, 2015
)
3.3
"Levetiracetam is a homologue of piracetam with an a-ethyl side-chain substitution and it is a Food and Drug Administration (FDA) approved antiepileptic drug. "( Levetiracetam might act as an efficacious drug to attenuate cognitive deficits of Alzheimer's disease.
Xiao, R, 2016
)
3.32
"Levetiracetam is an anticonvulsant used for control of canine epilepsy. "( Disposition of Extended Release Levetiracetam in Normal Healthy Dogs After Single Oral Dosing.
Beasley, MJ; Boothe, DM,
)
1.86
"Levetiracetam is a new drug that has been approved in the treatment of partial seizures."( The Effect of Levetiracetam on Closure of the Midline in Early Chicken Embryos.
Armagan, E; Bozkurt, M; Eroglu, U; Kahilogullari, G; Ozgural, O; Unlu, A, 2015
)
1.5
"Levetiracetam is a commonly used antiepileptic medication for tumor-related epilepsy. "( A Pilot Chemical and Physical Stability Study of Extemporaneously Compounded Levetiracetam Intravenous Solution.
Hughes, SE; Juba, KM; Raphael, CD; Zhao, F, 2015
)
2.09
"Levetiracetam (LEV) is an antiepileptic agent targeting novel pathways. "( Levetiracetam Treatment in Traumatic Brain Injury: Operation Brain Trauma Therapy.
Bramlett, HM; Browning, M; Dietrich, WD; Dixon, CE; Hayes, RL; Kochanek, PM; Mondello, S; Poloyac, SM; Povlishock, JT; Schmid, KE; Shear, DA; Tortella, FC; Wang, KK, 2016
)
3.32
"Levetiracetam (LEV) is a broad-spectrum antiepileptic drug that has been used in both partial and generalized seizures and less commonly adverse effects including psychiatric and behavioral problems."( Levetiracetam: Probably Associated Diurnal Frequent Urination.
Hu, LY; Ju, J; Pang, LY; Shi, XY; Zou, LP,
)
2.3
"Levetiracetam is a drug whose effectiveness and safety is well established and is available in different oral formulations (granulates in sachets, tablets, oral solution), but information on treatment adherence/compliance with these oral formulations is limited."( [Treatment adherence with levetiracetam: a non-interventionist retrospective observation-based study].
Garcia, A; Garcia-Garcia, P; Mauri-Llerda, JA; Pardo-Merino, A; Rocamora, R; Serrano-Castro, PJ, 2016
)
1.46
"Levetiracetam is a new generation antiepileptic drug used in treatment of patients with epilepsy and has adverse effects on different tissues. "( Evaluation of apoptotic cell death on liver and kidney tissues following administration of levetiracetam during prenatal period.
Ayas, B; Elbistan, M; Guvenc, T; Kara, N; Tekcan, A; Tural, S, 2017
)
2.12
"Levetiracetam is a relatively novel antiepileptic drug used for the treatment of partial and generalized seizures in adult and children. "( Osteochondral alteration in a child treated with levetiracetam: a rare case of juvenile osteochondritis dissecans of the talar head.
Afonso, D; Bigoni, M; Glard, Y; Griffet, J; Turati, M, 2017
)
2.15
"Levetiracetam (LEV) is a novel anti-epileptic drug (AED) used to treat partial seizures and idiopathic generalized epilepsy."( Chronic treatment with levetiracetam reverses deficits in hippocampal LTP in vivo in experimental temporal lobe epilepsy rats.
Ge, YX; Lin, YY; Liu, XY; Tian, XZ, 2016
)
1.47
"Levetiracetam is an anti-epileptic drug commonly used in intensive care when seizure is suspected as a possible cause of coma. "( Marked EEG worsening following Levetiracetam overdose: How a pharmacological issue can confound coma prognosis.
André-Obadia, N; Bouchier, B; Demarquay, G; Gobert, F; Guérin, C, 2017
)
2.18
"Levetiracetam (LEV) is a new-generation anti epileptic drug (AED)."( [Efficacy and Safety of Levetiracetam as an Add-on Therapy for Symptomatic Refractory Epilepsy Treated in a Department of Neurosurgery].
Kawataki, T; Kinouchi, H; Ogiwara, M; Sato, H; Suzuki, K, 2016
)
1.46
"Levetiracetam is an antiepileptic drug used for the treatment of generalised or partial seizures, either alone or in a combination therapy. "( Levetiracetam Induced Increase in Creatine Phosphokinase Levels.
Ain, Q-; Khan, MA; Khan, SA; Memon, MH; Shahbaz, N; Younus, SM, 2017
)
3.34
"Levetiracetam (LEV) is an effective antiepileptic drug (AED) with distinct mechanism from the conventional AEDs. "( PKA-mediated phosphorylation is a novel mechanism for levetiracetam, an antiepileptic drug, activating ROMK1 channels.
Lee, CH; Lee, CY; Liou, HH; Tsai, TS, 2008
)
2.04
"Levetiracetam (Keppra) is an antiepileptic drug (AED) characterized by a novel mechanism of action, unique profile of activity in seizure models, and broad-spectrum clinical efficacy. "( Benefit of combination therapy in epilepsy: a review of the preclinical evidence with levetiracetam.
Kaminski, RM; Klitgaard, H; Matagne, A; Patsalos, PN, 2009
)
2.02
"Levetiracetam (Keppra) is a new generation antiepileptic drug characterized by a unique profile of activity in experimental models of epilepsy. "( Effects of chronic treatment with levetiracetam on hippocampal field responses after pilocarpine-induced status epilepticus in rats.
Kaminski, RM; Klitgaard, H; Margineanu, DG; Matagne, A, 2008
)
2.07
"Levetiracetam is an effective antiepileptic drug in elderly individuals with cognitive impairment."( Levetiracetam: a practical option for seizure management in elderly patients with cognitive impairment.
Hepler, M; Irwin, D; Jenssen, S; Lippa, CF; Pillai, J; Rosso, A, 2010
)
2.52
"Levetiracetam is a promising symptomatic therapy in subacute sclerosing panencephalitis for both the myoclonus and the encephalopathy."( Successful treatment of encephalopathy and myoclonus with levetiracetam in a case of subacute sclerosing panencephalitis.
Abou-Khalil, BW; Becker, D; Patel, A; Pina-Garza, JE, 2009
)
1.32
"Levetiracetam (LEV) is a newer antiepileptic drug (AED) with fewer SEs and essentially no drug interactions."( Safety and feasibility of switching from phenytoin to levetiracetam monotherapy for glioma-related seizure control following craniotomy: a randomized phase II pilot study.
Barbaro, N; Burt, M; Chakalian, L; Chang, E; Chang, S; Lamborn, KR; Lim, DA; McDermott, MW; Tarapore, P, 2009
)
1.32
"Levetiracetam (LVM) is a novel AED that does not undergo extensive liver metabolism, does not require drug level monitoring, and is not associated with hemodynamic instability."( Safety and efficacy of levetiracetam for critically ill patients with seizures.
Divertie, GD; Freeman, WD; Nau, KM; Valentino, AK, 2009
)
1.38
"Levetiracetam is a broad spectrum anti-epileptic drug with renal elimination and no hepatic metabolism."( Levetiracetam accumulation in renal failure causing myoclonic encephalopathy with triphasic waves.
Iwanowski, P; Jallon, P; Landis, T; Vulliemoz, S, 2009
)
2.52
"Levetiracetam is an effective AED with potential benefits in other neurologic and psychiatric disorders. "( Levetiracetam for managing neurologic and psychiatric disorders.
Bhatt, A; Farooq, MU; Gupta, R; Kassab, MY; Khasnis, A; Majid, A, 2009
)
3.24
"Levetiracetam is an antiepileptic drug widely prescribed. "( Levetiracetam-induced platelet dysfunction.
Hacquard, M; Lacour, JC; Lecompte, T; Richard, S; Vespignani, H, 2009
)
3.24
"Levetiracetam (LEV) is a novel anticonvulsant available for intravenous (i.v.) application."( Intravenous levetiracetam as treatment for status epilepticus.
Berning, S; Boesebeck, F; Kellinghaus, C; van Baalen, A, 2009
)
1.45
"Levetiracetam is a pyrrolidine derivate that is approved for the treatment of seizures. "( Pancytopenia associated with levetiracetam treatment.
Boari, B; Carletti, R; Cavallo, M; Gallerani, M; Mari, E; Marra, A, 2009
)
2.09
"Levetiracetam is an effective anti-epileptic drug in the treatment of partial and generalized seizure. "( Levetiracetam inhibits glutamate transmission through presynaptic P/Q-type calcium channels on the granule cells of the dentate gyrus.
Chen, CC; Lee, CY; Liou, HH, 2009
)
3.24
"Levetiracetam is an effective and well-tolerated option for long-term treatment of epilepsy in adults."( Long-term levetiracetam treatment in patients with epilepsy: 3-year follow up.
Brázdil, M; Kocvarová, J; Kuba, R; Mastík, J; Novotná, I; Rektor, I; Tyrlíková, I, 2010
)
2.21
"Levetiracetam (LEV) is an S-enantiomer pyrrolidone derivative with established antiepileptic efficacy in generalized epilepsy and partial epilepsy. "( Experimental and simulation studies on the mechanisms of levetiracetam-mediated inhibition of delayed-rectifier potassium current (KV3.1): contribution to the firing of action potentials.
Huang, CC; Huang, CW; Tsai, JJ; Wu, SN, 2009
)
2.04
"Levetiracetam (LEV) is a unique antiepileptic drug that preferentially interacts with synaptic vesicle protein 2A (SV2A). "( Antiepileptogenic and anticonvulsive actions of levetiracetam in a pentylenetetrazole kindling model.
Ishihara, S; Ohno, Y; Sasa, M; Serikawa, T; Terada, R, 2010
)
2.06
"Levetiracetam is an antiepileptic drug (AED) with a favourable tolerability profile with little or no effect on liver function. "( Unexpected gamma glutamyltransferase rise increase during levetiracetam monotherapy.
Baruzzi, A; Bisulli, F; Broli, M; Naldi, I; Provini, F; Riva, R; Sama, C; Tinuper, P, 2010
)
2.05
"Levetiracetam is an anticonvulsant drug used to treat partial seizures, myoclonic seizures of juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures. "( [Therapeutic drug monitoring of levetiracetam].
Bentué-Ferrer, D; Bouquié, R; Dailly, E,
)
1.86
"Levetiracetam (LEV) is a broad-spectrum antiepileptic drug (AED) with possibly also antiepileptogenic properties. "( Effect of levetiracetam on hippocampal protein expression and cell proliferation in rats.
Ben-Menachem, E; Boon, P; Kuhn, HG; Paulson, L; Persson, A; Raedt, R; Van Dycke, A; Vonck, K, 2010
)
2.21
"Levetiracetam is an antiepileptic drug that has been shown to be effective in various types of seizures, both partial and generalized. "( Levetiracetam in childhood epilepsy.
Chiarelli, F; Curatolo, P; D'Adamo, E; Parisi, P; Verrotti, A, 2010
)
3.25
"Levetiracetam is a safe, effective, and preferred alternative for seizure management in patients with glioma."( Seizures in patients with glioma treated with phenytoin and levetiracetam.
Anderson, SK; Lachance, DH; Merrell, RT; Meyer, FB, 2010
)
1.32
"Levetiracetam is an anticonvulsant which is assumed to act by modulating neurotransmitter release via binding to the vesicle protein SV2A. "( The anticonvulsant levetiracetam for the treatment of pain in polyneuropathy: a randomized, placebo-controlled, cross-over trial.
Bach, FW; Holbech, JV; Jensen, TS; Otto, M; Sindrup, SH, 2011
)
2.14
"Levetiracetam is a broad-spectrum antiepileptic drug that binds to synaptic vesicle protein SV2A. "( Assessment of levetiracetam bioavailability from targeted sites in the human intestine using remotely activated capsules and gamma scintigraphy: Open-label, single-dose, randomized, four-way crossover study in healthy male volunteers.
Connor, A; Otoul, C; Sargentini-Maier, ML; Stockis, A; Wilding, I; Wray, H, 2010
)
2.16
"Levetiracetam (LEV) is a commonly used add-on medication in dogs with refractory epilepsy. "( The pharmacokinetics of levetiracetam in healthy dogs concurrently receiving phenobarbital.
Moore, SA; Muñana, KR; Nettifee-Osborne, JA; Papich, MG, 2011
)
2.12
"Levetiracetam is likely to be an effective anticonvulsant in children and adolescents with hemiplegic cerebral palsy and infrequent but persistent focal seizures."( Levetiracetam in children and adolescents with epilepsy and hemiplegic cerebral palsy.
Harbord, MG, 2011
)
3.25
"Levetiracetam is an antiepileptic drug (AED) approved for the adjunctive treatment of partial seizures firstly in the US in 1999. "( [Are clinical features derived from evidences and experiences outside of Japan applicable to clinical practices in Japan? Comparisons of results among studies conducted in US, Europe, Asian Countries and Japan].
Kamada, K, 2011
)
1.81
"Levetiracetam is an effective adjunctive agent for refractory epilepsy. "( Meta-analysis of randomized trials on first line and adjunctive levetiracetam.
Akl, EA; Jichici, D; Kyu, HH; Lo, BW; Meade, MO; Upton, AM, 2011
)
2.05
"Levetiracetam is a second-generation antiepileptic drug with a novel mechanism of action."( Levetiracetam protects hippocampal neurons in culture against hypoxia-induced injury.
Boćkowski, L; Iłendo, E; Jaworowska, B; Sendrowski, K; Smigielska-Kuzia, J; Sobaniec, W, 2011
)
2.53
"Levetiracetam (LEV) is a broad spectrum antiepileptic drug (AED) with a unique mechanism of action. "( Levetiracetam monotherapy--outcomes from an epilepsy clinic.
Brodie, MJ; Kelly, K; Parker, P; Stephen, LJ, 2011
)
3.25
"Levetiracetam is a state of the art antiepileptic drug that has displayed antinociceptive activity in experimental models of pain and clinical effectiveness as an analgesic in series of patients with neuropathic pain."( [The effectiveness of levetiracetam in the treatment of neuropathic pain].
Del Pozo, E; González-Contreras, LG; Pereira-Pérez, E, 2011
)
1.41
"Levetiracetam (LEV) is a newer anticonvulsant with a favorable safety profile. "( Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial.
Bähr, O; Franz, K; Hermisson, M; Körtvelyessy, P; Nussbaum, S; Rieger, J; Rona, S; Seifert, V; Steinbach, JP; Tatagiba, M; Weller, M, 2012
)
2.14
"Levetiracetam (LEV) is a commonly used antiepileptic drug targeting high-voltage activated N-type calcium channels."( Levetiracetam exhibits protective properties on rat Schwann cells in vitro.
Dehmel, T; Kieseier, BC; Köhne, A; Mausberg, AK; Rose, CR; Stettner, M, 2011
)
2.53
"Levetiracetam (LEV) is a novel anticonvulsive drug that is commonly used in humans with seizure disorders who have hepatic comorbidity."( Incidence of postoperative seizures with and without levetiracetam pretreatment in dogs undergoing portosystemic shunt attenuation.
Cohen, ND; Fryer, KJ; Levine, JM; Peycke, LE; Thompson, JA,
)
1.1
"Levetiracetam (LEV) is a novel antiepileptic drug used to treat epilepsy, but its effects on spatial and emotional learning and memory are not yet well understood."( Positive impact of levetiracetam on emotional learning and memory in naive mice.
Akar, FY; Celikyurt, IK; Erden, F; Komsuoglu, SS; Mulayim, S; Mutlu, O; Ulak, G, 2012
)
1.43
"Levetiracetam is an FDA-approved drug used to treat epilepsy and other disorders of the nervous system. "( Levetiracetam reverses synaptic deficits produced by overexpression of SV2A.
Bajjalieh, SM; Bleckert, A; Hill, J; Malarkey, EB; Nowack, A; Yao, J, 2011
)
3.25
"Levetiracetam (LEV) is a new AED with few side effects."( Levetiracetam as alternative stage two antiepileptic drug in status epilepticus: a systematic review.
Kumlien, E; Zelano, J, 2012
)
2.54
"Levetiracetam is an anticonvulsant which is assumed to act by modulating neurotransmitter release via binding to the vesicle protein SV2A. "( A randomized, placebo-controlled trial of levetiracetam in central pain in multiple sclerosis.
Falah, M; Holbech, JV; Madsen, C; Sindrup, SH, 2012
)
2.09
"Levetiracetam (Keppra) is a commonly prescribed anticonvulsant that has been shown to attenuate alcohol consumption in an open-label study of treatment-seeking, alcohol-dependent subjects."( The anticonvulsant levetiracetam potentiates alcohol consumption in non-treatment seeking alcohol abusers.
Coker, AR; Grossman, LE; Messing, RO; Mitchell, JM, 2012
)
2.15
"Levetiracetam (LEV) is a novel antiepileptic drug (AED) which was discovered in early 1980s and soon, in 1999 FDA approved LEV for the management of partial onset seizure. "( Levetiracetam.
Dave, P; Gohel, KH; Krishna, K; Raut, AL, 2011
)
3.25
"Levetiracetam (LEV) is a prominent antiepileptic drug that binds to neuronal synaptic vesicle glycoprotein 2A protein and has reported effects on ion channels, but with a poorly defined mechanism of action. "( The synaptic vesicle glycoprotein 2A ligand levetiracetam inhibits presynaptic Ca2+ channels through an intracellular pathway.
Mochida, S; Stephens, GJ; Vogl, C; Whalley, BJ; Wolff, C, 2012
)
2.08
"Levetiracetam (LEV) is an established anticonvulsant with numerous mechanisms of action. "( Anti-inflammatory effects of levetiracetam in experimental autoimmune encephalomyelitis.
Ellrichmann, G; Faustmann, PM; Gold, R; Haghikia, A; Thöne, J, 2012
)
2.11
"Levetiracetam is a commonly prescribed antiepileptic drug, and is generally well tolerated, but can eventually cause behavioral disturbances. "( Levetiracetam-induced reversible autistic regression.
Camacho, A; Espín, JC; Nuñez, N; Simón, R, 2012
)
3.26
"Levetiracetam is an anticonvulsant agent that was first approved for use in the United States in 1999 and has a maximum recommended adult dose of 3000 mg daily. "( Overdose with levetiracetam: a case report and review of the literature.
Catalano, G; Catalano, MC; Cohen-Oram, AN; Larkin, TM, 2013
)
2.19
"Levetiracetam (LEV) is a highly effective antiepileptic agent. "( Genetic variation in dopaminergic activity is associated with the risk for psychiatric side effects of levetiracetam.
Elger, CE; Helmstaedter, C; Hurlemann, R; Kunz, WS; Mihov, Y; Nuernberg, P; Schoch, S; Surges, R; Thiele, H; Toliat, MR, 2013
)
2.05
"Levetiracetam (LEV) is an antiepileptic drug with a favorable tolerability and safety profile with little or no effect on liver function."( Probable levetiracetam-related serum alkaline phosphatase elevation.
Hou, L; Huang, Y; Lu, N; Mohamed, AA; Wang, T; Xiong, N, 2012
)
2.24
"Levetiracetam (LEV) is a widely used antiepileptic agent for partial refractory epilepsy in humans. "( Inhibitory effects of levetiracetam on the high-voltage-activated L-type Ca²⁺ channels in hippocampal CA3 neurons of spontaneously epileptic rat (SER).
Arita, K; Hanaya, R; Ishihara, K; Kurisu, K; Sasa, M; Seki, T; Serikawa, T; Yan, HD, 2013
)
2.15
"Levetiracetam is a broad-spectrum antiepileptic drug (AED) which is currently licensed in the United States and the United Kingdom and Ireland for use as adjunctive treatment of focal-onset seizures and myoclonic seizures or generalized tonic-clonic seizures, occurring as part of generalized epilepsy syndromes. "( Levetiracetam in pregnancy: results from the UK and Ireland epilepsy and pregnancy registers.
Craig, J; Delanty, N; Hunt, SJ; Irwin, B; Liggan, B; Mawhinney, E; Morrison, PJ; Morrow, J; Parsons, L; Russell, A; Smithson, WH, 2013
)
3.28
"Levetiracetam is a new anticonvulsant for adjunctive treatment of partial epilepsy. "( [Levetiracetam: an anti-epileptic drug with interesting pharmacokinetic properties].
Vecht, ChJ; Wagner, GL; Wilms, EB, 2002
)
2.67
"Levetiracetam is a novel antiepileptic drug which has recently been released as an adjunctive treatment for partial epilepsy. "( The effects of levetiracetam on objective and subjective sleep parameters in healthy volunteers and patients with partial epilepsy.
Bell, C; Hiersemenzel, R; Nutt, D; Otoul, C; Vanderlinden, H; Wilson, S, 2002
)
2.11
"Levetiracetam (Keppra) is a new anticonvulsant used to treat partial complex seizures that is also being investigated for its mood-stabilizing properties. "( A case of levetiracetam (Keppra) poisoning with clinical and toxicokinetic data.
Barrueto, F; Hoffman, RS; Howland, MA; Nelson, LS; Williams, K, 2002
)
2.16
"Levetiracetam (LEV) is a new antiepileptic drug shown to be effective for the treatment of partial seizures in pivotal clinical trials. "( Efficacy and tolerability of levetiracetam during 1-year follow-up in patients with refractory epilepsy.
Ben-Menachem, E; Gilland, E, 2003
)
2.05
"Levetiracetam is a new anti-convulsant with impressive pivotal trial credentials. "( Clinical experience of marketed Levetiracetam in an epilepsy clinic-a one year follow up study.
Barrett, M; Betts, T; Greenhill, L; Yarrow, H, 2003
)
2.05
"Levetiracetam is a new antiepileptic drug with a broad-spectrum activity that includes efficacy against positive myoclonus."( Dramatic effect of levetiracetam on epileptic negative myoclonus.
Baldy-Moulinier, M; Crespel, A; Gelisse, P; Genton, P, 2003
)
1.37
"Levetiracetam (LEV) is a novel anticonvulsant that is currently investigated in bipolar disorder. "( Levetiracetam in the treatment of rapid cycling bipolar disorder.
Bräunig, P; Krüger, S, 2003
)
3.2
"Levetiracetam is a novel antiepileptic drug (AED) with proven efficacy against partial seizures, but there is limited information about its effectiveness against generalized seizures. "( Levetiracetam: preliminary efficacy in generalized seizures.
Hirsch, E; Kasteleijn-Nolst Trenité, DG, 2003
)
3.2
"Levetiracetam is a novel antiepileptic drug with a broad spectrum of efficacy in epilepsy. "( Levetiracetam in the treatment of acute mania: an open add-on study with an on-off-on design.
Born, C; Grunze, H; Langosch, J; Schaub, G; Walden, J, 2003
)
3.2
"Levetiracetam (LEV) is a recently approved anticonvulsant with proven efficacy and safety in the treatment of partial seizures. "( Discontinuation of levetiracetam because of behavioral side effects: a case-control study.
Beniak, TE; Gumnit, RJ; Leppik, IE; Matchinsky, DJ; Rarick, J; Tran, T; Walczak, TS; White, JR, 2003
)
2.09
"Levetiracetam (LEV) is a new antiepileptic drug approved as add-on therapy. "( Serum concentrations of Levetiracetam in epileptic patients: the influence of dose and co-medication.
Jürgens, U; May, TW; Rambeck, B, 2003
)
2.07
"Levetiracetam is a novel anti-epileptic drug known to exhibit unique desynchronizing properties in contrast to other anti-epileptic drugs."( Levetiracetam improves choreic levodopa-induced dyskinesia in the MPTP-treated macaque.
Bezard, E; Brotchie, JM; Crossman, AR; Grimée, R; Hill, MP; Klitgaard, H; Michel, A, 2004
)
2.49
"Levetiracetam is a new anti-epileptic drug that is currently not licensed for use in children. "( Efficacy and tolerability of levetiracetam in children aged 10 years and younger: a clinical experience.
Appleton, RE; Tan, MJ, 2004
)
2.06
"Levetiracetam is a potent and generally well tolerable new antiepileptic drug which is also efficacious in patients with difficult-to-treat focal epilepsies."( [Levetiracetam in combined therapy for focal epilepsy: experience with 80 patients].
Fauser, S; Feil, B; Homberg, V; Schulze-Bonhage, A, 2004
)
2.68
"Levetiracetam is a novel anticonvulsant drug that delays the process of kindling, i.e., possesses antiepileptogenic properties."( Levetiracetam prevents changes in levels of brain-derived neurotrophic factor and neuropeptide Y mRNA and of Y1- and Y5-like receptors in the hippocampus of rats undergoing amygdala kindling: implications for antiepileptogenic and mood-stabilizing propert
Bolwig, TG; Hansen, SL; Husum, H; Mathé, AA; Sánchez, C, 2004
)
2.49
"Levetiracetam (LEV) is a recently marketed novel anti-epileptic drug with a promising efficacy and safety profile. "( Enterocolitis: an adverse event in refractory epilepsy patients treated with levetiracetam?
Boon, P; Bosman, T; Claeys, P; De Clercq, M; De Reuck, J; Van Vlierberghe, H; Vonck, K, 2004
)
2
"Levetiracetam (LEV) is a new antiepileptic drug with efficacy in partial-onset seizures. "( Levetiracetam induces a rapid and sustained reduction of generalized spike-wave and clinical absence.
Cavitt, J; Privitera, M, 2004
)
3.21
"Levetiracetam (LEV) is a new compound with anticonvulsive efficacy in focal and generalized epilepsies. "( Levetiracetam influences human motor cortex excitability mainly by modulation of ion channel function--a TMS study.
Hamer, HM; Knake, S; Mueller, HH; Oertel, WH; Reis, J; Rosenow, F; Tergau, F; Wentrup, A, 2004
)
3.21
"Levetiracetam (LEV) is a novel antiepileptic drug (AED) with efficacy against a wide range of seizures types. "( Levetiracetam for people with mental retardation and refractory epilepsy.
Brodie, MJ; Kelly, K; Stephen, LJ, 2004
)
3.21
"Levetiracetam is a novel anticonvulsant with antikindling, inhibitory, and neuroprotective properties that is effective in an animal model of mania."( Monotherapy treatment of bipolar disorder with levetiracetam.
Kaufman, KR, 2004
)
1.3
"Levetiracetam is an antiepileptic drug with atypical mechanisms of action that might be beneficial for this indication."( Use of levetiracetam to treat tics in children and adolescents with Tourette syndrome.
Awaad, Y; Michon, AM; Minarik, S, 2005
)
1.5
"Levetiracetam is a relatively new antiepileptic drug, which has been reported to have promising antimyoclonic properties, especially in posthypoxic myoclonus, progressive myoclonic epilepsy (PME) and spinal myoclonus. "( Limited efficacy of levetiracetam on myoclonus of different etiologies.
Ahmed, A; Lim, LL, 2005
)
2.09
"Levetiracetam is a recently approved, well-tolerated anticonvulsant with a unique mechanism of action yielding efficacy in treatment-refractory seizure disorders and positive effects in an animal model of mania. "( Preliminary observations on the effectiveness of levetiracetam in the open adjunctive treatment of refractory bipolar disorder.
Altshuler, LL; Frye, MA; Grunze, H; Keck, PE; Kupka, R; Leverich, GS; Luckenbaugh, DA; McElroy, SL; Nolen, WA; Post, RM; Suppes, T; Walden, J, 2005
)
2.03
"Levetiracetam is an attractive treatment because of its efficacy, lack of hepatic enzyme induction, and its rapid attainment of serum levels."( Levetiracetam for seizures after liver transplantation.
Bergethon, PR; Freeman, R; Glass, GA; Mithoefer, A; Stankiewicz, J, 2005
)
2.49
"Levetiracetam is a new antiepileptic drug whose efficacy and tolerability are already well known in adults. "( Levetiracetam in pediatrics.
Vigevano, F, 2005
)
3.21
"Levetiracetam is an AED with unique mechanisms of action that may have analgesic properties in various pain syndromes."( Levetiracetam as an adjunctive analgesic in neoplastic plexopathies: case series and commentary.
Dunteman, ED, 2005
)
2.49
"Levetiracetam is a new antiepileptic drug. "( Specific effect of levetiracetam in experimental human pain models.
Enggaard, TP; Klitgaard, NA; Sindrup, SH, 2006
)
2.1
"Levetiracetam is an antiepileptic drug approved for use as adjunctive therapy in adults with partial-onset seizures. "( Pharmacokinetics of levetiracetam in patients with moderate to severe liver cirrhosis (Child-Pugh classes A, B, and C): characterization by dynamic liver function tests.
Brockmöller, J; Coupez, R; Lochs, H; Roots, I; Thomsen, T; Wittstock, M, 2005
)
2.09
"Levetiracetam (LEV) is a new antiepileptic drug effective as adjunctive therapy for partial seizures. "( Evaluation of levetiracetam effects on pilocarpine-induced seizures: cholinergic muscarinic system involvement.
Aguiar, LM; Fonteles, MM; Freitas, RM; Nascimento, VS; Nogueira, CR; Oliveira, AA; Sousa, FC; Viana, GS, 2005
)
2.13
"Levetiracetam (LEV) is an antiepileptic drug with a favorable pharmacokinetic profile, including negligible protein binding and linear elimination kinetics. "( Oral absorption kinetics of levetiracetam: the effect of mixing with food or enteral nutrition formulas.
Fay, MA; Gidal, BE; Sheth, RD, 2005
)
2.07
"Levetiracetam is a new antiepileptic agent that exerts antimyoclonic effects. "( Levetiracetam in patients with cortical myoclonus: a clinical and electrophysiological study.
Boccella, P; Manganelli, F; Perretti, A; Striano, P; Striano, S, 2005
)
3.21
"Levetiracetam is a novel anticonvulsant effective for the treatment of partial seizures."( Effects of levetiracetam on sleep in normal volunteers.
Basner, RC; Battista, J; Bazil, CW, 2005
)
1.44
"Levetiracetam is a novel antiepileptic drug that has been demonstrated as being effective in the management of partial seizures. "( Benefit-risk assessment of levetiracetam in the treatment of partial seizures.
Abou-Khalil, B, 2005
)
2.07
"Levetiracetam (Keppra) is a novel antiepileptic drug approved as adjunctive treatment for adults with partial onset seizures. "( Catatonia induced by levetiracetam.
Bruneau, MA; Chouinard, MJ; Clément, JF; Nguyen, DK, 2006
)
2.1
"Levetiracetam (LEV) is a novel antiepileptic drug characterized by a wide spectrum of action; no pharmacologic interaction and poor adverse events are reported. "( Efficacy of levetiracetam in Huntington disease.
Cormio, C; De Caro, MF; de Tommaso, M; Di Fruscolo, O; Livrea, P; Sciruicchio, V; Specchio, N,
)
1.95
"Levetiracetam (Lev) is a new antiepileptic drug with a distinct mechanism of action, shown in regulatory trials to be effective. "( The long term retention of levetiracetam in a large cohort of patients with epilepsy.
Bell, GS; Depondt, C; Duncan, JS; Koepp, MJ; Mitchell, T; Sander, JW; Yuen, AW, 2006
)
2.07
"Levetiracetam (LEV) is a new AED with a novel mechanism of action, which includes reducing the Ca++ current through neuron-specific, high voltage activated Ca++ channels (n-type)."( Retrospective analysis of the efficacy and tolerability of levetiracetam in brain tumor patients.
Goldlust, SA; Newton, HB; Pearl, D, 2006
)
1.3
"Levetiracetam is a well tolerated new antiepileptic drug that may effectively improve seizures control as an add-on drug in resistant epilepsy in childhood with good tolerability."( [Experience with levetiracetam in childhood epilepsy].
Fogarasi, A; Hegyi, M; Herczegfalvi, A; Kollár, K; Móser, J; Neuwirth, M; Paraicz, E; Rosdy, B; Saracz, J, 2006
)
2.12
"Levetiracetam (LEV) is a new antiepileptic drug highly effective as add-on treatment in refractory partial epilepsies. "( Levetiracetam reduces frequency and duration of epileptic activity in patients with refractory primary generalized epilepsy.
Rocamora, R; Schulze-Bonhage, A; Wagner, K, 2006
)
3.22
"Levetiracetam (Keppra) is a novel antiepileptic drug recently approved by the U.S. "( Determination of levetiracetam in human plasma/serum/saliva by liquid chromatography-electrospray tandem mass spectrometry.
Guo, T; Mendu, DR; Oswald, LM; Soldin, SJ, 2007
)
2.12
"Levetiracetam (LEV) is a promising, new antiepileptic drug that may represent an alternative to VPA for many patients."( Comparison of reproductive effects of levetiracetam and valproate studied in prepubertal porcine ovarian follicular cells.
Gregoraszczuk, EL; Ropstad, E; Taubøll, E; Tworzydø, A; Wójtowicz, AK, 2006
)
1.33
"Levetiracetam is a well-known drug for the control of myoclonic seizures."( Levetiracetam-induced myoclonic status epilepticus in myoclonic-astatic epilepsy: a case report.
Krämer, G; Kröll-Seger, J; Mothersill, IW; Novak, S; Sälke-Kellermann, RA, 2006
)
2.5
"Levetiracetam is a new antiepileptic drug with an excellent tolerability profile."( Levetiracetam in the prophylaxis of migraine with aura: a 6-month open-label study.
Aloisio, A; Brighina, F; Fierro, B; Francolini, M; Giglia, G; Palermo, A,
)
2.3
"Levetiracetam seems to be a safe and effective treatment for migraine with aura. "( Levetiracetam in the prophylaxis of migraine with aura: a 6-month open-label study.
Aloisio, A; Brighina, F; Fierro, B; Francolini, M; Giglia, G; Palermo, A,
)
3.02
"Levetiracetam is a newer antiepileptic agent that was first approved by the US FDA in 1999 as an adjunctive therapy for the treatment of refractory partial epilepsy in adults. "( Potential of levetiracetam in mood disorders: a preliminary review.
Bhagwagar, Z; Muralidharan, A, 2006
)
2.15
"Levetiracetam (LEV) is a new antiepileptic agent with broad-spectrum effects on seizures and animal models of epilepsy."( Effects of levetiracetam in lipid peroxidation level, nitrite-nitrate formation and antioxidant enzymatic activity in mice brain after pilocarpine-induced seizures.
Aguiar, LM; Almeida, JP; Fonseca, FN; Fonteles, MM; Freitas, RM; Júnior, HV; Nascimento, VS; Oliveira, AA; Sousa, FC; Viana, GS, 2007
)
1.45
"Levetiracetam appears to be a useful antimyoclonic agent in cases of progressive myoclonic epilepsy and should be considered for adjunctive therapy."( Levetiracetam in three cases of progressive myoclonus epilepsy.
Kkolou, E; Papacostas, S; Papathanasiou, E, 2007
)
2.5
"Levetiracetam (LEV) is a novel antiepileptic drug (AED) that has recently obtained marketing authorisation for use in children. "( Retention rate of levetiracetam in children with intractable epilepsy at 1 year.
Buch, S; Crane, J; Donnelly, J; Gosalakkal, J; Mordekar, S; Mukhtyar, B; Peake, D; Philip, S; Rittey, C; Wheway, R; Whitehouse, WP, 2007
)
2.12
"Levetiracetam is a new antiepileptic drug that appears to be a useful add-on treatment in patients with refractory epilepsy. "( Levetiracetam in clinical practice: long-term experience in patients with refractory epilepsy referred to a tertiary epilepsy center.
Aldenkamp, AP; Bootsma, HP; de Krom, M; Diepman, L; Gehring, J; Hulsman, J; Lambrechts, D; Leenen, L; Majoie, M; Ricker, L; Schellekens, A, 2007
)
3.23
"Levetiracetam (LEV) is a 2nd generation non-enzyme inducing AED with a novel mechanism of action, binding to neuronal synaptic vesicle protein SV2A, that has been previously shown to reduce seizure activity in patients with primary brain tumors."( Retrospective analysis of the efficacy and tolerability of levetiracetam in patients with metastatic brain tumors.
Dalton, J; Goldlust, S; Newton, HB; Pearl, D, 2007
)
1.3
"Levetiracetam is an effective, well tolerable, broad-spectrum drug as adjunctive treatment or monotherapy in adult patients unsuccessfully treated with other antiepileptic drugs."( [Clinical experience with levetiracetam for adults with epilepsy].
Barcs, G; Szucs, A, 2007
)
2.08
"Levetiracetam (LEV) is a new generation anti-epileptic drug, which has been approved as add-on therapy for partial epilepsy. "( [Efficacy and safety of levetiracetam (keppra) add-on treatment in adult patients with refractory epilepsy in two tertiary centers].
Auriel, E; Blatt, I; Chistik, V; Margolin, N; Neufeld, M, 2007
)
2.09
"Levetiracetam is an antiepileptic drug approved for use as an adjunct agent in partial-onset seizures in adults and children aged > or = 4 years. "( The safety of levetiracetam.
Safdieh, JE; Sirsi, D, 2007
)
2.14
"Levetiracetam (LEV) is a structurally novel antiepileptic drug (AED) which has demonstrated a broad spectrum of anticonvulsant activities both in experimental and clinical studies. "( Prophylactic treatment with levetiracetam after status epilepticus: lack of effect on epileptogenesis, neuronal damage, and behavioral alterations in rats.
Bethmann, K; Brandt, C; Fedrowitz, M; Gastens, AM; Glien, M; Löscher, W; Potschka, H; Volk, HA, 2007
)
2.08
"Levetiracetam is a new antiepileptic drug reported to be effective and well-tolerated in adults and children affected by epilepsy. "( No kinetic interaction between levetiracetam and cyclosporine: a case report.
Franzoni, E; Garone, C; Malaspina, E; Marchiani, V; Sarajlija, J, 2007
)
2.07
"Levetiracetam is a new antiepileptic drug prescribed for the treatment of patients with refractory partial seizures with or without secondary generalization as well as for the treatment of juvenile myoclonic epilepsy. "( Therapeutic drug monitoring of levetiracetam by high-performance liquid chromatography with photodiode array ultraviolet detection: preliminary observations on correlation between plasma concentration and clinical response in patients with refractory epil
Brovedani, S; Chassoux, F; Franchon, E; Garciau, I; Kraoul, L; Lancelin, F; Landré, E; Paubel, P; Piketty, ML; Tabaouti, K, 2007
)
2.07
"Levetiracetam (LEV) is an antiepileptic drug recently approved in monotherapy. "( [Levetiracetam in the treatment of epilepsy in adults. Experience with monotherapy].
Molins, A; Villanueva, VE,
)
2.48
"Levetiracetam proved to be an effective and well-tolerated add-on treatment in this group of children with refractory epilepsy."( Add-on levetiracetam in children and adolescents with refractory epilepsy: results of an open-label multi-centre study.
Arts, WF; Augustijn, P; Brouwer, OF; Callenbach, PM; Geerts, AT; Geerts, Y; Gunning, WB; Peeters, EA; Stroink, H; ten Houten, R; Weber, AM, 2008
)
2.24
"Levetiracetam (LEV) is a broad-spectrum antiepileptic drug that is effective against a variety of seizure types. "( Levetiracetam.
Carreno, M, 2007
)
3.23
"Levetiracetam is an antiepileptic drug that was shown to be effective in various seizure types. "( The use of levetiracetam in a child with nonconvulsive status epilepticus.
Alehan, F; Haberal, M; Ozcay, F, 2008
)
2.18
"Levetiracetam (LEV) is a broad-spectrum antiepileptic drug with no known interactions and a favorable profile of adverse events. "( Intravenous levetiracetam: treatment experience with the first 50 critically ill patients.
Fuhr, P; Hardmeier, M; Marsch, S; Naegelin, Y; Rüegg, S; Winkler, DT, 2008
)
2.17
"Levetiracetam (LEV) is a novel AED and despite its increasingly widespread clinical use, its mechanism of action is as yet undetermined."( Levetiracetam inhibits both ryanodine and IP3 receptor activated calcium induced calcium release in hippocampal neurons in culture.
DeLorenzo, RJ; Deshpande, LS; Nagarkatti, N, 2008
)
2.51
"Levetiracetam is a novel antiepileptic drug which has shown strong anti-kindling activity in animal models of epilepsy."( Levetiracetam for treatment of premenstrual dysphoric disorder: a pilot, open-label study.
Halbreich, U; Kayatekin, ZE; Sabo, AN, 2008
)
2.51
"Levetiracetam (LEV) is a newer AED, with a recently approved parenteral formulation, that can be initiated at doses effective in controlling seizures."( Tolerability and efficacy of oral loading of levetiracetam.
Amina, S; Bergey, GK; Koubeissi, MZ; Pita, I; Werz, MA, 2008
)
1.33
"Levetiracetam is a novel antiepileptic agent with a wide spectrum of activity against experimental and clinical seizures. "( Neurochemical studies with the novel anticonvulsant levetiracetam in mouse brain.
Brodie, MJ; Forrest, G; Fraser, CM; Leach, JP; Patsalos, PN; Sills, GJ, 1997
)
1.99
"Levetiracetam is a novel orally active antiepileptic drug with a unique preclinical profile. "( Pharmacokinetic profile of levetiracetam: toward ideal characteristics.
Patsalos, PN, 2000
)
2.05
"Levetiracetam is a new anticonvulsant agent with a favourable tolerability profile and a low potential for drug interactions. "( Levetiracetam. A review of its adjunctive use in the management of partial onset seizures.
Dooley, M; Plosker, GL, 2000
)
3.19
"Levetiracetam (LEV) is an interesting novel antiepileptic drug with proven efficacy in both animal models and patients with partial epilepsy. "( Development of tolerance during chronic treatment of kindled rats with the novel antiepileptic drug levetiracetam.
Hönack, D; Löscher, W, 2000
)
1.97
"Levetiracetam appears to be a promising agent for treating action myoclonus caused by hypoxic and encephalitic brain injury-the degree of functional improvement may depend on the severity of associated motor dysfunction."( Suppression of post-hypoxic and post-encephalitic myoclonus with levetiracetam.
Bergin, A; Cho, YW; Kramer, RE; Krauss, GL; Reich, SG, 2001
)
1.27
"Levetiracetam is an adjunctive treatment for partial-onset epileptic seizures."( Levetiracetam.
Nash, EM; Sangha, KS, 2001
)
2.47
"Levetiracetam (LEV) is a new antiepileptic drug with a promising preclinical profile involving both anticonvulsant and antiepileptogenic effects in kindling models. "( Neuroprotective properties of the novel antiepileptic drug levetiracetam in the rat middle cerebral artery occlusion model of focal cerebral ischemia.
Hanon, E; Klitgaard, H, 2001
)
2
"Levetiracetam is a new antiepileptic drug (AED) devoid of anticonvulsant activity in the two classic screening models for AEDs, the maximal electroshock and pentylenetetrazol seizure tests in both mice and rats. "( Levetiracetam: the preclinical profile of a new class of antiepileptic drugs?
Klitgaard, H, 2001
)
3.2
"Levetiracetam is a novel antiepileptic drug (AED) with favorable pharmacologic characteristics and demonstrated activity in improving seizure control. "( Efficacy of levetiracetam: a review of three pivotal clinical trials.
Privitera, M, 2001
)
2.13
"Levetiracetam is a Pregnancy Category C drug."( Safety profile of levetiracetam.
Harden, C, 2001
)
1.37
"Levetiracetam is a new antiepileptic drug, structurally and mechanistically dissimilar to other marketed antiepileptic drugs. "( Levetiracetam: a novel antiepileptic drug.
Hovinga, CA, 2001
)
3.2
"Levetiracetam is a new antiepileptic drug with a chemical structure similar to piracetam, but different pharmacological properties. "( [Levetiracetam].
Calleja, S; Salas-Puig, J, 2001
)
2.66
"Levetiracetam is a new antiepileptic drug (AED) that appears to work by a unique mechanism. "( Levetiracetam: a different approach to the pharmacotherapy of epilepsy.
Ficker, DM; Gidal, BE; Privitera, MD; Welty, TE, 2002
)
3.2
"Levetiracetam is a safe and effective new AED. "( Levetiracetam: a different approach to the pharmacotherapy of epilepsy.
Ficker, DM; Gidal, BE; Privitera, MD; Welty, TE, 2002
)
3.2
"Levetiracetam is a new anticonvulsant (AED) with a novel mechanism of action. "( Levetiracetam psychosis in children with epilepsy.
Bergey, GK; Freeman, JM; Kossoff, EH; Vining, EP, 2001
)
3.2
"Levetiracetam is a novel antiepileptic drug with an unknown mechanism of action. "( Carbamazepine toxicity during combination therapy with levetiracetam: a pharmacodynamic interaction.
Patsalos, PN; Sander, JW; Sisodiya, SM, 2002
)
2

Effects

Levetiracetam (LEV) has an improved pharmacological profile and is one of the most commonly used antiepileptic drugs (AEDs) It has a unique receptor binding site, rapid absorption, no known cardiac effects at therapeutic doses, and is theoretically a good candidate for use in drug-induced seizures.

Levetiracetam has been reported to have antiepileptogenic and disease-modifying properties. It also has a low malformation rate, but showed a better effect on seizure outcome during pregnancy than lamotrigine. Levetir acetam has proven efficacy and an excellent safety profile in older patients.

ExcerptReferenceRelevance
"Levetiracetam (LEV) has a low risk of hepatotoxicity due to low liver metabolism. "( Analysis of the clinical characteristics of the liver injury induced by levetiracetam.
He, Y; Li, Z; Sun, W; Wang, C, 2022
)
2.4
"Levetiracetam (LEV) has an improved pharmacological profile and is one of the most commonly used antiepileptic drugs (AEDs). "( Behavioral alterations associated with levetiracetam in pediatric epilepsy.
Cortes, C; Manterola, C, 2020
)
2.27
"Levetiracetam has a unique receptor binding site, rapid absorption, no known cardiac effects at therapeutic doses, and is theoretically a good candidate for use in drug-induced seizures."( Levetiracetam in toxic seizures.
Alunday, RL; Bussmann, S; Lee, T; Sarangarm, P; Seifert, SA; Smolinske, SC; Warrick, BJ, 2018
)
2.64
"Levetiracetam has an ideal safety and pharmacokinetic profile in multiple species, including the adult horse, and may be a safe and cost-effective alternative anticonvulsant in neonatal foals."( Pharmacokinetics of the anticonvulsant levetiracetam in neonatal foals.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; MacDonald, KD, 2018
)
1.47
"Levetiracetam has a high tolerability and is effective against various seizure types and epilepsy syndromes. "( Efficacy and tolerability of levetiracetam for pediatric refractory epilepsy.
Arakawa, H; Hazama, K; Ida, K; Makioka, N; Motojima, T; Muramatsu, K; Ogata, T; Sawaura, N; Tomita, K, 2017
)
2.19
"Levetiracetam has a novel structure and unique mechanisms of action."( Levetiracetam: a review of its use in epilepsy.
Lyseng-Williamson, KA, 2011
)
2.53
"Levetiracetam has a unique profile in preclinical models of epilepsy and has been shown to increase the potency of other antiepileptic drugs."( Enhanced efficacy of anticonvulsants when combined with levetiracetam in soman-exposed rats.
Aas, P; Enger, S; Jonassen, M; Myhrer, T, 2011
)
1.34
"Levetiracetam has a novel structure and unique mechanisms of action."( Spotlight on levetiracetam in epilepsy.
Lyseng-Williamson, KA, 2011
)
1.46
"Levetiracetam monitoring has a role in patients on antiepileptic polypharmacy and for confirmation of compliance."( An initial experience with therapeutic drug monitoring of levetiracetam as reported from a pediatric clinical setting in India.
Fleming, DH; Mathew, BS; Prabha, R; Saravanakumar, K; Thomas, M,
)
1.82
"Levetiracetam also has a favourable pharmacokinetic profile characterised by rapid and nearly complete absorption, very low potential for drug interactions and a prolonged pharmacodynamic effect that permits twice-daily dosing."( Levetiracetam: treatment in epilepsy.
Ben-Menachem, E, 2003
)
2.48
"Levetiracetam has an analgesic effect in the electrical sural nerve stimulation pain model, but it did not increase temporal pain summation threshold. "( Specific effect of levetiracetam in experimental human pain models.
Enggaard, TP; Klitgaard, NA; Sindrup, SH, 2006
)
2.1
"Levetiracetam (LEV) has a wide spectrum of action and a favorable pharmacokinetic profile; however, little data exist regarding its use in SE."( Levetiracetam in the treatment of status epilepticus in adults: a study of 13 episodes.
Bromfield, EB; Rossetti, AO, 2005
)
2.49
"Levetiracetam has a wide margin of safety and patient-friendly pharmacokinetics that distinguish it from other currently available antiepileptic drugs."( Pharmacokinetic profile of levetiracetam: toward ideal characteristics.
Patsalos, PN, 2000
)
1.33
"Levetiracetam has a near perfect pharmacokinetic profile, with rapid absorption following oral administration, excellent bioavailability, quick attainment of steady-state concentrations, linear kinetics and minimal plasma protein binding."( An assessment of levetiracetam as an anti-epileptic drug.
Jain, KK, 2000
)
1.37
"Levetiracetam also has a low malformation rate, but showed a better effect on seizure outcome during pregnancy than lamotrigine."( [Women with epilepsy before and during pregnancy: a case series of outpatient counseling in a tertiary epilepsy center].
Bien, CG; Hagemann, A; Knaak, N; Müffelmann, B, 2022
)
1.44
"Levetiracetam (LEV) has a low risk of hepatotoxicity due to low liver metabolism. "( Analysis of the clinical characteristics of the liver injury induced by levetiracetam.
He, Y; Li, Z; Sun, W; Wang, C, 2022
)
2.4
"Levetiracetam has been confirmed to alleviate the injury of nerve cells, while its functions in SCI remains unclear."( Levetiracetam Attenuates the Spinal Cord Injury Induced by Acute Trauma via Suppressing the Expression of Perforin.
Chen, D; Huang, J; Liu, J; Liu, Z; Wei, Z; Xia, H; Zhang, H; Zhang, W; Zhou, X, 2022
)
2.89
"Levetiracetam (LEV) has been approval for epilepsy seizures."( Levetiracetam, an Antiepileptic Drug has Neuroprotective Effects on Intracranial Hemorrhage Injury.
Hara, H; Imai, T; Iwata, S; Nakamura, S; Shimazawa, M; Sugiyama, T, 2020
)
2.72
"Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates."( Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial.
Arnell, K; Battin, MR; Bridge, R; Davis, SL; Ernstrom, K; Gold, JJ; Haas, RH; Harbert, MJ; Honold, J; Joe, P; Kim, J; Knodel, E; Kuperman, R; Lane, B; Le, NM; Lee, L; Michelson, D; Mower, A; Nespeca, M; Raman, R; Rasmussen, M; Reiner, GE; Rismanchi, N; Sharpe, C; Wang, S, 2020
)
2.72
"Levetiracetam (LEV) has been demonstrated to improve cognitive function. "( Levetiracetam induction of theta frequency oscillations in rodent hippocampus in vitro.
Han, X; Lu, C; Wang, Y; Xie, X; Xing, H; Xu, S, 2020
)
3.44
"Levetiracetam has fewer cardiovascular side effects and has a safer profile than phenytoin."( Efficacy and safety profile of intravenous levetiracetam versus phenytoin in convulsive status epilepticus and acute repetitive seizures in children.
Besli, GE; Yilmaz, S; Yuksel Karatoprak, E, 2020
)
1.54
"Levetiracetam has replaced sodium valproate as the most frequently prescribed ASM in pediatric patients."( Trends of anti-seizure medication use in pediatric patients in six cities in China from 2013 to 2018.
Dai, H; Feng, J; Yu, L; Yu, Z, 2020
)
1.28
"Levetiracetam has shown to have promising anti-epileptic properties for the management of neonatal seizure with better efficacy and less or no side effects. "( Efficacy of Levetiracetam in neonatal seizures: a systematic review.
Hussain, AM; Sharma, D; Sharma, SS, 2022
)
2.54
"Levetiracetam (LEV) has an improved pharmacological profile and is one of the most commonly used antiepileptic drugs (AEDs). "( Behavioral alterations associated with levetiracetam in pediatric epilepsy.
Cortes, C; Manterola, C, 2020
)
2.27
"Levetiracetam has been widely used as a treatment option for different types of epilepsy in both adults and children. "( Population Pharmacokinetics of Levetiracetam: A Systematic Review.
Jiao, Z; Li, ZR; Wang, CY; Zhu, X, 2021
)
2.35
"Levetiracetam reportedly has similar efficacy and higher safety for SE; however, evidence to support its use for adult SE is lacking."( Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for status epilepticus: study protocol for a multicenter non-inferiority designed randomized control trial.
Asami, M; Egawa, S; Hoshiyama, E; Inoue, Y; Kaneko, J; Kimura, A; Kondo, Y; Maruo, K; Marushima, A; Nakamura, K; Takahashi, Y; Yamada, T; Yonekawa, C, 2021
)
2.79
"Levetiracetam has also been shown to improve memory difficulties in patients with mild cognitive impairment, a precursor to Alzheimer's disease."( An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD): a double-blind, placebo-controlled, randomised crossover proof of concept study.
Akinola, M; Butler, C; Chan, JYC; Davis Jones, G; Frangou, E; Galloway, J; Geddes, J; Hallam, A; Husain, M; Koychev, I; Love, S; Manohar, SG; McShane, R; Mura, S; Sen, A; Symmonds, M; Tai, XY; Thompson, S; Van Der Putt, R, 2021
)
1.67
"Levetiracetam has been emerging as a potential therapeutic option for refractory neonatal convulsions owing to its non-hepatic elimination, linear pharmacokinetics, low protein binding and better safety profile."( A Review on Pharmacokinetics of Levetiracetam in Neonates.
Agrawal, A; Banergee, A, 2017
)
2.18
"Levetiracetam has a unique receptor binding site, rapid absorption, no known cardiac effects at therapeutic doses, and is theoretically a good candidate for use in drug-induced seizures."( Levetiracetam in toxic seizures.
Alunday, RL; Bussmann, S; Lee, T; Sarangarm, P; Seifert, SA; Smolinske, SC; Warrick, BJ, 2018
)
2.64
"Levetiracetam has an ideal safety and pharmacokinetic profile in multiple species, including the adult horse, and may be a safe and cost-effective alternative anticonvulsant in neonatal foals."( Pharmacokinetics of the anticonvulsant levetiracetam in neonatal foals.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; MacDonald, KD, 2018
)
1.47
"Levetiracetam has excellent intragastric bioavailability in foals and is predicted to maintain plasma concentrations at or above the proposed target concentration with twice daily i.v. "( Pharmacokinetics of the anticonvulsant levetiracetam in neonatal foals.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; MacDonald, KD, 2018
)
2.19
"Levetiracetam has replaced valproic acid as the most frequently prescribed first line antiepileptic drug in children since 2012, which is in line with national guidelines."( Antiepileptic drug prescription in Dutch children from 2006-2014 using pharmacy-dispensing data.
Bos, JHJ; Brouwer, OF; Callenbach, PMC; Schuiling-Veninga, CCM; Weijenberg, A, 2018
)
1.2
"Levetiracetam (LEV) has been introduced as an AED with an almost perfect pharmacokinetic (PK) profile."( Review on the relevance of therapeutic drug monitoring of levetiracetam.
Chan, H; de Haan, GJ; Evers, S; Klarenbeek, P; Majoie, M; Sourbron, J; van der Kuy, H; Wammes-van der Heijden, EA; Wijnen, BFM, 2018
)
1.45
"Levetiracetam has been introduced for the control of seizures besides phenobarbital as monotherapy in children with epilepsy. "( A Randomized Controlled Trial of Phenobarbital and Levetiracetam in Childhood Epilepsy.
Akhter, S; Akter, N; Fatema, K; Rahman, MM, 2018
)
2.18
"Levetiracetam (LEV) has several properties that make it an appealing drug for transdermal application."( Serum levetiracetam concentrations after transdermal levetiracetam administration, 3 times daily, to healthy cats.
Barnes Heller, HL; Reif, N; Reinhart, JM; Smith, C; Van Hesteren, M, 2019
)
1.72
"Levetiracetam has been used to prevent and treat paediatric epilepsy for years."( Efficacy and safety of levetiracetam in children with epilepsy: protocol for an umbrella review of systematic reviews and meta-analyses of randomised controlled trials.
Gan, J; Ma, D; Xiong, T, 2019
)
1.55
"Levetiracetam has been reported to be well tolerated and effective in status epilepticus (SE) refractory to benzodiazepine. "( The effect of levetiracetam on status epilepticus-induced neuronal death in the rat hippocampus.
Choi, HC; Kang, TC; Kim, JE; Kim, YI; Lee, DS; Ryu, HJ; Song, HK, 2013
)
2.19
"Levetiracetam has been used in children and infants with good efficacy, an excellent safety profile, and near-ideal pharmacokinetic characteristics."( Newly emerging therapies for neonatal seizures.
Mangum, B; Pressler, RM, 2013
)
1.11
"Levetiracetam has been proven to be effective in both partial and generalized seizures in children. "( Efficacy and safety of IV levetiracetam in children with acute repetitive seizures.
Ağın, H; Akarcan, SE; Celik, T; Güzel, O; İşgüder, R; Ünalp, A; Yılmaz, Ü, 2014
)
2.15
"Levetiracetam has been considered relatively safe compared with other antiepileptics with regard to skin eruptions."( Rare Red Rashes: A Case Report of Levetiracetam-Induced Cutaneous Reaction and Review of the Literature.
Evans, W; Jones, RT; Kavanaugh, K; Mersfelder, TL,
)
1.13
"Levetiracetam (LEV) has been proposed as an alternative to PHT."( The safety and efficacy of levetiracetam versus phenytoin for seizure prophylaxis after traumatic brain injury: A systematic review and meta-analysis.
Li, J; Qi, L; Shao, WZ; Shen, J; Sun, YZ; Tang, LJ; Xu, JC; Zhai, XF; Zheng, JY, 2016
)
1.45
"Levetiracetam has a high tolerability and is effective against various seizure types and epilepsy syndromes. "( Efficacy and tolerability of levetiracetam for pediatric refractory epilepsy.
Arakawa, H; Hazama, K; Ida, K; Makioka, N; Motojima, T; Muramatsu, K; Ogata, T; Sawaura, N; Tomita, K, 2017
)
2.19
"Levetiracetam has broad-spectrum activity in epilepsy. "( Levetiracetam-induced thrombocytopenia in a patient with status epilepticus.
Kim, J; Shin, JW, 2017
)
3.34
"Levetiracetam (LEV) has been considered to undergo no significant change in bioavailability during pregnancy; however, it was recently demonstrated to display modifications leading to a drop in its serum level. "( Impending status epilepticus and anxiety in a pregnant woman treated with levetiracetam.
Hubschmid, M; Michel, P; Novy, J; Rossetti, AO, 2008
)
2.02
"Levetiracetam has been reported to have antiepileptogenic and disease-modifying properties."( Effects of chronic treatment with levetiracetam on hippocampal field responses after pilocarpine-induced status epilepticus in rats.
Kaminski, RM; Klitgaard, H; Margineanu, DG; Matagne, A, 2008
)
1.35
"Levetiracetam has favorable pharmacokinetics, good efficacy in elderly individuals, a favorable side effect profile, and lacks major drug interactions."( Levetiracetam: a practical option for seizure management in elderly patients with cognitive impairment.
Hepler, M; Irwin, D; Jenssen, S; Lippa, CF; Pillai, J; Rosso, A, 2010
)
2.52
"Levetiracetam has shown some efficacy in open studies in migraine prevention, both in adults and children."( [The role of the neuromodulators in the preventive treatment of migraine].
Pascual-Gómez, J,
)
0.85
"Levetiracetam (LEV) has been shown to suppress myoclonus of various origins. "( Levetiracetam reduces myoclonus in corticobasal degeneration: report of two cases.
Barsi, P; Farsang, M; Györke, T; Kamondi, A; Kovács, T; Szirmai, I; Vitaszil, E, 2009
)
3.24
"Levetiracetam also has the potential for less drug interactions compared to phenytoin in these patients."( A prospective evaluation and literature review of levetiracetam use in patients with brain tumors and seizures.
Finch, CK; Michael, LM; Sills, AK; Usery, JB, 2010
)
1.34
"Levetiracetam has been widely used for childhood epilepsy, but there is no high quality evidence to support its use. "( [Levetiracetam therapy for childhood epilepsy: a systematic review].
Dai, J; Han, L; Wang, L; Zhang, LL, 2010
)
2.71
"Levetiracetam has shown good safety/tolerability and efficacy in regulatory trials. "( The EULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year.
Blazejewski, S; Blin, P; Droz-Perroteau, C; Dureau-Pournin, C; Fourrier-Réglat, A; Jové, J; Marchal, C; Moore, N; Pollet, C; Robinson, P; Vespignani, H, 2011
)
2.04
"Levetiracetam has a novel structure and unique mechanisms of action."( Levetiracetam: a review of its use in epilepsy.
Lyseng-Williamson, KA, 2011
)
2.53
"Levetiracetam has a unique profile in preclinical models of epilepsy and has been shown to increase the potency of other antiepileptic drugs."( Enhanced efficacy of anticonvulsants when combined with levetiracetam in soman-exposed rats.
Aas, P; Enger, S; Jonassen, M; Myhrer, T, 2011
)
1.34
"Levetiracetam has a novel structure and unique mechanisms of action."( Spotlight on levetiracetam in epilepsy.
Lyseng-Williamson, KA, 2011
)
1.46
"Levetiracetam monitoring has a role in patients on antiepileptic polypharmacy and for confirmation of compliance."( An initial experience with therapeutic drug monitoring of levetiracetam as reported from a pediatric clinical setting in India.
Fleming, DH; Mathew, BS; Prabha, R; Saravanakumar, K; Thomas, M,
)
1.82
"Levetiracetam (LEV) has antiepileptogenic effects in animals and is a candidate for prevention of epilepsy after traumatic brain injury. "( Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy.
Atabaki, SM; He, J; Herr, D; Klein, P; Levine, Z; McCarter, R; Natale, J; Nogay, C; Pearl, PL; Sandoval, F; Soldin, SJ; Trzcinsky, S; Tsuchida, T; van den Anker, J, 2012
)
2.08
"Levetiracetam has been authorized for use in Israel as an add-on therapy for intractable epilepsy since May 2006. "( Levetiracetam in children, adolescents and young adults with intractable epilepsy: efficacy, tolerability and effect on electroencephalogram--a pilot study.
Eidlitz-Markus, T; Feldman, L; Goldberg-Stern, H; Kramer, U; Perez, S; Phatal-Valevski, A; Pollak, L, 2013
)
3.28
"Levetiracetam has been shown to be an antiepileptic drug with unquestionable advantages: favourable pharmacokinetic properties, rapid titration, high efficiency and low toxicity profile. "( [Effectiveness and tolerability of the new antiepileptic drugs: the position of levetiracetam].
Arroyo, S,
)
1.8
"Levetiracetam has specific characteristics that make it an optimal choice for many patient populations."( Role of levetiracetam in the treatment of epilepsy.
Brodie, MJ; French, JA, 2003
)
1.47
"Levetiracetam also has a favourable pharmacokinetic profile characterised by rapid and nearly complete absorption, very low potential for drug interactions and a prolonged pharmacodynamic effect that permits twice-daily dosing."( Levetiracetam: treatment in epilepsy.
Ben-Menachem, E, 2003
)
2.48
"Levetiracetam (LEV) has proven effective for partial seizures, suggesting the need to trial it in generalised epilepsy. "( A pilot study of compassionate use of Levetiracetam in patients with generalised epilepsy.
Beran, RG; Weber, S, 2004
)
2.04
"Levetiracetam has promising but selective antimyoclonic potential, which should be the subject of further study."( Limited efficacy of levetiracetam on myoclonus of different etiologies.
Ahmed, A; Lim, LL, 2005
)
1.37
"Levetiracetam has an analgesic effect in the electrical sural nerve stimulation pain model, but it did not increase temporal pain summation threshold. "( Specific effect of levetiracetam in experimental human pain models.
Enggaard, TP; Klitgaard, NA; Sindrup, SH, 2006
)
2.1
"Levetiracetam (LEV) has a wide spectrum of action and a favorable pharmacokinetic profile; however, little data exist regarding its use in SE."( Levetiracetam in the treatment of status epilepticus in adults: a study of 13 episodes.
Bromfield, EB; Rossetti, AO, 2005
)
2.49
"Levetiracetam has no effect on peripheral nerve conduction even at high concentrations."( The actions of lamotrigine and levetiracetam on the conduction properties of isolated rat sciatic nerve.
Bozdemir, H; Gunay, I; Guven, M; Kahraman, I; Koc, F; Sarica, Y, 2006
)
1.34
"* Levetiracetam has been evaluated for epilepsy since 1992. "( Single-dose pharmacokinetics of levetiracetam in healthy Chinese male subjects.
Hu, P; Jiang, J; Li, X; Lu, ZS; Zhao, Q, 2007
)
1.34
"Levetiracetam has been a commonly prescribed oral anticonvulsant for the use of adjunctive therapy for partial seizures in adults with favorable tolerability, and it has been recently approved for children older than age 4 years."( Levetiracetam for the treatment of neonatal seizures.
Rotenberg, JS; Shoemaker, MT, 2007
)
2.5
"Levetiracetam has been associated with improved language function in LKS and seizure reduction in BRE."( A pilot study transitioning children onto levetiracetam monotherapy to improve language dysfunction associated with benign rolandic epilepsy.
Boatman, DF; Kossoff, EH; Los, JG, 2007
)
1.33
"Levetiracetam has a wide margin of safety and patient-friendly pharmacokinetics that distinguish it from other currently available antiepileptic drugs."( Pharmacokinetic profile of levetiracetam: toward ideal characteristics.
Patsalos, PN, 2000
)
1.33
"Levetiracetam has recently been approved as an adjunctive medication for partial seizures and frequently will be added to phenytoin. "( Absence of pharmacokinetic drug interaction of levetiracetam with phenytoin in patients with epilepsy determined by new technique.
Baltes, E; Browne, TR; Jensen, CM; Josephs, E; Leppik, IE; Paz, J; Szabo, GK, 2000
)
2.01
"Levetiracetam has been shown to be effective in genetic and kindled animal models of epilepsy and against chemoconvulsant-induced partial epileptic seizures."( An assessment of levetiracetam as an anti-epileptic drug.
Jain, KK, 2000
)
1.37
"Levetiracetam has the more favourable 'responder-withdrawal ratio' followed by zonisamide and oxcarbazepine."( Levetiracetam, oxcarbazepine, remacemide and zonisamide for drug resistant localization-related epilepsy: a systematic review.
Castillo, S; Chadwick, DW; Chaisewikul, R; Hutton, JL; Leach, JP; Marson, AG; Privitera, M; Schmidt, D; White, S, 2001
)
2.47
"Levetiracetam has many therapeutic advantages for patients with epilepsy."( Levetiracetam: a novel antiepileptic drug.
Hovinga, CA, 2001
)
2.47

Actions

Levetiracetam showed lower retention rate than VPA, primarily due to poorer seizure control during long-term follow-up. The drug can suppress sialidosis-related myoclonus but its effects on cerebral metabolism warrant elucidation.

ExcerptReferenceRelevance
"levetiracetam tends to produce ocular neuromuscular disorder-related AEs."( Eye disorders associated with newer antiepileptic drugs: A real-world disproportionality analysis of FDA adverse event reporting system.
Chen, L; Hu, W; Li, H; Liu, J, 2022
)
1.44
"Levetiracetam may cause less respiratory depression."( Levetiracetam Versus Phenytoin or Fosphenytoin for Second-Line Treatment of Pediatric Status Epilepticus: A Meta-Analysis.
Catenacci, V; Choong, K; Duffett, M; Hewitt, M; Jones, K; Klowak, JA; Rochwerg, B, 2021
)
2.79
"Levetiracetam resulted in a lower risk of short-term adverse events compared to phenobarbital (risk ratio [95% CI] 0.24 [0.06-0.92]) (GRADE - moderate)."( Levetiracetam as the first-line treatment for neonatal seizures: a systematic review and meta-analysis.
Bhulani, A; Hooper, RG; Ramaswamy, VV; Satodia, P; Wahid, RM, 2021
)
2.79
"Levetiracetam did not cause miscarriage during pregnancy in mother rats."( Genotoxic effects of prenatal exposure to levetiracetam during pregnancy on rat offsprings.
Elbistan, M; Kara, N; Karakuş, N; Ozyurek, H; Tekcan, A; Tural, S,
)
1.12
"Levetiracetam showed lower retention rate than VPA, primarily due to poorer seizure control during long-term follow-up. "( Levetiracetam and Valproate Retention Rate in Juvenile Myoclonic Epilepsy.
González-Cuevas, M; Quintana, M; Raspall-Chaure, M; Sala-Padró, J; Salas-Puig, X; Santamarina, E; Sueiras-Gil, M; Toledo, M,
)
3.02
"Levetiracetam is known to cause less cognitive disruption and may be a suitable alternative for seizure prophylaxis."( Levetiracetam is associated with improved cognitive outcome for patients with intracranial hemorrhage.
Ehtisham, A; Heinrichs, RJ; Janzen, JM; Taylor, S, 2011
)
2.53
"Levetiracetam can suppress sialidosis-related myoclonus but its effects on cerebral metabolism warrant elucidation. "( Functional neuroimages of cortical myoclonus altered by levetiracetam in a patient with sialidosis.
Chen, KF; Lai, SC; Lu, CS; Lu, MK; Tsai, CH; Wu, YC, 2013
)
2.08
"Levetiracetam does not cause induction or inhibition of the P450 enzyme system or other enzyme systems, there is no active metabolite and it exhibits almost no protein binding."( [Levetiracetam: an anti-epileptic drug with interesting pharmacokinetic properties].
Vecht, ChJ; Wagner, GL; Wilms, EB, 2002
)
1.95
"Levetiracetam may allow patients to decrease the number of concomi-tant antiepileptic medications or withdraw to monotherapy."( Long-term experience with levetiracetam.
Abou-Khalil, B; Lazenby, B, 2003
)
1.34
"Levetiracetam did not increase or decrease mean steady-state serum concentrations of carbamazepine, phenytoin, valproic acid, lamotrigine, gabapentin, phenobarbital, or primidone."( Effect of levetiracetam on the pharmacokinetics of adjunctive antiepileptic drugs: a pooled analysis of data from randomized clinical trials.
Baltès, E; Gidal, BE; Otoul, C; Perucca, E,
)
1.26

Treatment

Levetiracetam treatment for 25 days, initiated 24 hours after induction of kainate-induced SE, significantly decreased the mean duration of spontaneous EEG seizures 58 days later. The levetir acetam XR treatment group showed significantly fewer consequences than did the placebo group during the maintenance period.

ExcerptReferenceRelevance
"Levetiracetam treatment may not be effective for all GBM patients. "( The effect of levetiracetam treatment on survival in patients with glioblastoma: a systematic review and meta-analysis.
Chen, ES; Chen, JS; Clarke, R; Haddad, AF; Lacroix, M; Sarkar, IN; Toms, SA; Wang, EJ; Zand, R, 2022
)
2.52
"Levetiracetam-treated PWEs with SR have significantly low AED levels than PWE with no-SR (P < 0.001)."( Antiepileptic-drug tapering and seizure recurrence: Correlation with serum drug levels and biomarkers in persons with epilepsy.
Gupta, YK; Kaleekal, T; Kumar, S; Sarangi, SC; Singh, S; Tripathi, M,
)
0.85
"Levetiracetam is a frequent treatment choice in these situations."( The safety of rapid infusion levetiracetam: A systematic review.
Douville, A; Jense, A; Weiss, A, 2022
)
1.73
"Levetiracetam treatment decreased NF-κB activity and the expression of proinflammatory mediators TNF-α, IL-6, IL-1β, IFN-γ, MCP-1 and ICAM-1."( Levetiracetam attenuates experimental ulcerative colitis through promoting Nrf2/HO-1 antioxidant and inhibiting NF-κB, proinflammatory cytokines and iNOS/NO pathways.
Amirshahrokhi, K; Imani, M, 2023
)
3.07
"Levetiracetam treatment showed reduction in the body weight of adult rats and their offspring and pathological changes in their liver."( Morphological, biochemical, and histopathological effects of levetiracetam on pregnant albino rats and their offspring.
Abdelaziz, SMH; Abdelgalil, RM; Abdelmohsen, SR, 2023
)
1.87
"Levetiracetam treatment seems to be effective in improving upper limb dexterity in MS patients with cerebellar signs."( Efficacy of levetiracetam on upper limb movement in multiple sclerosis patients with cerebellar signs: a multicenter double-blind, placebo-controlled, crossover study.
Bergamaschi, R; de Sire, A; Gasperini, C; Messmer Uccelli, M; Mueller, M; Patti, F; Restivo, DA; Solaro, C; Stabile, MR, 2020
)
2.38
"Levetiracetam-treated patients showed no significant changes in thyroid hormone levels, bone metabolism, and bone mineral density during the 12-month follow-up period compared with baseline values."( The effect of levetiracetam and oxcarbazepine monotherapy on thyroid hormones and bone metabolism in children with epilepsy: A prospective study.
Du, LJ; Guo, JX; Hong, H; Shi, KL; Wu, YH; Yang, CZ; Zhao, HM, 2020
)
1.64
"Levetiracetam treatment did not affect bone strength, bone mass, and bone turnover."( Effects of the Antiepileptic Drugs Phenytoin, Gabapentin, and Levetiracetam on Bone Strength, Bone Mass, and Bone Turnover in Rats.
Izumo, N; Kanda, J; Kobayashi, Y; Onodera, K; Shimakura, T; Takahashi, HE; Wakabayashi, H; Yamamoto, N, 2017
)
1.42
"Levetiracetam-treated mice showed downregulation of retinal GLUT1 with relief and regression of retinal inflammation and improved retinal structural organization."( Neuroprotective effect of levetiracetam in mouse diabetic retinopathy: Effect on glucose transporter-1 and GAP43 expression.
El-Ghaiesh, SH; Makary, S; Mohamed, AO; Mohammad, HMF; Sami, MM; Toraih, EA, 2019
)
1.54
"Levetiracetam treatment resulted in a decrease of the percentage of CD4(+)CD25(+)-lymphocytes (26.1±8.0% vs."( Chronic valproate or levetiracetam treatment does not influence cytokine levels in humans.
Bauer, S; Guenther, S; Hagge, M; Hamer, HM; Knake, S; Olmes, DG; Rosenow, F; Tackenberg, B, 2014
)
1.44
"Levetiracetam-treated cats had higher freedom from myoclonic seizures (50.0% vs 0%; P <0.001) during the treatment period."( Levetiracetam in the management of feline audiogenic reflex seizures: a randomised, controlled, open-label study.
Bessant, C; Garosi, L; Harvey, RJ; Lowrie, M; Sparkes, A; Thomson, S, 2017
)
2.62
"Levetiracetam treatment had a clear beneficial effect on the overall quality of life (QOL) scores of the patients, as indicated by significantly improved cognitive functioning, behavior problems, emotional conditioning, physical condition, social functioning, self-assessed life quality score, self-assessed health score, and the total QOL score (P < 0.05)."( The Effects of Levetiracetam on Cerebrospinal Fluid and Plasma NPY and GAL, and on the Components of Stress Response System, hs-CRP, and S100B Protein in Serum of Patients with Refractory Epilepsy.
Chen, W; Chen, Y; Ge, Y; Liu, X; Tan, Y, 2015
)
1.49
"Levetiracetam-treated patients manifested an early augmentation of self-rated aggressiveness, which increased in intensity over the course of days. "( Early detection of behavioral side effects of antiepileptic treatment using handheld computers.
Carius, A; Frings, L; Lehmann, C; Maiwald, T; Schinkel, A; Schulze-Bonhage, A; Wagner, K, 2008
)
1.79
"Levetiracetam treatment dose-dependently counteracted these long-term effects of pilocarpine-induced SE."( Effects of chronic treatment with levetiracetam on hippocampal field responses after pilocarpine-induced status epilepticus in rats.
Kaminski, RM; Klitgaard, H; Margineanu, DG; Matagne, A, 2008
)
1.35
"Levetiracetam treatment for 25 days, initiated 24 hours after induction of kainate-induced SE, significantly decreased the mean duration of spontaneous EEG seizures 58 days later."( Levetiracetam suppresses development of spontaneous EEG seizures and aberrant neurogenesis following kainate-induced status epilepticus.
Kato, N; Kudo, K; Maru, E; Shibasaki, T; Sugaya, Y, 2010
)
2.52
"Levetiracetam treatment lasted 8 months."( Epileptic seizures after octreotide administration in a 6.5-year-old female with ALL and L-asparaginase associated pancreatitis: a possible drug interaction.
Athanassiadou, F; Balakou, E; Hatzipantelis, E; Pana, ZD; Papageorgiou, T; Pavlou, E; Tragiannidis, A; Tsotoulidou, V, 2011
)
1.09
"The levetiracetam XR treatment group showed significantly fewer consequences than did the placebo group during the maintenance period (p = 0.02)."( A double-blind, placebo-controlled trial assessing the efficacy of levetiracetam extended-release in very heavy drinking alcohol-dependent patients.
A Tompkins, D; Brunette, MF; Ciraulo, D; Devine, E; Falk, DE; Fertig, JB; Green, AI; Johnson, B; Kampman, K; Litten, RZ; Mattson, ME; Pettinati, H; Ransom, J; Rickman, WJ; Ryan, ML; Scott, C; Stout, R; Strain, EC; Tiouririne, NA, 2012
)
1.1
"Levetiracetam treatment was restarted, and 3 hours after the first dose of 1000 mg, spike-wave bursts dropped to 135 per hour."( Levetiracetam induces a rapid and sustained reduction of generalized spike-wave and clinical absence.
Cavitt, J; Privitera, M, 2004
)
2.49
"Levetiracetam (LEV) treatment was started in combination with VPA in a patient with typical clinical, histological, and biochemical features of MERRF due to a mutation on the tRNA of Phenilalanine gene."( Antimyoclonic effect of levetiracetam in MERRF syndrome.
Filosto, M; Galli, R; Mancuso, M; Murri, L; Pizzanelli, C; Siciliano, G, 2006
)
1.36
"Levetiracetam-treated patients commonly report daytime drowsiness, fatique, asthenia and decreasing of motor activity. "( Comparison of motor activity and sleep in patients with complex partial seizures on levetiracetam treatment and a group of healthy subjects.
Yilmaz, H, 2007
)
2.01
"Levetiracetam-treated patients were more likely to respond to treatment than patients receiving placebo (OR = 4.77; 95% CI, 2.12 to 10.77; p < 0.001)."( Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures.
Andermann, E; Andermann, F; Gough, WB; Meyvisch, P; Noachtar, S; Schiemann-Delgado, J, 2008
)
2.51
"Levetiracetam treatment was safe and effective in this group of very young patients with various types of epilepsy."( Efficacy of levetiracetam in children with epilepsy younger than 2 years of age.
Krief, P; Maytal, J, 2008
)
1.45
"Treatment with levetiracetam as a first-line ASM resulted in a significant increase in the probability of seizure freedom (p < .05) at 2 years compared with treatment with an alternative ASM. "( Levetiracetam as a first-line antiseizure medication in WHO grade 2 glioma: Time to seizure freedom and rates of treatment failure.
Chumas, P; Fairclough, S; Goodden, J; Maguire, M; Mathew, R, 2023
)
2.71
"Treatment with levetiracetam induced undesirable histopathological changes in the liver and kidney of pregnant albino rats. "( Biochemical and histological study on the effect of levetiracetam on the liver and kidney of pregnant albino rats.
Arafa, MAA; Hanafy, SM; Sabbah, WS, 2019
)
1.12
"Treatment with levetiracetam resulted in complete recovery and seizure freedom that was confirmed on a second long-term EEG."( Transient epileptic amnesia diagnosed using long-term electroencephalography.
Beier, CP; Jensen, CD; Krøigård, T, 2020
)
0.9
"Treatment with levetiracetam dose-dependently improved memory performance of the ketamine-exposed rats."( Treatment with levetiracetam improves cognition in a ketamine rat model of schizophrenia.
Gallagher, M; Koh, MT; Rosenzweig-Lipson, S; Shao, Y, 2018
)
1.17
"Oral treatment with levetiracetam resolved his seizures."( Generalised electrographic seizures presenting as perioral myoclonia.
Dearborn, JL; Kaplan, PW, 2014
)
0.72
"Treatment with levetiracetam or topiramate (off-label use) is the new option for patients with refractory status epilepticus, which is characterized by downregulation of the inhibitory gamma-aminobutyric acid system, because these drugs act via different mechanisms and are rapidly titratable, espec"( [Antiepileptic drugs in North America].
Akiyama, T; Otsubo, H, 2010
)
0.7
"Pretreatment with levetiracetam failed to exert any antiepileptogenic effect."( Protein kinase inhibitor as a potential candidate for epilepsy treatment.
Gajda, Z; Horváth, Z; Kéri, G; Orfi, L; Szántai-Kis, C; Szente, M; Török, R, 2011
)
0.69
"Treatment with levetiracetam rescued normal neurotransmission and restored normal levels of SV2 and synaptotagmin at the synapse."( Levetiracetam reverses synaptic deficits produced by overexpression of SV2A.
Bajjalieh, SM; Bleckert, A; Hill, J; Malarkey, EB; Nowack, A; Yao, J, 2011
)
2.15
"Treatment with levetiracetam (55 mg/kg/d) for 30 days starting within 8 hours after injury."( Results of phase 2 safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy.
Atabaki, SM; He, J; Herr, D; Klein, P; Levine, Z; McCarter, R; Natale, J; Nogay, C; Pearl, PL; Sandoval, F; Soldin, SJ; Trzcinski, S; Tsuchida, T; van den Anker, J, 2012
)
0.97
"Pretreatment with levetiracetam markedly delays the progression of kindling and, in addition, exhibits a clear anticonvulsant effect."( Levetiracetam prevents changes in levels of brain-derived neurotrophic factor and neuropeptide Y mRNA and of Y1- and Y5-like receptors in the hippocampus of rats undergoing amygdala kindling: implications for antiepileptogenic and mood-stabilizing propert
Bolwig, TG; Hansen, SL; Husum, H; Mathé, AA; Sánchez, C, 2004
)
2.09
"Treatment with levetiracetam is efficacious, and levetiracetam-treated patients require significantly lower doses of immunosuppressant medications to achieve an equivalent antirejection effect."( Levetiracetam for seizures after liver transplantation.
Bergethon, PR; Freeman, R; Glass, GA; Mithoefer, A; Stankiewicz, J, 2005
)
2.11
"Treatment with levetiracetam improved both ictal and interictal status."( Levetiracetam in a neonate with malignant migrating partial seizures.
Bonnier, C; Hmaimess, G; Kadhim, H; Nassogne, MC; van Rijckevorsel, K, 2006
)
2.12
"Treatment with levetiracetam also improved functional outcomes and reduced vasospasm following SAH."( Levetiracetam is neuroprotective in murine models of closed head injury and subarachnoid hemorrhage.
Gao, J; Laskowitz, DT; Lassiter, TF; Lynch, JR; McDonagh, DL; Sheng, H; Wang, H; Warner, DS, 2006
)
2.12
"Treatment with levetiracetam produced a striking remission of seizures."( Coexistence of epileptic nocturnal wanderings and an arachnoid cyst.
Avila-Ordoñez, MU; Díaz-Galviz, JL; García-Reyna, JC; Jiménez-Genchi, A, 2007
)
0.68
"Treatment with levetiracetam 250 mg orally b.i.d."( Treatment of tardive dyskinesia with levetiracetam in a transplant patient.
Abu-Elmagd, KM; Bond, G; Costa, G; Zivković, SA, 2008
)
0.96

Toxicity

Levetiracetam is effective and safe as add-on treatment for partial-onset seizures in clinical practice. Adverse effects were minimal throughout dosing period, indicating that the drug was well tolerated.

ExcerptReferenceRelevance
"A number of commonly used antiepileptic drugs (AEDs) produce severe adverse effects if they are introduced at their usual daily maintenance doses."( Concerns with antiepileptic drug initiation: safety, tolerability, and efficacy.
Ferrendelli, JA, 2001
)
0.31
" When levetiracetam was given along with other antiepileptic drugs (AEDs), the most frequently reported adverse events were central nervous system related."( Safety profile of levetiracetam.
Harden, C, 2001
)
1.13
"The integrated summary of safety report submitted for regulatory review was examined to collate information about abnormal laboratory tests values and adverse event reports collected during the overall LEV development program."( A systematic review of the safety profile of levetiracetam: a new antiepileptic drug.
Cramer, JA; Edrich, P; French, J, 2001
)
0.57
"Safety data from all studies depict a similar pattern of adverse effects, predominantly somnolence, asthenia, and dizziness that occurred most frequently during the first month of LEV treatment."( A systematic review of the safety profile of levetiracetam: a new antiepileptic drug.
Cramer, JA; Edrich, P; French, J, 2001
)
0.57
"This review of patients evaluated during the clinical development program suggests that LEV was well tolerated and safe for patients with seizure, cognitive and anxiety disorders."( A systematic review of the safety profile of levetiracetam: a new antiepileptic drug.
Cramer, JA; Edrich, P; French, J, 2001
)
0.57
" The most commonly reported adverse events were headache, infection, anorexia, and somnolence."( Efficacy and safety of levetiracetam in children with partial seizures: an open-label trial.
Bebin, EM; Fountain, NB; Glauser, TA; Jensen, CM; Pellock, JM; Ritter, FJ; Shields, WD, 2002
)
0.63
" Controlled clinical trials, open-label studies, and postmarketing surveillance indicate that leveti-racetam has a favorable safety profile characterized by little effect on vital signs or clinical laboratory values, reported adverse events that are mild to moderate, and no known drug-drug interactions."( Safety profile of levetiracetam.
Arroyo, S; Crawford, P, 2003
)
0.65
"The prevalence and psychopathologic features of psychiatric adverse events (PAE) in 517 patients taking levetiracetam (LEV) were investigated."( Psychiatric adverse events during levetiracetam therapy.
Liu, RS; Mula, M; Sander, JW; Trimble, MR; Yuen, A, 2003
)
0.81
"To investigate the prevalence and psychopathological features of psychiatric adverse events (PAEs) in patients with learning disabilities (LD) in therapy with levetiracetam (LEV)."( Psychiatric adverse events in patients with epilepsy and learning disabilities taking levetiracetam.
Mula, M; Sander, JW; Trimble, MR, 2004
)
0.74
" A haematological adverse event is another possibility since piracetam, a related molecule, has a known impact on erythrocytes and platelets."( Enterocolitis: an adverse event in refractory epilepsy patients treated with levetiracetam?
Boon, P; Bosman, T; Claeys, P; De Clercq, M; De Reuck, J; Van Vlierberghe, H; Vonck, K, 2004
)
0.55
"The close temporal relationship between initiation of LEV intake, symptomatic colitis and clinical improvement following LEV tapering, suggests that colitis may be a possible and previously undescribed adverse effect of LEV."( Enterocolitis: an adverse event in refractory epilepsy patients treated with levetiracetam?
Boon, P; Bosman, T; Claeys, P; De Clercq, M; De Reuck, J; Van Vlierberghe, H; Vonck, K, 2004
)
0.55
" Safety evaluation was adverse events reporting."( [Safety of levetiracetam as adjunctive therapy in epilepsy: the SKATE trial in Spain].
Gil-Nágel-Rein, A; Salas-Puig, J; Serratosa, JM; Viteri, C,
)
0.52
"1%) experienced at least one adverse event."( [Safety of levetiracetam as adjunctive therapy in epilepsy: the SKATE trial in Spain].
Gil-Nágel-Rein, A; Salas-Puig, J; Serratosa, JM; Viteri, C,
)
0.52
" In Phase II/III trials, the adverse effects occurring more commonly in the treatment groups versus the placebo group were; somnolence (14."( Levetiracetam safety profiles and tolerability in epilepsy patients.
Briggs, DE; French, JA, 2004
)
1.77
" Seizure count and adverse events were recorded by patients in a diary."( Efficacy and safety of levetiracetam 1000-3000 mg/day in patients with refractory partial-onset seizures: a multicenter, open-label single-arm study.
Beran, RG; Berkovic, SF; Black, AB; Danta, G; Hiersemenzel, R; Schapel, GJ; Vajda, FJ, 2005
)
0.64
" The most frequent drug-related adverse events were fatigue (27."( Efficacy and safety of levetiracetam 1000-3000 mg/day in patients with refractory partial-onset seizures: a multicenter, open-label single-arm study.
Beran, RG; Berkovic, SF; Black, AB; Danta, G; Hiersemenzel, R; Schapel, GJ; Vajda, FJ, 2005
)
0.64
" Overall, the adverse effects were not severe."( Efficacy and safety of levetiracetam: an add-on trial in children with refractory epilepsy.
Acampora, B; Balestri, P; Coppola, G; Cordelli, DM; Franzoni, E; Grosso, S; Iannetti, P; Marchiani, V; Morgese, G; Pascotto, A; Spalice, A; Verrotti, A, 2005
)
0.64
"The effect of levetiracetam (LEV) on the acute neurotoxic profiles of various antiepileptic drugs (carbamazepine [CBZ], phenytoin [PHT], phenobarbital [PB], valproate [VPA], lamotrigine [LTG], topiramate [TPM], oxcarbazepine [OXC], and felbamate [FBM]) was evaluated in the rotarod test, allowing the determination of median toxic doses (TD50 values) with respect to impairment of motor coordination in mice."( Levetiracetam selectively potentiates the acute neurotoxic effects of topiramate and carbamazepine in the rotarod test in mice.
Andres, MM; Cioczek-Czuczwar, A; Czuczwar, P; Czuczwar, SJ; Luszczki, JJ; Patsalos, PN; Ratnaraj, N; Wojcik-Cwikla, J, 2005
)
2.13
" Adverse events were reported in 34 (72."( Efficacy and safety of levetiracetam (up to 2000 mg/day) in Taiwanese patients with refractory partial seizures: a multicenter, randomized, double-blind, placebo-controlled study.
Chen, SS; Edrich, P; Hiersemenzel, R; Hsih, MS; Lai, CW; Tsai, JJ; Yen, DJ, 2006
)
0.64
" Adverse events reported after IV administration of LEV (( Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study.
Daoust, A; Lu, ZS; Otoul, C; Ramael, S; Stockis, A; Toublanc, N; Troenaru, M, 2006
)
1.78
" Analysis of safety was based on occurrence of adverse events."( Efficacy and safety of levetiracetam in clinical practice: results of the SKATE trial from Belgium and The Netherlands.
Boon, PA; Bourgeois, P; Carpay, J; Lambrechts, DA; Sadzot, B; Urbain, E; van Leusden, JA; van Paesschen, W, 2006
)
0.64
" Tolerance of levetiracetam treatment was good, with most adverse events being only mild to moderate in severity, and only 10."( Efficacy and safety of levetiracetam in clinical practice: results of the SKATE trial from Belgium and The Netherlands.
Boon, PA; Bourgeois, P; Carpay, J; Lambrechts, DA; Sadzot, B; Urbain, E; van Leusden, JA; van Paesschen, W, 2006
)
1.01
"Levetiracetam is effective and safe as add-on treatment for partial-onset seizures in clinical practice."( Efficacy and safety of levetiracetam in clinical practice: results of the SKATE trial from Belgium and The Netherlands.
Boon, PA; Bourgeois, P; Carpay, J; Lambrechts, DA; Sadzot, B; Urbain, E; van Leusden, JA; van Paesschen, W, 2006
)
2.09
" Most adverse events were mild or moderate and unrelated to study drug."( Levetiracetam: a long-term follow-up study of efficacy and safety.
Bauer, J; Ben-Menachem, E; Da Silva, S; Fryze, W; Kasteleijn-Nolst Trenité, DG; Krämer, G, 2006
)
1.78
"Given its favorable pharmacokinetics, side effect profile, and, if confirmed, early onset of action and efficacy, levetiracetam might represent significant progress in the pharmacologic management of panic disorder."( Safety and efficacy of levetiracetam for patients with panic disorder: results of an open-label, fixed-flexible dose study.
Papp, LA, 2006
)
0.85
" Adverse events were seen in 18 (34%) patients."( Efficacy and safety of levetiracetam in infants and young children with refractory epilepsy.
Balestri, P; Capovilla, G; Coppola, G; Cordelli, DM; Franzoni, E; Grosso, S; Morgese, G; Verrotti, A; Zamponi, N, 2007
)
0.65
" Seizure count and adverse events (AEs) were recorded by patients."( Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients.
Dubois, C; Heo, K; Huh, K; Kim, JM; Kim, JY; Lee, BI; Lee, SA; Lee, SK; Lu, S; Shin, DJ; Song, HK; Tonner, F; Yi, SD, 2007
)
0.65
" In conclusion, NEP administered by gavage is embryotoxic and teratogenic at maternal toxic doses."( Developmental toxic effects of N-ethyl-2-pyrrolidone administered orally to rats.
Gallissot, F; Sabaté, JP; Saillenfait, AM,
)
0.13
" No serious persistent adverse events were reported."( [Efficacy and safety of levetiracetam (keppra) add-on treatment in adult patients with refractory epilepsy in two tertiary centers].
Auriel, E; Blatt, I; Chistik, V; Margolin, N; Neufeld, M, 2007
)
0.65
" The most common adverse effects are somnolence, asthenia and dizziness, which usually appear early after initiation of levetiracetam therapy and generally resolve without medication withdrawal."( The safety of levetiracetam.
Safdieh, JE; Sirsi, D, 2007
)
0.91
"To investigate the hypothesis that some patients with epilepsy are generally prone to develop psychiatric adverse events (PAEs) during antiepileptic drug (AED) therapy irrespective of the mechanism of action of the drugs."( Are psychiatric adverse events of antiepileptic drugs a unique entity? A study on topiramate and levetiracetam.
Mula, M; Sander, JW; Trimble, MR, 2007
)
0.56
" Parenteral LEV is well tolerated and appears safe following IM and IV injections in dogs."( Intramuscular, intravenous and oral levetiracetam in dogs: safety and pharmacokinetics.
Cloyd, JC; Dunn, AW; Fisher, JE; Goel, V; Leppik, IE; O'Brien, TD; Patterson, EE, 2008
)
0.62
" So far, monitoring of such adverse events in outpatients has often been limited to intervals of weeks or months."( Early detection of behavioral side effects of antiepileptic treatment using handheld computers.
Carius, A; Frings, L; Lehmann, C; Maiwald, T; Schinkel, A; Schulze-Bonhage, A; Wagner, K, 2008
)
0.35
" Pyridoxine is an easily available, inexpensive, and safe therapeutic option."( Pyridoxine supplementation for the treatment of levetiracetam-induced behavior side effects in children: preliminary results.
Greenberg, E; Khan, A; Major, P; Thiele, EA, 2008
)
0.6
"To determine long-term retention, percentage of patients withdrawing because of adverse events, percentage of patients achieving seizure freedom, safety profile of the new anti-epileptic drugs lamotrigine, levetiracetam and topiramate."( The impact of side effects on long-term retention in three new antiepileptic drugs.
Aldenkamp, AP; Bootsma, HP; de Krom, M; Hekster, YA; Hulsman, J; Lambrechts, D; Majoie, M; Ricker, L; Schellekens, A, 2009
)
0.54
" Adverse events played a role in drug discontinuation in 154/429 patients (35."( The impact of side effects on long-term retention in three new antiepileptic drugs.
Aldenkamp, AP; Bootsma, HP; de Krom, M; Hekster, YA; Hulsman, J; Lambrechts, D; Majoie, M; Ricker, L; Schellekens, A, 2009
)
0.35
"A drug that is only modestly efficacious but has a favourable safety profile may look better than a drug that is more efficacious but produces clinically meaningful adverse events."( The impact of side effects on long-term retention in three new antiepileptic drugs.
Aldenkamp, AP; Bootsma, HP; de Krom, M; Hekster, YA; Hulsman, J; Lambrechts, D; Majoie, M; Ricker, L; Schellekens, A, 2009
)
0.35
" The pilot data presented here suggest that it is safe to switch patients from PHT to LEV monotherapy following craniotomy for supratentorial glioma."( Safety and feasibility of switching from phenytoin to levetiracetam monotherapy for glioma-related seizure control following craniotomy: a randomized phase II pilot study.
Barbaro, N; Burt, M; Chakalian, L; Chang, E; Chang, S; Lamborn, KR; Lim, DA; McDermott, MW; Tarapore, P, 2009
)
0.6
" The most common treatment-emergent adverse events, mostly mild to moderate in severity, were somnolence, dizziness and agitation."( Efficacy and safety of levetiracetam (3,000 mg/Day) as an adjunctive therapy in Chinese patients with refractory partial seizures.
Li, JM; Lv, Y; Sun, HB; Wang, XF; Xi, ZQ; Xiao, F; Xiao, Z, 2009
)
0.66
"Collected data included age, sex, therapy indication and duration, dosing regimen, documented seizure activity, ICU admission diagnoses, length of ICU stay, serum creatinine, liver function tests, adverse reactions, concomitant use of other AEDs, and drug interactions."( Safety and efficacy of levetiracetam for critically ill patients with seizures.
Divertie, GD; Freeman, WD; Nau, KM; Valentino, AK, 2009
)
0.66
" No adverse hemodynamic events or cardiac arrhythmias were reported."( Safety and efficacy of levetiracetam for critically ill patients with seizures.
Divertie, GD; Freeman, WD; Nau, KM; Valentino, AK, 2009
)
0.66
"LVM appears to be safe for ICU patients when dosing is adjusted for renal function."( Safety and efficacy of levetiracetam for critically ill patients with seizures.
Divertie, GD; Freeman, WD; Nau, KM; Valentino, AK, 2009
)
0.66
"0 treatment-emergent adverse events (TEAEs) were indirectly compared using meta-analytic techniques, including calculation of risk difference (RD) and mixed-effects analysis."( Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques.
Banerjee, S; Brabant, Y; Helmers, S; Richy, FF, 2009
)
1.8
" During the study, levetiracetam was tapered off in 2 patients due to seizure worsening and was discontinued in other 2 patients due to unacceptable adverse effects."( Efficacy and safety of levetiracetam as an add-on therapy in children aged less than 4 years with refractory epilepsy.
Cai, F; Cao, J; Li, S; Xiao, N, 2010
)
1
" The most common complaint was irritability (5%), and none of the adverse events were life threatening."( Efficacy and safety of adjunctive levetiracetam therapy in pediatric intractable epilepsy.
Kang, HC; Kim, HD; Lee, JS; Lee, YJ, 2010
)
0.64
" At the last evaluation (May 1, 2009), 75 of 82 patients (91%) treated with levetiracetam were seizure free; in 2 of these patients, levetiracetam was withdrawn because of intolerable adverse effects."( Efficacy and safety of levetiracetam in patients with glioma: a clinical prospective study.
Buttolo, L; Cenzato, M; Padovani, A; Rosati, A; Stefini, R; Todeschini, A, 2010
)
0.9
"The results of this study provide good evidence that levetiracetam is efficacious and safe in patients with epilepsy due to glioma."( Efficacy and safety of levetiracetam in patients with glioma: a clinical prospective study.
Buttolo, L; Cenzato, M; Padovani, A; Rosati, A; Stefini, R; Todeschini, A, 2010
)
0.92
" Thrombocytopenia is not a well-known adverse effect of this medication."( Thrombocytopenia as an adverse effect of levetiracetam therapy in a child.
Mohamed, BP; Peer Mohamed, B; Prabhakar, P, 2009
)
0.62
" There were no serious adverse reactions."( Intravenous levetiracetam in children with seizures: a prospective safety study.
Cardenas, JF; Chapman, KE; Hastriter, EV; Khoury, EM; Ng, YT, 2010
)
0.74
" The therapy-related adverse events were mild, including restlessness, reduction in sleep time, night terrors, debility, somnolence, nausea and vomiting."( [Efficacy and safety of adjunctive levetiracetam in children younger than 4 years with refractory epilepsy].
Chen, L; Hu, Y; Huang, TS; Li, B; Liao, JX, 2010
)
0.64
" Adverse events were reported by 73."( Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II Study.
Aziz, ZA; Beh, K; Cabral-Lim, L; Chinvarun, Y; Edrich, P; Kwan, P; Lim, SH; Lo, YK; Tonner, F, 2010
)
0.67
"The findings of this study provide some evidence that levetiracetam is an efficacious and safe treatment option for outpatient alcohol detoxification."( Efficacy and safety of levetiracetam for outpatient alcohol detoxification.
Förg, A; Heimann, HM; Hein, J; Heinz, A; Hinzpeter, A; Müller, CA; Schäfer, M; Schneider, S; Volkmar, K, 2010
)
0.92
" No severe adverse effects were observed."( Levetiracetam: safety and efficacy in neonatal seizures.
Dinger, J; Ikonomidou, C; Ramantani, G; Rating, D; Walter, B, 2011
)
1.81
"We performed a case series analysis to evaluate the effects of levetiracetam (LEV) monotherapy on seizures, adverse events, cognitive functioning and quality of life (QoL) in patients with brain tumor-related epilepsy (BTRE)."( Levetiracetam monotherapy in patients with brain tumor-related epilepsy: seizure control, safety, and quality of life.
Dinapoli, L; Fabi, A; Maschio, M; Muti, P; Pace, A; Sperati, F; Vidiri, A, 2011
)
2.05
"We reported a patient with epilepsy who took an overdose of 63 grams of levetiracetam with mild adverse events."( Acute levetiracetam overdose presented with mild adverse events.
Chayasirisobhon, S; Chayasirisobhon, WV; Tsay, CC, 2010
)
1.07
"The pharmacokinetics, tolerability and adaptation of levetiracetam might play a role in the mild adverse events of levetiracetam overdose in our patient."( Acute levetiracetam overdose presented with mild adverse events.
Chayasirisobhon, S; Chayasirisobhon, WV; Tsay, CC, 2010
)
1.09
"Patients (53% men, median age 71 years) had a total of 97 adverse events (AEs) reported in 53 patients."( The safety and efficacy of add-on levetiracetam in elderly patients with focal epilepsy: a one-year observational study.
Balkaya, S; Klimpe, S; Krämer, G; Trinka, E; Werhahn, KJ, 2011
)
0.65
"Add-on treatment with LEV in elderly patients with focal epilepsy was safe and efficient."( The safety and efficacy of add-on levetiracetam in elderly patients with focal epilepsy: a one-year observational study.
Balkaya, S; Klimpe, S; Krämer, G; Trinka, E; Werhahn, KJ, 2011
)
0.65
"All cases of single agent ingestions of levetiracetam, excluding adverse drug reactions (ADRs), reported to 61 American poison control centers during 2000-2009 were identified."( Safety of non-therapeutic levetiracetam ingestions--a poison center based study.
Bodmer, M; Kokko, J; Monte, AA; Yin, S, 2011
)
0.94
"In this study with a limited number of cases, intentional and unintentional ingestions of levetiracetam were safe in the majority of cases."( Safety of non-therapeutic levetiracetam ingestions--a poison center based study.
Bodmer, M; Kokko, J; Monte, AA; Yin, S, 2011
)
0.89
" Safety was evaluated using adverse events (AEs)."( Pregabalin or placebo used adjunctively with levetiracetam in refractory partial-onset epilepsy: a post hoc efficacy and safety analysis in combined clinical trials.
Almas, M; Emir, B; Giordano, S; Leon, T; Uthman, BM, 2011
)
0.63
" Plasma concentrations (pc), interactions between drugs in the ICU context, adverse effects and seizure occurrences were observed and recorded."( Levetiracetam compared to valproic acid: plasma concentration levels, adverse effects and interactions in aneurysmal subarachnoid hemorrhage.
Bjeljac, M; Keller, E; Mink, S; Muroi, C; Seule, M, 2011
)
1.81
" Adjunctive levetiracetam was well tolerated (most frequently reported central nervous system-related treatment-emergent adverse events: headache [24."( A long-term open-label extension study assessing cognition and behavior, tolerability, safety, and efficacy of adjunctive levetiracetam in children aged 4 to 16 years with partial-onset seizures.
Jones, J; Legoff, D; Loge, Cde L; Mintz, M; Schiemann-Delgado, J; Stalvey, TJ; Yang, H, 2012
)
0.97
" When prescribing these drugs to patients of this age bracket, treatment should be based not only on the diagnosis and seizure type but also on the propensity of the drugs for adverse effects and their drug-drug interactions."( Choice of antiepileptic drugs for the elderly: possible drug interactions and adverse effects.
Dostic, M; Jankovic, SM, 2012
)
0.38
"This article reviews antiepileptic drugs currently used for treating the elderly and highlights the adverse effects and potential drug-drug interactions for these treatments."( Choice of antiepileptic drugs for the elderly: possible drug interactions and adverse effects.
Dostic, M; Jankovic, SM, 2012
)
0.38
" This study aims to compare the tolerability, safety, and side effect profiles of levetiracetam (LEV) against the standard agent phenytoin (PHT) when given intravenously and in total regimen for seizure prophylaxis in a neurosurgical setting."( Tolerability, safety, and side effects of levetiracetam versus phenytoin in intravenous and total prophylactic regimen among craniotomy patients: a prospective randomized study.
Cook, MJ; D'Souza, WJ; Fuller, KL; Murphy, MA; Wang, YY, 2013
)
0.88
" Primary tolerability end points were discontinuation because of side effect and first side effect."( Tolerability, safety, and side effects of levetiracetam versus phenytoin in intravenous and total prophylactic regimen among craniotomy patients: a prospective randomized study.
Cook, MJ; D'Souza, WJ; Fuller, KL; Murphy, MA; Wang, YY, 2013
)
0.65
" Comparative safety and differing side effect profile of intravenous LEV supports use as an alternative to intravenous PHT."( Tolerability, safety, and side effects of levetiracetam versus phenytoin in intravenous and total prophylactic regimen among craniotomy patients: a prospective randomized study.
Cook, MJ; D'Souza, WJ; Fuller, KL; Murphy, MA; Wang, YY, 2013
)
0.65
"Number of adverse events, mood score, number of infections, trough level of levetiracetam, and PTE."( Results of phase 2 safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy.
Atabaki, SM; He, J; Herr, D; Klein, P; Levine, Z; McCarter, R; Natale, J; Nogay, C; Pearl, PL; Sandoval, F; Soldin, SJ; Trzcinski, S; Tsuchida, T; van den Anker, J, 2012
)
0.85
" The most common adverse events were fatigue, headache, and somnolence."( Results of phase 2 safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy.
Atabaki, SM; He, J; Herr, D; Klein, P; Levine, Z; McCarter, R; Natale, J; Nogay, C; Pearl, PL; Sandoval, F; Soldin, SJ; Trzcinski, S; Tsuchida, T; van den Anker, J, 2012
)
0.62
"Treatment with 55 mg/kg/d of levetiracetam (a dose with an antiepileptogenic effect on animals) for patients with TBI at risk for PTE is safe and well tolerated, with plasma levels similar to those in animal studies."( Results of phase 2 safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy.
Atabaki, SM; He, J; Herr, D; Klein, P; Levine, Z; McCarter, R; Natale, J; Nogay, C; Pearl, PL; Sandoval, F; Soldin, SJ; Trzcinski, S; Tsuchida, T; van den Anker, J, 2012
)
0.91
" Adverse events occurred in only two patients who did not require LEV discontinuation."( Efficacy and safety of add-on levetiracetam in refractory childhood epilepsy.
Aihara, M; Kanemura, H; Sano, F; Sugita, K; Tando, T, 2013
)
0.68
" To assess the genetic basis of the adverse psychotropic profile of LEV, a candidate gene-based two-stage association study was conducted."( Genetic variation in dopaminergic activity is associated with the risk for psychiatric side effects of levetiracetam.
Elger, CE; Helmstaedter, C; Hurlemann, R; Kunz, WS; Mihov, Y; Nuernberg, P; Schoch, S; Surges, R; Thiele, H; Toliat, MR, 2013
)
0.6
"Stage 1 analysis included 290 patients with epilepsy and revealed a higher load of adverse psychotropic side effects of LEV in patients carrying genetic variants associated with decreased dopaminergic activity: rs1611115 (dopamine-β-hydroxylase, DBH), rs4680 (catechol-O-methyltransferase, COMT), and rs1800497 (dopamine receptor D2-associated ANKK1 TAQ-1A)."( Genetic variation in dopaminergic activity is associated with the risk for psychiatric side effects of levetiracetam.
Elger, CE; Helmstaedter, C; Hurlemann, R; Kunz, WS; Mihov, Y; Nuernberg, P; Schoch, S; Surges, R; Thiele, H; Toliat, MR, 2013
)
0.6
" Overall, the pharmacogenomic approach to behavioral side effects may provide a future tool to predict adverse psychotropic effects related to antiepileptic drugs."( Genetic variation in dopaminergic activity is associated with the risk for psychiatric side effects of levetiracetam.
Elger, CE; Helmstaedter, C; Hurlemann, R; Kunz, WS; Mihov, Y; Nuernberg, P; Schoch, S; Surges, R; Thiele, H; Toliat, MR, 2013
)
0.6
" A total of 486 adverse events developed in 316 patients."( The long-term efficacy and safety of levetiracetam in a tertiary epilepsy centre.
Chu, K; Jung, KH; Kang, BS; Kim, YS; Lee, SK; Lee, ST; Moon, HJ, 2013
)
0.66
"Levetiracetam was effective and safe as monotherapy and add-on therapy for partial and generalised epilepsy."( The long-term efficacy and safety of levetiracetam in a tertiary epilepsy centre.
Chu, K; Jung, KH; Kang, BS; Kim, YS; Lee, SK; Lee, ST; Moon, HJ, 2013
)
2.11
" The incidences of treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) were 82."( [Efficacy and safety of levetiracetam as adjunctive therapy in Japanese children with uncontrolled partial-onset seizures: multicenter and open-label study (N01223), short term evaluation].
Nakamura, H; Osawa, M; Suzuki, A; Yokoyama, T; Yoshida, K, 2013
)
0.7
"The adverse effects profile of levetiracetam in epilepsy is still being fully described."( The adverse effects profile of levetiracetam in epilepsy: a more detailed look.
Dixon, P; Hutton, JL; Marson, AG; Mbizvo, GK, 2014
)
0.97
" Collected data included age, gender, diagnosis on admission, dosing regimen, documented seizure activity, adverse reactions, concomitant use of other antiepileptic drugs, and condition on discharge."( The safety and tolerability of different intravenous administrations of levetiracetam, bolus versus infusion, in intensive care unit patients.
Bashir, S; Burakgazi, E; Doss, V; Pellock, J, 2014
)
0.63
" Risk of clinical and/or electrographic seizures, and risk of adverse drug events were compared between the two exposure arms."( Levetiracetam versus phenytoin: a comparison of efficacy of seizure prophylaxis and adverse event risk following acute or subacute subdural hematoma diagnosis.
Chou, SH; Du, R; Lee, JW; Radic, JA, 2014
)
1.85
" Levetiracetam is associated with a lower risk of adverse drug effects."( Levetiracetam versus phenytoin: a comparison of efficacy of seizure prophylaxis and adverse event risk following acute or subacute subdural hematoma diagnosis.
Chou, SH; Du, R; Lee, JW; Radic, JA, 2014
)
2.76
"The current evidence suggests that the overall risk of major malformation after first trimester exposure to Levetiracetam is within the population baseline risk of 1-3%, with no apparent adverse effects on long term child development."( The fetal safety of Levetiracetam: a systematic review.
Chaudhry, SA; Jong, G; Koren, G, 2014
)
0.94
" Taking all together, this demo-case study showed that inclusion of multiple-endpoints in ZET may increase the sensitivity of the assay, contribute to the elucidation of the mode of toxic action and to a better definition of the applicability domain of ZET."( Zebrafish embryotoxicity test for developmental (neuro)toxicity: Demo case of an integrated screening approach system using anti-epileptic drugs.
Beker van Woudenberg, A; Bouma, M; de Groot, D; Hermsen, S; Menke, A; Piersma, A; Rijkmans, E; Snel, C; Wolterbeek, A, 2014
)
0.4
"Intravenous levetiracetam appears to be effective and safe in the treatment of acute repetitive seizures."( Efficacy and safety of IV levetiracetam in children with acute repetitive seizures.
Ağın, H; Akarcan, SE; Celik, T; Güzel, O; İşgüder, R; Ünalp, A; Yılmaz, Ü, 2014
)
1.08
" Haematological toxicity is a limiting side effect of both, first line radio-chemotherapy with temozolomide (TMZ) and co-medication with antiepileptic drugs."( Haematological toxicity of Valproic acid compared to Levetiracetam in patients with glioblastoma multiforme undergoing concomitant radio-chemotherapy: a retrospective cohort study.
Geroldinger, A; Gleiss, A; Grisold, W; Marosi, C; Moser, W; Oberndorfer, S; Sax, C; Sherif, C; Tinchon, A, 2015
)
0.67
"Weight gain and alopecia were the most common patient-reported CSEs in this study, and weight gain was the most likely cosmetic side effect to result in dosage adjustment or medication discontinuation."( Cosmetic side effects of antiepileptic drugs in adults with epilepsy.
Buchsbaum, R; Chen, B; Choi, H; Detyniecki, K; Hirsch, LJ; Javed, A; Kato, K; Legge, A; Moeller, J, 2015
)
0.42
" We suggest that LEV with fewer adverse effects comparing to other drugs may be considered to be a good alternative in the treatment of Sydenham chorea."( A New Alternative Drug With Fewer Adverse Effects in the Treatment of Sydenham Chorea: Levetiracetam Efficacy in a Child.
Cansu, A; Şahin, S,
)
0.35
" Treatment-emergent adverse events occurred in 82% (CBZ/OXC), 76% (LTG), 73% (LEV), and 67% (VPA) of patients; most were of mild-to-moderate intensity."( Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures.
Brandt, C; Daniluk, J; DeRossett, S; Edwards, S; Lerche, H; Lotay, N, 2015
)
0.42
" The efficacy of LEV treatment was assessed retrospectively as the proportion of patients who experienced at least a 50% reduction in the frequency of seizures (50% RR), and adverse events were analyzed."( [Effectiveness and safety of long-term levetiracetam treatment in patients with refractory epilepsy].
Baba, H; Fuji, A; Matsuo, M; Matsuzaka, T; Moriuchi, H; Ono, T; Sato, T; Tanaka, S; Toda, K, 2015
)
0.69
" Among adverse events, irritability and hyperactivity/impulsivity were observed more frequently in this study than in previous reports."( [Effectiveness and safety of long-term levetiracetam treatment in patients with refractory epilepsy].
Baba, H; Fuji, A; Matsuo, M; Matsuzaka, T; Moriuchi, H; Ono, T; Sato, T; Tanaka, S; Toda, K, 2015
)
0.69
"To analyze the adverse events (AEs) significantly associated with levetiracetam (LEV) therapy through a meta-analysis of all available double-blind, randomized placebo-controlled trials (RCTs), performed in any age, gender, ethnic background and disease."( The adverse event profile of levetiracetam: A meta-analysis on children and adults.
Chiarelli, F; Di Sabatino, F; Franco, V; Prezioso, G; Verrotti, A; Zaccara, G, 2015
)
0.95
" At T0 and at T1, there was no statistically significant difference in terms of seizure frequency and intensity, occurrence of adverse events, laboratory parameters and electroencephalographic features."( Safety of Overnight Switch from Brand-Name to Generic Levetiracetam.
del Gaudio, L; Francavilla, T; Giudizioso, G; La Neve, A; Mencaroni, E; Minetti, C; Piccioli, M; Pinto, F; Striano, P; Striano, S; Tovo, P; Vari, MS; Verrotti, A, 2016
)
0.68
"No increase of seizures and adverse effects were observed when branded levetiracetam was interchanged to a generic equivalent."( Safety of Overnight Switch from Brand-Name to Generic Levetiracetam.
del Gaudio, L; Francavilla, T; Giudizioso, G; La Neve, A; Mencaroni, E; Minetti, C; Piccioli, M; Pinto, F; Striano, P; Striano, S; Tovo, P; Vari, MS; Verrotti, A, 2016
)
0.92
"In patients taking antiepileptic drugs (AEDs) for epilepsy, adverse effects (AEs) often lead to unfavorable quality of life, impaired adherence, and, eventually, discontinuation of pharmacological treatment."( Specific adverse effects of antiepileptic drugs--A true-to-life monotherapy study.
Fidzinski, P; Gaus, V; Holtkamp, M; Kowski, AB; Losch, F; Weissinger, F, 2016
)
0.43
"All patients ≥16years of age with epilepsy for ≥12months were routinely asked to complete the Liverpool Adverse Event Profile (LAEP) just before their appointment."( Specific adverse effects of antiepileptic drugs--A true-to-life monotherapy study.
Fidzinski, P; Gaus, V; Holtkamp, M; Kowski, AB; Losch, F; Weissinger, F, 2016
)
0.43
" Overall, 61 (17%) patients showed adverse events."( The efficacy, tolerability and safety of levetiracetam therapy in a pediatric population.
Çavuşoğlu, D; Dündar, NO; Gencpinar, P; Tekgül, H, 2016
)
0.7
" The primary variable was treatment-emergent adverse events (TEAEs)."( Safety of levetiracetam among infants younger than 12 months--Results from a European multicenter observational study.
Arzimanoglou, A; Bentz, J; Garate, P; Lösch, C, 2016
)
0.84
"To identify adverse events (AEs) associated with Levetiracetam (LEV) in children."( Safety of Levetiracetam in Paediatrics: A Systematic Review.
Choonara, I; Egunsola, O; Sammons, HM, 2016
)
1.09
"Behavioural problems and somnolence were the most prevalent adverse events to LEV and the most common causes of treatment discontinuation."( Safety of Levetiracetam in Paediatrics: A Systematic Review.
Choonara, I; Egunsola, O; Sammons, HM, 2016
)
0.84
"This noninterventional, observational, postauthorization safety study (SP0942, NCT00771927) evaluated the incidence of predefined cardiovascular- (CV) and psychiatric-related treatment-emergent adverse events (TEAEs), in patients with epilepsy and uncontrolled partial-onset seizures, when initiating adjunctive therapy with lacosamide or another approved antiepileptic drug (AED) according to standard medical practice."( A long-term noninterventional safety study of adjunctive lacosamide therapy in patients with epilepsy and uncontrolled partial-onset seizures.
Brunnert, M; De Backer, M; Doty, P; Eckhardt, K; Schulze-Bonhage, A; Steinhoff, BJ, 2016
)
0.43
" Treatment-emergent adverse events (TEAEs) were reported by 68."( Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies.
Ben-Menachem, E; Eckhardt, K; Gamage, J; Johnson, ME; Klein, P; Mameniškienė, R; McDonough, B; Quarato, PP; Schiemann, J; Whitesides, J, 2016
)
0.43
" Clinical examination was performed for every patient, and seizure number, antiepileptic medication, and adverse events were detailed at every visit."( Efficacy and safety of levetiracetam in the management of seizures in neonates.
Asadi, F; Moradian, M; Moradian, N; Sedighi, M; Vakiliamini, M, 2016
)
0.74
" Electroencephalogram (EGG) changes and adverse reactions were observed in these children respectively in three, six and twelve months after the therapy."( The clinical efficacy and safety of levetiracetam add-on therapy for child refractory epilepsy.
Chen, J; Chen, SZ; Liu, XM; Yue, X, 2016
)
0.71
" Adverse reactions were expressed in 3% of the child patients, and the symptoms were dysphoria, mental and behavior disorders."( The clinical efficacy and safety of levetiracetam add-on therapy for child refractory epilepsy.
Chen, J; Chen, SZ; Liu, XM; Yue, X, 2016
)
0.71
"The levetiracetam add-on therapy for child refractory epilepsy, demonstrates fast and obvious efficacy as well as fewer adverse reactions."( The clinical efficacy and safety of levetiracetam add-on therapy for child refractory epilepsy.
Chen, J; Chen, SZ; Liu, XM; Yue, X, 2016
)
1.27
" Psychiatric symptoms occurring after initiation of AED therapy were considered as treatment emergent psychiatric adverse events (TE-PAEs) if they fulfilled the following conditions: (1) onset within 4 weeks after the beginning of AED therapy; (2) disappearance on drug discontinuation; (3) absence of any other identified possible concurrent cause."( Brain tumor location influences the onset of acute psychiatric adverse events of levetiracetam therapy: an observational study.
Belcastro, V; Bellocchi, S; Casiraghi, P; Gorgone, G; Mula, M; Pisani, F; Pisani, LR, 2017
)
0.68
" It is remarkable that there are no studies evaluating the toxic effects of this drug on the male reproductive system, as it is commonly used in male patients of reproductive age."( Reproductive toxicity after levetiracetam administration in male rats: Evidence for role of hormonal status and oxidative stress.
Atli, O; Baysal, M; Ilgin, S; Kilic, G; Kilic, V; Ucarcan, S, 2017
)
0.75
"To examine the prevalence and clinical correlates of fatigue as an adverse event (AE) of antiepileptic drug (AED) treatment in patients with epilepsy."( Fatigue during treatment with antiepileptic drugs: A levetiracetam-specific adverse event?
Agrawal, N; Cock, HR; Lozsadi, DA; Mula, M; von Oertzen, TJ; Yogarajah, M, 2017
)
0.7
"Data from 443 adult outpatients with epilepsy assessed with the Adverse Event Profile (AEP) and the Neurological Disorder Depression Inventory for Epilepsy (NDDIE) were analysed."( Fatigue during treatment with antiepileptic drugs: A levetiracetam-specific adverse event?
Agrawal, N; Cock, HR; Lozsadi, DA; Mula, M; von Oertzen, TJ; Yogarajah, M, 2017
)
0.7
" We report a patient with cerebral palsy and epilepsy who took 200 mg/kg per day of levetiracetam for 55 days with no apparent adverse effects."( Can High-Dose Levetiracetam Be Safe? A Case Report of Prolonged Accidental High-Dose Levetiracetam Administration and Review of the Literature.
Kartal, A,
)
0.72
"We assessed the prevalence and magnitude of neuropsychiatric adverse events (NPAEs) associated with antiepileptic drugs (AEDs) among patients with brain tumour-related epilepsy (BTRE)."( Neuropsychiatric adverse events of antiepileptic drugs in brain tumour-related epilepsy: an Italian multicentre prospective observational study.
Bedetti, C; Calabresi, P; Costa, C; Di Bonaventura, C; Dispenza, S; Eusebi, P; Maschio, M; Nardi Cesarini, E; Romoli, M; Siliquini, S, 2017
)
0.46
" Evaluating non-neurobehavioural adverse events of AEDs, no significant differences were found among AEDs, although patients treated with old AEDs had a higher prevalence of adverse events than those treated with new AEDs."( Neuropsychiatric adverse events of antiepileptic drugs in brain tumour-related epilepsy: an Italian multicentre prospective observational study.
Bedetti, C; Calabresi, P; Costa, C; Di Bonaventura, C; Dispenza, S; Eusebi, P; Maschio, M; Nardi Cesarini, E; Romoli, M; Siliquini, S, 2017
)
0.46
" The aim of the study was to assess the risk of increased frequency of seizures or other adverse events after replacement of a brand-name LEV with a generic one."( Safety of switching from brand-name to generic levetiracetam in patients with epilepsy.
Bosak, M; Słowik, A; Turaj, W, 2017
)
0.71
" We registered an increase in the frequency of seizures and in the occurrence of adverse events."( Safety of switching from brand-name to generic levetiracetam in patients with epilepsy.
Bosak, M; Słowik, A; Turaj, W, 2017
)
0.71
" Adverse events were noted in six other patients (4%) and included somnolence, irritability, or dizziness."( Safety of switching from brand-name to generic levetiracetam in patients with epilepsy.
Bosak, M; Słowik, A; Turaj, W, 2017
)
0.71
" The tryptophan metabolite quinolinic acid (QUIN) acts as an excitotoxin when its brain concentrations reach toxic levels under pathological conditions."( The Antiepileptic Drug Levetiracetam Protects Against Quinolinic Acid-Induced Toxicity in the Rat Striatum.
Aguilera, G; Colín-González, AL; Dircio-Bautista, M; Galván-Arzate, S; García, E; Maya-López, M; Santamaría, A; Túnez, I; Villeda-Hernández, J, 2018
)
0.79
" Additionally, patients receiving LEV had significantly less adverse effects compared to patients treated with another AED."( Efficacy and safety of Levetiracetam vs. other antiepileptic drugs in Hispanic patients with glioblastoma.
Arrieta, O; Balaña, C; Bermúdez, S; Bernal, L; Cardona, AF; Carranza, H; Franco, S; Gil-Gil, M; Hakim, EJ; Hakim, F; Mayor, LC; Mejía, JA; Ortíz, C; Ortíz, LD; Otero, J; Rojas, L; Ruiz-Patiño, A; Useche, N; Vargas, C; Wills, B; Zatarain-Barrón, ZL, 2018
)
0.79
" Behavioral changes are the most significant adverse effects reported by patients taking LEV."( Favorable adverse effect profile of brivaracetam vs levetiracetam in a preclinical model.
Aboulamer, S; Bosoi, CM; Carmant, L; Desgent, S; Gagné, J; Messiet, E; Sanon, NT; Simard, A; Wolf, DC, 2018
)
0.73
"To describe a serious adverse event as a result of rapid intravenous injection of undiluted levetiracetam in a dog."( A serious adverse event secondary to rapid intravenous levetiracetam injection in a dog.
Bacek, LM; Biddick, AA; Taylor, AR, 2018
)
0.95
"This report documents a serious adverse event associated with intravenous levetiracetam administration to a dog."( A serious adverse event secondary to rapid intravenous levetiracetam injection in a dog.
Bacek, LM; Biddick, AA; Taylor, AR, 2018
)
0.96
"This study aims to describe the incidence of adverse drug reactions (ADRs) in children receiving antiepileptic drugs (AEDs) and compare ADRs to the individual drugs when given as monotherapy."( Safety of antiepileptic drugs in children and young people: A prospective cohort study.
Choonara, I; Egunsola, O; Sammons, HM; Whitehouse, WP, 2018
)
0.48
" Adverse reactions to antiepileptic drugs (AEDs) were elicited at the time of enrolment and after 3 months using the Paediatric Epilepsy Side Effects Questionnaire."( Safety of antiepileptic drugs in children and young people: A prospective cohort study.
Choonara, I; Egunsola, O; Sammons, HM; Whitehouse, WP, 2018
)
0.48
"Few studies on adult and pediatric patients have shown pyridoxine efficacy as additional therapy for those receiving levetiracetam (LEV) to prevent and mitigate behavioral adverse effects (BAEs)."( Pyridoxine Add-On Treatment for the Control of Behavioral Adverse Effects Induced by Levetiracetam in Children: A Case-Control Prospective Study.
Falsaperla, R; Marino, S; Marino, SD; Pavone, P; Provvidenti, S; Romano, C; Vitaliti, G, 2018
)
0.91
"The aim of our study was to analyze the safety and efficacy of pyridoxine supplementation in the prevention of LEV adverse effects, including suicidal ideation."( Pyridoxine Add-On Treatment for the Control of Behavioral Adverse Effects Induced by Levetiracetam in Children: A Case-Control Prospective Study.
Falsaperla, R; Marino, S; Marino, SD; Pavone, P; Provvidenti, S; Romano, C; Vitaliti, G, 2018
)
0.7
" None of the patients complained of symptoms of pyridoxine toxicity, and no new adverse effects of LEV off-label were reported."( Pyridoxine Add-On Treatment for the Control of Behavioral Adverse Effects Induced by Levetiracetam in Children: A Case-Control Prospective Study.
Falsaperla, R; Marino, S; Marino, SD; Pavone, P; Provvidenti, S; Romano, C; Vitaliti, G, 2018
)
0.7
"In our study, we found pyridoxine to be safe and effective in controlling LEV-induced BAEs in children."( Pyridoxine Add-On Treatment for the Control of Behavioral Adverse Effects Induced by Levetiracetam in Children: A Case-Control Prospective Study.
Falsaperla, R; Marino, S; Marino, SD; Pavone, P; Provvidenti, S; Romano, C; Vitaliti, G, 2018
)
0.7
"Evaluate serum levetiracetam concentrations and adverse clinical effects after 11 days of once daily XRL administration to healthy cats."( Serum levetiracetam concentrations and adverse events after multiple dose extended release levetiracetam administration to healthy cats.
Barnes Heller, H; Boothe, DM; Granick, M; Van Hesteren, M, 2018
)
1.31
" Owners maintained records of adverse effects throughout study."( Serum levetiracetam concentrations and adverse events after multiple dose extended release levetiracetam administration to healthy cats.
Barnes Heller, H; Boothe, DM; Granick, M; Van Hesteren, M, 2018
)
0.96
"Mean trough serum levetiracetam concentrations were ≥5 μg/mL and adverse effects were minimal throughout dosing period, indicating that the drug was well tolerated."( Serum levetiracetam concentrations and adverse events after multiple dose extended release levetiracetam administration to healthy cats.
Barnes Heller, H; Boothe, DM; Granick, M; Van Hesteren, M, 2018
)
1.3
" The most common adverse effects noted included somnolence, dizziness and behavioural effects but generally did not require discontinuation."( Efficacy and safety of levetiracetam for migraine prophylaxis: A systematic review.
Brown, JN; Gee, ME; Watkins, AK, 2018
)
0.79
" However, some psychiatric adverse events (PAEs) have been reported, resulting in drug withdrawal."( HLA-A*11:01 is associated with levetiracetam-induced psychiatric adverse events.
Chu, K; Jun, JS; Jung, KH; Jung, KY; Kim, TJ; Lee, SK; Lee, ST; Lim, JA; Moon, J; Park, KI; Yang, TW, 2018
)
0.77
" No serious adverse events occurred during the trial period."( A randomized, double-blind, double-dummy, multicenter trial comparing the efficacy and safety of extended- and immediate-release levetiracetam in people with partial epilepsy.
Chuang, YC; Fung, HC; Hsu, CH; Huang, CW; Lee, CH; Lim, SN; Lin, CC; Tsai, JJ; Wu, T, 2018
)
0.69
"There is limited literature on cognitive, behaviour and sleep-related adverse effects of levetiracetam and oxcarbazepine among adult epilepsy patients, except for what is available from the initial efficacy trials."( Cognitive, behavioural and sleep-related adverse effects on introduction of levetiracetam versus oxcarbazepine for epilepsy.
Gupta, A; Pandit, AK; Prasad, K; Rajan, R; Shukla, G; Singh, MB; Srivastava, A; Thelengana, A; Vibha, D, 2019
)
0.97
" Trail making test A & B, digit symbol substitution test, Stroop colour and word test, controlled oral word association test and PGI memory scale, Neuropsychiatric Inventory, sleep log and ESS-I were used for assessment of cognitive, behaviour and sleep-related adverse effects."( Cognitive, behavioural and sleep-related adverse effects on introduction of levetiracetam versus oxcarbazepine for epilepsy.
Gupta, A; Pandit, AK; Prasad, K; Rajan, R; Shukla, G; Singh, MB; Srivastava, A; Thelengana, A; Vibha, D, 2019
)
0.74
"On cross-sectional as well as on longitudinal assessment, nearly one-fifth of patients on levetiracetam have behaviour related adverse effects, with dose modification required for half among these."( Cognitive, behavioural and sleep-related adverse effects on introduction of levetiracetam versus oxcarbazepine for epilepsy.
Gupta, A; Pandit, AK; Prasad, K; Rajan, R; Shukla, G; Singh, MB; Srivastava, A; Thelengana, A; Vibha, D, 2019
)
0.96
"Levetiracetam is a commonly used antiepileptic drug, yet psychiatric adverse effects are common and may lead to treatment discontinuation."( Prediction Tools for Psychiatric Adverse Effects After Levetiracetam Prescription.
Agha-Khani, Y; Engbers, JDT; Federico, P; Jette, N; Josephson, CB; Mackie, A; Macrodimitris, S; Marshall, D; McLane, B; Patten, SB; Pillay, N; Sajobi, TT; Sharma, R; Singh, S; Wiebe, S, 2019
)
2.2
"To derive prediction models to estimate the risk of psychiatric adverse effects from levetiracetam use."( Prediction Tools for Psychiatric Adverse Effects After Levetiracetam Prescription.
Agha-Khani, Y; Engbers, JDT; Federico, P; Jette, N; Josephson, CB; Mackie, A; Macrodimitris, S; Marshall, D; McLane, B; Patten, SB; Pillay, N; Sajobi, TT; Sharma, R; Singh, S; Wiebe, S, 2019
)
0.99
"This study derived 2 simple models that predict the risk of a psychiatric adverse effect from levetiracetam."( Prediction Tools for Psychiatric Adverse Effects After Levetiracetam Prescription.
Agha-Khani, Y; Engbers, JDT; Federico, P; Jette, N; Josephson, CB; Mackie, A; Macrodimitris, S; Marshall, D; McLane, B; Patten, SB; Pillay, N; Sajobi, TT; Sharma, R; Singh, S; Wiebe, S, 2019
)
0.98
"To investigate the potential toxic effects of levetiracetam monotherapy on ocular tissues in cases of pediatric epilepsy using optical coherence tomography (OCT)."( An investigation of the ocular toxic effects of levetiracetam therapy in children with epilepsy.
Acar Arslan, E; Cansu, A; Dilber, B; Diler Durgut, B; Kamasak, T; Sahin, S; Turk, A; Turkcan Soguksulu, T, 2019
)
1.03
" Minimally diluted doses administered over 5-6 min were found to be both safe and effective."( Safety and Tolerability of Rapid Administration Undiluted Levetiracetam.
Medenwald, B; Morgan, O, 2020
)
0.8
"This was a retrospective study evaluating adverse drug reactions associated with undiluted LEV from January 1, 2018-June 1, 2018."( Safety and Tolerability of Rapid Administration Undiluted Levetiracetam.
Medenwald, B; Morgan, O, 2020
)
0.8
" Although LEV is generally well tolerated, neuropsychiatric adverse events (NPAEs) might occur, limiting compliance and seizure control."( Synaptic vesicle protein 2A tumoral expression predicts levetiracetam adverse events.
Bedetti, C; Calabresi, P; Calvello, C; Costa, C; Eusebi, P; Giovenali, P; Loreti, E; Mandarano, M; Nardi Cesarini, E; Romoli, M; Romozzi, M; Sidoni, A; Verzina, A, 2019
)
0.76
" The secondary outcomes are adverse events and withdrawal rates due to adverse effects."( Efficacy and safety of levetiracetam in children with epilepsy: protocol for an umbrella review of systematic reviews and meta-analyses of randomised controlled trials.
Gan, J; Ma, D; Xiong, T, 2019
)
0.82
" Electronic medical records were accessed to analyse clinical parameters including blood concentrations of levetiracetam and concomitant antiepileptic drugs, clinical laboratory values and adverse reactions."( Efficacy and safety of levetiracetam in Japanese epilepsy patients: A retrospective cohort study.
Rikitake, Y; Sekimoto, H, 2019
)
1.04
" Although blood levetiracetam concentration was significantly increased in older patients and those with renal dysfunction, the rates of adverse reactions were not increased."( Efficacy and safety of levetiracetam in Japanese epilepsy patients: A retrospective cohort study.
Rikitake, Y; Sekimoto, H, 2019
)
1.17
" This is only the ninth case reported in literature regarding this rare and potentially serious adverse effect of levetiracetam."( Rhabdomyolysis: a rare adverse effect of levetiracetam.
Ahmed, N; Mirza, MMF; Shaikh, NA; Thomas, L, 2019
)
0.99
"Among people with epilepsy, levetiracetam (LEV) can cause neuropsychiatric adverse events (NPAEs) that impact negatively on quality of life."( Pyridoxine supplementation for levetiracetam-related neuropsychiatric adverse events: A systematic review.
Perucca, E; Romoli, M; Sen, A, 2020
)
1.14
" LEV has milder adverse events than OXC and LTG in clinical practice."( Comparison of long-term efficacy, tolerability, and safety of oxcarbazepine, lamotrigine, and levetiracetam in patients with newly diagnosed focal epilepsy: An observational study in the real world.
Li, R; Li, Y; Ou, S; Pan, S; Wang, Y; Xia, L; Zhou, Q, 2020
)
0.78
" The secondary outcomes included application of an additional second-line AED, induction of anesthesia, and admission to the intensive care unit (ICU), and drug-related adverse reactions."( Efficacy and safety profile of intravenous levetiracetam versus phenytoin in convulsive status epilepticus and acute repetitive seizures in children.
Besli, GE; Yilmaz, S; Yuksel Karatoprak, E, 2020
)
0.82
" Drug-related adverse reactions were more frequent in the phenytoin group than the levetiracetam group (23."( Efficacy and safety profile of intravenous levetiracetam versus phenytoin in convulsive status epilepticus and acute repetitive seizures in children.
Besli, GE; Yilmaz, S; Yuksel Karatoprak, E, 2020
)
1.05
" Treatment-emergent adverse events (TEAEs; 81 % vs 73 %) and TEAEs leading to discontinuation (16 % vs 2 %) were reported more frequently in Arm 2 than Arm 1, respectively."( Efficacy and safety of eslicarbazepine acetate as a first or later adjunctive therapy in patients with focal seizures.
Blum, D; Cantu, D; Gidal, B; Grinnell, T; Hixson, J; Mehta, D; Pikalov, A; Zhang, Y, 2021
)
0.62
"6 million adverse event reports made to the FDA Adverse Event Reporting System (FAERS) database between July 1, 2018 and March 31, 2020 for DILI due to ASMs commonly used in clinical practice."( Drug-induced liver injury associated with antiseizure medications from the FDA Adverse Event Reporting System (FAERS).
Catalano, C; Gupta, K; Kamitaki, BK; Minacapelli, CD; Rustgi, V; Wachuku, C; Zhang, P, 2021
)
0.62
" Despite its favorable side effect profile and minimal drug-drug interactions, neuropsychiatric side effects are reported in up to 13% of children."( Amelioration of Levetiracetam-Induced Behavioral Side Effects by Pyridoxine. A Randomized Double Blind Controlled Study.
Al Enazi, S; Al Otaibi, A; Al Wadei, A; Benini, R; Jad, L; Lubbad, N; Mahmoud, A; Tabassum, S, 2021
)
0.97
"To understand the currently available post-marketing real-world evidence of the incidences of and discontinuations due to the BAEs of irritability, anger, and aggression in people with epilepsy (PWE) treated with the anti-seizure medications (ASMs) brivaracetam (BRV), levetiracetam (LEV), perampanel (PER), and topiramate (TPM), as well as behavioral adverse events (BAEs) in PWE switching from LEV to BRV."( Behavioral adverse events with brivaracetam, levetiracetam, perampanel, and topiramate: A systematic review.
Klein, P; Klitgaard, H; Laloyaux, C; Moseley, BD; Ricchetti-Masterson, K; Rosenow, F; Sirven, JI; Smith, B; Steinhoff, BJ; Stern, JM; Toledo, M; Villanueva, V; Zipfel, PA, 2021
)
1.06
" Behavioral and psychiatric adverse events in PWE switching from LEV to BRV were summarized descriptively."( Behavioral adverse events with brivaracetam, levetiracetam, perampanel, and topiramate: A systematic review.
Klein, P; Klitgaard, H; Laloyaux, C; Moseley, BD; Ricchetti-Masterson, K; Rosenow, F; Sirven, JI; Smith, B; Steinhoff, BJ; Stern, JM; Toledo, M; Villanueva, V; Zipfel, PA, 2021
)
0.88
"LEV has a better clinical effect than PHT in the treatment of children with CSE and does not increase the incidence rate of adverse events."( [Efficacy and safety of levetiracetam versus phenytoin as second-line drugs for the treatment of children with convulsive status epilepticus: a Meta analysis].
Shi, R; Wang, ZZ; Yin, HQ, 2021
)
0.93
" Safety variables included the incidence and type of adverse reactions."( Long-term safety, efficacy, and tolerability of levetiracetam in pediatric patients with epilepsy in Uygur, China: A retrospective analysis.
Feng, J; Li, HJ; Ma, L; Sun, L; Sun, Y; Wang, TT; Yu, J; Yu, LH; Zhao, T, 2021
)
0.88
" During levetiracetam treatment, 233 pediatric patients (22%) experienced at least one adverse reaction."( Long-term safety, efficacy, and tolerability of levetiracetam in pediatric patients with epilepsy in Uygur, China: A retrospective analysis.
Feng, J; Li, HJ; Ma, L; Sun, L; Sun, Y; Wang, TT; Yu, J; Yu, LH; Zhao, T, 2021
)
1.31
" The PubMed, Web of Science, Cochrane Library, and Embase databases were searched to identify eligible articles reporting outcomes including clinical seizure cessation within 60 min, clinical recurrence rate within 24 h, good final outcome at discharge, and adverse events (AEs) of treatment with levetiracetam and phenytoin."( Comparison of the efficacy and safety of levetiracetam and phenytoin in the treatment of established status epilepticus: A systematic review and meta-analysis.
Cui, XH; Dong, XZ; Liu, JM; Liu, WN; Yang, L; Zhang, L, 2021
)
1.06
" There were no differences found in the rates of adverse effects between groups."( Evaluation of Time to Administration, Benzodiazepine Use, and Safety of Intravenous Push Levetiracetam in a Neuro-Spine Intensive Care Unit.
Adams, T; Greathouse, K, 2021
)
0.84
"Administration of levetiracetam doses up to 2000 mg via IVP is a safe method of administration that results in a reduction of time to medication administration and a reduction of benzodiazepine use."( Evaluation of Time to Administration, Benzodiazepine Use, and Safety of Intravenous Push Levetiracetam in a Neuro-Spine Intensive Care Unit.
Adams, T; Greathouse, K, 2021
)
1.18
" It has been shown to be effective and safe for treating adults and children with epilepsy."( Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy.
Carbone, EQ; Cardoso, RA; Herrera, R; Kowacs, PA; Lacerda, GCB; Lin, K; Manreza, MLG; Morais, DC; Nakano, FN; Palmini, ALF; Pan, TA; Souza, AMMH; Vattimo, ACA; Yacubian, EMT; Zung, S, 2021
)
0.93
" Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo."( Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy.
Carbone, EQ; Cardoso, RA; Herrera, R; Kowacs, PA; Lacerda, GCB; Lin, K; Manreza, MLG; Morais, DC; Nakano, FN; Palmini, ALF; Pan, TA; Souza, AMMH; Vattimo, ACA; Yacubian, EMT; Zung, S, 2021
)
1.84
"Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy."( Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy.
Carbone, EQ; Cardoso, RA; Herrera, R; Kowacs, PA; Lacerda, GCB; Lin, K; Manreza, MLG; Morais, DC; Nakano, FN; Palmini, ALF; Pan, TA; Souza, AMMH; Vattimo, ACA; Yacubian, EMT; Zung, S, 2021
)
1.19
"Medication administration via intravenous push presents multiple potential advantages; however, there may be an increased risk of adverse drug reactions."( Safety of Intravenous Push Levetiracetam Compared to Intravenous Piggyback at a Tertiary Academic Medical Center: A Retrospective Analysis.
Alkazemi, A; Anger, KE; Chan, MG; McLaughlin, KC; Schontz, MJ; Szumita, PM, 2022
)
1.02
"Intravenous push levetiracetam administration of doses up to 4000 mg was associated with a similar incidence of cardiovascular, sedation, and infusion site-related adverse events compared to IVPB and resulted in a significant reduction in time to first-dose administration."( Safety of Intravenous Push Levetiracetam Compared to Intravenous Piggyback at a Tertiary Academic Medical Center: A Retrospective Analysis.
Alkazemi, A; Anger, KE; Chan, MG; McLaughlin, KC; Schontz, MJ; Szumita, PM, 2022
)
1.36
" Adverse events were also recorded."( Effectiveness and safety of perampanel in Chinese paediatric patients (2-14 years) with refractory epilepsy: a retrospective, observational study.
Chen, X; Dai, Y; Li, R; Liu, M; Qu, R; Zhu, Y, 2021
)
0.62
" Finally, there was no significant difference in the frequency of adverse events."( Levetiracetam adjunct to quetiapine for the acute manic phase of bipolar disorder: a randomized, double-blind and placebo-controlled clinical trial of efficacy, safety and tolerability.
Akhondzadeh, S; Arbabi, M; Hasanzadeh, A; Naderi, S; Ostadpour, M; Samsami, FS; Shamabadi, A; Zarezadeh, F, 2022
)
2.16
"Aggression is the most commonly encountered antiepileptic-drug (AED)-induced psychiatric adverse effects."( Differences in aggression as psychiatric side effect of levetiracetam and perampanel in patients with epilepsy.
Goji, H; Kanemoto, K; Kawai, M, 2022
)
0.97
"This study aimed to evaluate the association between eye disorders and several newer AEDs, and also to examine the differences in the frequency of adverse events across individual AEDs through data mining of the self-reporting US Food and Drug Administration Adverse Event Report System (FAERS) database."( Eye disorders associated with newer antiepileptic drugs: A real-world disproportionality analysis of FDA adverse event reporting system.
Chen, L; Hu, W; Li, H; Liu, J, 2022
)
0.72
" Adverse events were monitored and recorded."( Bioequivalence and Safety of Levetiracetam Granules and Oral Solution: A Randomized, Single-Dose, 2-Period Crossover Study in Healthy Chinese Volunteers Under a Fasting Condition.
Fang, L; Hu, L; Jia, J; Jiang, F; Liu, S; Liu, Y; Long, J; Pu, H; Wang, Y; Xu, W; Yu, C; Zhang, KE; Zou, Y, 2022
)
1.01
"Switching from brand-name to generic levetiracetam is safe and effective and holds promise for clinical application, but more prospective randomized controlled trials are required in future."( Efficacy and safety of switching from brand-name to domestic generic levetiracetam in children with epilepsy.
Chen, ZH; Li, XP; Liang, MJ; Qiu, WF; Shi, GA; Zhai, QX; Zhang, JW; Zhang, YX, 2022
)
1.23
" Although oxcarbazepine (OXC) is often considered efficacious for focal seizures in NCC, due to adverse effects, newer ASMs like levetiracetam (LCM) and lacosamide are also being explored."( Comparative Efficacy and Safety of Lacosamide and Oxcarbazepine for Seizure Control in Children with Newly Diagnosed Solitary Neurocysticercosis.
Kumar, V; Panda, PK; Sharawat, IK; Sherwani, P, 2022
)
0.93
" Seizure control, electroencephalographic abnormalities, resolution of inflammatory granulomas and adverse effects were compared between two arms at 12 and 24 weeks."( Comparative Efficacy and Safety of Lacosamide and Oxcarbazepine for Seizure Control in Children with Newly Diagnosed Solitary Neurocysticercosis.
Kumar, V; Panda, PK; Sharawat, IK; Sherwani, P, 2022
)
0.72
" Patients receiving OXC had more frequent treatment-emergent adverse events (p = 0."( Comparative Efficacy and Safety of Lacosamide and Oxcarbazepine for Seizure Control in Children with Newly Diagnosed Solitary Neurocysticercosis.
Kumar, V; Panda, PK; Sharawat, IK; Sherwani, P, 2022
)
0.72
"Lacosamide appears to be efficacious and safe for achieving seizure freedom in patients with solitary viable parenchymal neurocysticercosis."( Comparative Efficacy and Safety of Lacosamide and Oxcarbazepine for Seizure Control in Children with Newly Diagnosed Solitary Neurocysticercosis.
Kumar, V; Panda, PK; Sharawat, IK; Sherwani, P, 2022
)
0.72
" There were few adverse effects, including specific adverse effects relating to medication concentration and speed of infusion, in all the studies."( The safety of rapid infusion levetiracetam: A systematic review.
Douville, A; Jense, A; Weiss, A, 2022
)
1.01
"There have been several reports that switching formulations of antiseizure medications (ASMs) has been associated with a deterioration of seizure control, seizure relapse or increased adverse effects."( Analyzing excipient-related adverse events in antiseizure drug formulations.
Ionova, Y; Peterson, T; Wilson, L, 2022
)
0.72
"Acute kidney injury is an expected adverse drug reaction listed in the European Union (EU) Summary of Product Characteristics (SmPC) for levetiracetam, one of the most widely used modern antiseizure medications (ASMs)."( Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study.
Beau-Lejdstrom, R; Bonfitto, F; Floricel, F; Foskett, N; Garcia de Albeniz, X; Hong, LS; Kalilani, L; Loesch, C; Lorenzen, J; Luscombe, G; Mottet, I; Perez-Gutthann, S, 2022
)
1.18
" The most common treatment-emergent adverse events in the levetiracetam group versus the placebo group were headache (nine [39%] vs six [24%]), pain (three [13%] vs ten [40%]), and falls (seven [30%] vs four [16%])."( Safety and efficacy of prophylactic levetiracetam for prevention of epileptic seizures in the acute phase of intracerebral haemorrhage (PEACH): a randomised, double-blind, placebo-controlled, phase 3 trial.
André-Obadia, N; Berthezène, Y; Boulogne, S; Boutitie, F; Catenoix, H; Cho, TH; Convers, P; Derex, L; Dhelens, C; Esteban, M; Filip, A; Fontaine, J; Garnier, P; Gouttard, M; Haesebaert, J; Mazzola, L; Mechtouff, L; Nighoghossian, N; Ong, E; Perreton, N; Peter-Derex, L; Philippeau, F; Pivot, C; Rabilloud, M; Rheims, S; Schott, AM; Termoz, A, 2022
)
1.24
" The mainstay of treatment is with multiple anti-seizure medications (ASMs); however, the ASMs themselves can be associated with psychobehavioural adverse events, and effects (negative or positive) on cognition and sleep."( Psychobehavioural and Cognitive Adverse Events of Anti-Seizure Medications for the Treatment of Developmental and Epileptic Encephalopathies.
Schubert-Bast, S; Strzelczyk, A, 2022
)
0.72
"In this study, the dose schedule efficacy, safety and late adverse effects of stereotactic radiosurgery (SRS) were evaluated for patients with symptomatic cavernomas who were not eligible for surgery and treated with SRS."( Radiosurgery effects and adverse effects in symptomatic eloquent brain-located Cavernomas.
Açan, Hİ; Aksaray, F; Berber, T; Celik, SE; Dinçer, ST; Harmanci, K; Numanoglu, C; Tambas, M; Yıldırım, BA; Yılmaz, BD; Yolcu, A; Yoney, A, 2023
)
0.91
"There were no statistically significant differences in the behavioral adverse effects between the pyridoxine-treated group and the placebo group."( Pyridoxine for treatment of levetiracetam-induced behavioral adverse events: A randomized double-blind placebo-controlled trial.
Alizadeh-Navaei, R; Asghari, F; Cheraghmakani, H; Ghazaeian, M; Rezapour, M; Tabrizi, N, 2022
)
1.02
"Although this study showed no statistically significant beneficial effects of pyridoxine on the behavioral adverse effects of levetiracetam, placebo-controlled trials with a larger size and higher doses are needed to determine whether it is effective or not."( Pyridoxine for treatment of levetiracetam-induced behavioral adverse events: A randomized double-blind placebo-controlled trial.
Alizadeh-Navaei, R; Asghari, F; Cheraghmakani, H; Ghazaeian, M; Rezapour, M; Tabrizi, N, 2022
)
1.22
" Efficacy variables were derived from seizure-related changes, and tolerability and safety variables from reported treatment-emergent adverse events (TEAEs), BRV withdrawal, and changes to questionnaire scores."( BRIVEST: A 'real-world' observational, single-centre study investigating the efficacy, safety and tolerability of Brivaracetam.
Cavill, R; Manuel, M; Naddell, S; Sieradzan, K; White, P, 2023
)
0.91
"Levetiracetam (LVT), while an effective treatment for multiple seizure types, is associated with a high incidence of neuropsychiatric adverse events (NPAEs)."( Current evidence for adjunct pyridoxine (vitamin B6) for the treatment of behavioral adverse effects associated with levetiracetam: A systematic review.
Besag, FMC; Sen, A; Vasey, MJ, 2023
)
2.56
" One RCT reported significant improvements from baseline in behavioral adverse events (BAEs) in both the intervention (PN) group and the low-dose control group (both p < 0."( Current evidence for adjunct pyridoxine (vitamin B6) for the treatment of behavioral adverse effects associated with levetiracetam: A systematic review.
Besag, FMC; Sen, A; Vasey, MJ, 2023
)
1.12
" Among the novel antiseizure medications (ASM), Perampanel (PER), Levetiracetam (LEV), and Topiramate (TPM) have been reported to have a relatively high frequency of psychiatric adverse events."( [Psychiatric Symptoms of Patients With Epilepsy: Characteristics of Psychiatric Adverse Events by Novel Antiepileptic Medications].
Hasegawa, N; Kanemoto, K; Nishida, T, 2023
)
1.15
" Therefore, knowledge about the typical adverse events (AEs) for ASMs and other coadministered drugs (CDs) is essential for practitioners and patients."( Adverse Event Profiles of Antiseizure Medications and the Impact of Coadministration on Drug Tolerability in Adults with Epilepsy.
Knake, S; Kovac, S; Rosenow, F; Strzelczyk, A; van der Goten, M; von Podewils, F; Willems, LM; Zöllner, JP, 2023
)
0.91
" The toxic effects of this medication in tissues have been associated with redox state imbalance, which can lead to salivary gland dysfunction."( Assessment of the toxic effects of levetiracetam on biochemical, functional, and redox parameters of salivary glands in male Wistar rats.
Antoniali, C; Chaves-Neto, AH; da Silva, LGL; de Freitas, RN; Dornelles, RCM; Fakhouri, WD; Ferreira, DSB; Fiais, GA; Kawaguchi, M; Nakamune, ACMS; Teixeira, GR; Veras, ASC, 2023
)
1.19
" We should collaborate with obstetricians and other professionals to help ensure a safe environment for pregnancy and childbirth."( [Safe and Effective Management of Epilepsy in Pregnancy].
Iwasaki, M; Kimura, Y, 2023
)
0.91

Pharmacokinetics

The pharmacokinetic variability of levetiracetam is wider than originally thought. Pharmacokinetic studies have been conducted in healthy volunteers, in patients of all ages with epilepsy, and in certain special populations.

ExcerptReferenceRelevance
"The temporal pharmacokinetic interrelationship of levetiracetam in blood and cerebrospinal fluid (CSF) was studied after acute intraperitoneal administration of levetiracetam (20, 40 and 80 mg/kg), using an animal model that permits concurrent blood and CSF sampling in freely moving rats."( Blood and cerebrospinal fluid pharmacokinetics of the novel anticonvulsant levetiracetam (ucb L059) in the rat.
Doheny, HC; Jefferys, JG; Patsalos, PN; Ratnaraj, N; Whittington, MA, 1999
)
0.79
" The pharmacokinetic profile of levetiracetam closely approximates the ideal characteristics expected of an antiepileptic drug, with good bioavailability, rapid achievement of steady-state concentrations, linear and time-invariant kinetics, minimal protein binding, and minimal metabolism."( Pharmacokinetic profile of levetiracetam: toward ideal characteristics.
Patsalos, PN, 2000
)
0.89
" The objective of this study was to determine the presence or absence of a pharmacokinetic drug interaction of levetiracetam with phenytoin."( Absence of pharmacokinetic drug interaction of levetiracetam with phenytoin in patients with epilepsy determined by new technique.
Baltes, E; Browne, TR; Jensen, CM; Josephs, E; Leppik, IE; Paz, J; Szabo, GK, 2000
)
0.78
"This study was undertaken to determine whether levetiracetam (Keppra) affected the pharmacokinetic or pharmacodynamic profile of digoxin in healthy adults."( Repeated administration of the novel antiepileptic agent levetiracetam does not alter digoxin pharmacokinetics and pharmacodynamics in healthy volunteers.
Baltes, E; Levy, RH; Ragueneau-Majlessi, I, 2001
)
0.81
" Although digoxin produced predictable changes in ECG, its pharmacodynamic parameters did not differ significantly between levetiracetam and placebo administration."( Repeated administration of the novel antiepileptic agent levetiracetam does not alter digoxin pharmacokinetics and pharmacodynamics in healthy volunteers.
Baltes, E; Levy, RH; Ragueneau-Majlessi, I, 2001
)
0.76
"At the doses administered, there was no pharmacokinetic interaction and no evidence of a pharmacodynamic interaction between digoxin and levetiracetam."( Repeated administration of the novel antiepileptic agent levetiracetam does not alter digoxin pharmacokinetics and pharmacodynamics in healthy volunteers.
Baltes, E; Levy, RH; Ragueneau-Majlessi, I, 2001
)
0.76
" Because REV has more favorable PK in dogs than LEV, the higher antiepileptic potency of LEV is more likely due to intrinsic pharmacodynamic activity rather than to enantioselective PK."( Pharmacokinetics of levetiracetam and its enantiomer (R)-alpha-ethyl-2-oxo-pyrrolidine acetamide in dogs.
Bialer, M; Isoherranen, N; Roeder, M; Schurig, V; Soback, S; Yagen, B, 2001
)
0.63
"Each antiepileptic drug has a characteristic pharmacokinetic profile, and the unique properties of each must be considered when selecting the optimal agent for a particular patient."( Pharmacokinetic considerations in prescribing antiepileptic drugs.
Faught, E, 2001
)
0.31
" The protein binding and the pharmacokinetic profiles of R- and S-warfarin were assessed at steady state by analysis of blood samples, and the anticoagulant effect was measured using the international normalized ratio (INR)."( Lack of effect of repeated administration of levetiracetam on the pharmacodynamic and pharmacokinetic profiles of warfarin.
Levy, RH; Meyerhoff, C; Ragueneau-Majlessi, I, 2001
)
0.57
"Twenty-four children (15 boys, nine girls), 6 to 12 years old, received a single dose of levetiracetam (20 mg/kg) as an adjunct to their stable regimen of a single concomitant AED, followed by a 24-h pharmacokinetic evaluation."( Pharmacokinetic study of levetiracetam in children.
Bebin, EM; Coupez, RM; Fountain, NB; Glauser, TA; Pellock, JM; Ritter, FJ; Shields, WD, 2001
)
0.84
" The Cmax and area under the curve (AUC) of levetiracetam equated for a 1-mg/kg dose were lower in children (Cmax, norm=1."( Pharmacokinetic study of levetiracetam in children.
Bebin, EM; Coupez, RM; Fountain, NB; Glauser, TA; Pellock, JM; Ritter, FJ; Shields, WD, 2001
)
0.88
" To-date levetiracetam is not known to be associated with any clinically significant pharmacokinetic interaction."( Carbamazepine toxicity during combination therapy with levetiracetam: a pharmacodynamic interaction.
Patsalos, PN; Sander, JW; Sisodiya, SM, 2002
)
0.98
"The plasma concentration-time curves and pharmacokinetic parameters of ethinyl estradiol and levonorgestrel were not statistically different during concomitant treatment with either levetiracetam or placebo."( Levetiracetam does not alter the pharmacokinetics of an oral contraceptive in healthy women.
Janik, F; Levy, RH; Ragueneau-Majlessi, I, 2002
)
1.95
"The novel antiepileptic drug (AED) levetiracetam (LEV; Keppra) has a wide therapeutic index and pharmacokinetic characteristics predicting limited drug-interaction potential."( Levetiracetam, a new antiepileptic agent: lack of in vitro and in vivo pharmacokinetic interaction with valproic acid.
Browne, TR; Coupez, R; Nicolas, JM, 2003
)
2.04
" An open-label, one-way, one-sequence crossover clinical trial was conducted in 16 healthy volunteers to assess further the possibility of any relevant pharmacokinetic interaction."( Levetiracetam, a new antiepileptic agent: lack of in vitro and in vivo pharmacokinetic interaction with valproic acid.
Browne, TR; Coupez, R; Nicolas, JM, 2003
)
1.76
"These findings suggest the absence of a pharmacokinetic interaction between VPA and LEV during short-term administration, and suggest that dose adjustment is not required when these two drugs are given together."( Levetiracetam, a new antiepileptic agent: lack of in vitro and in vivo pharmacokinetic interaction with valproic acid.
Browne, TR; Coupez, R; Nicolas, JM, 2003
)
1.76
" Pharmacokinetic studies of levetiracetam have been conducted in healthy volunteers, in patients of all ages with epilepsy, and in certain special populations."( The pharmacokinetic characteristics of levetiracetam.
Patsalos, PN, 2003
)
0.88
"The pharmacokinetic properties of a drug are the primary deter-minant of the extent and duration of drug action, and influence susceptibility to clinically important drug interactions."( The ideal pharmacokinetic properties of an antiepileptic drug: how close does levetiracetam come?
Johannessen, SI; Perucca, E, 2003
)
0.55
" Pharmacokinetic studies of levetiracetam have been conducted in healthy volunteers, in adults, children and elderly patients with epilepsy, and in patients with renal and hepatic impairment."( Clinical pharmacokinetics of levetiracetam.
Patsalos, PN, 2004
)
0.91
"In pharmacokinetic studies of hepatic impairment, including all classes of cirrhosis may be more revealing than including only selected classes of liver failure."( Pharmacokinetics of levetiracetam in patients with moderate to severe liver cirrhosis (Child-Pugh classes A, B, and C): characterization by dynamic liver function tests.
Brockmöller, J; Coupez, R; Lochs, H; Roots, I; Thomsen, T; Wittstock, M, 2005
)
0.65
" Brain AED concentrations were determined to ascertain any pharmacokinetic contribution to the observed antiseizure effect."( Pharmacodynamic and pharmacokinetic characterization of interactions between levetiracetam and numerous antiepileptic drugs in the mouse maximal electroshock seizure model: an isobolographic analysis.
Andres, MM; Cioczek-Czuczwar, A; Czuczwar, P; Czuczwar, SJ; Luszczki, JJ; Patsalos, PN; Ratnaraj, N, 2006
)
0.56
"These preclinical data would suggest that LEV in combination with TPM is associated with beneficial anticonvulsant pharmacodynamic interactions."( Pharmacodynamic and pharmacokinetic characterization of interactions between levetiracetam and numerous antiepileptic drugs in the mouse maximal electroshock seizure model: an isobolographic analysis.
Andres, MM; Cioczek-Czuczwar, A; Czuczwar, P; Czuczwar, SJ; Luszczki, JJ; Patsalos, PN; Ratnaraj, N, 2006
)
0.56
" Subjects then entered the second phase, a multiple-dose, randomized, double-blind, placebo-controlled (2:1), parallel-group tolerability and pharmacokinetic study, in which they received 9 successive doses of levetiracetam 1,500 mg IV or placebo at 12-hour intervals."( Single-dose bioavailability of levetiracetam intravenous infusion relative to oral tablets and multiple-dose pharmacokinetics and tolerability of levetiracetam intravenous infusion compared with placebo in healthy subjects.
Boulanger, P; De Smedt, F; Otoul, C; Ramael, S; Riethuisen, JM; Stockis, A; Toublanc, N, 2006
)
0.81
"LEV administered by IV infusion at dosages and/or infusion rates higher than those proposed was well tolerated in healthy subjects, and the pharmacokinetic profile was consistent with that for LEV administered orally."( Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study.
Daoust, A; Lu, ZS; Otoul, C; Ramael, S; Stockis, A; Toublanc, N; Troenaru, M, 2006
)
1.78
" For drugs that are eliminated renally completely unchanged (gabapentin, pregabalin and vigabatrin) or mainly unchanged (levetiracetam and topiramate), the pharmacokinetic variability is less pronounced and more predictable."( Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed?
Johannessen, SI; Tomson, T, 2006
)
0.54
" LEV and FBM brain concentrations were measured by HPLC in order to determine any pharmacokinetic contribution to the observed antiseizure effect."( Levetiracetam and felbamate interact both pharmacodynamically and pharmacokinetically: an isobolographic analysis in the mouse maximal electroshock model.
Andres-Mach, MM; Czuczwar, SJ; Luszczki, JJ; Patsalos, PN; Ratnaraj, N, 2007
)
1.78
"LEV in combination with FBM was associated with pharmacodynamic supraadditivity in the MES test."( Levetiracetam and felbamate interact both pharmacodynamically and pharmacokinetically: an isobolographic analysis in the mouse maximal electroshock model.
Andres-Mach, MM; Czuczwar, SJ; Luszczki, JJ; Patsalos, PN; Ratnaraj, N, 2007
)
1.78
" * Pharmacokinetic studies of levetiracetam have been conducted in healthy volunteers, in adults, children and elderly patients with epilepsy, and in patients with renal and hepatic impairment."( Single-dose pharmacokinetics of levetiracetam in healthy Chinese male subjects.
Hu, P; Jiang, J; Li, X; Lu, ZS; Zhao, Q, 2007
)
0.91
" Blood was obtained for a 36-h pharmacokinetic evaluation."( Single-dose pharmacokinetics of levetiracetam in healthy Chinese male subjects.
Hu, P; Jiang, J; Li, X; Lu, ZS; Zhao, Q, 2007
)
0.62
" The pharmacokinetic data obtained in these Chinese subjects were similar to the historical data from a matched group of White subjects."( Single-dose pharmacokinetics of levetiracetam in healthy Chinese male subjects.
Hu, P; Jiang, J; Li, X; Lu, ZS; Zhao, Q, 2007
)
0.62
" LEV plasma concentrations in the neonates declined with an estimated half-life of 18 h (n=13)."( Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation.
Ben-Menachem, E; Danielsson, B; Johansson, R; Källén, K; Luef, G; Ohman, I; Palm, R; Söderfeldt, B; Tomson, T, 2007
)
0.66
"Eligible patients with a stable regimen of antiepileptic medications received a single oral dose of levetiracetam 20 mg/kg administered as a 10% oral solution followed by a 24-hour pharmacokinetic evaluation."( Pharmacokinetics of levetiracetam in infants and young children with epilepsy.
Bebin, M; Chen, D; Coupez, R; Glauser, TA; Lu, ZS; Mitchell, WG; Stockis, A; Weinstock, A, 2007
)
0.88
"2 months) enrolled and received levetiracetam; 12 provided evaluable pharmacokinetic data."( Pharmacokinetics of levetiracetam in infants and young children with epilepsy.
Bebin, M; Chen, D; Coupez, R; Glauser, TA; Lu, ZS; Mitchell, WG; Stockis, A; Weinstock, A, 2007
)
0.95
"Population pharmacokinetic analysis points to the absence of ethnic differences in the pharmacokinetics of levetiracetam between Japanese and Western populations, other than those arising from bodyweight differences."( Population pharmacokinetics of levetiracetam in Japanese and Western adults.
Jacqmin, P; Pigeolet, E; Sargentini-Maier, ML; Stockis, A, 2007
)
0.84
"To develop a pharmacokinetic model for intravenous levetiracetam in children, based on adult intravenous data and pediatric oral data."( Modeling and simulation of intravenous levetiracetam pharmacokinetic profiles in children to evaluate dose adaptation rules.
Jacqmin, P; Sargentini-Maier, ML; Snoeck, E; Stockis, A, 2007
)
0.86
"Data from two adult Phase-I studies in which levetiracetam was given intravenously were utilized to develop the adult population pharmacokinetic two-compartment intravenous model."( Modeling and simulation of intravenous levetiracetam pharmacokinetic profiles in children to evaluate dose adaptation rules.
Jacqmin, P; Sargentini-Maier, ML; Snoeck, E; Stockis, A, 2007
)
0.87
"The population pharmacokinetic two-compartment model successfully described intravenous levetiracetam pharmacokinetics in healthy adults."( Modeling and simulation of intravenous levetiracetam pharmacokinetic profiles in children to evaluate dose adaptation rules.
Jacqmin, P; Sargentini-Maier, ML; Snoeck, E; Stockis, A, 2007
)
0.83
" Intravenous LEV half-life was 180 +/- 18 min."( Intramuscular, intravenous and oral levetiracetam in dogs: safety and pharmacokinetics.
Cloyd, JC; Dunn, AW; Fisher, JE; Goel, V; Leppik, IE; O'Brien, TD; Patterson, EE, 2008
)
0.62
" Whole-body physiologically based pharmacokinetic (WB-PBPK) modelling is a predictive technique that quantitatively relates the pharmacokinetic parameters of a drug to such (patho-)physiological conditions."( Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis.
Edginton, AN; Willmann, S, 2008
)
0.35
" Predictions of pharmacokinetic profiles and parameters were compared with literature data for the model compounds alfentanil, lidocaine (lignocaine), theophylline and levetiracetam."( Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis.
Edginton, AN; Willmann, S, 2008
)
0.54
"The predicted versus observed plasma concentration-time profiles for alfentanil and lidocaine were similar, such that the pharmacokinetic changes associated with Child-Pugh class A, B and C liver cirrhosis were adequately described."( Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis.
Edginton, AN; Willmann, S, 2008
)
0.35
"To evaluate the feasibility and safety of intravenous (iv) levetiracetam (LEV) added to the standard therapeutic regimen in adults with status epilepticus (SE), and as secondary objective to assess a population pharmacokinetic (PK) model for ivLEV in patients with SE."( Safety and pharmacokinetics of intravenous levetiracetam infusion as add-on in status epilepticus.
Engelsman, J; Peeters, E; Touw, DJ; Uges, JW; van Huizen, MD; Vecht, CJ; Wilms, EB, 2009
)
0.86
" In contrast, levetiracetam was without affect on tiagabine or vigabatrin concentrations and co-administration with gabapentin, tiagabine or vigabatrin had no effect on levetiracetam brain concentrations, indicating the pharmacodynamic nature of interaction between these antiepileptic drugs in the mouse pentylenetetrazole model."( Pharmacodynamic and pharmacokinetic interaction profiles of levetiracetam in combination with gabapentin, tiagabine and vigabatrin in the mouse pentylenetetrazole-induced seizure model: an isobolographic analysis.
Andres-Mach, MM; Czuczwar, SJ; Dudra-Jastrzebska, M; Luszczki, JJ; Patsalos, PN; Ratnaraj, N; Sielski, M, 2009
)
0.96
"To develop a population pharmacokinetic model to evaluate the demographic and physiologic determinants of levetiracetam (LEV) pharmacokinetics (PK) and to suggest recommended doses of LEV in children."( Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy.
Chhun, S; Chiron, C; Dulac, O; Jullien, V; Pons, G; Rey, E, 2009
)
0.85
" Possible associations between pharmacokinetic parameters and age, gender, body weight, creatinine clearance, and concomitant antiepileptic drugs (AEDs) were assessed."( Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy.
Chhun, S; Chiron, C; Dulac, O; Jullien, V; Pons, G; Rey, E, 2009
)
0.64
" Both LEV apparent clearance and distribution volume were related to body weight, and no pharmacokinetic interaction was observed."( Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy.
Chhun, S; Chiron, C; Dulac, O; Jullien, V; Pons, G; Rey, E, 2009
)
0.64
" Pharmacokinetic data were analyzed by use of a 1-compartment model with first-order absorption."( Levetiracetam pharmacokinetics in healthy dogs following oral administration of single and multiple doses.
Moore, SA; Muñana, KR; Nettifee-Osborne, J; Papich, MG, 2010
)
1.8
" Compared with values determined when LEV was administered alone, concurrent administration of PB resulted in a decrease in LEV peak concentration (C(max) ) from 32."( The pharmacokinetics of levetiracetam in healthy dogs concurrently receiving phenobarbital.
Moore, SA; Muñana, KR; Nettifee-Osborne, JA; Papich, MG, 2011
)
0.68
"01) and a shorter half-life (p=0."( Influence of enzyme inducing antiepileptic drugs on the pharmacokinetics of levetiracetam in patients with epilepsy.
Alexandre, V; Feletti, F; Freitas-Lima, P; Pereira, LR; Perucca, E; Sakamoto, AC, 2011
)
0.6
" Neonates were found to have lower clearance, higher volume of distribution, and a longer half-life as compared with older children and adults."( Pharmacokinetics of levetiracetam in neonates with seizures.
Balmakund, T; Meinzen-Derr, J; Merhar, SL; Schibler, KR; Sherwin, CM; Shi, J; Vinks, AA, 2011
)
0.69
"Mean ± SD peak concentration was 25."( Pharmacokinetics of levetiracetam after oral and intravenous administration of a single dose to clinically normal cats.
Axlund, TW; Boothe, DM; Carnes, MB, 2011
)
0.69
" Prospective, open-label, steady-state pharmacokinetic study."( Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients.
Fleck, JD; Jacobi, J; Juenke, JM; Kays, MB; Spencer, DD, 2011
)
0.63
" Serum levetiracetam concentrations were determined by ultraperformance liquid chromatography with tandem mass spectrometry detection, and pharmacokinetic data were analyzed by compartmental and noncompartmental methods."( Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients.
Fleck, JD; Jacobi, J; Juenke, JM; Kays, MB; Spencer, DD, 2011
)
1.08
"Compared with previously published results in healthy volunteers and adults in status epilepticus, levetiracetam systemic clearance was faster and the terminal elimination half-life was shorter in neurocritical care patients."( Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients.
Fleck, JD; Jacobi, J; Juenke, JM; Kays, MB; Spencer, DD, 2011
)
0.85
" Pharmacokinetic data were analyzed using a nonlinear mixed-effects population approach."( A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life.
Capparelli, EV; Farrell, MJ; Haas, RH; Mower, A; Sharpe, CM; Soldin, SJ, 2012
)
0.62
" Mean half-life was 18."( A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life.
Capparelli, EV; Farrell, MJ; Haas, RH; Mower, A; Sharpe, CM; Soldin, SJ, 2012
)
0.62
" We report pharmacokinetics of TBI subjects≥6years with high PTE risk treated with LEV 55mg/kg/day orally, nasogastrically or intravenously for 30days starting ≤8h after injury in a phase II safety and pharmacokinetic study."( Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy.
Atabaki, SM; He, J; Herr, D; Klein, P; Levine, Z; McCarter, R; Natale, J; Nogay, C; Pearl, PL; Sandoval, F; Soldin, SJ; Trzcinsky, S; Tsuchida, T; van den Anker, J, 2012
)
0.64
" There is still insufficient documentation regarding pharmacokinetic variability of these AEDs in different patient groups."( Pharmacokinetic variability of four newer antiepileptic drugs, lamotrigine, levetiracetam, oxcarbazepine, and topiramate: a comparison of the impact of age and comedication.
Baftiu, A; Johannessen Landmark, C; Johannessen, SI; Larsson, PG; Rytter, E; Tysse, I; Valsø, B, 2012
)
0.61
"The purpose of this study was to compare age and comedication as factors contributing to pharmacokinetic variability between 4 newer AEDs (lamotrigine, levetiracetam, oxcarbazepine, and topiramate) among patients with refractory epilepsy."( Pharmacokinetic variability of four newer antiepileptic drugs, lamotrigine, levetiracetam, oxcarbazepine, and topiramate: a comparison of the impact of age and comedication.
Baftiu, A; Johannessen Landmark, C; Johannessen, SI; Larsson, PG; Rytter, E; Tysse, I; Valsø, B, 2012
)
0.81
" The interindividual pharmacokinetic variability was extensive, as illustrated by a 10-fold variability in serum concentration compared with dose."( Pharmacokinetic variability of four newer antiepileptic drugs, lamotrigine, levetiracetam, oxcarbazepine, and topiramate: a comparison of the impact of age and comedication.
Baftiu, A; Johannessen Landmark, C; Johannessen, SI; Larsson, PG; Rytter, E; Tysse, I; Valsø, B, 2012
)
0.61
"Age and comedication are important contributors to pharmacokinetic variability."( Pharmacokinetic variability of four newer antiepileptic drugs, lamotrigine, levetiracetam, oxcarbazepine, and topiramate: a comparison of the impact of age and comedication.
Baftiu, A; Johannessen Landmark, C; Johannessen, SI; Larsson, PG; Rytter, E; Tysse, I; Valsø, B, 2012
)
0.61
" The objective is to develop a population pharmacokinetic model to describe the pharmacokinetics of levetiracetam in Japanese children and adults as well as North American children, the purpose being to explore potential dosing recommendations in Japanese children."( Development of an integrated population pharmacokinetic model for oral levetiracetam in populations of various ages and ethnicities.
Lacroix, BD; Toublanc, N; Yamamoto, J, 2014
)
0.85
" For most of the drugs pharmacokinetic data and dosing recommendations for patients undergoing peritoneal dialysis are not available."( A missed opportunity - consequences of unknown levetiracepam pharmacokinetics in a peritoneal dialysis patient.
Bahte, SK; Hiss, M; Kielstein, JT; Lichtinghagen, R, 2014
)
0.4
" Both half-life and dialysate content might help to guide dosing in this patient population."( A missed opportunity - consequences of unknown levetiracepam pharmacokinetics in a peritoneal dialysis patient.
Bahte, SK; Hiss, M; Kielstein, JT; Lichtinghagen, R, 2014
)
0.4
" Pharmacokinetic changes associated with pregnancy may increase apparent clearance of extended-release formulations of levetiracetam, leading to periods of subtherapeutic blood or central nervous system concentrations."( Increased levetiracetam clearance associated with a breakthrough seizure in a pregnant patient receiving once/day extended-release levetiracetam.
Garrity, LC; Standridge, SM; Turner, M, 2014
)
1.01
" Study B, however, showed that pharmacokinetic profiles were generally similar between Japanese and Caucasian adults after single and repeated iv infusions of levetiracetam 1,500 mg."( Pharmacokinetics of the antiepileptic drug levetiracetam in healthy Japanese and Caucasian volunteers following intravenous administration.
Andreas, JO; Boyce, M; Chan, R; Mugitani, A; Okagaki, T; Toublanc, N; Watanabe, S; Yamamoto, K; Yoshida, K, 2015
)
0.88
" Noncompartmental pharmacokinetic parameters were calculated and steady-state profiles were simulated using the superposition method."( Levetiracetam pharmacokinetics in Japanese subjects with renal impairment.
Kumagai, Y; Stockis, A; Toublanc, N; Yamamoto, J, 2014
)
1.85
" An intensive pharmacokinetic study was performed from immediately before to 11 hours after the morning LVT dose administration and suggested that the patient was not adequately exposed to the drug during the night."( Increased levetiracetam clearance and breakthrough seizure in a pregnant patient successfully handled by intensive therapeutic drug monitoring.
Cappellari, AM; Cattaneo, D; Clementi, E; Kustermann, A, 2015
)
0.82
"Prospective pharmacokinetic study."( Effect of chronic administration of phenobarbital, or bromide, on pharmacokinetics of levetiracetam in dogs with epilepsy.
Muñana, KR; Nettifee-Osborne, JA; Papich, MG,
)
0.35
"Compared to the PB and PB-BR groups, the BR group had significantly higher peak concentration (Cmax ) (73."( Effect of chronic administration of phenobarbital, or bromide, on pharmacokinetics of levetiracetam in dogs with epilepsy.
Muñana, KR; Nettifee-Osborne, JA; Papich, MG,
)
0.35
" Geometric mean Cmax (77."( Pharmacokinetics, Safety and Bioequivalence of Levetiracetam Intravenous Infusion and Oral Tablets in Healthy Chinese Subjects.
Chan, R; Chen, Q; Du, X; Liu, Y; Singh, P; Stockis, A; Toublanc, N, 2015
)
0.67
" Serum samples were analyzed to determine pharmacokinetic properties of each formulation by means of ultra-high-performance liquid chromatography with tandem mass spectrometry."( Pharmacokinetic evaluation of immediate- and extended-release formulations of levetiracetam in dogs.
Arnold, RD; Barron, LE; Boozer, LB; Haley, AC; Kent, M; Linville, AV; Nie, B; Platt, SR, 2015
)
0.65
"All ER formulations of levetiracetam had similar pharmacokinetic properties in healthy dogs, with some exceptions."( Pharmacokinetic evaluation of immediate- and extended-release formulations of levetiracetam in dogs.
Arnold, RD; Barron, LE; Boozer, LB; Haley, AC; Kent, M; Linville, AV; Nie, B; Platt, SR, 2015
)
0.96
" This review examines strategies to overcome ARC and summarizes current pharmacokinetic and pharmacodynamic literature in patients with ARC in an effort to provide dosing guidance for this patient population."( Implications of Augmented Renal Clearance on Drug Dosing in Critically Ill Patients: A Focus on Antibiotics.
Daley, MJ; Hobbs, AL; Roberts, KM; Shea, KM, 2015
)
0.42
" The peak concentration at steady state was 32."( Levetiracetam Pharmacokinetics During Continuous Venovenous Hemofiltration and Acute Liver Dysfunction.
Frazee, EN; Kashani, KB; Nei, SD; New, AM; Rabinstein, AA, 2016
)
1.88
" In this study, a population pharmacokinetic model of levetiracetam was developed using routinely monitored serum concentration data for individualized levetiracetam therapy."( Population Pharmacokinetic Modeling of Levetiracetam in Pediatric and Adult Patients With Epilepsy by Using Routinely Monitored Data.
Hashi, S; Ikeda, A; Ito, S; Matsubara, K; Sugimoto, M; Tsuda, M; Yano, I; Yonezawa, A, 2016
)
0.95
" This study aimed to develop a population pharmacokinetic (PK) model of LEV, based on sparse data, and to explore LEV efficacy relative to its PK properties in patients with epilepsy."( Population pharmacokinetics and dose-response relationship of levetiracetam in adult patients with epilepsy.
Chu, K; Jang, IJ; Jung, KH; Jung, KY; Kim, TJ; Lee, S; Lee, SK; Lee, ST; Moon, J; Park, KI; Rhee, SJ; Shin, JW; Yu, KS, 2017
)
0.7
" Clinical pharmacokinetic monitoring (CPM) is often recommended in pediatric patients for certain AEDs due to large interindividual pharmacokinetic differences and unpredictable drug disposition."( Levetiracetam Clinical Pharmacokinetic Monitoring in Pediatric Patients with Epilepsy.
Ensom, MHH; Levine, M; Paquette, V; Tan, J, 2017
)
1.9
" CASE REPORT We report the levetiracetam pharmacokinetic profile of a patient being treated with levetiracetam 1000 mg intravenously every 12 h who required continuous veno-venous hemofiltration (CVVH)."( Levetiracetam Pharmacokinetics in a Patient with Intracranial Hemorrhage Undergoing Continuous Veno-Venous Hemofiltration.
Cava, LF; Fish, DN; Kiser, TH; MacLaren, R; Mueller, SW; Neumann, RT; Van Matre, ET, 2017
)
2.19
" The preferred levetiracetam dosing regimen in critically ill patients exhibiting complex pharmacokinetic profiles undergoing hemodialysis is unknown."( Levetiracetam Pharmacokinetics in a Critically Ill Anephric Patient on Intermittent Hemodialysis.
Frazee, E; Kashani, KB; Rabinstein, AA; Wieruszewski, PM, 2018
)
2.28
"48 L/kg, and the interdialytic elimination half-life was 31 h."( Levetiracetam Pharmacokinetics in a Critically Ill Anephric Patient on Intermittent Hemodialysis.
Frazee, E; Kashani, KB; Rabinstein, AA; Wieruszewski, PM, 2018
)
1.92
" Levetiracetam has an ideal safety and pharmacokinetic profile in multiple species, including the adult horse, and may be a safe and cost-effective alternative anticonvulsant in neonatal foals."( Pharmacokinetics of the anticonvulsant levetiracetam in neonatal foals.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; MacDonald, KD, 2018
)
1.66
"This study developed a population pharmacokinetic (PK) model of levetiracetam (LEV) for treating neonatal seizures (NS) and determined the influence of clinically relevant covariates to explain the interindividual variability and residual error."( Population pharmacokinetics of levetiracetam in neonates with seizures.
Gómez-Ruiz, LM; Lima-Rogel, V; López-López, EJ; Medellín-Garibay, SE; Milán-Segovia, RC; Romano-Moreno, S; Romero-Méndez, C, 2018
)
1.01
" Plasma levels were obtained for analysis of potential pharmacokinetic interactions for each combination studied in the mouse 6-Hz model."( Potent and selective pharmacodynamic synergy between the metabotropic glutamate receptor subtype 2-positive allosteric modulator JNJ-46356479 and levetiracetam in the mouse 6-Hz (44-mA) model.
Ceusters, M; Klein, BD; Lavreysen, H; Metcalf, CS; Pype, S; Smith, MD; Twyman, R; Van Osselaer, N; White, HS, 2018
)
0.68
" Using 1:1, 1:3, and 3:1 fixed dose-ratio combinations (LEV:JNJ-46356479), coadministration was significantly more potent than predicted for additive effects, and plasma levels suggest this synergism was not due to pharmacokinetic interactions."( Potent and selective pharmacodynamic synergy between the metabotropic glutamate receptor subtype 2-positive allosteric modulator JNJ-46356479 and levetiracetam in the mouse 6-Hz (44-mA) model.
Ceusters, M; Klein, BD; Lavreysen, H; Metcalf, CS; Pype, S; Smith, MD; Twyman, R; Van Osselaer, N; White, HS, 2018
)
0.68
"This study was conducted to develop a population pharmacokinetic (PK) model of levetiracetam in Korean neonates with seizures."( Population pharmacokinetic model of levetiracetam in Korean neonates with seizures
.
Jung, YS; Lee, SM; Park, K; Park, MS, 2018
)
0.98
" In this study, we developed and validated a method for determination of LEV in plasma by liquid chromatography tandem mass spectrometry for the purpose of pharmacokinetic study."( Determination of plasma Levetiracetam level by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS-MS) and its application in pharmacokinetics studies in neonates.
Horsuwan, S; Jenjirattithigarn, N; Khongkhatithum, C; Prempunpong, C; Prommas, S; Puangpetch, A; Sukasem, C; Thampratankul, L; Visudtibhan, A; Worachat, N, 2018
)
0.79
"This method was reliable, accurate and applicable for LEV pharmacokinetic study in neonates with seizure."( Determination of plasma Levetiracetam level by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS-MS) and its application in pharmacokinetics studies in neonates.
Horsuwan, S; Jenjirattithigarn, N; Khongkhatithum, C; Prempunpong, C; Prommas, S; Puangpetch, A; Sukasem, C; Thampratankul, L; Visudtibhan, A; Worachat, N, 2018
)
0.79
" A population pharmacokinetic approach and nonlinear mixed effects modeling were used to analyze the data."( Population pharmacokinetics of extended-release levetiracetam in epileptic dogs when administered alone, with phenobarbital or zonisamide.
Muñana, KR; Nettifee, JA; Otamendi, AJ; Papich, MG, 2018
)
0.74
"69 L/kg, elimination half-life of 13."( Lacosamide Pharmacokinetics in a Critically Ill Patient During Continuous Renal Replacement Therapy.
Albright, RC; Barreto, EF; Fugate, JE; Lopez-Ruiz, A; Wieruszewski, PM, 2020
)
0.56
" Serum and brain levels of antiepileptic drugs and cannabidiol were determined by using HPLC in order to ascertain any pharmacokinetic contribution to the observed behavioral effects."( Acute effect of cannabidiol on the activity of various novel antiepileptic drugs in the maximal electroshock- and 6 Hz-induced seizures in mice: Pharmacodynamic and pharmacokinetic studies.
Nieoczym, D; Socała, K; Szafarz, M; Wlaź, P; Wyska, E, 2019
)
0.51
"The objective was to develop and externally validate a population pharmacokinetic model of levetiracetam in adult and elderly patients with epilepsy, and to perform dosing simulations to propose individualized dosing regimens more likely to achieve therapeutic concentrations."( Population Pharmacokinetics and Dosing Recommendations of Levetiracetam in Adult and Elderly Patients With Epilepsy.
Hernández-Mitre, MP; Jung-Cook, HH; Medellín-Garibay, SE; Milán-Segovia, RDC; Roberts, JA; Rodríguez-Leyva, I; Rodríguez-Pinal, CJ; Romano-Moreno, S; Zarazúa, S, 2020
)
1.02
"The clinical value of therapeutic drug monitoring can be increased most significantly by integrating assay results into clinical pharmacokinetic models for optimal dosing."( Development of a methodology to make individual estimates of the precision of liquid chromatography-tandem mass spectrometry drug assay results for use in population pharmacokinetic modeling and the optimization of dosage regimens.
Jelliffe, RW; Karvaly, GB; Kovács, K; Neely, MN; Vásárhelyi, B; Vincze, I, 2020
)
0.56
" This permits optimal dosages by providing the correct weighting factor of assay results in the development of population and individual pharmacokinetic models."( Development of a methodology to make individual estimates of the precision of liquid chromatography-tandem mass spectrometry drug assay results for use in population pharmacokinetic modeling and the optimization of dosage regimens.
Jelliffe, RW; Karvaly, GB; Kovács, K; Neely, MN; Vásárhelyi, B; Vincze, I, 2020
)
0.56
" The aim was to use long-term TDM to investigate pharmacokinetic variability of ASMs in these patients."( Pharmacokinetic Variability During Long-Term Therapeutic Drug Monitoring of Valproate, Clobazam, and Levetiracetam in Patients With Dravet Syndrome.
Bjørnvold, M; Burns, ML; Heger, K; Johannessen Landmark, C; Johannessen, SI; Lund, C; Sætre, E, 2020
)
0.77
" Pharmacokinetic variability of the total number of measurements of valproate (n = 417), clobazam and N-desmethylclobazam (n = 328), and levetiracetam (n = 238) was determined."( Pharmacokinetic Variability During Long-Term Therapeutic Drug Monitoring of Valproate, Clobazam, and Levetiracetam in Patients With Dravet Syndrome.
Bjørnvold, M; Burns, ML; Heger, K; Johannessen Landmark, C; Johannessen, SI; Lund, C; Sætre, E, 2020
)
0.98
" Pharmacokinetic variability and interactions can thus be identified and adjusted to facilitate decision making to achieve the optimal treatment outcome."( Pharmacokinetic Variability During Long-Term Therapeutic Drug Monitoring of Valproate, Clobazam, and Levetiracetam in Patients With Dravet Syndrome.
Bjørnvold, M; Burns, ML; Heger, K; Johannessen Landmark, C; Johannessen, SI; Lund, C; Sætre, E, 2020
)
0.77
" Because of its large between-subject variability, several population pharmacokinetic studies have been performed to identify its pharmacokinetic covariates, and thus facilitate individualised therapy."( Population Pharmacokinetics of Levetiracetam: A Systematic Review.
Jiao, Z; Li, ZR; Wang, CY; Zhu, X, 2021
)
0.91
"The aim of this review was to provide a synopsis for population pharmacokinetic studies of levetiracetam and explore the identified influencing covariates."( Population Pharmacokinetics of Levetiracetam: A Systematic Review.
Jiao, Z; Li, ZR; Wang, CY; Zhu, X, 2021
)
1.13
" Moreover, the pharmacokinetic profiles were compared among neonates, children, and adults."( Population Pharmacokinetics of Levetiracetam: A Systematic Review.
Jiao, Z; Li, ZR; Wang, CY; Zhu, X, 2021
)
0.91
"The use of levetiracetam (LEV) has been increasing, given its favorable pharmacokinetic profile."( Population Pharmacokinetics of Levetiracetam: A Systematic Review.
Leelakanok, N; Methaneethorn, J, 2022
)
1.4
"We performed a systematic search for population pharmacokinetic studies of LEV conducted using a nonlinear-mixed effect approach from PubMed, Scopus, CINAHL Complete, and Science Direct databases from their inception to March 2020."( Population Pharmacokinetics of Levetiracetam: A Systematic Review.
Leelakanok, N; Methaneethorn, J, 2022
)
1.01
" The objective of this work was to evaluate predictive performance of two early concentrations and prior pharmacokinetic (PK) information for estimating early exposure."( A pharmacokinetic simulation study to assess the performance of a sparse blood sampling approach to quantify early drug exposure.
Brundage, RC; Chamberlain, JM; Cloyd, JC; Coles, LD; Elm, JJ; Ivaturi, V; Kapur, J; Sathe, AG; Silbergleit, R, 2021
)
0.62
" A population pharmacokinetic approach can be used to explain this variability and optimize dosing schemes."( Predictive Performance of Population Pharmacokinetic Models of Levetiracetam in Children and Evaluation of Dosing Regimen.
Benaboud, S; Billette de Villemeur, T; Bouazza, N; Boujaafar, S; Chemaly, N; Chenevier-Gobeaux, C; Desguerre, I; Freihuber, C; Gana, I; Hirt, D; Lui, G; Nabbout, R; Tauzin, M; Tréluyer, JM; Zheng, Y, 2021
)
0.86
"6 h*μg/mL, Cmax 19."( The Pharmacokinetics of Crushed Levetiracetam Tablets Administered to Neonates.
Abulfathi, AA; Bekker, A; Decloedt, EH; Kali, GTJ; Lloyd, LG; Pillay-Fuentes Lorente, V; Van der Merwe, AW, 2021
)
0.9
" No pharmacokinetic differences were observed between oral vs."( The Pharmacokinetics of Crushed Levetiracetam Tablets Administered to Neonates.
Abulfathi, AA; Bekker, A; Decloedt, EH; Kali, GTJ; Lloyd, LG; Pillay-Fuentes Lorente, V; Van der Merwe, AW, 2021
)
0.9
" This study characterized the pharmacokinetic profile of crushed levetiracetam administered to neonates."( The Pharmacokinetics of Crushed Levetiracetam Tablets Administered to Neonates.
Abulfathi, AA; Bekker, A; Decloedt, EH; Kali, GTJ; Lloyd, LG; Pillay-Fuentes Lorente, V; Van der Merwe, AW, 2021
)
1.14
"In this study, we examined whether the pharmacokinetic profiles of sodium valproate (SVA), levetiracetam (LEV), and carbamazepine (CBZ) are affected by altering the dosing time of RACOL®-NF Semi Solid for Enteral Use (RASS), a prescribed semi-solid formula."( Effects of concurrent and staggered dosing of semi-solid enteral nutrients on pharmacokinetic behavior of antiepileptic drugs after oral administration in rats.
Fukuno, S; Hatsuda, Y; Iwanami, Y; Konishi, H; Myotoku, M; Nagai, K; Omotani, S; Ryuno, Y, 2021
)
0.84
"There was no difference in pharmacokinetic characteristics of SVA and LEV when the dosing time of RASS was altered."( Effects of concurrent and staggered dosing of semi-solid enteral nutrients on pharmacokinetic behavior of antiepileptic drugs after oral administration in rats.
Fukuno, S; Hatsuda, Y; Iwanami, Y; Konishi, H; Myotoku, M; Nagai, K; Omotani, S; Ryuno, Y, 2021
)
0.62
"We concluded that the pharmacokinetic profiles of CBZ, but not SVA and LEV, after its oral administration are affected by the dosing time of RASS, but staggered administration of CBZ and RASS prevented their interaction."( Effects of concurrent and staggered dosing of semi-solid enteral nutrients on pharmacokinetic behavior of antiepileptic drugs after oral administration in rats.
Fukuno, S; Hatsuda, Y; Iwanami, Y; Konishi, H; Myotoku, M; Nagai, K; Omotani, S; Ryuno, Y, 2021
)
0.62
"Individual levetiracetam pharmacokinetic parameters were calculated based on therapeutic drug monitoring data, using a one-compartmental model, and regression models were used to explore possible covariates."( Levetiracetam pharmacokinetics and its covariates: proposal for optimal dosing in the paediatric population.
Pokorná, P; Šíma, M; Slanař, O; Švestková, N, 2023
)
2.74
" To address this knowledge gap, physiologically-based pharmacokinetic (PBPK) modeling was performed in the PK-Sim software using literature data from children greater than or equal to 2 years of age."( Physiologically-based pharmacokinetic modeling of oxcarbazepine and levetiracetam during adjunctive antiepileptic therapy in children and adolescents.
Gonzalez, D; Karatza, E; Sinha, J, 2022
)
0.96
" The purpose of this study was to evaluate clinical experience with BRV with focus on efficacy, tolerability and pharmacokinetic variability among adult patients with difficult-to-treat epilepsy."( Efficacy, tolerability and pharmacokinetic variability of brivaracetam in adults with difficult-to-treat epilepsy.
Brodtkorb, E; Burns, ML; Johannessen, SI; Landmark, CJ; Linge, HL; Lossius, MI; Nakken, KO; Svendsen, T, 2022
)
0.72
" Pharmacokinetic variability between patients was considerable; 14-fold variation in concentration/dose (C/D)-ratios."( Efficacy, tolerability and pharmacokinetic variability of brivaracetam in adults with difficult-to-treat epilepsy.
Brodtkorb, E; Burns, ML; Johannessen, SI; Landmark, CJ; Linge, HL; Lossius, MI; Nakken, KO; Svendsen, T, 2022
)
0.72
" The combination of clinical and pharmacokinetic data provides insight into factors contributing to efficacy and tolerability of new ASMs."( Efficacy, tolerability and pharmacokinetic variability of brivaracetam in adults with difficult-to-treat epilepsy.
Brodtkorb, E; Burns, ML; Johannessen, SI; Landmark, CJ; Linge, HL; Lossius, MI; Nakken, KO; Svendsen, T, 2022
)
0.72
" Indeed, because of its interesting pharmacokinetic properties, it is often used outside of the labeled indications, notably in the neurocritical setting as prophylaxis of epileptic seizures."( Pharmacokinetic considerations surrounding the use of levetiracetam for seizure prophylaxis in neurocritical care - an overview.
Amadori, E; D'Onofrio, G; Lattanzi, S; Riva, A; Rose, K; Striano, P; Verrotti, A, 2022
)
0.97
"A literature search was conducted and the most relevant studies on the pharmacokinetic properties of LEV were selected by two independent investigators."( Pharmacokinetic considerations surrounding the use of levetiracetam for seizure prophylaxis in neurocritical care - an overview.
Amadori, E; D'Onofrio, G; Lattanzi, S; Riva, A; Rose, K; Striano, P; Verrotti, A, 2022
)
0.97
"LEV has a 'near-ideal' pharmacokinetic profile, which makes it an attractive drug for ASM prophylaxis in neurocritical care."( Pharmacokinetic considerations surrounding the use of levetiracetam for seizure prophylaxis in neurocritical care - an overview.
Amadori, E; D'Onofrio, G; Lattanzi, S; Riva, A; Rose, K; Striano, P; Verrotti, A, 2022
)
0.97
" VPA showed a relatively short half-life in both mice and rats, which correlated with a sharp decline in efficacy."( Evaluating the efficacy of prototype antiseizure drugs using a preclinical pharmacokinetic approach.
Johnson, K; Mensah, JA; Metcalf, CS; Reilly, CA; Rower, JE; Wilcox, KS, 2022
)
0.72
" This study aimed to establish a population pharmacokinetic model of LEV in women with epilepsy (WWE) during pregnancy to analyse the factors of pharmacokinetic variability and to develop a model-based individualized dosing regimen."( Population pharmacokinetics and dosing regimen optimization of levetiracetam in epilepsy during pregnancy.
Cao, YF; Guo, Y; Li, Y; Wang, ML; Zhao, LM; Zhao, MM, 2023
)
1.15
"This first population pharmacokinetic study of LEV in WWE during pregnancy supports the use of a weight-based and pregnancy-based dosing regimen and can lay a foundation for further optimizing the individualized dosing regimens."( Population pharmacokinetics and dosing regimen optimization of levetiracetam in epilepsy during pregnancy.
Cao, YF; Guo, Y; Li, Y; Wang, ML; Zhao, LM; Zhao, MM, 2023
)
1.15
" There is currently evidence on its extensive pharmacokinetic variability in real clinical practice."( Extensive pharmacokinetic variability of Levetiracetam. ¿Are doctors aware?
de la Fuente, E; de Toledo, M; de Toledo, MP; Ferreiros-Martinez, R; Lagares, A; Muro, I; Ovejero-Benito, MC; Ramos, C; Sobrado, M; Vieira Campos, A, 2022
)
0.99
"To describe levetiracetam pharmacokinetic variability in patients with epilepsy in real clinical practice."( Extensive pharmacokinetic variability of Levetiracetam. ¿Are doctors aware?
de la Fuente, E; de Toledo, M; de Toledo, MP; Ferreiros-Martinez, R; Lagares, A; Muro, I; Ovejero-Benito, MC; Ramos, C; Sobrado, M; Vieira Campos, A, 2022
)
1.37
"The pharmacokinetic variability of levetiracetam is wider than originally thought."( Extensive pharmacokinetic variability of Levetiracetam. ¿Are doctors aware?
de la Fuente, E; de Toledo, M; de Toledo, MP; Ferreiros-Martinez, R; Lagares, A; Muro, I; Ovejero-Benito, MC; Ramos, C; Sobrado, M; Vieira Campos, A, 2022
)
1.26
" The physiology-based pharmacokinetics (PBPK) model was developed using PK-Sim and Mobi software, and validated following comparison of the observed plasma concentration and pharmacokinetic parameters."( Application of PBPK modeling in predicting maternal and fetal pharmacokinetics of levetiracetam during pregnancy.
Chen, J; Guo, G; Huang, P; Ke, M; Lin, C; Lin, R; Wu, W; You, X, 2023
)
1.14
"Levetiracetam (Lev) is an antiepileptic drug that has been increasingly used in the epilepsy pediatric population in recent years, but its pharmacokinetic behavior in pediatric population needs to be characterized clearly."( Development and Validation of Physiologically Based Pharmacokinetic Model of Levetiracetam to Predict Exposure and Dose Optimization in Pediatrics.
Geng, K; Shao, W; Shen, C; Sun, H; Wang, W; Wang, X; Xie, H, 2023
)
2.58
" The pharmacokinetic (PK) behavior of LEV may be altered in the elderly and patients with renal and hepatic impairment."( Physiologically based pharmacokinetic modeling of levetiracetam to predict the exposure in hepatic and renal impairment and elderly populations.
Geng, K; Shao, W; Shen, C; Sun, H; Wang, W; Wang, X; Xie, H, 2023
)
1.16
" The single-dose pharmacokinetic data were used to guide dose selection for the longer-term studies, and target drug exposures were confirmed."( Levetiracetam Pharmacokinetics and Brain Uptake in a Lateral Fluid Percussion Injury Rat Model.
Ali, I; Brady, R; Braine, E; Casillas-Espinosa, PM; Cloyd, JC; Coles, LD; Galanopoulou, AS; Hudson, M; Jones, NC; Li, Q; Lisgaras, CP; Liu, W; Mishra, U; Moshé, SL; O'Brien, TJ; Saletti, PG; Shultz, S; Silva, J; Yamakawa, G, 2023
)
2.35

Compound-Compound Interactions

The study looked at the efficacy of levetiracetam (LEV) combined with short-term clonazepam (CZP) in the treatment of electrical status epilepticus during sleep (ESES) in children with benign childhood epilepsy with centrotemporal spikes (BECCT) Compared to vehicle controls, the most effective drug combination consisted of low doses of Levetir acetam, atorvastatin and ceftriaxone.

ExcerptReferenceRelevance
" Measurement of total brain antiepileptic drug concentrations revealed that levetiracetam in combination with gabapentin at the fixed-ratio of 1:4 significantly elevated (21%) total brain gabapentin concentrations."( Pharmacodynamic and pharmacokinetic interaction profiles of levetiracetam in combination with gabapentin, tiagabine and vigabatrin in the mouse pentylenetetrazole-induced seizure model: an isobolographic analysis.
Andres-Mach, MM; Czuczwar, SJ; Dudra-Jastrzebska, M; Luszczki, JJ; Patsalos, PN; Ratnaraj, N; Sielski, M, 2009
)
0.82
" Male Wistar rats were used for the estimation of the in vivo antioxidant effect of LEV through microdialysis combined with electron spin resonance spectroscopy."( Levetiracetam enhances endogenous antioxidant in the hippocampus of rats: in vivo evaluation by brain microdialysis combined with ESR spectroscopy.
Doi, T; Nagatomo, K; Nakajima, A; Takaki, M; Ueda, Y; Willmore, LJ, 2009
)
1.8
" Adverse-effect profiles of the drugs in combination were determined and brain AED concentrations were measured."( Isobolographic characterization of the anticonvulsant interaction profiles of levetiracetam in combination with clonazepam, ethosuximide, phenobarbital and valproate in the mouse pentylenetetrazole-induced seizure model.
Andres-Mach, MM; Czuczwar, SJ; Dudra-Jastrzebska, M; Luszczki, JJ; Patsalos, PN; Ratnaraj, N, 2009
)
0.58
" However, when levetiracetam (LEV; 50mg/kg) was combined with either procyclidine (PCD; 10mg/kg) or caramiphen (CMP; 10mg/kg) complete cessation of seizures was achieved, but the nicotinic antagonist mecamylamine was needed to induce full motor rest in some rats."( Enhanced efficacy of anticonvulsants when combined with levetiracetam in soman-exposed rats.
Aas, P; Enger, S; Jonassen, M; Myhrer, T, 2011
)
0.97
" When prescribing these drugs to patients of this age bracket, treatment should be based not only on the diagnosis and seizure type but also on the propensity of the drugs for adverse effects and their drug-drug interactions."( Choice of antiepileptic drugs for the elderly: possible drug interactions and adverse effects.
Dostic, M; Jankovic, SM, 2012
)
0.38
"This article reviews antiepileptic drugs currently used for treating the elderly and highlights the adverse effects and potential drug-drug interactions for these treatments."( Choice of antiepileptic drugs for the elderly: possible drug interactions and adverse effects.
Dostic, M; Jankovic, SM, 2012
)
0.38
" While the majority of antiepileptic drugs interact with other drugs, hepatic enzymes and plasma proteins, a few newer antiepileptic drugs are free from such interactions (e."( Choice of antiepileptic drugs for the elderly: possible drug interactions and adverse effects.
Dostic, M; Jankovic, SM, 2012
)
0.38
" No other drugs known to interact with MTX were administered."( Drug-drug interaction between methotrexate and levetiracetam resulting in delayed methotrexate elimination.
Bain, E; Birhiray, RE; Reeves, DJ, 2014
)
0.66
"To study the efficacy of levetiracetam (LEV) combined with short-term clonazepam (CZP) in the treatment of electrical status epilepticus during sleep (ESES) in children with benign childhood epilepsy with centrotemporal spikes (BECCT)."( [Efficacy of levetiracetam combined with short-term clonazepam in treatment of electrical status epilepticus during sleep in children with benign childhood epilepsy with centrotemporal spikes].
Chen, L; Su, TF; Xu, SQ, 2014
)
1.08
" Then, they received LEV in combination with short-term CZP."( [Efficacy of levetiracetam combined with short-term clonazepam in treatment of electrical status epilepticus during sleep in children with benign childhood epilepsy with centrotemporal spikes].
Chen, L; Su, TF; Xu, SQ, 2014
)
0.77
"LEV combined with short-term CZP is effective and has few side effects in treating ESES syndrome among children with BECCT."( [Efficacy of levetiracetam combined with short-term clonazepam in treatment of electrical status epilepticus during sleep in children with benign childhood epilepsy with centrotemporal spikes].
Chen, L; Su, TF; Xu, SQ, 2014
)
0.77
" Here, we investigated behavioral and neurochemical effects of liraglutide (LIRA), a GLP-1 receptor agonist, alone or combined with LEV in mice subjected to PTZ-induced kindling."( Prevention of pentylenetetrazole-induced kindling and behavioral comorbidities in mice by levetiracetam combined with the GLP-1 agonist liraglutide: Involvement of brain antioxidant and BDNF upregulating properties.
Chaves Filho, AJM; de Carvalho, MAJ; de França Fonteles, MM; de Lima, KA; de Souza, AG; de Souza, DAA; Florenço Sousa, FC; Lopes, IS; Macedo, D; Mendes Vasconcelos, SM; Souza Oliveira, JV, 2019
)
0.74
" Additionally, we established the relationship between treatment with ACEA in combination with LEV and hippocampal neurogenesis in mouse brain."( Levetiracetam combined with ACEA, highly selective cannabinoid CB1 receptor agonist changes neurogenesis in mouse brain.
Andres-Mach, M; Haratym-Maj, A; Maj, M; Rola, R; Szewczyk, A; Zagaja, M; Łuszczki, JJ, 2019
)
1.96
" When pantoprazole is used in combination with clobazam, dose reduction of clobazam should be considered, or significance of PPIs is seen to avoid adverse effects."( Clinical Impact of Co-medication of Levetiracetam and Clobazam with Proton Pump Inhibitors: A Drug Interaction Study.
Baddam, R; Gone, V; Pasupuleti, B; Prasad, OP; Venisetty, RK, 2020
)
0.83
" Compared to vehicle controls, the most effective drug combination consisted of low doses of levetiracetam, atorvastatin and ceftriaxone, which markedly reduced the incidence of electrographic seizures (by 60%; p<0."( Systematic evaluation of rationally chosen multitargeted drug combinations: a combination of low doses of levetiracetam, atorvastatin and ceftriaxone exerts antiepileptogenic effects in a mouse model of acquired epilepsy.
Bergin, DH; Johne, M; Klein, P; Löscher, W; Schidlitzki, A; Twele, F; Welzel, L, 2021
)
1.05
"To determine whether there is a drug-drug interaction precluding the concomitant use of levetiracetam and high-dose methotrexate (HDMTX)."( Lack of drug interaction between levetiracetam and high-dose methotrexate in patients with lymphoma.
Barreto, JN; Carabenciov, ID; DeFino, CE; Mara, KC; Pawlenty, AG; Ruff, MW; Thompson, CA, 2021
)
1.12
"High-dose methotrexate administered with concomitant levetiracetam was not associated with increased risk for delayed MTX elimination or AKI."( Lack of drug interaction between levetiracetam and high-dose methotrexate in patients with lymphoma.
Barreto, JN; Carabenciov, ID; DeFino, CE; Mara, KC; Pawlenty, AG; Ruff, MW; Thompson, CA, 2021
)
1.15

Bioavailability

Levetiracetam has excellent intragastric bioavailability in foals. It is predicted to maintain plasma concentrations at or above the proposed target concentration with twice daily i.d.

ExcerptReferenceRelevance
" Oral bioavailability is about 100%, and food does not alter absorption."( Levetiracetam.
Nash, EM; Sangha, KS, 2001
)
1.75
" Results of these studies indicate that levetiracetam has a very favorable pharmacokinetic profile, characterized by excellent oral absorption and bioavailability (> 95%) and a mean elimination half-life in adults, children and the elderly of 7, 6 and 10."( The pharmacokinetic characteristics of levetiracetam.
Patsalos, PN, 2003
)
0.86
"3 hours, and its bioavailability is >95%."( Clinical pharmacokinetics of levetiracetam.
Patsalos, PN, 2004
)
0.61
"The purpose of this study was to evaluate the single-dose bioavailability of an IV formulation of levetiracetam relative to oral tablets and the multiple-dose tolerability and pharmacokinetics of this formulation compared with placebo in healthy subjects."( Single-dose bioavailability of levetiracetam intravenous infusion relative to oral tablets and multiple-dose pharmacokinetics and tolerability of levetiracetam intravenous infusion compared with placebo in healthy subjects.
Boulanger, P; De Smedt, F; Otoul, C; Ramael, S; Riethuisen, JM; Stockis, A; Toublanc, N, 2006
)
0.84
" Subjects entered the first phase, which was a single-dose, randomized, open-label, 2-way crossover bioavailability comparison of a 15-minute IV infusion of levetiracetam 1,500 mg and three 500-mg oral tablets."( Single-dose bioavailability of levetiracetam intravenous infusion relative to oral tablets and multiple-dose pharmacokinetics and tolerability of levetiracetam intravenous infusion compared with placebo in healthy subjects.
Boulanger, P; De Smedt, F; Otoul, C; Ramael, S; Riethuisen, JM; Stockis, A; Toublanc, N, 2006
)
0.82
" The following significant covariates were identified: (i) age on the absorption rate constant (k(a)); (ii) bodyweight, dose, CL(CR) and concomitant enzyme-inducing AED on plasma oral clearance (CL/F); and (iii) bodyweight on the apparent volume of distribution after oral administration (V(d)/F)."( Retrospective population pharmacokinetic analysis of levetiracetam in children and adolescents with epilepsy: dosing recommendations.
Jacqmin, P; Lacroix, B; Sargentini-Maier, ML; Stockis, A; Toublanc, N, 2008
)
0.6
" Bioavailability of IM LEV was 100%."( Intramuscular, intravenous and oral levetiracetam in dogs: safety and pharmacokinetics.
Cloyd, JC; Dunn, AW; Fisher, JE; Goel, V; Leppik, IE; O'Brien, TD; Patterson, EE, 2008
)
0.62
"Levetiracetam (LEV) has been considered to undergo no significant change in bioavailability during pregnancy; however, it was recently demonstrated to display modifications leading to a drop in its serum level."( Impending status epilepticus and anxiety in a pregnant woman treated with levetiracetam.
Hubschmid, M; Michel, P; Novy, J; Rossetti, AO, 2008
)
2.02
"This study was conducted in order to compare the bioavailability of two tablet formulations containing 1,000 mg levetiracetam, (S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, 102767-28-2 CAS registry number."( Bioequivalence of two formulations of levetiracetam.
Almeida, S; Filipe, A; Franco Spínola, AC; Neves, RI; Tanguay, M; Yritia, M, 2008
)
0.83
"To compare the relative bioavailability of levetiracetam extended-release tablets (XR) with immediate release tablets (IR) following single and multiple dosing; to assess the food effect and the dose-proportionality of XR from 1000 to 3000mg."( Pharmacokinetics of levetiracetam XR 500mg tablets.
Burton, I; Guénolé, E; Rouits, E; Sargentini-Maier, ML; Stockis, A; Troenaru, MM, 2009
)
0.94
" This study demonstrates that administration of 5ml (500mg) IM LEV is well tolerated and its bioavailability is equivalent to an IV injection."( Intramuscular and intravenous levetiracetam in humans: safety and pharmacokinetics.
Cloyd, JC; Goel, V; Leppik, IE; Nixdorf, DR; Rarick, J, 2010
)
0.65
"This study evaluated the relative bioavailability of levetiracetam in various regions of the GI tract using a noninvasive, remote-controlled capsule device providing targeted drug delivery, relative to that after oral administration, and explored the drug's absorption characteristics in healthy volunteers."( Assessment of levetiracetam bioavailability from targeted sites in the human intestine using remotely activated capsules and gamma scintigraphy: Open-label, single-dose, randomized, four-way crossover study in healthy male volunteers.
Connor, A; Otoul, C; Sargentini-Maier, ML; Stockis, A; Wilding, I; Wray, H, 2010
)
0.97
" Values for bioavailability in the proximal small bowel, distal small bowel, and ascending colon relative to the tablet were 98."( Assessment of levetiracetam bioavailability from targeted sites in the human intestine using remotely activated capsules and gamma scintigraphy: Open-label, single-dose, randomized, four-way crossover study in healthy male volunteers.
Connor, A; Otoul, C; Sargentini-Maier, ML; Stockis, A; Wilding, I; Wray, H, 2010
)
0.72
"After delivery in the proximal small bowel, distal small bowel, or ascending colon, the systemic bioavailability of levetiracetam (AUC), but not C(max) and T(max), appeared comparable to that after oral administration and thus appeared site independent in this small group of healthy fasting men."( Assessment of levetiracetam bioavailability from targeted sites in the human intestine using remotely activated capsules and gamma scintigraphy: Open-label, single-dose, randomized, four-way crossover study in healthy male volunteers.
Connor, A; Otoul, C; Sargentini-Maier, ML; Stockis, A; Wilding, I; Wray, H, 2010
)
0.93
"3% bioavailability for enteral liquid applications."( Levetiracetam compared to valproic acid: plasma concentration levels, adverse effects and interactions in aneurysmal subarachnoid hemorrhage.
Bjeljac, M; Keller, E; Mink, S; Muroi, C; Seule, M, 2011
)
1.81
"Though this finding needs further verification, the enteral liquid application of levetiracetam seems to be associated with lower bioavailability than the common oral application of levetiracetam."( Levetiracetam compared to valproic acid: plasma concentration levels, adverse effects and interactions in aneurysmal subarachnoid hemorrhage.
Bjeljac, M; Keller, E; Mink, S; Muroi, C; Seule, M, 2011
)
2.04
" Mean oral bioavailability was 102 ± 39%."( Pharmacokinetics of levetiracetam after oral and intravenous administration of a single dose to clinically normal cats.
Axlund, TW; Boothe, DM; Carnes, MB, 2011
)
0.69
"To determine and compare the relative bioavailability of a novel 3DP fast melt containing levetiracetam in healthy male and female subjects."( Randomized Comparative Bioavailability of a Novel Three-Dimensional Printed Fast-Melt Formulation of Levetiracetam Following the Administration of a Single 1000-mg Dose to Healthy Human Volunteers Under Fasting and Fed Conditions.
Boudriau, S; Hanzel, C; Lefebvre, M; Massicotte, J; Sayegh, L; Wang, J, 2016
)
0.87
" This study also evaluated the food effect on the bioavailability of the levetiracetam 3DP fast melt."( Randomized Comparative Bioavailability of a Novel Three-Dimensional Printed Fast-Melt Formulation of Levetiracetam Following the Administration of a Single 1000-mg Dose to Healthy Human Volunteers Under Fasting and Fed Conditions.
Boudriau, S; Hanzel, C; Lefebvre, M; Massicotte, J; Sayegh, L; Wang, J, 2016
)
0.88
" Mean bioavailability for IG administration was excellent (103."( Pharmacokinetics of the anticonvulsant levetiracetam in neonatal foals.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; MacDonald, KD, 2018
)
0.75
" Similar plasma pharmacokinetic profiles were obtained and the intranasal absolute bioavailability was 107."( Nose-to-brain delivery of levetiracetam after intranasal administration to mice.
Alves, G; Bicker, J; Falcão, A; Fortuna, A; Gonçalves, J; Gouveia, F; Liberal, J; Oliveira, RC, 2019
)
0.81
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" Intrarectal administration of LEV tablets could be an effective option for treating canine seizures although it might be a limit for treating CSE because the absorption rate is not fast enough."( Comparison of pharmacokinetics of intragastrically and intrarectally administered levetiracetam tablets in healthy non-epileptic dogs.
Chongphaibulpatana, P; Takamura, H; Uzuka, Y, 2020
)
0.78
" The most common method to facilitate drug administration in dysphagia patients is to mix the powdered drug with a small amount of thickened water, however little is known about the effects of this method on in vivo bioavailability of drugs."( Do Thickening Agents Used in Dysphagia Diet Affect Drug Bioavailability?
Erdem, ÇE; Eroğlu, H; Eylem, CC; Gökmen-Özel, H; Ilgaz, F; Nemutlu, E; Timur, SS, 2022
)
0.72

Dosage Studied

Levetiracetam and controlled-release carbamazepine produced equivalent seizure freedom rates in newly diagnosed epilepsy at optimal dosing. Prompt and long-lasting control of seizures was obtained in 49 of 82 patients (60%) with a dose of levetira.

ExcerptRelevanceReference
", with a U-shape dose-response relationship."( Inhibition by levetiracetam of a non-GABAA receptor-associated epileptiform effect of bicuculline in rat hippocampus.
Margineanu, DG; Wülfert, E, 1997
)
0.66
" It can be concluded that the kinetics of levetiracetam, in the rat, is simple and, thus, dosing strategies in studies designed to elucidate its mechanism of action should be straightforward."( Blood and cerebrospinal fluid pharmacokinetics of the novel anticonvulsant levetiracetam (ucb L059) in the rat.
Doheny, HC; Jefferys, JG; Patsalos, PN; Ratnaraj, N; Whittington, MA, 1999
)
0.8
" The authors conclude that the addition of levetiracetam did not bring about clinically important changes in phenytoin pharmacokinetic parameters and that it is not necessary to change the phenytoin dosing rate when levetiracetam is added to phenytoin."( Absence of pharmacokinetic drug interaction of levetiracetam with phenytoin in patients with epilepsy determined by new technique.
Baltes, E; Browne, TR; Jensen, CM; Josephs, E; Leppik, IE; Paz, J; Szabo, GK, 2000
)
0.83
" Although not yet approved as monotherapy or for use in paediatric patients, efficacy was observed with levetiracetam 3000 mg/day as monotherapy in adult patients with refractory partial seizures with or without secondary generalisation and with the 10 to 40 mg/kg/day dosage as adjunctive therapy in children with refractory partial seizures."( Levetiracetam. A review of its adjunctive use in the management of partial onset seizures.
Dooley, M; Plosker, GL, 2000
)
1.96
"The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of levetiracetam are reviewed."( Levetiracetam.
Nash, EM; Sangha, KS, 2001
)
1.97
" The results of these studies indicate that higher doses need to be used for children (on a per-weight basis), and individuals with renal dysfunction require dosage modifications related to creatinine clearance."( Use of levetiracetam in special populations.
French, J, 2001
)
0.77
"This study provides additional information on dose-response effects and withdrawal phenomena and confirms the responder and seizure freedom rates previously reported in the parallel part of the study (Epilepsia 41 (2000) 1179-1186)."( Dose-response effect of levetiracetam 1000 and 2000 mg/day in partial epilepsy.
Boon, P; Chauvel, P; Otoul, C; Pohlmann-Eden, B; Wroe, S, 2002
)
0.62
"On the basis of these data, a daily maintenance dose equivalent to 130-140% of the usual daily adult maintenance dosage (1,000-3,000 mg/day) in two divided doses, on a weight-normalized level (mg/kg/day) is initially recommended."( Pharmacokinetic study of levetiracetam in children.
Bebin, EM; Coupez, RM; Fountain, NB; Glauser, TA; Pellock, JM; Ritter, FJ; Shields, WD, 2001
)
0.61
" A dose-response relationship was also explored."( Aggravation of partial seizures by antiepileptic drugs: is there evidence from clinical trials?
Somerville, ER, 2002
)
0.31
" There was some evidence for a dose-response effect with TGB but a negative effect with TPM (aggravation less likely with increasing dose)."( Aggravation of partial seizures by antiepileptic drugs: is there evidence from clinical trials?
Somerville, ER, 2002
)
0.31
" The simple dosing schedule is an additional benefit."( [Levetiracetam: an anti-epileptic drug with interesting pharmacokinetic properties].
Vecht, ChJ; Wagner, GL; Wilms, EB, 2002
)
1.22
" Parameters were similar between genders and among dosage subgroups."( Effects of antiepileptic comedication on levetiracetam pharmacokinetics: a pooled analysis of data from randomized adjunctive therapy trials.
Baltès, E; Gidal, BE; Perucca, E, 2003
)
0.58
" Based on this, no need is anticipated for adjusting levetiracetam dosage according to type of concomitantly prescribed AEDs."( Effects of antiepileptic comedication on levetiracetam pharmacokinetics: a pooled analysis of data from randomized adjunctive therapy trials.
Baltès, E; Gidal, BE; Perucca, E, 2003
)
0.83
" The primary aim of this study was to measure the safety and tolerability of LEV individualised dosing in a heterogeneous refractory epilepsy population."( An open-label study of levetiracetam at individualised doses between 1000 and 3000 mg day(-1) in adult patients with refractory epilepsy.
Abou-Khalil, B; Hemdal, P; Privitera, MD, 2003
)
0.63
" As levetiracetam is primarily excreted unchanged in urine, dosage adjustments are necessary for patients with moderate-to-severe renal impairment."( The pharmacokinetic characteristics of levetiracetam.
Patsalos, PN, 2003
)
1.15
" Starting dosage was 10 mg/kg/day, increased every 4th day by 10 mg/kg up to a maximum of 60 mg/kg/day, depending on efficacy and tolerability."( Effect of levetiracetam in refractory childhood epilepsy syndromes.
Buyse, G; Ceulemans, B; Deconinck, A; Lagae, L, 2003
)
0.72
" A final dosage of 60 mg/kg was used."( Acute psychosis associated with levetiracetam.
Karagianni, J; Lazopoulou, D; Michelakou, D; Youroukos, S, 2003
)
0.6
" Although its half-life is relatively short (6 to 8 hours), its duration of action is longer than anticipated from its pharmacokinetics in plasma, and a twice-daily dosing regimen is adequate to produce the desired response."( The ideal pharmacokinetic properties of an antiepileptic drug: how close does levetiracetam come?
Johannessen, SI; Perucca, E, 2003
)
0.55
" Increasing the dosage to more than 3,500 mg/day did not improve efficacy but could induce a paradoxical increase in seizure frequency and psychic side effects."( [Levetiracetam in combined therapy for focal epilepsy: experience with 80 patients].
Fauser, S; Feil, B; Homberg, V; Schulze-Bonhage, A, 2004
)
1.23
" On the basis of concomitant AEDs, patients were divided into two groups, otherwise comparable for age, gender, weight-adjusted daily dose of levetiracetam, and dosing frequency: group A (n = 65), receiving levetiracetam plus AED inducers of cytochrome P450 (CYP) metabolism, such as carbamazepine, phenobarbital, and phenytoin; group B (n = 35), receiving levetiracetam plus AEDs without inducing properties of CYP metabolism, namely valproic acid and lamotrigine."( Levetiracetam therapeutic monitoring in patients with epilepsy: effect of concomitant antiepileptic drugs.
Albani, F; Baruzzi, A; Contin, M; Riva, R, 2004
)
1.97
" Consequently, dosage adjustments are necessary for patients with moderate to severe renal impairment."( Clinical pharmacokinetics of levetiracetam.
Patsalos, PN, 2004
)
0.61
" Adjustments in dosing are required for decreases in renal clearance."( Levetiracetam safety profiles and tolerability in epilepsy patients.
Briggs, DE; French, JA, 2004
)
1.77
" The active pharmaceutical ingredient was extracted from its finished dosage form (tablet) using isopropanol."( A validated chiral LC method for the enantioselective analysis of Levetiracetam and its enantiomer R-alpha-ethyl-2-oxo-pyrrolidine acetamide on amylose-based stationary phase.
Acharyulu, PV; Gopi Chand, I; Om Reddy, G; Praveen Kumar, K; Rao, BM; Ravi, R; Shyam Sundar Reddy, B; Sivakumar, S; Srinivasu, MK, 2004
)
0.56
"This article reviews preclinical and clinical data on the efficacy and tolerability of these 4 AEDs in the management of neuropathic pain, as well as the pharmacokinetics, drug-interaction potential, adverse effects, and dosing of these agents, with an emphasis on their use in older individuals."( Oxcarbazepine, topiramate, zonisamide, and levetiracetam: potential use in neuropathic pain.
Guay, DR, 2003
)
0.58
" LEV was initially dosed at 250 mg daily and increased by 250 mg every 2 weeks thereafter according to clinical response."( Levetiracetam for people with mental retardation and refractory epilepsy.
Brodie, MJ; Kelly, K; Stephen, LJ, 2004
)
1.77
"This prospective open-label study used flexible dosing schedules of levetiracetam (LEV) in patients with refractory epilepsy attending a single centre to explore its effectiveness in everyday clinical practice."( Levetiracetam in refractory epilepsy: a prospective observational study.
Brodie, MJ; Mohanraj, R; Parker, PG; Stephen, LJ, 2005
)
2.01
"We examined the efficacy, optimum dosage and adverse effects of levetiracetam in two prospective trials in children with epilepsy."( Clinical experience with levetiracetam in childhood epilepsy: an add-on and mono-therapy trial.
Buyse, G; Ceulemans, B; Lagae, L, 2005
)
0.87
" The dosage was titrated over 3 weeks to 1,000 to 2,000 mg/day."( Use of levetiracetam to treat tics in children and adolescents with Tourette syndrome.
Awaad, Y; Michon, AM; Minarik, S, 2005
)
0.78
" Levetiracetam was dosed to efficacy or unacceptable side effects, with a range of 8 to 315 mg/kg/day."( Retrospective study of the use of levetiracetam in childhood seizure disorders.
Guarino, EJ; Koukkari, MW, 2004
)
1.51
" Serum concentrations of these AEDs did not change over time after adjunctive levetiracetam therapy, irrespective of the dosage of levetiracetam used."( Effect of levetiracetam on the pharmacokinetics of adjunctive antiepileptic drugs: a pooled analysis of data from randomized clinical trials.
Baltès, E; Gidal, BE; Otoul, C; Perucca, E,
)
0.76
" Mean LEV serum concentrations at 12 hours after dosing were similar for all study treatments (3."( Oral absorption kinetics of levetiracetam: the effect of mixing with food or enteral nutrition formulas.
Fay, MA; Gidal, BE; Sheth, RD, 2005
)
0.62
" Further work should be carried out with larger sample sizes and optimal dosing strategies of the drug."( Levetiracetam in social phobia: a placebo controlled pilot study.
Connor, KM; Davidson, JR; Zhang, W, 2005
)
1.77
" LEV was added at the dose of 500 mg twice daily for the first 2 months and then the dosage was increased until 1000 mg twice daily for the next 4 more months."( Efficacy of levetiracetam in Huntington disease.
Cormio, C; De Caro, MF; de Tommaso, M; Di Fruscolo, O; Livrea, P; Sciruicchio, V; Specchio, N,
)
0.51
" After the first 2 weeks, LEV patients had their dosage increased from 500 mg twice daily to 1,000 mg twice daily."( Efficacy and safety of levetiracetam (up to 2000 mg/day) in Taiwanese patients with refractory partial seizures: a multicenter, randomized, double-blind, placebo-controlled study.
Chen, SS; Edrich, P; Hiersemenzel, R; Hsih, MS; Lai, CW; Tsai, JJ; Yen, DJ, 2006
)
0.64
"The use of new antiepileptic drugs for treatment of status epilepticus (SE) has not been studied systematically, particularly with respect to response predictors, the possibility of a dose-response relationship, and the efficacy of administration through a nasogastric tube."( Determinants of success in the use of oral levetiracetam in status epilepticus.
Bromfield, EB; Rossetti, AO, 2006
)
0.6
" PD medications were unchanged during the study, and levetiracetam was slowly titrated up to a maximum dosage of 3,000 mg/d over a 2-month period."( Efficacy and tolerability of levetiracetam in Parkinson disease patients with levodopa-induced dyskinesia.
Lyons, KE; Pahwa, R,
)
0.67
" General and local tolerability during multiple dosing were good."( Single-dose bioavailability of levetiracetam intravenous infusion relative to oral tablets and multiple-dose pharmacokinetics and tolerability of levetiracetam intravenous infusion compared with placebo in healthy subjects.
Boulanger, P; De Smedt, F; Otoul, C; Ramael, S; Riethuisen, JM; Stockis, A; Toublanc, N, 2006
)
0.62
" Median daily dosage was 3,000 mg/day (range: 250-6,000 mg/day), with 250 (49."( Levetiracetam: a long-term follow-up study of efficacy and safety.
Bauer, J; Ben-Menachem, E; Da Silva, S; Fryze, W; Kasteleijn-Nolst Trenité, DG; Krämer, G, 2006
)
1.78
" Dose-response relationships for levetiracetam efficacy were evaluated using pooled data from three trials including adults with refractory partial epilepsy."( Assessment of a dose-response relationship of levetiracetam.
Buyle, S; Meencke, HJ, 2006
)
0.87
" The mean maximum dosage for levetiracetam was 862."( Levetiracetam versus placebo in childhood and adolescent autism: a double-blind placebo-controlled study.
Anagnostou, E; Chaplin, WF; Hollander, E; Iyengar, R; Soorya, L; Waldoks, SE; Wasserman, S; Watner, D, 2006
)
2.07
" For these older drugs it has been common practice to adjust the dosage to achieve a serum drug concentration within a predefined 'therapeutic range', representing an interval where most patients are expected to show an optimal response."( Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed?
Johannessen, SI; Tomson, T, 2006
)
0.33
" After a 1-month run-in period, patients were treated with levetiracetam at a dosage of 1000 mg/d for 6 months."( Levetiracetam in the prophylaxis of migraine with aura: a 6-month open-label study.
Aloisio, A; Brighina, F; Fierro, B; Francolini, M; Giglia, G; Palermo, A,
)
1.82
" In the second stage, the dose-response relationship in improving patients was determined by fitting the data to an E(max) model including a placebo effect."( Dose-response population analysis of levetiracetam add-on treatment in refractory epileptic patients with partial onset seizures.
Snoeck, E; Stockis, A, 2007
)
0.61
" LEV dosage ranged from 1000 to 2500mg/daily."( Levetiracetam monotherapy for children and adolescents with benign rolandic seizures.
Balestri, P; Chiarelli, F; Ciambra, G; Coppola, G; Franzoni, E; Grosso, S; Iannetti, P; Manco, R; Verrotti, A, 2007
)
1.78
" If a seizure occurred within 26 weeks of stabilization, dosage was increased incrementally to a maximum of levetiracetam 1,500 mg twice daily or carbamazepine 600 mg twice daily."( Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy.
Ben-Menachem, E; Brodie, MJ; Meencke, HJ; Perucca, E; Ryvlin, P, 2007
)
0.91
"Levetiracetam and controlled-release carbamazepine produced equivalent seizure freedom rates in newly diagnosed epilepsy at optimal dosing in a setting mimicking clinical practice."( Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy.
Ben-Menachem, E; Brodie, MJ; Meencke, HJ; Perucca, E; Ryvlin, P, 2007
)
2.14
" All subjects received a single dose of 500 mg or 1500 mg levetiracetam tablet(s) on the dosing day, and the wash-out period was 7 days."( Single-dose pharmacokinetics of levetiracetam in healthy Chinese male subjects.
Hu, P; Jiang, J; Li, X; Lu, ZS; Zhao, Q, 2007
)
0.87
" Adverse events were either tolerable or resolved in time with dosage reduction or discontinuation of the drug."( Efficacy and safety of levetiracetam in infants and young children with refractory epilepsy.
Balestri, P; Capovilla, G; Coppola, G; Cordelli, DM; Franzoni, E; Grosso, S; Morgese, G; Verrotti, A; Zamponi, N, 2007
)
0.65
" Individualization of dosage and avoidance of unnecessary polypharmacy are essential for safe utilization of anti-epileptic drugs."( [Epilepsy in the elderly].
Yoshino, A, 2007
)
0.34
" The average maximum LEV dosage was 39."( Long-term use of Levetiracetam in patients with severe childhood-onset epilepsy.
Holthausen, H; Kluger, G; von Stuelpnagel, C, 2007
)
0.68
" In dogs that remained refractory, the dosage was increased to 20 mg/kg TID for 2 months."( The efficacy and tolerability of levetiracetam in pharmacoresistant epileptic dogs.
Chandler, KE; Luján Feliu-Pascual, A; Matiasek, LA; Platt, SR; Volk, HA, 2008
)
0.63
" Levetiracetam exposure (the area under the plasma concentration-time curve over the 12-hour dosing interval at steady state) was 12% higher in females than in males."( Population pharmacokinetics of levetiracetam in Japanese and Western adults.
Jacqmin, P; Pigeolet, E; Sargentini-Maier, ML; Stockis, A, 2007
)
1.54
" LEV dosage was adjusted based on seizure control and tolerability to a maximum of 3000 mg/day."( The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy.
Ryvlin, P; Schelstraete, I; Somerville, ER; Steinhoff, BJ; Van Paesschen, W, 2007
)
0.59
" She has been on low-dose levetiracetam for her epilepsy over the past 2 years, and the dosage was increased just prior to this admission."( Levetiracetam-induced diffuse interstitial lung disease.
Castaneda, GY; Jennings, T; Newsome, SD; Xue, LY, 2007
)
2.08
" In 4 patients, there was a decreased dosage or cessation of a previous drug known to produce weight gain in some cases simultaneously to the introduction of levetiracetam, but in two of these patients these drugs had not produced any weight gain."( Dramatic weight loss with levetiracetam.
Coubes, P; Crespel, A; Diaz, O; Gelisse, P; Genton, P; Hillaire-Buys, D; Juntas-Morales, R, 2008
)
0.84
"7% after 26 weeks on a median levetiracetam dosage of 22 mg/kg/day."( Add-on levetiracetam in children and adolescents with refractory epilepsy: results of an open-label multi-centre study.
Arts, WF; Augustijn, P; Brouwer, OF; Callenbach, PM; Geerts, AT; Geerts, Y; Gunning, WB; Peeters, EA; Stroink, H; ten Houten, R; Weber, AM, 2008
)
1.09
" During the 2 treatment periods, levetiracetam or placebo was titrated from 500 to 3000 mg/d during a 5-week titration phase, as tolerated, and the maximum tolerated dosage was then maintained for 4 weeks."( Levetiracetam is not effective for essential tremor.
Elble, RJ; Lyons, KE; Pahwa, R,
)
1.86
" One patient failed to achieve the 3000-mg/d dosage of levetiracetam."( Levetiracetam is not effective for essential tremor.
Elble, RJ; Lyons, KE; Pahwa, R,
)
1.82
" Data regarding demographics, disease characteristics, previous use of antiepileptics, levetiracetam dosage titration schedule, and clinical outcomes were collected and analyzed."( Rapid dosage titration of levetiracetam in children.
Neft, RA; Vaisleib, II, 2008
)
0.87
" The levetiracetam dosage was titrated to full maintenance doses over 2-14 days (mean 10 days)."( Rapid dosage titration of levetiracetam in children.
Neft, RA; Vaisleib, II, 2008
)
1.16
"Rapid dosage titration of levetiracetam is feasible and well tolerated in children who require rapid escalation to therapeutic doses."( Rapid dosage titration of levetiracetam in children.
Neft, RA; Vaisleib, II, 2008
)
0.95
" Demonstration of prolonged effects would help to explain the efficacy of LEV at conventional dosing intervals that are longer than the serum half-life."( Prolonged neurophysiologic effects of levetiracetam after oral administration in humans.
Ehrenberg, JA; Epstein, CM; Girard-Siqueira, L, 2008
)
0.62
" Simulations were used to identify dosing regimens achieving levetiracetam steady-state peak and trough plasma concentrations similar to those attained in adults receiving the recommended starting dose for adjunctive therapy (500 mg twice daily)."( Retrospective population pharmacokinetic analysis of levetiracetam in children and adolescents with epilepsy: dosing recommendations.
Jacqmin, P; Lacroix, B; Sargentini-Maier, ML; Stockis, A; Toublanc, N, 2008
)
0.84
" Dosing can be carried out with either 10 mg/kg of oral solution twice daily in children weighing <50 kg and a 500-mg tablet twice daily in those weighing >50 kg or, when patients favour a solid formulation, 10 mg/kg of oral solution twice daily in children weighing <20 kg, a 250-mg tablet twice daily in those weighing 20-40 kg, and a 500-mg tablet twice daily in those weighing >40 kg."( Retrospective population pharmacokinetic analysis of levetiracetam in children and adolescents with epilepsy: dosing recommendations.
Jacqmin, P; Lacroix, B; Sargentini-Maier, ML; Stockis, A; Toublanc, N, 2008
)
0.6
" LEV was used at the maximum dosage of 1500 mg daily."( Activity, tolerability and efficacy of levetiracetam on cerebellar symptoms in multiple sclerosis patients: a pilot kinematic study.
Abuarqub, S; Brichetto, G; Capello, E; Sanguineti, V; Solaro, C, 2008
)
0.62
" LEV needs to be tested in a larger group of subjects designed to verify treatment efficacy using higher dosage of the medication."( Activity, tolerability and efficacy of levetiracetam on cerebellar symptoms in multiple sclerosis patients: a pilot kinematic study.
Abuarqub, S; Brichetto, G; Capello, E; Sanguineti, V; Solaro, C, 2008
)
0.62
" Dosage was gradually increased up to 1,500 mg bid as tolerated or clinically effective."( Levetiracetam for treatment of premenstrual dysphoric disorder: a pilot, open-label study.
Halbreich, U; Kayatekin, ZE; Sabo, AN, 2008
)
1.79
" The oral LEV dosage was increased, and phenytoin and benzodiazepines were transiently prescribed."( Impending status epilepticus and anxiety in a pregnant woman treated with levetiracetam.
Hubschmid, M; Michel, P; Novy, J; Rossetti, AO, 2008
)
0.58
" Mean dosage was 1,643 mg/day (range 500-4,000)."( Intravenous levetiracetam for epileptic seizure emergencies in older people.
Beyenburg, S; Maraite, N; Reuber, M, 2009
)
0.73
" The final model was used to perform Monte Carlo simulations in order to identify the dosing regimens that should achieve the same nominal target concentration range as in adults."( Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy.
Chhun, S; Chiron, C; Dulac, O; Jullien, V; Pons, G; Rey, E, 2009
)
0.64
"Our results support the use of a weight-based LEV dosing regimen and provide a basis for a recommended pediatric dosage regimen."( Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy.
Chhun, S; Chiron, C; Dulac, O; Jullien, V; Pons, G; Rey, E, 2009
)
0.64
" Considering the lower mean weight of this study population, we suggest the dosage of LEV 3,000 mg daily may contribute to the results."( Efficacy and safety of levetiracetam (3,000 mg/Day) as an adjunctive therapy in Chinese patients with refractory partial seizures.
Li, JM; Lv, Y; Sun, HB; Wang, XF; Xi, ZQ; Xiao, F; Xiao, Z, 2009
)
0.66
"Collected data included age, sex, therapy indication and duration, dosing regimen, documented seizure activity, ICU admission diagnoses, length of ICU stay, serum creatinine, liver function tests, adverse reactions, concomitant use of other AEDs, and drug interactions."( Safety and efficacy of levetiracetam for critically ill patients with seizures.
Divertie, GD; Freeman, WD; Nau, KM; Valentino, AK, 2009
)
0.66
"LVM appears to be safe for ICU patients when dosing is adjusted for renal function."( Safety and efficacy of levetiracetam for critically ill patients with seizures.
Divertie, GD; Freeman, WD; Nau, KM; Valentino, AK, 2009
)
0.66
" Maintenance dosing of Phenobarbital was initiated and no further seizures were noted."( Levetiracetam as monotherapy for seizures in a neonate with acute lymphoblastic leukemia.
Brannon Morris, E; Ledet, DS; Rubnitz, JE; Wheless, JW, 2010
)
1.8
" Moreover, this patient suffered from a probable cortical myoclonus that relapsed after cessation of the drug but was well controlled by a low dosage adapted to the renal failure."( Levetiracetam accumulation in renal failure causing myoclonic encephalopathy with triphasic waves.
Iwanowski, P; Jallon, P; Landis, T; Vulliemoz, S, 2009
)
1.8
" For each class, the dosing scheme and practical issues related to administration are described, based on evidence when available in the literature."( [Drugs for status epilepticus treatment].
Mazoit, JX; Navarro, V, 2009
)
0.35
" Patients were divided into 3 equal dosing groups (N = 15 each): 20, 40, and 60 mg/kg (corresponding to maximum doses of 1, 2, and 3 g)."( Rapid infusion of a loading dose of intravenous levetiracetam with minimal dilution: a safety study.
Clarke, D; Durmeier, M; Ellis, M; Hovinga, CA; McGregor, A; Perkins, F; Wheless, JW, 2009
)
0.61
"During the time of 6 months 28 patients underwent EEG-recording and neuropsychological testing at the three timepoints: before initiating LEV therapy, after 2 months and again after 4 months after achieving plateau dosing of LEV."( Impact of levetiracetam add-on therapy on different EEG occipital frequencies in epileptic patients.
Haettig, H; Meencke, HJ; Veauthier, J, 2009
)
0.76
" Limbic (psychomotor) seizure activity was evoked in albino Swiss mice by a current (32 mA, 6 Hz, 3s stimulus duration) delivered via ocular electrodes and isobolographic analysis for parallel and non-parallel dose-response effects was used to characterize the consequent anticonvulsant interactions between the various drug combinations."( Isobolographic characterization of interactions of levetiracetam with the various antiepileptic drugs in the mouse 6 Hz psychomotor seizure model.
Luszczki, JJ; Patsalos, PN; Wlaz, A; Wojda, E, 2009
)
0.6
" The mean levetiracetam dosage used on the 24 patients in this study was 38."( Efficacy and safety of levetiracetam as an add-on therapy in children aged less than 4 years with refractory epilepsy.
Cai, F; Cao, J; Li, S; Xiao, N, 2010
)
1.07
" Data on demographics, epileptic syndrome, aetiology, treatment dosage and adverse effects were analysed."( Experience with intravenous levetiracetam in status epilepticus: a retrospective case series.
Aristín, JL; Fernández, E; Gámez-Leyva, G; Pascual, J, 2009
)
0.65
" The median loading dose of IV levetiracetam was 1000 mg and the maintenance dosage ranged from 500 to 1500 mg/12 hours (median 1000 mg/12 hours)."( Experience with intravenous levetiracetam in status epilepticus: a retrospective case series.
Aristín, JL; Fernández, E; Gámez-Leyva, G; Pascual, J, 2009
)
0.93
" Dosage was held stable for the last 6 weeks of treatment."( Levetiracetam in generalized social anxiety disorder: a double-blind, randomized controlled trial.
Brawman-Mintzer, O; Khan, A; Liebowitz, MR; Lydiard, RB; Pollack, MH; Ravindran, LN; Simon, NM; Stein, MB, 2010
)
1.8
" LEV-SC significantly depended on daily dosage and the interval between the time the medication was taken and the time of blood extraction."( [Which factors have an impact on levetiracetam serum concentrations? An analysis in 163 patients with epilepsy].
Bauer, J; Burr, W; Pfeiffer, C, 2010
)
0.64
" A significant factor in using levetiracetam for seizures and other disorders has been its ease of dosing and tolerability."( Levetiracetam: a comprehensive review.
Crepeau, AZ; Treiman, DM, 2010
)
2.09
" Administration of LEV at a dosage of 20 mg/kg, PO, every 8 hours to healthy dogs yielded plasma drug concentrations consistently within the therapeutic range established for LEV in humans."( Levetiracetam pharmacokinetics in healthy dogs following oral administration of single and multiple doses.
Moore, SA; Muñana, KR; Nettifee-Osborne, J; Papich, MG, 2010
)
1.8
" Prompt and long-lasting control of seizures was obtained in 49 of 82 patients (60%) with a dose of levetiracetam that ranged from 1500 to 3000 mg/d, and 9 (11%) of the treated patients needed an increase of levetiracetam dosage to 4000 mg/d to become seizure free."( Efficacy and safety of levetiracetam in patients with glioma: a clinical prospective study.
Buttolo, L; Cenzato, M; Padovani, A; Rosati, A; Stefini, R; Todeschini, A, 2010
)
0.89
" We have established the safety, tolerability, and dosage of intravenous levetiracetam in children."( Intravenous levetiracetam in children with seizures: a prospective safety study.
Cardenas, JF; Chapman, KE; Hastriter, EV; Khoury, EM; Ng, YT, 2010
)
0.97
" The adverse events were either tolerable or resolved in time with dosage reduction in most of children, and only 3 cases required discontinuation."( [Efficacy and safety of adjunctive levetiracetam in children younger than 4 years with refractory epilepsy].
Chen, L; Hu, Y; Huang, TS; Li, B; Liao, JX, 2010
)
0.64
" Therefore, the dosage was titrated downward to allow discontinuation of the drug; levetiracetam was replaced with pregabalin 150 mg twice daily."( Separate episodes of delirium associated with levetiracetam and amiodarone treatment in an elderly woman.
Bugg, KS; Foley, KT, 2010
)
0.84
" The onset of signs/symptoms usually occurs early, even during the titration phase, and, in many cases, at a low dosage (<20 mg/kg/day)."( Levetiracetam in childhood epilepsy.
Chiarelli, F; Curatolo, P; D'Adamo, E; Parisi, P; Verrotti, A, 2010
)
1.8
" After screening eligibility for outpatient alcohol detoxification, patients were seen daily for 5 days and received levetiracetam in a flexible dosage regime between 500 and 4 000 mg/d for a maximum of 7 days."( Efficacy and safety of levetiracetam for outpatient alcohol detoxification.
Förg, A; Heimann, HM; Hein, J; Heinz, A; Hinzpeter, A; Müller, CA; Schäfer, M; Schneider, S; Volkmar, K, 2010
)
0.88
" When adjusting for age, sex, type of seizure, type of glioma, and dosage using univariate and multivariate models, there were no differences between the treatment groups and none of these covariates were statistically significant for explaining the second seizure rates between treatment groups (all p values>0."( Seizures in patients with glioma treated with phenytoin and levetiracetam.
Anderson, SK; Lachance, DH; Merrell, RT; Meyer, FB, 2010
)
0.6
" The median dosage of levetiracetam was 146mg/kg/day (range, 70-275mg/kg/day), and the median maximum serum trough level was 43mcg/ml (range, 20-121mcg/ml)."( Efficacy and tolerability of high oral doses of levetiracetam in children with epilepsy.
Obeid, M; Pong, AW, 2010
)
0.93
" Dosing and plasma levels of levetiracetam and concomitant antiepileptic drugs were reviewed retrospectively."( Age and comedications influence levetiracetam pharmacokinetics in children.
Dahlin, MG; Ohman, I; Wide, K, 2010
)
0.94
"A randomized, double-blind, placebo-controlled, four-way cross-over design was employed in 16 healthy volunteers comparing acute dosing (i."( Neurocognitive effects of brivaracetam, levetiracetam, and lorazepam.
Gevins, A; Leese, PT; Loring, DW; Meador, KJ; Otoul, C, 2011
)
0.64
" At final follow-up, mean LEV dosage was 1991."( Levetiracetam monotherapy in patients with brain tumor-related epilepsy: seizure control, safety, and quality of life.
Dinapoli, L; Fabi, A; Maschio, M; Muti, P; Pace, A; Sperati, F; Vidiri, A, 2011
)
1.81
"Although levetiracetam is recognized for ease of dosing and being well tolerated, therapeutic drug monitoring is potentially useful in certain clinical situations."( Performance characteristics of a new levetiracetam immunoassay and method comparison with a high-performance liquid chromatography method.
Lawson, SE; Lembright, KE; Reineks, EZ; Wang, S, 2011
)
1.06
" Differential dosing led to seizure freedom in 64."( Higher evening antiepileptic drug dose for nocturnal and early-morning seizures.
Bergin, A; Bourgeois, BF; Guilhoto, LM; Kothare, SV; Loddenkemper, T; Vendrame, M, 2011
)
0.37
" Concurrent PB administration significantly alters the pharmacokinetics of LEV in the dog, indicating that dosage adjustments might be necessary when the drug is administered with PB."( The pharmacokinetics of levetiracetam in healthy dogs concurrently receiving phenobarbital.
Moore, SA; Muñana, KR; Nettifee-Osborne, JA; Papich, MG, 2011
)
0.68
" Further study is warranted to determine optimal levetiracetam dosing in neonates and to compare efficacy with other antiseizure medications."( Levetiracetam for treatment of neonatal seizures.
Abend, NS; Clancy, RR; Dlugos, DJ; Gutierrez-Colina, AM; Monk, HM, 2011
)
2.07
" Initial dosing was 250 mg twice daily for 2 weeks, followed by 500 mg twice daily."( Levetiracetam monotherapy--outcomes from an epilepsy clinic.
Brodie, MJ; Kelly, K; Parker, P; Stephen, LJ, 2011
)
1.81
" In Group B, LEV was given at 420 mg/ml for the first 2 weeks followed by doubling the dosage (840 mg/ml) in the following 2 weeks."( Neuroprotective effect of levetiracetam on hippocampal sclerosis-like change in spontaneously epileptic rats.
Arita, K; Hanaya, R; Kumafuji, K; Kurisu, K; Sasa, M; Serikawa, T; Sugata, S; Tokudome, M, 2011
)
0.67
" After screening eligibility for outpatient detoxification, 9 alcohol-dependent patients received levetiracetam and tiapride in a flexible dosage regimen up to 2500 and 300 mg/d, respectively, for a maximum of 7 days."( A combination of levetiracetam and tiapride for outpatient alcohol detoxification: a case series.
Banas, R; Förg, A; Heimann, HM; Hein, J; Heinz, A; Müller, CA; Schäfer, M; Volkmar, K, 2011
)
0.93
" and oral dosing intervals that would not be associated with adverse effects in cats."( Pharmacokinetics of levetiracetam after oral and intravenous administration of a single dose to clinically normal cats.
Axlund, TW; Boothe, DM; Carnes, MB, 2011
)
0.69
"To characterize the steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients requiring seizure prophylaxis after a neurologic injury and to determine which dosing regimens achieve serum concentrations within the recommended therapeutic range of 6-20 μg/ml."( Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients.
Fleck, JD; Jacobi, J; Juenke, JM; Kays, MB; Spencer, DD, 2011
)
0.87
" Monte Carlo simulations were performed for multiple levetiracetam dosing regimens to determine the probability of achieving a target trough concentration of 6 μg/ml or greater, 20 μg/ml or greater, and 6-20 μg/ml."( Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients.
Fleck, JD; Jacobi, J; Juenke, JM; Kays, MB; Spencer, DD, 2011
)
0.88
" Higher doses or more frequent dosing may be needed to achieve target trough concentrations of 6-20 μg/ml."( Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients.
Fleck, JD; Jacobi, J; Juenke, JM; Kays, MB; Spencer, DD, 2011
)
0.63
"We found no significant effect of dosage or treatment on stance duration (P = ."( Levetiracetam in primary orthostatic tremor: a double-blind placebo-controlled crossover study.
Deuschl, G; Hellriegel, H; Raethjen, J; Volkmann, J, 2011
)
1.81
" However, in order to make further recommendations regarding the choice and dosing regimens of antiepileptic drugs in elderly patients, more extensive clinical research in this specific population is necessary."( Choice of antiepileptic drugs for the elderly: possible drug interactions and adverse effects.
Dostic, M; Jankovic, SM, 2012
)
0.38
" Evidence also suggests that LEV is much better than other AEDs in the way of broad therapeutic window, convenient dosing and less adverse effect."( Levetiracetam.
Dave, P; Gohel, KH; Krishna, K; Raut, AL, 2011
)
1.81
" More frequent dosing of LEV is needed in term infants to maintain serum concentrations in the range seen in children and adults."( A seven-day study of the pharmacokinetics of intravenous levetiracetam in neonates: marked changes in pharmacokinetics occur during the first week of life.
Capparelli, EV; Farrell, MJ; Haas, RH; Mower, A; Sharpe, CM; Soldin, SJ, 2012
)
0.62
" Patients aged 12-75 years with 2-40 partial-onset seizures per 4 weeks, taking 1-2 antiepileptic drugs (AEDs) and receiving a stable dosage for ≥4 weeks prior to screening were randomised in a 3:1 ratio to LEV XR 2000 or 1000 mg/day."( Levetiracetam extended release conversion to monotherapy for the treatment of patients with partial-onset seizures: a double-blind, randomised, multicentre, historical control study.
Avakyan, G; Ceja, H; Chung, S; Gawłowicz, J; Lu, S; McShea, C; Schiemann, J, 2012
)
1.82
" There was no difference in dosing between responders and non-responders."( An initial experience with therapeutic drug monitoring of levetiracetam as reported from a pediatric clinical setting in India.
Fleming, DH; Mathew, BS; Prabha, R; Saravanakumar, K; Thomas, M,
)
0.38
" This model will be valuable to facilitate individualized dosage regimens."( Population pharmacokinetics modeling of levetiracetam in Chinese children with epilepsy.
Lu, W; Shang, DW; Wang, L; Wang, YH; Wei, MJ; Wu, Y, 2012
)
0.65
"A 31-year-old white male with a low-grade astrocytoma presenting with tonic-clonic seizures was treated with levetiracetam 1 g twice daily and dexamethasone (initial dosage 12 mg/day, tapered down to 2 mg/day)."( Levetiracetam-induced drug reaction with eosinophilia and systemic symptoms syndrome.
Ferraz, AV; Gómez-Zorrilla, S; Lemus, M; Pedrós, C; Peña, C,
)
1.79
" The effective dosage of LEV in the responders demonstrated a wide range (mean, 46."( Efficacy and safety of add-on levetiracetam in refractory childhood epilepsy.
Aihara, M; Kanemura, H; Sano, F; Sugita, K; Tando, T, 2013
)
0.68
" Levetiracetam monotherapy at a dosage of 40 mg/kg/day improved the clinical findings, and seizures were controlled at the end of the first month of treatment."( Acquired epileptiform opercular syndrome: F-18 fluorodeoxyglucose positron emission tomography (FDG-PET) findings and efficacy of levetiracetam therapy.
Akın, R; Arslan, M; Ince, S; Ünay, B; Vurucu, S; Yiş, U, 2012
)
1.49
" The level of average LEV dosage itself did not reveal any significant association with BMD and bone metabolism."( Effects of levetiracetam as a monotherapy on bone mineral density and biochemical markers of bone metabolism in patients with epilepsy.
Hong, SB; Joo, EY; Kim, D; Koo, DL, 2013
)
0.78
" Mean PGB dosage was 279 mg/day."( Effect of pregabalin add-on treatment on seizure control, quality of life, and anxiety in patients with brain tumour-related epilepsy: a pilot study.
Carapella, CM; Dinapoli, L; Fabi, A; Maschio, M; Pace, A; Pompili, A; Sperati, F; Vidiri, A, 2012
)
0.38
"0 g/kg alcohol, attenuated the development of locomotor sensitization to alcohol with repeated exposure, and produced a shift in the dose-response curve for alcohol on BSR threshold without affecting maximum operant response rate (MAX)."( Levetiracetam has opposite effects on alcohol- and cocaine-related behaviors in C57BL/6J mice.
Chen, M; Faccidomo, S; Fish, EW; Hodge, CW; Howard, EC; Krouse, MC; Malanga, CJ; Robinson, JE; Stamatakis, AM, 2013
)
1.83
" The objective is to develop a population pharmacokinetic model to describe the pharmacokinetics of levetiracetam in Japanese children and adults as well as North American children, the purpose being to explore potential dosing recommendations in Japanese children."( Development of an integrated population pharmacokinetic model for oral levetiracetam in populations of various ages and ethnicities.
Lacroix, BD; Toublanc, N; Yamamoto, J, 2014
)
0.85
" Clinicians should be mindful that standard dosing of these agents may not achieve typical target concentrations in this clinical scenario."( Augmented renal clearance of vancomycin and levetiracetam in a traumatic brain injury patient.
Arora, S; Cook, AM; Davis, J; Pittman, T, 2013
)
0.65
" The type of interaction between components was determined by isobolographic analysis or by analysis of the log dose-response curves for drug combination and drugs alone."( Levetiracetam interacts synergistically with nonsteroidal analgesics and caffeine to produce antihyperalgesia in rats.
Micov, AM; Stepanović-Petrović, RM; Tomić, MA, 2013
)
1.83
" There was a strong correlation between initial response and dose-up response in 351 patients with increased dosage during the follow-up period."( The long-term efficacy and safety of levetiracetam in a tertiary epilepsy centre.
Chu, K; Jung, KH; Kang, BS; Kim, YS; Lee, SK; Lee, ST; Moon, HJ, 2013
)
0.66
" The canines were given three different dosage levels of anti-convulsant medication in an attempt to manipulate the excitability of the network."( A method for actively tracking excitability of brain networks using a fully implantable monitoring system.
Cook, MJ; Freestone, DR; Frey, S; Giftakis, JE; Long, SN; Stypulkowski, PH, 2013
)
0.39
" After a 1-month run in period, LEV was started at a dose of 250 mg/d (or the matching placebo) and was increased by 250 mg/wk until the final dosage of 1000 mg/d was reached."( Levetiracetam in migraine prophylaxis: a randomized placebo-controlled study in a rural medical institute in northern India.
Kumar, A; Singh, V; Srivastava, D; Verma, A,
)
1.57
" Collected data included age, gender, diagnosis on admission, dosing regimen, documented seizure activity, adverse reactions, concomitant use of other antiepileptic drugs, and condition on discharge."( The safety and tolerability of different intravenous administrations of levetiracetam, bolus versus infusion, in intensive care unit patients.
Bashir, S; Burakgazi, E; Doss, V; Pellock, J, 2014
)
0.63
"Therapeutic drug monitoring of the anticonvulsant levetiracetam may be indicated in patients with conditions that may alter pharmacokinetic characteristics, for tailoring individual dosage regimens or to investigate patient compliance."( Therapeutic drug monitoring of levetiracetam: comparison of a novel immunoassay with an HPLC method.
Arfini, C; Bianchi, V; Vidali, M, 2014
)
0.94
" Levetiracetam dosage was then adjusted up to a maximum of 60 mg/kg/day."( Effect of levetiracetam on behavioral problems in pervasive developmental disorder children with epilepsy.
Aihara, M; Kanemura, H; Ohyama, T; Sano, F; Sugita, K, 2014
)
1.72
" For most of the drugs pharmacokinetic data and dosing recommendations for patients undergoing peritoneal dialysis are not available."( A missed opportunity - consequences of unknown levetiracepam pharmacokinetics in a peritoneal dialysis patient.
Bahte, SK; Hiss, M; Kielstein, JT; Lichtinghagen, R, 2014
)
0.4
" Both half-life and dialysate content might help to guide dosing in this patient population."( A missed opportunity - consequences of unknown levetiracepam pharmacokinetics in a peritoneal dialysis patient.
Bahte, SK; Hiss, M; Kielstein, JT; Lichtinghagen, R, 2014
)
0.4
" Extended-release levetiracetam provides a way to improve medication adherence in adults with epilepsy by allowing once/day dosing and may be considered for use in pregnancy to minimize the fluctuation of levetiracetam levels throughout the day, thus potentially minimizing dose-related adverse effects."( Increased levetiracetam clearance associated with a breakthrough seizure in a pregnant patient receiving once/day extended-release levetiracetam.
Garrity, LC; Standridge, SM; Turner, M, 2014
)
1.14
"The average dosage of LEV was 22."( Evaluation of levetiracetam and valproic acid as low-dose monotherapies for children with typical benign childhood epilepsy with centrotemporal spikes (BECTS).
An, D; Chen, S; Deng, H; Ren, J; Xiao, F; Zhou, D, 2014
)
0.76
" The proposed method was checked in bulk drugs, dosage formulations, physiological condition, and clinical investigations and excellent outcome was witnessed."( Development of new method for simultaneous analysis of piracetam and levetiracetam in pharmaceuticals and biological fluids: application in stability studies.
Ahmad, M; Naseem, H; Shafi, N; Sher, N; Siddiqui, FA; Wafa Sial, A, 2014
)
0.64
" Secondary end points were presence of early seizures (0 to 7 days post-TBI) or late seizures (8 days post-TBI to phone interview), use of anticonvulsant medication when interviewed, medication-related hospital complications, and a summary of phenytoin (PHT) and LEV dosing regimens."( Long-term comparison of GOS-E scores in patients treated with phenytoin or levetiracetam for posttraumatic seizure prophylaxis after traumatic brain injury.
Gabriel, WM; Rowe, AS, 2014
)
0.63
"1 μg/ml) and potassium bromide (n=2; 30-36 mg/kg/d)) resulted in successful reduction of intravenous barbiturate dosage and withdrawal from artificial ventilation."( Effect of levetiracetam in acute encephalitis with refractory, repetitive partial seizures during acute and chronic phase.
Imamura, A; Maegaki, Y; Maruta, K; Matsunami, K; Narita, A; Nishimura, Y; Ohno, K; Saiki, Y; Saito, Y; Sokota, T; Sugihara, S; Tamasaki, A; Ueda, R, 2015
)
0.82
"Pre-clinical trial of abbreviated LEV dosing in an experimental model of TBI Methods: After either controlled cortical impact (CCI) injury or sham surgery, rats received three 50 mg kg(-1) doses over 24 hours or vehicle."( Abbreviated levetiracetam treatment effects on behavioural and histological outcomes after experimental TBI.
Fowler, L; Hurwitz, M; Wagner, AK; Zou, H, 2015
)
0.8
" These findings may guide (1) future experimental studies assessing minimal effective dosing for neuroprotection and anti-epileptogenesis and (2) treatment guideline updates for seizure prophylaxis post-TBI."( Abbreviated levetiracetam treatment effects on behavioural and histological outcomes after experimental TBI.
Fowler, L; Hurwitz, M; Wagner, AK; Zou, H, 2015
)
0.8
" No dose-response relationship was demonstrated; however, the odds of a levetiracetam-naive patient, (median dose, 26."( An 11-year review of levetiracetam ingestions in children less than 6 years of age.
Albertson, TE; Lewis, JC; Walsh, MJ, 2014
)
0.95
" The objective of this trial was to evaluate the pharmacokinetics of levetiracetam in Japanese patients with renal impairment including end-stage renal disease (ESRD) to confirm that existing dosing instructions-based on data from European patients-are appropriate in a Japanese population."( Levetiracetam pharmacokinetics in Japanese subjects with renal impairment.
Kumagai, Y; Stockis, A; Toublanc, N; Yamamoto, J, 2014
)
2.08
"These findings confirm that the dosing instructions are appropriate for Japanese patients with renal impairment including ESRD."( Levetiracetam pharmacokinetics in Japanese subjects with renal impairment.
Kumagai, Y; Stockis, A; Toublanc, N; Yamamoto, J, 2014
)
1.85
"We report a 36-year-old pregnant patient with subtherapeutic trough plasma levels of levetiracetam (LVT) and a breakthrough nocturnal seizure while assuming 3 times a day dosing of the drug."( Increased levetiracetam clearance and breakthrough seizure in a pregnant patient successfully handled by intensive therapeutic drug monitoring.
Cappellari, AM; Cattaneo, D; Clementi, E; Kustermann, A, 2015
)
1.04
" We compared the overall rate of CSEs and intolerable CSEs (ICSEs-CSEs that led to dosage reduction or discontinuation) between different AEDs in both monotherapy and polytherapy."( Cosmetic side effects of antiepileptic drugs in adults with epilepsy.
Buchsbaum, R; Chen, B; Choi, H; Detyniecki, K; Hirsch, LJ; Javed, A; Kato, K; Legge, A; Moeller, J, 2015
)
0.42
" Cosmetic side effects leading to dosage change or discontinuation occurred most frequently with pregabalin and valproic acid compared with all other AEDs (13."( Cosmetic side effects of antiepileptic drugs in adults with epilepsy.
Buchsbaum, R; Chen, B; Choi, H; Detyniecki, K; Hirsch, LJ; Javed, A; Kato, K; Legge, A; Moeller, J, 2015
)
0.42
"Weight gain and alopecia were the most common patient-reported CSEs in this study, and weight gain was the most likely cosmetic side effect to result in dosage adjustment or medication discontinuation."( Cosmetic side effects of antiepileptic drugs in adults with epilepsy.
Buchsbaum, R; Chen, B; Choi, H; Detyniecki, K; Hirsch, LJ; Javed, A; Kato, K; Legge, A; Moeller, J, 2015
)
0.42
" Dose-response curves for phenytoin and levetiracetam were generated in the three strains at 32 and 44 mA current intensities using both devices."( Genetic background of mice strongly influences treatment resistance in the 6 Hz seizure model.
Kaminski, RM; Leclercq, K, 2015
)
0.68
"In Japanese children treated with LEV, the dosage and blood level showed positive correlations."( The efficacy of levetiracetam for focal seizures and its blood levels in children.
Ishii, M; Iwasaki, T; Nonoda, Y; Toki, T, 2015
)
0.76
" LEV was administered to LEV group at an initial dosage of 500 mg twice daily."( [Clinical efficacy of levetiracetam on bone mineral density and bone metabolism in middle-aged and elderly patients with generalized tonic-clonic seizures].
Chen, X; Wang, H, 2014
)
0.72
" The LEV dosage was 30-50mg/kg/day."( Levetiracetam efficacy in children with epilepsy with electrical status epilepticus in sleep.
Cai, F; Chen, J; Feng, C; Hu, Y; Jiang, L, 2015
)
1.86
" The patients were given ZNS as add-on treatment, and the ZNS dosing and the visit frequency were governed by the treating physician."( Retention rate of zonisamide in intractable epilepsy.
Andersen, H; Lindstrøm, P; Nakken, KO, 2015
)
0.42
"Literature and experimental data relevant for the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing levetiracetam are reviewed."( Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam.
Abrahamsson, B; Berglez, S; Cristofoletti, R; Dressman, J; Groot, DW; Kopp, S; Krisch, I; Langguth, P; Legen, I; Megušar, K; Mehta, M; Peternel, L; Petruševska, M; Polli, JE; Shah, VP, 2015
)
0.84
" Dosage increases might be indicated when utilizing LEV as add-on treatment with phenobarbital in dogs."( Effect of chronic administration of phenobarbital, or bromide, on pharmacokinetics of levetiracetam in dogs with epilepsy.
Muñana, KR; Nettifee-Osborne, JA; Papich, MG,
)
0.35
"No correlation between levetiracetam serum levels and clinical efficacy, tolerability or administered dosage was found."( Correlation between efficacy of levetiracetam and serum levels among children with refractory epilepsy.
Berkovitch, M; Dagan, Z; Gandelman-Marton, R; Heyman, E; Kohn, E; Sheinberg, R; Youngster, I, 2015
)
1.01
" Also, an appropriate dosage has yet to be determined."( Intravenous levetiracetam in Thai children and adolescents with status epilepticus and acute repetitive seizures.
Khongkhatithum, C; Thampratankul, L; Visudtibhan, A; Wiwattanadittakul, N, 2015
)
0.8
" Further study of appropriate initial dosage and pharmacokinetic variations in the patients is needed as possible explanation of the unresponsiveness."( Intravenous levetiracetam in Thai children and adolescents with status epilepticus and acute repetitive seizures.
Khongkhatithum, C; Thampratankul, L; Visudtibhan, A; Wiwattanadittakul, N, 2015
)
0.8
" Similar to findings in animal studies, higher dosing at 250 mg BID had no significant benefit on either task performance or fMRI activation."( Response of the medial temporal lobe network in amnestic mild cognitive impairment to therapeutic intervention assessed by fMRI and memory task performance.
Albert, MS; Bakker, A; Gallagher, M; Krauss, G; Speck, CL, 2015
)
0.42
" Linear pharmacokinetics were demonstrated (geometric least-squares mean AUC during the dosing interval τ at steady state (AUC(τ,ss)) 475."( Pharmacokinetics, Safety and Bioequivalence of Levetiracetam Intravenous Infusion and Oral Tablets in Healthy Chinese Subjects.
Chan, R; Chen, Q; Du, X; Liu, Y; Singh, P; Stockis, A; Toublanc, N, 2015
)
0.67
" Once patients respond to low-dose treatment, maintenance of the effective dosage may prolong response."( Clinical features of long-term low-dose levetiracetam treatment for epilepsy.
Fukui, M; Nomura, S; Shimakawa, S; Tamai, H; Tanabe, T; Yoshikawa, S, 2016
)
0.7
"To assess efficacy/tolerability of ezogabine (EZG)/retigabine (RTG) in combination with specified monotherapy antiepileptic drug (AED) treatments in adults with uncontrolled partial-onset seizures using a flexible dosing regimen."( Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures.
Brandt, C; Daniluk, J; DeRossett, S; Edwards, S; Lerche, H; Lotay, N, 2015
)
0.42
"NCT01227902 was an open-label, uncontrolled study of flexibly dosed EZG/RTG."( Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures.
Brandt, C; Daniluk, J; DeRossett, S; Edwards, S; Lerche, H; Lotay, N, 2015
)
0.42
"EZG/RTG was effective as adjunctive therapy to CBZ/OXC, LTG, LEV, and VPA, using a flexible dosing regimen, in adults with partial-onset seizures; safety and tolerability were consistent with that previously observed."( Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures.
Brandt, C; Daniluk, J; DeRossett, S; Edwards, S; Lerche, H; Lotay, N, 2015
)
0.42
" Renal dysfunction reduces levetiracetam clearance, and dosage reductions are recommended to prevent accumulation."( Levetiracetam Pharmacokinetics in a Patient Receiving Continuous Venovenous Hemofiltration and Venoarterial Extracorporeal Membrane Oxygenation.
Frazee, EN; Kashani, KB; Nei, SD; Wittwer, ED, 2015
)
2.16
" An extended release preparation should improve dosing convenience."( Disposition of Extended Release Levetiracetam in Normal Healthy Dogs After Single Oral Dosing.
Beasley, MJ; Boothe, DM,
)
0.41
" No dose-response relationship was found for any of the assessed variables."( The adverse event profile of levetiracetam: A meta-analysis on children and adults.
Chiarelli, F; Di Sabatino, F; Franco, V; Prezioso, G; Verrotti, A; Zaccara, G, 2015
)
0.71
" However, there does not seem to be a clear dose-response relationship."( The adverse event profile of levetiracetam: A meta-analysis on children and adults.
Chiarelli, F; Di Sabatino, F; Franco, V; Prezioso, G; Verrotti, A; Zaccara, G, 2015
)
0.71
" The dosage of immunosuppressants did not change before and after levetiracetam treatment, and there were no changes in hematological and biochemical data before and after treatment."( Levetiracetam in the Treatment of Epileptic Seizures After Liver Transplantation.
Chen, CL; Chen, NC; Chuang, YC; Lin, CH; Lin, TK; Tsai, MH, 2015
)
2.1
" In addition, an 8-hour continuous urine collection should be considered to assess a measured creatinine clearance for evaluating the necessity of medication dosage adjustments."( Implications of Augmented Renal Clearance on Drug Dosing in Critically Ill Patients: A Focus on Antibiotics.
Daley, MJ; Hobbs, AL; Roberts, KM; Shea, KM, 2015
)
0.42
" Two or more seizures within 3 months led to an increase in drug dosage (levetiracetam: 10 mg/kg/day, phenobarbital: 1 mg/kg/day)."( A single-blinded phenobarbital-controlled trial of levetiracetam as mono-therapy in dogs with newly diagnosed epilepsy.
Berendt, M; Fredsø, N; Møller, A; Sabers, A; Toft, N, 2016
)
0.92
" Plasma and brain levels were measured over time after single oral dosing to audiogenic mice and were correlated with anticonvulsant activity."( Brivaracetam, a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand with preclinical evidence of high brain permeability and fast onset of action.
Carson, RE; Chanteux, H; Hannestad, J; Holden, D; Huang, Y; Kervyn, S; Klitgaard, H; Matagne, A; Mathy, FX; Mercier, J; Nabulsi, N; Nicolas, JM; Staelens, L; Stockis, A; Tytgat, D, 2016
)
0.43
" Continuous venovenous hemofiltration (CVVH) has been shown to eliminate levetiracetam, but the preferred dosing regimen when a patient is on CVVH and has concomitant acute liver dysfunction is unknown."( Levetiracetam Pharmacokinetics During Continuous Venovenous Hemofiltration and Acute Liver Dysfunction.
Frazee, EN; Kashani, KB; Nei, SD; New, AM; Rabinstein, AA, 2016
)
2.11
" Levetiracetam monotherapy was initiated and dosed to efficacy or unacceptable side effects, with a range of 10-112 mg/kg/day."( The efficacy, tolerability and safety of levetiracetam therapy in a pediatric population.
Çavuşoğlu, D; Dündar, NO; Gencpinar, P; Tekgül, H, 2016
)
1.61
" LEV3D treatment failed to improve cognitive or motor performance; however extending the dosing regimen through 10 days post-injury afforded significant neuroprotective benefit."( Neuroprotection and anti-seizure effects of levetiracetam in a rat model of penetrating ballistic-like brain injury.
Caudle, KL; Lu, XC; Mountney, A; Shear, DA; Tortella, FC, 2016
)
0.7
"These findings support the dual anti- seizure and neuroprotective role of LEV, but more importantly identify the importance of an extended dosing protocol which was specific to the therapeutic targets studied."( Neuroprotection and anti-seizure effects of levetiracetam in a rat model of penetrating ballistic-like brain injury.
Caudle, KL; Lu, XC; Mountney, A; Shear, DA; Tortella, FC, 2016
)
0.7
" About 70% of the administered dose is excreted in urine unchanged, and dosage adjustment is recommended based on the individual's renal function."( Population Pharmacokinetic Modeling of Levetiracetam in Pediatric and Adult Patients With Epilepsy by Using Routinely Monitored Data.
Hashi, S; Ikeda, A; Ito, S; Matsubara, K; Sugimoto, M; Tsuda, M; Yano, I; Yonezawa, A, 2016
)
0.7
" Dosage adjustments based on renal function are effective in controlling the trough and peak concentrations in similar ranges."( Population Pharmacokinetic Modeling of Levetiracetam in Pediatric and Adult Patients With Epilepsy by Using Routinely Monitored Data.
Hashi, S; Ikeda, A; Ito, S; Matsubara, K; Sugimoto, M; Tsuda, M; Yano, I; Yonezawa, A, 2016
)
0.7
" Symptoms increased accompanied by the raised dosage of LEV."( Levetiracetam: Probably Associated Diurnal Frequent Urination.
Hu, LY; Ju, J; Pang, LY; Shi, XY; Zou, LP,
)
1.57
" For patients who fail low dose levetiracetam (LEV), a reasonable alternative to increasing dosage may be the addition of a low-dose adjunctive AED."( Open Label Trial of Add on Lacosamide Versus High Dose Levetiracetam Monotherapy in Patients With Breakthrough Seizures.
Alam, J; Bubrick, EB; Dworetzky, BA; Hurwitz, S; Lee, JW; Llewellyn, N; Pennell, PB; Putta, S; Sarkis, RA; Weisholtz, D; Yu, H,
)
0.66
" Even though these formulations have helped to improve therapy adherence, some of their limitations include: the dissolution time, their facility to be swallowed, and the dosage strengths that may be accommodated."( Randomized Comparative Bioavailability of a Novel Three-Dimensional Printed Fast-Melt Formulation of Levetiracetam Following the Administration of a Single 1000-mg Dose to Healthy Human Volunteers Under Fasting and Fed Conditions.
Boudriau, S; Hanzel, C; Lefebvre, M; Massicotte, J; Sayegh, L; Wang, J, 2016
)
0.65
"Orally administered medications in extended-release (ER) dosage forms continue to play a pivotal role in the treatment of various central nervous system disorders."( Ghost-Pill-Buster: A Case Study of Intact Levetiracetam Extended-Release Tablets after Dissolution Testing.
Externbrink, A; Gao, Z; Jiang, W; Keire, D; Krauss, G; Sun, D; Wen, H, 2016
)
0.7
" LEV in low- dosage had no additive neuroprotective effect following acute hypoxic brain injury."( Dose-dependent effects of levetiracetam after hypoxia and hypothermia in the neonatal mouse brain.
Bendix, I; Bertsche, A; Fandrey, J; Felderhoff-Mueser, U; Hoeber, D; Kluever, V; Lueckemann, L; Strasser, K; Thavaneetharajah, S, 2016
)
0.73
" In this phase IIIb, prospective, multicenter, open-label, single-arm trial (NCT01375374), the serum concentrations of CYP-related reproductive hormones, thyroid hormones, and lipids were assessed in otherwise healthy male patients with focal seizures (N=11), before and after a switch from CBZ (600-1200mg/day at baseline) to lacosamide (target dose: 400mg/day by the end of titration) as adjunctive treatment to the nonenzyme-inducing AED levetiracetam (LEV, stable dosage of >1000mg/day throughout)."( Changes in hormone and lipid levels in male patients with focal seizures when switched from carbamazepine to lacosamide as adjunctive treatment to levetiracetam: A small phase IIIb, prospective, multicenter, open-label trial.
Brandt, C; De Backer, M; Dedeken, P; Eckhardt, K; Elger, CE; Elmoufti, S; Rademacher, M; Tennigkeit, F, 2016
)
0.8
"The aim of this review was to evaluate current literature for dosing recommendations for the use of antiepileptic medications in patients receiving renal replacement therapy (RRT)."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
" Micromedex® DRUGDEX as well as package inserts were used to obtain known pharmacokinetic properties and dosage adjustment recommendations in RRT if known."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
"Data regarding antiepileptic drug use in RRT are limited and mostly consist of case reports limiting our proposed dosing recommendations."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
"Additional studies are necessary before specific dosing recommendations can be made for most antiepileptic drugs in critically ill patients receiving RRT, specifically with newer agents."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
" For any suspicion, the drug's dosage and replacement should be managed before any premature care's withdrawal."( Marked EEG worsening following Levetiracetam overdose: How a pharmacological issue can confound coma prognosis.
André-Obadia, N; Bouchier, B; Demarquay, G; Gobert, F; Guérin, C, 2017
)
0.74
" The findings in this study can be utilized to optimize LEV dosing regimens in clinical practice."( Population pharmacokinetics and dose-response relationship of levetiracetam in adult patients with epilepsy.
Chu, K; Jang, IJ; Jung, KH; Jung, KY; Kim, TJ; Lee, S; Lee, SK; Lee, ST; Moon, J; Park, KI; Rhee, SJ; Shin, JW; Yu, KS, 2017
)
0.7
"In this study, we evaluated the dose-response efficacy of levetiracetam (12."( Combination therapy of levetiracetam and gabapentin against nonconvulsive seizures induced by penetrating traumatic brain injury.
Cao, Y; Liao, Z; Lu, XM; Mountney, A; Shear, DA; Tortella, FC, 2017
)
1.01
" However, the two drugs manifested different dose-response profiles."( Combination therapy of levetiracetam and gabapentin against nonconvulsive seizures induced by penetrating traumatic brain injury.
Cao, Y; Liao, Z; Lu, XM; Mountney, A; Shear, DA; Tortella, FC, 2017
)
0.77
" Criterion 2=the last drug introduced into the antiepileptic therapy within 72h before the cessation of SE and without changes in dosage or number of the co-medication."( The efficacy of different kinds of intravenously applied antiepileptic drugs in the treatment of status epilepticus. How can it be determined?
Redecker, J; Rösche, J; Wittstock, M, 2017
)
0.46
" In end-stage renal disease (ESRD) patients on hemodialysis (HD), pharmacokinetic studies recommend daily dosing with 50% supplemental doses after 4-hour HD sessions."( Comparison of Levetiracetam Dosing Regimens in End-Stage Renal Disease Patients Undergoing Intermittent Hemodialysis.
Sands, KA; Shiue, HJ; Taylor, M, 2017
)
0.82
"To compare two LEV dosing regimens, daily versus twice-daily (BID), in ESRD patients undergoing HD."( Comparison of Levetiracetam Dosing Regimens in End-Stage Renal Disease Patients Undergoing Intermittent Hemodialysis.
Sands, KA; Shiue, HJ; Taylor, M, 2017
)
0.82
"Compared to LEV daily, BID dosing achieved significantly higher levels and a better recovery to predialysis levels."( Comparison of Levetiracetam Dosing Regimens in End-Stage Renal Disease Patients Undergoing Intermittent Hemodialysis.
Sands, KA; Shiue, HJ; Taylor, M, 2017
)
0.82
" LCM was added up to reach the maximum dosage of 400mg/die (mean final dose 300mg/die)."( Quality of life, mood and seizure control in patients with brain tumor related epilepsy treated with lacosamide as add-on therapy: A prospective explorative study with a historical control group.
Fabi, A; Giannarelli, D; Maialetti, A; Maschio, M; Vidiri, A; Villani, V; Zarabla, A, 2017
)
0.46
" The preferred levetiracetam dosing regimen in critically ill patients exhibiting complex pharmacokinetic profiles undergoing hemodialysis is unknown."( Levetiracetam Pharmacokinetics in a Critically Ill Anephric Patient on Intermittent Hemodialysis.
Frazee, E; Kashani, KB; Rabinstein, AA; Wieruszewski, PM, 2018
)
2.28
"Simulation with the adult brivaracetam PK/PD model in combination with an existing pediatric brivaracetam population PK model allowed characterization of the dose-response curve, suggesting maximum response at brivaracetam 4 mg/kg/day dosing (capped at 200 mg/day, the maximum adult dose) in children aged ≥4 years."( Extrapolation of a Brivaracetam Exposure-Response Model from Adults to Children with Focal Seizures.
Schoemaker, R; Stockis, A; Wade, JR, 2018
)
0.48
"Repeated PO dosing of anti-epileptic drugs may contribute to poor compliance in treated cats."( Pharmacokinetics of Single Oral Dose Extended-Release Levetiracetam in Healthy Cats.
Barnard, L; Barnes Heller, H; Boothe, DM, 2018
)
0.73
" Due to differences in drug disposition and clearance dosages in neonates, dosing recommendations in other species or adult horses cannot be extrapolated to foals."( Pharmacokinetics of the anticonvulsant levetiracetam in neonatal foals.
Berghaus, LJ; Davis, JL; Giguère, S; Hart, KA; MacDonald, KD, 2018
)
0.75
" 25-OHD levels were categorized as low (<20ng/ml), borderline (20-29ng/ml), or normal (>30ng/ml) RESULTS: The average dosage of VPA and LEV was 20."( Vitamin D deficiency in children with epilepsy taking valproate and levetiracetam as monotherapy.
Aguilera-Albesa, S; Durá-Travé, T; Gallinas-Victoriano, F; Malumbres-Chacón, M; Moreno-Gónzalez, P; Yoldi-Petri, ME, 2018
)
0.72
"Based on the PK of LEV in neonates and the influence of the final PK model, a priori dosing guidelines are proposed considering CRCL, BW and LEV plasma concentrations between 6 and 20 mg/L for NS treatment."( Population pharmacokinetics of levetiracetam in neonates with seizures.
Gómez-Ruiz, LM; Lima-Rogel, V; López-López, EJ; Medellín-Garibay, SE; Milán-Segovia, RC; Romano-Moreno, S; Romero-Méndez, C, 2018
)
0.77
" The purpose of this review is to provide an up-to-date evidence summary of the incidence and outcomes of seizures following an SAH as well as the use of different AEDs post-SAH in order to evaluate the need for seizure prophylaxis, the choice of AEDs, and their dosing considerations in SAH patients."( Seizures and Choice of Antiepileptic Drugs Following Subarachnoid Hemorrhage: A Review.
Buxton, J; Mahmoud, SH, 2017
)
0.46
" Sampling and dosing times were recorded by clinical research coordinators on case report forms."( Population pharmacokinetic model of levetiracetam in Korean neonates with seizures
.
Jung, YS; Lee, SM; Park, K; Park, MS, 2018
)
0.76
" The result of this study can be used as a basis to develop an optimal dosage regimen in Korean neonates with seizures."( Population pharmacokinetic model of levetiracetam in Korean neonates with seizures
.
Jung, YS; Lee, SM; Park, K; Park, MS, 2018
)
0.76
" Extended release levetiracetam (XRL) has once daily recommended dosing interval, but multiple dose administration of XRL has not been evaluated in cats."( Serum levetiracetam concentrations and adverse events after multiple dose extended release levetiracetam administration to healthy cats.
Barnes Heller, H; Boothe, DM; Granick, M; Van Hesteren, M, 2018
)
1.3
"Mean trough serum levetiracetam concentrations were ≥5 μg/mL and adverse effects were minimal throughout dosing period, indicating that the drug was well tolerated."( Serum levetiracetam concentrations and adverse events after multiple dose extended release levetiracetam administration to healthy cats.
Barnes Heller, H; Boothe, DM; Granick, M; Van Hesteren, M, 2018
)
1.3
"Evidence for the comparative teratogenic risk of antiepileptic drugs is insufficient, particularly in relation to the dosage used."( Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry.
Battino, D; Bonizzoni, E; Craig, J; Lindhout, D; Perucca, E; Sabers, A; Thomas, SV; Tomson, T; Vajda, F, 2018
)
0.48
"In the therapeutic drug monitoring group, clinicians had access to clinical findings and monthly serum AED levels to guide AED dosage adjustment for seizure control."( AntiEpileptic drug Monitoring in PREgnancy (EMPiRE): a double-blind randomised trial on effectiveness and acceptability of monitoring strategies.
Bagary, M; Coleman, J; D'Amico, M; Denny, E; Dodds, J; Eldridge, S; Greenhill, L; Hard, K; Kelso, A; Khan, KS; Marlin, N; McCorry, D; Middleton, L; Moss, N; Newton, S; Pirie, A; Pullen, A; Rikunenko, R; Roberts, T; Rogozińska, E; Thangaratinam, S; Weckesser, A, 2018
)
0.48
" At the onset of fever, the patients who presented epileptiform discharge were orally administered with LEV with a dose of 15-30 mg/kg per day twice daily for 1 week, thereafter, the dosage was gradually reduced until totally discontinued in the second week."( Intermittent oral levetiracetam reduced recurrence of febrile seizure accompanied with epileptiform discharge: a pilot study.
Hu, LY; Li, H; Ma, SF; Shi, XY; Zhang, MN; Zou, LP, 2018
)
0.81
"Sex, age, and weight affect LEV pharmacokinetics, having an impact on the individual dosage regimen needed to achieve the therapeutic objective."( Influence of Sex, Age, and Weight on Levetiracetam Pharmacokinetics.
Aldaz, A; Alzueta, N; Ortega, A, 2018
)
0.75
" No association was found between all parameters and LEV dosage (mg/kg) at 12 months of treatment."( Long-term effect of levetiracetam monotherapy on haematological parameters in children with epilepsy: A prospective study.
Attilakos, A; Dinopoulos, A; Garoufi, A; Karalexi, M; Paschalidou, M; Prasouli, A; Tsirouda, M, 2018
)
0.8
" In particular, the current use of a weight-based IV LEV dosing regimen in pediatric children is practical."( Pharmacokinetic and Pharmacodynamic Evaluation of Intravenous Levetiracetam in Children With Epilepsy.
Kim, MJ; Ko, TS; Lim, HS; Yeh, HR; Yum, MS, 2018
)
0.72
"Therapeutic Drug Monitoring (TDM) of anti-epileptic drugs (AEDs) is not routinely performed, although this can guide the dosage regimen to achieve greater efficacy and safety."( Review on the relevance of therapeutic drug monitoring of levetiracetam.
Chan, H; de Haan, GJ; Evers, S; Klarenbeek, P; Majoie, M; Sourbron, J; van der Kuy, H; Wammes-van der Heijden, EA; Wijnen, BFM, 2018
)
0.73
" Yet, we demonstrated that measuring serum lacosamide concentrations in the critically ill population during continuous renal replacement therapy may be useful to individualize dosing programs."( Lacosamide Pharmacokinetics in a Critically Ill Patient During Continuous Renal Replacement Therapy.
Albright, RC; Barreto, EF; Fugate, JE; Lopez-Ruiz, A; Wieruszewski, PM, 2020
)
0.56
"Fast and accurate manufacturing of individually tailored solid dosage forms is one of the main challenges for personalized medicine."( On-demand manufacturing of immediate release levetiracetam tablets using pressure-assisted microsyringe printing.
Breitkreutz, J; El Aita, I; Quodbach, J, 2019
)
0.77
" Our data suggest that sufficiently dosed benzodiazepines should be used as a first treatment step."( Factors predicting cessation of status epilepticus in clinical practice: Data from a prospective observational registry (SENSE).
Kellinghaus, C; Lang, N; May, TW; Rosenow, F; Rossetti, AO; Rüegg, S; Strzelczyk, A; Sutter, R; Tilz, C; Trinka, E; Unterberger, I; Uzelac, Z, 2019
)
0.51
" Transdermal LEV was applied to the inner pinna at a dosage of 60 mg/kg (400 mg/mL concentration) at home for 6 days."( Serum levetiracetam concentrations after transdermal levetiracetam administration, 3 times daily, to healthy cats.
Barnes Heller, HL; Reif, N; Reinhart, JM; Smith, C; Van Hesteren, M, 2019
)
0.99
"Thirty epileptic children (group 1) receiving levetiracetam monotherapy at a dosage of 20-40 mg/kg/day for at least 1 year with a first diagnosis of epilepsy and 30 age- and gender-matched healthy children (group 2) were included in the study."( An investigation of the ocular toxic effects of levetiracetam therapy in children with epilepsy.
Acar Arslan, E; Cansu, A; Dilber, B; Diler Durgut, B; Kamasak, T; Sahin, S; Turk, A; Turkcan Soguksulu, T, 2019
)
1.03
" In vitro and in vivo animal studies suggest faster brain penetration and SV2A occupancy (SO) after dosing with BRV than LEV."( A single-center, open-label positron emission tomography study to evaluate brivaracetam and levetiracetam synaptic vesicle glycoprotein 2A binding in healthy volunteers.
Carson, RE; DeBruyn, S; Finnema, SJ; Gao, H; Hannestad, J; Henry, S; Huang, Y; Kaminski, RM; Kervyn, S; Klitgaard, H; Maguire, RP; Martin, P; Matuskey, D; Mercier, J; Muglia, P; Nabulsi, NB; Naganawa, M; Nicolas, JM; Otoul, C; Pracitto, R; Rossano, S; Stockis, A, 2019
)
0.73
" Cohort 3 (n = 4) was examined at baseline and steady state after 4 days of twice-daily oral dosing of BRV (50-100 mg) and 4 hours postdose of LEV (250-600 mg)."( A single-center, open-label positron emission tomography study to evaluate brivaracetam and levetiracetam synaptic vesicle glycoprotein 2A binding in healthy volunteers.
Carson, RE; DeBruyn, S; Finnema, SJ; Gao, H; Hannestad, J; Henry, S; Huang, Y; Kaminski, RM; Kervyn, S; Klitgaard, H; Maguire, RP; Martin, P; Matuskey, D; Mercier, J; Muglia, P; Nabulsi, NB; Naganawa, M; Nicolas, JM; Otoul, C; Pracitto, R; Rossano, S; Stockis, A, 2019
)
0.73
"Despite being one of the most commonly prescribed antiepileptic drugs, levetiracetam is marketed in oral and intravenous dosage forms, which are associated to drug-drug interactions and drug-resistant epilepsy (DRE)."( Nose-to-brain delivery of levetiracetam after intranasal administration to mice.
Alves, G; Bicker, J; Falcão, A; Fortuna, A; Gonçalves, J; Gouveia, F; Liberal, J; Oliveira, RC, 2019
)
1.05
" The aim of this study was to establish a PPK model of MHD to investigate the effects of genetic polymorphisms in UGT2B7, UGT1A9, ABCB1, and ABCB2 in adult Chinese patients with epilepsy and to develop a new dosage guideline for OXC."( Glomerular Filtration Rate Is a Major Predictor of Clearance of Oxcarbazepine Active Metabolite in Adult Chinese Epileptic Patients: A Population Pharmacokinetic Analysis.
Jiao, Z; Lin, RF; Lin, S; Lin, WW; Lin, XH; Wang, CL; Yu, XL; Zhang, J; Zhang, WB, 2019
)
0.51
" Moreover, a new dosage guideline was proposed based on the final model to individualize OXC regimens for adult patients with varying BW and renal function."( Glomerular Filtration Rate Is a Major Predictor of Clearance of Oxcarbazepine Active Metabolite in Adult Chinese Epileptic Patients: A Population Pharmacokinetic Analysis.
Jiao, Z; Lin, RF; Lin, S; Lin, WW; Lin, XH; Wang, CL; Yu, XL; Zhang, J; Zhang, WB, 2019
)
0.51
" LEV administration on 6th day (dosage 50 mg/kg) did not have statistical effect on the epileptogenesis, while at a dosage of 200 mg/kg on 6th day LEV significantly suppressed paroxysmal activity in the studied structures of rats with cobalt epilepsy."( Levetiracetam effect and electrophysiological mechanism of action in rats with cobalt-induced chronic epilepsy.
Avakyan Gagik, N; Avakyan Georgii, G; Kutepova Inga, S; Litvinova Svetlana, A; Nerobkova Lubov, N; Voroninа Tatyana, A, 2019
)
1.96
"28), indicating a dose-response relationship."( Pregabalin add-on for drug-resistant focal epilepsy.
Bresnahan, R; Hemming, K; Marson, AG; Panebianco, M, 2019
)
0.51
" The objective of this study was to review the critical care management of patients with SE focusing on antiepileptic drugs (AEDs) as well as to determine the optimal dosing strategies of phenytoin (PHT) and predictors of its effectiveness."( Critical Care Management of Status Epilepticus at a Tertiary Care University Hospital.
Ahmed, SN; Lindqvist, T; Mahmoud, SH; Marette, V, 2019
)
0.51
" CIMT and EATT values were not associated with the dosage and duration of each antiepileptic drug."( Effects of valproic acid and levetiracetam monotherapy on carotid intima-media and epicardial adipose tissue thickness in non-obese children with epilepsy.
Karatoprak, E; Tosun, O, 2020
)
0.85
"Age and daily dose were the most significant predictors of levetiracetam target-concentration attainment and should be considered in further investigations to develop a dosing algorithm for optimal levetiracetam therapy."( What Are the Predictors for Achieving Therapeutic Levetiracetam Serum Concentrations in Adult Neurological Patients?
Abdul-Aziz, MH; Cotta, MO; Frey, OR; Roberts, JA; Roehr, AC; Sime, FB, 2020
)
1.05
"The objective was to develop and externally validate a population pharmacokinetic model of levetiracetam in adult and elderly patients with epilepsy, and to perform dosing simulations to propose individualized dosing regimens more likely to achieve therapeutic concentrations."( Population Pharmacokinetics and Dosing Recommendations of Levetiracetam in Adult and Elderly Patients With Epilepsy.
Hernández-Mitre, MP; Jung-Cook, HH; Medellín-Garibay, SE; Milán-Segovia, RDC; Roberts, JA; Rodríguez-Leyva, I; Rodríguez-Pinal, CJ; Romano-Moreno, S; Zarazúa, S, 2020
)
1.02
" Risk factors for the disease include older age, renal dysfunction, critical illness, and inappropriate dosing based upon renal function."( Cefepime-Induced Neurotoxicity Presenting with Nonconvulsive Status Epilepticus Admitted as a Stroke Alert.
Allyn, R; Cunningham, JM; Sachs, KV, 2020
)
0.56
" Dosage changes were more frequent in patients with assays in therapeutic ranges compared to patients with plasma assays outside the therapeutic ranges (P=0."( Clinical and biological assessment of lamotrigine and levetiracetam plasma assays at the Rennes University Hospital.
Biraben, A; Degremont, A; Gicquel, T; Le Daré, B; Morel, I; Polard, E, 2020
)
0.81
"Five groups of each of 12 female rats were orally dosed daily for 8 weeks with either carbamazepine (CBZ) (60 mg/kg), eslicarbazepine (ESL) (80 mg/kg), valproic acid (VPA) (300 mg/kg), levetiracetam (LEV) (50 mg/kg) or saline (control (CTL))."( Effects of carbamazepine, eslicarbazepine, valproic acid and levetiracetam on bone microarchitecture in rats.
Andersen, NB; Diemar, SS; Ding, M; Eiken, P; Ellegaard, M; Jørgensen, NR; Sejling, AS, 2020
)
0.99
" Furthermore, most preclinical antiepileptogenic studies lack information needed for translation, such as dose-blood level relationship, brain target engagement, and dose-response, and many use treatment parameters that cannot be applied clinically, for example, treatment initiation before or at the time of injury and dosing higher than tolerated human equivalent dosing."( Repurposed molecules for antiepileptogenesis: Missing an opportunity to prevent epilepsy?
Bar-Klein, G; Friedman, A; Hameed, MQ; Jozwiak, S; Kaminski, RM; Klein, P; Klitgaard, H; Koepp, M; Löscher, W; Prince, DA; Rotenberg, A; Twyman, R; Vezzani, A; Wong, M, 2020
)
0.56
" This prospective practice-based PK study aims to assess the impact of continuous venovenous hemofiltration (CVVH), a modality of CRRT, on levetiracetam PK in critically ill patients and to derive individualized dosing recommendations."( A Practice-Based, Clinical Pharmacokinetic Study to Inform Levetiracetam Dosing in Critically Ill Patients Undergoing Continuous Venovenous Hemofiltration (PADRE-01).
Armahizer, M; Badjatia, N; Gobburu, JV; Gopalakrishnan, M; Kalaria, SN; McCarthy, P, 2020
)
1
"Although levetiracetam presents an easy dosing and tolerability, therapeutic drug monitoring may be recommended in certain situations."( Therapeutic drug monitoring of levetiracetam in daily clinical practice: high-performance liquid chromatography versus immunoassay.
Álvarez Martín, T; Bellés Medall, MD; Ferrando Piqueres, R; Liñana Granell, C; Mendoza Aguilera, M; Pascual Marmaneu, Ó, 2020
)
1.26
" The levetiracetam dosage was increased (150 mg/kg [68 mg/lb], PO, q 8 h), and zonisamide (20 mg/kg [9."( Diagnosis and long-term management of post-traumatic seizures in a white-crowned pionus (
Beaufrère, H; Brouwer, E; James, F; Kabakchiev, C; Laniesse, D; Zur Linden, A, 2020
)
1.07
" Weight-based dosing was capped at 75 kg."( The association of patient weight and dose of fosphenytoin, levetiracetam, and valproic acid with treatment success in status epilepticus.
Bleck, TP; Chamberlain, JM; Cloyd, JC; Cock, HR; Coles, LD; Conwit, RA; Elm, JJ; Fountain, NB; Kapur, J; Lowenstein, DH; Sathe, AG; Shinnar, S; Silbergleit, R, 2020
)
0.8
"This patient was treated with the administration of levetiracetam at a dosage of 1000 mg/day."( Familial cerebral cavernous malformation presenting with epilepsy caused by mutation in the CCM2 gene: A case report.
Ishii, K; Muroi, A; Tamaoka, A; Tozaka, N; Tsutsumi, S, 2020
)
0.81
" A case is also provided that highlights the need for increased vigilance for neuropsychiatric sequelae in fragile epileptic patients prescribed levetiracetam, especially post dosage adjustment."( Levetiracetam and Suicidality: A Case Report and Literature Review.
Ahmed, S; Esang, M; Santos, MG, 2020
)
2.2
"To identify factors associated with low benzodiazepine (BZD) dosing in patients with refractory status epilepticus (RSE) and to assess the impact of BZD treatment variability on seizure cessation."( First-line medication dosing in pediatric refractory status epilepticus.
Abend, NS; Amengual-Gual, M; Anderson, A; Arya, R; Brenton, JN; Carpenter, JL; Chapman, K; Clark, J; Farias-Moeller, R; Gaillard, WD; Gaínza-Lein, M; Glauser, T; Goldstein, JL; Goodkin, HP; Guerriero, RM; Kapur, K; Lai, YC; Loddenkemper, T; McDonough, TL; Mikati, MA; Morgan, LA; Novotny, EJ; Ostendorf, AP; Payne, ET; Peariso, K; Piantino, J; Riviello, JJ; Sannagowdara, K; Tasker, RC; Tchapyjnikov, D; Topjian, A; Vasquez, A; Wainwright, MS; Wilfong, A; Williams, K, 2020
)
0.56
" We used logistic regression modeling to evaluate predictors of low BZD dosing and multivariate Cox regression analysis to assess the impact of low BZD dosing on time to seizure cessation."( First-line medication dosing in pediatric refractory status epilepticus.
Abend, NS; Amengual-Gual, M; Anderson, A; Arya, R; Brenton, JN; Carpenter, JL; Chapman, K; Clark, J; Farias-Moeller, R; Gaillard, WD; Gaínza-Lein, M; Glauser, T; Goldstein, JL; Goodkin, HP; Guerriero, RM; Kapur, K; Lai, YC; Loddenkemper, T; McDonough, TL; Mikati, MA; Morgan, LA; Novotny, EJ; Ostendorf, AP; Payne, ET; Peariso, K; Piantino, J; Riviello, JJ; Sannagowdara, K; Tasker, RC; Tchapyjnikov, D; Topjian, A; Vasquez, A; Wainwright, MS; Wilfong, A; Williams, K, 2020
)
0.56
" Low total BZD dosing was associated with decreased likelihood of Seizure cessation."( First-line medication dosing in pediatric refractory status epilepticus.
Abend, NS; Amengual-Gual, M; Anderson, A; Arya, R; Brenton, JN; Carpenter, JL; Chapman, K; Clark, J; Farias-Moeller, R; Gaillard, WD; Gaínza-Lein, M; Glauser, T; Goldstein, JL; Goodkin, HP; Guerriero, RM; Kapur, K; Lai, YC; Loddenkemper, T; McDonough, TL; Mikati, MA; Morgan, LA; Novotny, EJ; Ostendorf, AP; Payne, ET; Peariso, K; Piantino, J; Riviello, JJ; Sannagowdara, K; Tasker, RC; Tchapyjnikov, D; Topjian, A; Vasquez, A; Wainwright, MS; Wilfong, A; Williams, K, 2020
)
0.56
" The use of levetiracetam has been on the rise in the past several years due to its favorable safety profile in the face of limited data on its efficacy and optimal dosing regimens."( High-Dose Levetiracetam for Neonatal Seizures: A Retrospective Review.
Darwich, M; Hanneyan, S; Hnaini, M; Jaafar, F; Koleilat, N; Maalouf, FI; Mikati, IE; Nabout, R; Obeid, M; Rahal, S; Shbarou, RM, 2020
)
1.34
" Prospective studies are needed to confirm the promising role of such high dosing regimens, and to better elucidate the role of levetiracetam in neonatal seizures."( High-Dose Levetiracetam for Neonatal Seizures: A Retrospective Review.
Darwich, M; Hanneyan, S; Hnaini, M; Jaafar, F; Koleilat, N; Maalouf, FI; Mikati, IE; Nabout, R; Obeid, M; Rahal, S; Shbarou, RM, 2020
)
1.17
"The establishment of 3D-printing as manufacturing process for oral solid dosage forms enables new options for the individualized medicine."( 3D-Printing with precise layer-wise dose adjustments for paediatric use via pressure-assisted microsyringe printing.
Breitkreutz, J; El Aita, I; Quodbach, J; Rahman, J, 2020
)
0.56
" An additional aim was to evaluate the potential usefulness of the levetiracetam concentration measured as an index of a dosing schedule."( Hair as a matrix in monitoring drug epilepsy therapy.
Dermanowski, M; Kuczyńska, J; Mierzejewski, P; Zakrzewska, A, 2021
)
0.86
" It also reduced the dosage of levetiracetam and achieved better control of epilepsy compared to levetiracetam mono-treatment."( Effects of atorvastatin and aspirin on post-stroke epilepsy and usage of levetiracetam.
Ding, Y; Feng, X; Lin, W; Zhao, T; Zhou, C, 2020
)
1.08
"Atorvastatin and aspirin co-treatment with levetiracetam can reduce epilepsy in PSE patients and reduce the dosage of levetiracetam required for effective control of PSE."( Effects of atorvastatin and aspirin on post-stroke epilepsy and usage of levetiracetam.
Ding, Y; Feng, X; Lin, W; Zhao, T; Zhou, C, 2020
)
1.05
" Doses and dosing intervals were based on previous pharmacokinetic and tolerability studies in mice."( Systematic evaluation of rationally chosen multitargeted drug combinations: a combination of low doses of levetiracetam, atorvastatin and ceftriaxone exerts antiepileptogenic effects in a mouse model of acquired epilepsy.
Bergin, DH; Johne, M; Klein, P; Löscher, W; Schidlitzki, A; Twele, F; Welzel, L, 2021
)
0.83
" Logistic regression analysis showed that carbamazepine dosage had a statistically significant relationship with a decreasing rate of patient-recognized depression occurring during pregnancy and topiramate dosage with an increasing rate."( Antiepileptic drugs and depression during pregnancy in women with epilepsy.
Eadie, MJ; Graham, JE; Hitchcock, AA; Horgan, D; Lander, CM; Mitchell, J; O'Brien, TJ; Vajda, FJE, 2020
)
0.56
" Therefore, this systematic review aimed to summarize significant predictors for LEV pharmacokinetics as well as the need for dosage adjustments."( Population Pharmacokinetics of Levetiracetam: A Systematic Review.
Leelakanok, N; Methaneethorn, J, 2022
)
1.01
"This is a retrospective data analysis of 646 consecutive AED-naive patients aged 1-88 years treated with CBZ, LTG, or LEV between 2006 and 2012 with dosing adjustments permitted during the first 6 months."( Effectiveness at 24 Months of Single-Source Generic Carbamazepine, Lamotrigine, or Levetiracetam in Newly Diagnosed Focal Epilepsy.
Chayasirisobhon, S; Gurbani, A; Gurbani, S; Pietzsch, E; Spurgeon, B; Tovar, S, 2020
)
0.78
" A population pharmacokinetic approach can be used to explain this variability and optimize dosing schemes."( Predictive Performance of Population Pharmacokinetic Models of Levetiracetam in Children and Evaluation of Dosing Regimen.
Benaboud, S; Billette de Villemeur, T; Bouazza, N; Boujaafar, S; Chemaly, N; Chenevier-Gobeaux, C; Desguerre, I; Freihuber, C; Gana, I; Hirt, D; Lui, G; Nabbout, R; Tauzin, M; Tréluyer, JM; Zheng, Y, 2021
)
0.86
"Nineteen participants were grouped into three dosing ranges: (i) 5-15 mg/kg/12-hourly, (ii) 15-25 mg/kg/12-hourly and (iii) 25-35 mg/kg/12-hourly."( The Pharmacokinetics of Crushed Levetiracetam Tablets Administered to Neonates.
Abulfathi, AA; Bekker, A; Decloedt, EH; Kali, GTJ; Lloyd, LG; Pillay-Fuentes Lorente, V; Van der Merwe, AW, 2021
)
0.9
" After determining a cocaine dose-response curve (0."( Chronic levetiracetam (Keppra®) treatment increases the reinforcing strength of cocaine in rhesus monkeys.
Czoty, PW; Gould, RW; Nader, MA; O'Donovan, CA, 2021
)
1.06
" Furthermore, the serum levetiracetam concentration in patients with intraoperative seizures was below the 95% confidence interval (CI) of the regression line whereas the serum phenytoin concentration of two patients with seizures was within the 95% CI, indicating that evaluating the serum levetiracetam concentration against the BSA and eGFR-adjusted dosage may be useful in preventing intraoperative seizures during awake craniotomy by allowing prediction of the seizure risk and enabling more accurate dosage calibration."( Utility of monitoring the serum levetiracetam concentration for intraoperative seizure control during awake craniotomy.
Kawaguchi, K; Kikuchi, M; Kushihara, Y; Otani, R; Shinoura, N; Yamada, R, 2021
)
1.21
" Exposure to certain newer ASMs, such as lamotrigine and levetiracetam, does not thus far appear to impact certain aspects of neurodevelopment, but further delineation across the different neurodevelopmental domains and dosage levels is required."( Neurodevelopmental outcomes in children exposed to newer antiseizure medications: A systematic review.
Bromley, RL; Knight, R; Wittkowski, A, 2021
)
0.87
"The study was aimed to define appropriate levetiracetam dosing regimens from available published pharmacokinetics (PK) studies in critically ill patients with and without cirrhosis receiving continuous renal replacement therapy (CRRT) via Monte Carlo simulation (MCS)."( Levetiracetam dosing in patients receiving continuous renal replacement therapy.
Chaijamorn, W; Charoensareerat, T; Pattharachayakul, S; Phunpon, S; Rungkitwattanakul, D; Sathienluckana, T; Srisawat, N, 2021
)
2.33
"Our results showed the optimal levetiracetam dosing regimen of 750-1000 mg every 12 hours is recommended for adult patients receiving both CRRT modalities with two different effluent rates of 25 and 35 mL/kg/h."( Levetiracetam dosing in patients receiving continuous renal replacement therapy.
Chaijamorn, W; Charoensareerat, T; Pattharachayakul, S; Phunpon, S; Rungkitwattanakul, D; Sathienluckana, T; Srisawat, N, 2021
)
2.35
" Dosing adaptation in this vulnerable population should be concerned."( Levetiracetam dosing in patients receiving continuous renal replacement therapy.
Chaijamorn, W; Charoensareerat, T; Pattharachayakul, S; Phunpon, S; Rungkitwattanakul, D; Sathienluckana, T; Srisawat, N, 2021
)
2.06
" Similar dose-related responses were seen following the week-long dosing protocol for carbamazepine, phenobarbital, and phenytoin, and these responses were associated with drug levels that were in the human therapeutic range."( Chronic limbic epilepsy models for therapy discovery: Protocols to improve efficiency.
Bertram, EH; Edelbroek, P, 2021
)
0.62
" The time of maximal anticonvulsant effect and the dose-response relationship of the drugs were assessed."( Effects of new antiseizure drugs on seizure activity and anxiety-like behavior in adult zebrafish.
Doboszewska, U; Guz, L; Pieróg, M; Poleszak, E; Serefko, A; Socała, K; Szopa, A; Wlaź, P; Wyska, E, 2021
)
0.62
" The non-habitual seizures completely disappeared, and the frequency of the habitual seizures improved to the baseline level after the LEV dosage was reduced."( Seizure Deterioration with Increased Levetiracetam Blood Concentration during the Postpartum Period in Refractory Temporal Lobe Epilepsy.
Aoki, S; Iida, K; Kikumoto, M; Maruyama, H; Neshige, S; Shishido, T; Ueno, H, 2022
)
0.99
" The aim of this study was to compare the pharmacokinetic parameters of Bu after oral dosing between patients receiving phenytoin and those receiving levetiracetam prophylaxis."( Decreased Systemic Busulfan Exposure After Oral Dosing With Concomitant Levetiracetam Compared With Phenytoin.
Artul, T; Efrati, E; Henig, I; Kurnik, D; Lurie, Y; Nassar, L; Scherb, I; Yehudai-Ofir, D; Zuckerman, T, 2022
)
1.15
"In this study, we examined whether the pharmacokinetic profiles of sodium valproate (SVA), levetiracetam (LEV), and carbamazepine (CBZ) are affected by altering the dosing time of RACOL®-NF Semi Solid for Enteral Use (RASS), a prescribed semi-solid formula."( Effects of concurrent and staggered dosing of semi-solid enteral nutrients on pharmacokinetic behavior of antiepileptic drugs after oral administration in rats.
Fukuno, S; Hatsuda, Y; Iwanami, Y; Konishi, H; Myotoku, M; Nagai, K; Omotani, S; Ryuno, Y, 2021
)
0.84
"There was no difference in pharmacokinetic characteristics of SVA and LEV when the dosing time of RASS was altered."( Effects of concurrent and staggered dosing of semi-solid enteral nutrients on pharmacokinetic behavior of antiepileptic drugs after oral administration in rats.
Fukuno, S; Hatsuda, Y; Iwanami, Y; Konishi, H; Myotoku, M; Nagai, K; Omotani, S; Ryuno, Y, 2021
)
0.62
"We concluded that the pharmacokinetic profiles of CBZ, but not SVA and LEV, after its oral administration are affected by the dosing time of RASS, but staggered administration of CBZ and RASS prevented their interaction."( Effects of concurrent and staggered dosing of semi-solid enteral nutrients on pharmacokinetic behavior of antiepileptic drugs after oral administration in rats.
Fukuno, S; Hatsuda, Y; Iwanami, Y; Konishi, H; Myotoku, M; Nagai, K; Omotani, S; Ryuno, Y, 2021
)
0.62
" We therefore aimed to explore levetiracetam pharmacokinetics and to propose its optimal dosing in the paediatric population."( Levetiracetam pharmacokinetics and its covariates: proposal for optimal dosing in the paediatric population.
Pokorná, P; Šíma, M; Slanař, O; Švestková, N, 2023
)
2.64
" The trial confirmed that a single dose of 500-mg levetiracetam granules was bioequivalent to oral solution under a fasting condition, and may serve as a new dosage form of levetiracetam for clinical practice."( Bioequivalence and Safety of Levetiracetam Granules and Oral Solution: A Randomized, Single-Dose, 2-Period Crossover Study in Healthy Chinese Volunteers Under a Fasting Condition.
Fang, L; Hu, L; Jia, J; Jiang, F; Liu, S; Liu, Y; Long, J; Pu, H; Wang, Y; Xu, W; Yu, C; Zhang, KE; Zou, Y, 2022
)
1.27
"Swallowing oral solid dosage forms is challenging in patients with dysphagia who are at risk of aspiration or choking."( Do Thickening Agents Used in Dysphagia Diet Affect Drug Bioavailability?
Erdem, ÇE; Eroğlu, H; Eylem, CC; Gökmen-Özel, H; Ilgaz, F; Nemutlu, E; Timur, SS, 2022
)
0.72
" Additional research is needed to ensure that rapid administration of intravenous levetiracetam is as efficacious as the traditional dosing method."( The safety of rapid infusion levetiracetam: A systematic review.
Douville, A; Jense, A; Weiss, A, 2022
)
1.24
"This review aims to identify the optimal therapeutic dosage of anti-epileptic drugs in terms of efficacy and safety in patients with multiple comorbidities."( Individualizing doses of antiepileptic drugs.
Burchiani, B; Di Cara, G; Liparoti, G; Mencaroni, E; Tripodi, D; Verrotti, A, 2022
)
0.72
" The objectives of this study are to develop an ex-vivo in-vivo correlation (EVIVC) model to predict drug clearance for commonly used antiepileptics and to evaluate similarity in drug extraction across different CRRT modalities to extrapolate dosing recommendations."( Development and Use of an Ex-Vivo In-Vivo Correlation to Predict Antiepileptic Drug Clearance in Patients Undergoing Continuous Renal Replacement Therapy.
Armahizer, M; Badjatia, N; Gobburu, JV; Gopalakrishnan, M; Kalaria, SN; McCarthy, P, 2022
)
0.72
" This study has determined the influence of missed LEV doses on its pharmacokinetics and has explored the appropriate remedial dosage regimens."( Effect of Nonadherence on Levetiracetam Pharmacokinetics and Remedial Dose Recommendations Using Monte Carlo Simulations.
Methaneethorn, J, 2022
)
1.02
"Monte Carlo simulation was used to assess the impacts of different remedial dosage regimens on LEV concentrations."( Effect of Nonadherence on Levetiracetam Pharmacokinetics and Remedial Dose Recommendations Using Monte Carlo Simulations.
Methaneethorn, J, 2022
)
1.02
"The appropriate remedial dosage regimen for one and two consecutive missed doses of LEV have been proposed."( Effect of Nonadherence on Levetiracetam Pharmacokinetics and Remedial Dose Recommendations Using Monte Carlo Simulations.
Methaneethorn, J, 2022
)
1.02
"The scoping review identified 57 studies with most data available on their tolerability (68% local, 54% systemic), clinical effects (82%), details on dosage (96%) and routes of application (100%)."( Subcutaneous Drugs and Off-label Use in Hospice and Palliative Care: A Scoping Review.
Dürr, F; Jean-Petit-Matile, S; Kobleder, A; Meyer-Massetti, C; Wernli, U, 2022
)
0.72
"Although levetiracetam has been increasingly used as an alternative to phenytoin for early posttraumatic seizure prophylaxis following traumatic brain injury (TBI), an optimal dosing strategy has not been elucidated."( Evaluation of Levetiracetam Dosing Strategies for Seizure Prophylaxis Following Traumatic Brain Injury.
Kaleem, S; Komisarow, J; Kram, B; Lee, HJ; Ohman, K; Schultheis, J; Sigmon, J; Vatsaas, C; Yang, Z, 2023
)
1.69
" The primary outcome of this study was to evaluate three different dosing strategies of levetiracetam (≤ 1000 mg/day, 1500 mg/day, and ≥ 2000 mg/day) and associated rates of early posttraumatic seizures."( Evaluation of Levetiracetam Dosing Strategies for Seizure Prophylaxis Following Traumatic Brain Injury.
Kaleem, S; Komisarow, J; Kram, B; Lee, HJ; Ohman, K; Schultheis, J; Sigmon, J; Vatsaas, C; Yang, Z, 2023
)
1.49
"In conclusion, the results of this study demonstrate no statistically significant difference in the cumulative incidence of early posttraumatic seizures within 7 days of TBI between three different levetiracetam dosing strategies."( Evaluation of Levetiracetam Dosing Strategies for Seizure Prophylaxis Following Traumatic Brain Injury.
Kaleem, S; Komisarow, J; Kram, B; Lee, HJ; Ohman, K; Schultheis, J; Sigmon, J; Vatsaas, C; Yang, Z, 2023
)
1.46
" This study aimed to establish a population pharmacokinetic model of LEV in women with epilepsy (WWE) during pregnancy to analyse the factors of pharmacokinetic variability and to develop a model-based individualized dosing regimen."( Population pharmacokinetics and dosing regimen optimization of levetiracetam in epilepsy during pregnancy.
Cao, YF; Guo, Y; Li, Y; Wang, ML; Zhao, LM; Zhao, MM, 2023
)
1.15
" The dosing regimen was optimized by Monte Carlo simulations based on the final model."( Population pharmacokinetics and dosing regimen optimization of levetiracetam in epilepsy during pregnancy.
Cao, YF; Guo, Y; Li, Y; Wang, ML; Zhao, LM; Zhao, MM, 2023
)
1.15
" Monte Carlo simulations showed that dosing regimens for LEV should be individualized based on the patient's TBW and trimester of pregnancy to maximize the likelihood of achieving the therapeutic range."( Population pharmacokinetics and dosing regimen optimization of levetiracetam in epilepsy during pregnancy.
Cao, YF; Guo, Y; Li, Y; Wang, ML; Zhao, LM; Zhao, MM, 2023
)
1.15
"This first population pharmacokinetic study of LEV in WWE during pregnancy supports the use of a weight-based and pregnancy-based dosing regimen and can lay a foundation for further optimizing the individualized dosing regimens."( Population pharmacokinetics and dosing regimen optimization of levetiracetam in epilepsy during pregnancy.
Cao, YF; Guo, Y; Li, Y; Wang, ML; Zhao, LM; Zhao, MM, 2023
)
1.15
" Dosing studies with newer generation ASMs are needed to understand which treatments are the best in the older adults with different comorbidities."( Management of epilepsy in older adults: A critical review by the ILAE Task Force on Epilepsy in the elderly.
Akamatsu, N; Beghi, E; Costa, C; Cretin, B; Dhakar, MB; DiFrancesco, JC; Faught, E; Giussani, G; Krämer, G; Kwan, P; Leppik, I; O'Dwyer, R; Piccenna, L, 2023
)
0.91
" The levetiracetam PBPK model for pregnancy was successfully developed and validated, and could provide alternative levetiracetam dosing regimens across the stages of pregnancy."( Application of PBPK modeling in predicting maternal and fetal pharmacokinetics of levetiracetam during pregnancy.
Chen, J; Guo, G; Huang, P; Ke, M; Lin, C; Lin, R; Wu, W; You, X, 2023
)
1.65
" More prospective clinical trials with a larger population are needed to validate the optimal dosing of LEV for BIS prophylaxis in patients undergoing HSCT."( Optimal regimen of levetiracetam for prevention of busulfan-induced seizure in patients undergoing hematopoietic stem cell transplantation: A review of available evidence.
Hadjibabaie, M; Honarmand, H; Kiumarsi, A; Rostami, T; Shahrami, B; Tavajohi, R, 2023
)
1.24
" We aim to characterize the optimal levetiracetam dosage for seizure prophylaxis."( Levetiracetam dosing for seizure prophylaxis in neurocritical care patients.
Ansari, S; Davis, GE; Findlay, MC; Hawryluk, GWJ; Hedges, A; Menacho, ST; Wolfe, BM, 2023
)
2.63
"Patients may experience a reduced incidence of clinical and electroencephalographic seizures with levetiracetam dosing >1000-mg TDD."( Levetiracetam dosing for seizure prophylaxis in neurocritical care patients.
Ansari, S; Davis, GE; Findlay, MC; Hawryluk, GWJ; Hedges, A; Menacho, ST; Wolfe, BM, 2023
)
2.57
" Our comparative analysis suggests DOAC plasma concentration monitoring as a possible strategy to guide dosing owing to the predictable correlation between DOACs' plasma concentration and effect."( Interactions Between Direct Oral Anticoagulants (DOACs) and Antiseizure Medications: Potential Implications on DOAC Treatment.
Bialer, M; Goldstein, R; Gronich, N; Jacobs, AR; Muszkat, M; Zighan, L, 2023
)
0.91
" Thus, dosage adjustment is required."( Physiologically based pharmacokinetic modeling of levetiracetam to predict the exposure in hepatic and renal impairment and elderly populations.
Geng, K; Shao, W; Shen, C; Sun, H; Wang, W; Wang, X; Xie, H, 2023
)
1.16
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
anticonvulsantA drug used to prevent seizures or reduce their severity.
environmental contaminantAny minor or unwanted substance introduced into the environment that can have undesired effects.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
pyrrolidin-2-onesA pyrrolidinone in which the oxo group is at position 2 of the pyrrolidine ring.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (9)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
chaperonin-containing TCP-1 beta subunit homologHomo sapiens (human)Potency19.95263.981127.764939.8107AID504842
EWS/FLI fusion proteinHomo sapiens (human)Potency24.91780.001310.157742.8575AID1259255; AID1259256
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency3.16230.035520.977089.1251AID504332
flap endonuclease 1Homo sapiens (human)Potency37.68580.133725.412989.1251AID588795
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)566.50000.11007.190310.0000AID1449628; AID1473738
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (41)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (24)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (17)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (162)

Assay IDTitleYearJournalArticle
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID679128TP_TRANSPORTER: transcellular transport in MDR1-expressing LLC-PK1 cells2007Neuropharmacology, Feb, Volume: 52, Issue:2
Differences in the transport of the antiepileptic drugs phenytoin, levetiracetam and carbamazepine by human and mouse P-glycoprotein.
AID1269443Anticonvulsant activity in ip dosed Swiss mouse assessed as protection against maximal electroshock-induced seizures at 1 hr2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
New hybrid molecules with anticonvulsant and antinociceptive activity derived from 3-methyl- or 3,3-dimethyl-1-[1-oxo-1-(4-phenylpiperazin-1-yl)propan-2-yl]pyrrolidine-2,5-diones.
AID1229809Anticonvulsant activity in ip dosed Swiss mouse assessed as protection against seizures measured at 1 hr of time to peak effect by maximal electroshock test2015Journal of medicinal chemistry, Jul-09, Volume: 58, Issue:13
Design, synthesis, and anticonvulsant activity of new hybrid compounds derived from 2-(2,5-dioxopyrrolidin-1-yl)propanamides and 2-(2,5-dioxopyrrolidin-1-yl)butanamides.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1432537Protection index, ratio of TD50 for motor impairment in ip dosed albino CD1 mouse to ED50 for protection against 32 mA current-induced seizure in ip dosed albino CD1 mouse by 6 Hz psychomotor test2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Synthesis and evaluation of anticonvulsant properties of new N-Mannich bases derived from pyrrolidine-2,5-dione and its 3-methyl-, 3-isopropyl, and 3-benzhydryl analogs.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1864057Cytotoxicity against human HepG2 cells assessed as cell viability at 100 uM measured for 72 hrs
AID1304291Acute neurotoxicity in albino Swiss mouse pretreated for 2 hrs by rotorod test2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Design, synthesis and anticonvulsant activity of new hybrid compounds derived from N-phenyl-2-(2,5-dioxopyrrolidin-1-yl)-propanamides and -butanamides.
AID1378591Anticonvulsant activity in ip dosed CF1 mouse assessed as protection against 44 mA current-induced seizure after 15 mins by 6 Hz psychomotor test2017Journal of natural products, 08-25, Volume: 80, Issue:8
Modulating the Serotonin Receptor Spectrum of Pulicatin Natural Products.
AID780685Anticonvulsant activity in ip dosed albino mouse assessed as protection against 6 Hz psychomotor seizure by minimal clonic seizure test2013Bioorganic & medicinal chemistry letters, Nov-15, Volume: 23, Issue:22
Structure-activity relationships of the aromatic site in novel anticonvulsant pyrrolo[1,2-a]pyrazine derivatives.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID683983Protective index, ratio of TD50 for CF-1 albino mouse to ED50 for CF-1 albino mouse assessed as protection from 6 Hz psychomotor seizure2012Bioorganic & medicinal chemistry, Aug-01, Volume: 20, Issue:15
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 3-(2-fluorophenyl)- and 3-(2-bromophenyl)-pyrrolidine-2,5-diones. Part II.
AID1452162Anticonvulsant activity in Albino Swiss CD-1 mouse assessed as protection against maximal electroshock-induced seizures by measuring time to peak effect at 100 mg/kg, ip pretreated up to 2 hrs followed by 50 Hz current induction for 2 secs
AID1863980Anti-seizure activity against electrical stimulus induced seizure in ip dosed CD-1 mouse model assessed as normal behavior within 10 seconds after stimulation at 6 Hz and 32 mA for 3 secs pretreated for 1 hr by psychomotor seizure test
AID1269474Anticonvulsant activity in ip dosed Swiss mouse assessed as reduction in clonic seizures at 1 hr by subcutaneous pentylenetetrazole seizure test2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
New hybrid molecules with anticonvulsant and antinociceptive activity derived from 3-methyl- or 3,3-dimethyl-1-[1-oxo-1-(4-phenylpiperazin-1-yl)propan-2-yl]pyrrolidine-2,5-diones.
AID322671Antihyperalgesic activity in Sprague-Dawley rat assessed as lesioned paw pressure threshold at 500 ug/kg, icv after 45 mins2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
Synthesis and biological evaluation of novel dimiracetam derivatives useful for the treatment of neuropathic pain.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID1863986Toxicity in CD-1 seizure mouse model assessed as effect on motor coordination administered ip measured after 1 hrs for 3 mins by rotarod test
AID780686Neurotoxicity in ip dosed albino mouse minimal clonic seizure model assessed as minimal motor impairment by rotorod test2013Bioorganic & medicinal chemistry letters, Nov-15, Volume: 23, Issue:22
Structure-activity relationships of the aromatic site in novel anticonvulsant pyrrolo[1,2-a]pyrazine derivatives.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1432518Anticonvulsant activity in ip dosed albino CD1 mouse assessed as protection against 32 mA current-induced seizure by 6 Hz psychomotor test2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Synthesis and evaluation of anticonvulsant properties of new N-Mannich bases derived from pyrrolidine-2,5-dione and its 3-methyl-, 3-isopropyl, and 3-benzhydryl analogs.
AID1304294Protective index, ratio of TD50 for acute neurotoxicity in albino Swiss mouse to ED50 for anticonvulsant activity in albino Swiss mouse by 6Hz psychomotor seizure test2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Design, synthesis and anticonvulsant activity of new hybrid compounds derived from N-phenyl-2-(2,5-dioxopyrrolidin-1-yl)-propanamides and -butanamides.
AID1452170Neurotoxicity in ip dosed Albino Swiss CD-1 mouse assessed as induction of motor impairment measured up to 60 secs by chimney test
AID623232Anticonvulsant activity in CF1 albino mouse assessed as time to peak effect at 100 mg/kg, ip2011Bioorganic & medicinal chemistry, Oct-15, Volume: 19, Issue:20
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 5-cyclopropyl-5-phenyl- and 5-cyclopropyl-5-(4-chlorophenyl)-imidazolidine-2,4-diones.
AID1452159Anticonvulsant activity in ip dosed Albino Swiss CD-1 mouse assessed as protection against maximal electroshock-induced seizures pretreated up to 2 hrs followed by 50 Hz current induction for 2 secs measured at time to peak effect
AID1304288Anticonvulsant activity in albino Swiss mouse by maximal electroshock seizure test2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Design, synthesis and anticonvulsant activity of new hybrid compounds derived from N-phenyl-2-(2,5-dioxopyrrolidin-1-yl)-propanamides and -butanamides.
AID1285362Protection index, ratio of TD50 for CD1 albino mouse to ED50 for protection against 32 mA-current- for 3 secs induced seizure in CD1 albino mouse by 6Hz psychomotor seizure test2016Bioorganic & medicinal chemistry, Apr-15, Volume: 24, Issue:8
Synthesis, and anticonvulsant activity of new amides derived from 3-methyl- or 3-ethyl-3-methyl-2,5-dioxo-pyrrolidin-1-yl-acetic acids.
AID626719Anticonvulsant activity in ip dosed albino Carworth Farms No.1 mouse assessed as protection against electric-current for 3 secs-induced seizure after 0.25 hrs by 6Hz minimal clonic seizure test2011European journal of medicinal chemistry, Oct, Volume: 46, Issue:10
Synthesis and anticonvulsant activity of novel 2,6-diketopiperazine derivatives. Part 1: perhydropyrrole[1,2-a]pyrazines.
AID1161074Neurotoxicity in ip dosed 6 Hz current-induced seizure albino CF1 mouse model2014Bioorganic & medicinal chemistry, Oct-01, Volume: 22, Issue:19
Novel fluorinated pyrrolo[1,2-a]pyrazine-2,6-dione derivatives: synthesis and anticonvulsant evaluation in animal models of epilepsy.
AID1304287Anticonvulsant activity against albino Swiss mouse seizure model assessed as time to peak effect at 100 mg/kg, ip2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Design, synthesis and anticonvulsant activity of new hybrid compounds derived from N-phenyl-2-(2,5-dioxopyrrolidin-1-yl)-propanamides and -butanamides.
AID1285388Anticonvulsant activity in ip dosed CD1 albino mouse assessed as time to peak effect by 6Hz psychomotor seizure test2016Bioorganic & medicinal chemistry, Apr-15, Volume: 24, Issue:8
Synthesis, and anticonvulsant activity of new amides derived from 3-methyl- or 3-ethyl-3-methyl-2,5-dioxo-pyrrolidin-1-yl-acetic acids.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1304289Anticonvulsant activity in albino Swiss mouse measured after 30 mins by subcutaneous pentylenetetrazole seizure test2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Design, synthesis and anticonvulsant activity of new hybrid compounds derived from N-phenyl-2-(2,5-dioxopyrrolidin-1-yl)-propanamides and -butanamides.
AID626720Protective index, ratio of TD50 for albino Carworth Farms No.1 mouse to ED50 for albino Carworth Farms No.1 mouse by 6Hz minimal clonic seizure test2011European journal of medicinal chemistry, Oct, Volume: 46, Issue:10
Synthesis and anticonvulsant activity of novel 2,6-diketopiperazine derivatives. Part 1: perhydropyrrole[1,2-a]pyrazines.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1863983Antiseizure activity against ScPTZ-induced seizure in ip dosed CD-1 mouse model assessed as clonic seizures pretreated for 1 hr and measured after 30 mins by subcutaneous pentylenetetrazole test
AID1161077Anticonvulsant activity in ip dosed albino CF1 mouse assessed as protection against 6 Hz current-induced seizures measured as time to peak effect2014Bioorganic & medicinal chemistry, Oct-01, Volume: 22, Issue:19
Novel fluorinated pyrrolo[1,2-a]pyrazine-2,6-dione derivatives: synthesis and anticonvulsant evaluation in animal models of epilepsy.
AID1161075Protective index, ratio of TD50 for neurotoxicity in ip dosed albino CF1 mouse to ED50 for anticonvulsant activity in ip dosed 6 Hz current-induced seizure albino CF1 mouse model2014Bioorganic & medicinal chemistry, Oct-01, Volume: 22, Issue:19
Novel fluorinated pyrrolo[1,2-a]pyrazine-2,6-dione derivatives: synthesis and anticonvulsant evaluation in animal models of epilepsy.
AID778990Anticonvulsant activity against 6 Hz psychomotor seizure in ip dosed albino CF1 mouse assessed as time to peak effect by minimal clonic seizure test2013Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21
Design, synthesis and anticonvulsant properties of new N-Mannich bases derived from 3-phenylpyrrolidine-2,5-diones.
AID778988Anticonvulsant activity against 6 Hz psychomotor seizure in ip dosed albino CF1 mouse by minimal clonic seizure test2013Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21
Design, synthesis and anticonvulsant properties of new N-Mannich bases derived from 3-phenylpyrrolidine-2,5-diones.
AID679123TP_TRANSPORTER: transcellular transport in mdr1a-expressing LLC-PK1 cells2007Neuropharmacology, Feb, Volume: 52, Issue:2
Differences in the transport of the antiepileptic drugs phenytoin, levetiracetam and carbamazepine by human and mouse P-glycoprotein.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID679460TP_TRANSPORTER: transcellular transport in MDR1-expressing MDCKII cells2007Neuropharmacology, Feb, Volume: 52, Issue:2
Differences in the transport of the antiepileptic drugs phenytoin, levetiracetam and carbamazepine by human and mouse P-glycoprotein.
AID1863992Protective index, ratio of TD50 for toxicity in CD-1 seizure mouse model assessed as effect on motor coordination administered ip measured after 0.5 hrs for 3 mins by rotarod test to ED50 for antiseizure activity against electrical stimulus induced seizur
AID623233Anticonvulsant activity in ip dosed CF1 albino mouse assessed as protection against electrically-induced seizure by 6Hz psychomotor seizure test2011Bioorganic & medicinal chemistry, Oct-15, Volume: 19, Issue:20
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 5-cyclopropyl-5-phenyl- and 5-cyclopropyl-5-(4-chlorophenyl)-imidazolidine-2,4-diones.
AID679137TP_TRANSPORTER: transcellular transport in mdr1b-expressing LLC-PK1 cells2007Neuropharmacology, Feb, Volume: 52, Issue:2
Differences in the transport of the antiepileptic drugs phenytoin, levetiracetam and carbamazepine by human and mouse P-glycoprotein.
AID322670Antihyperalgesic activity in Sprague-Dawley rat assessed as lesioned paw pressure threshold at 500 ug/kg, icv after 30 mins2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
Synthesis and biological evaluation of novel dimiracetam derivatives useful for the treatment of neuropathic pain.
AID1229815Protective index, ratio of neurotoxic TD50 in Swiss mouse by by Chimney test to anticonvulsant ED50 in Swiss mouse measured at 1 hr of time to peak effect by 6 Hz test by 6 Hz psychomotor seizure test2015Journal of medicinal chemistry, Jul-09, Volume: 58, Issue:13
Design, synthesis, and anticonvulsant activity of new hybrid compounds derived from 2-(2,5-dioxopyrrolidin-1-yl)propanamides and 2-(2,5-dioxopyrrolidin-1-yl)butanamides.
AID1229812Toxicity in ip dosed Swiss mouse assessed as induction of motor performance impairment measured within 60 seconds measured at 1 hr of time to peak effect by Chimney test2015Journal of medicinal chemistry, Jul-09, Volume: 58, Issue:13
Design, synthesis, and anticonvulsant activity of new hybrid compounds derived from 2-(2,5-dioxopyrrolidin-1-yl)propanamides and 2-(2,5-dioxopyrrolidin-1-yl)butanamides.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1269476Neurotoxicity in ip dosed Swiss mouse seizure model assessed as motor impairment pretreated for 1 hr measured within 60 s by chimney test2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
New hybrid molecules with anticonvulsant and antinociceptive activity derived from 3-methyl- or 3,3-dimethyl-1-[1-oxo-1-(4-phenylpiperazin-1-yl)propan-2-yl]pyrrolidine-2,5-diones.
AID683982Anticonvulsant activity in ip dosed CF-1 albino mouse assessed as protection against 6 Hz psychomotor seizures2012Bioorganic & medicinal chemistry, Aug-01, Volume: 20, Issue:15
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 3-(2-fluorophenyl)- and 3-(2-bromophenyl)-pyrrolidine-2,5-diones. Part II.
AID778985Protection index, ratio of TD50 for neurotoxicity in ip dosed albino CF1 mouse by rotorod test to ED50 for anticonvulsant activity in ip dosed albino CF1 mouse by 6 Hz psychomotor seizure test2013Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21
Design, synthesis and anticonvulsant properties of new N-Mannich bases derived from 3-phenylpyrrolidine-2,5-diones.
AID643395Anticonvulsant activity in electric shock-induced Carworth farms No.1 albino mouse assessed as time of peak effect2012European journal of medicinal chemistry, Feb, Volume: 48Synthesis and anticonvulsant activity of novel 2,6-diketopiperazine derivatives. Part 2: Perhydropyrido[1,2-a]pyrazines.
AID1711721Anti-convulsant activity in ip dosed mouse assessed as protection against psychomotor seizures measured after 1 hr by 6 Hz limbic seizure test2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
Synthesis and evaluation of anticonvulsant properties of new N-Mannich bases derived from 3-(1-phenylethyl)- and 3-benzyl-pyrrolidine-2,5-dione.
AID626721Anticonvulsant activity in ip dosed albino Carworth Farms No.1 mouse assessed as time needs to show peak effect for electric-current for 3 secs-induced seizure after 0.25 hrs by 6Hz minimal clonic seizure test2011European journal of medicinal chemistry, Oct, Volume: 46, Issue:10
Synthesis and anticonvulsant activity of novel 2,6-diketopiperazine derivatives. Part 1: perhydropyrrole[1,2-a]pyrazines.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1378589Anticonvulsant activity in ip dosed CF1 mouse assessed as protection against 32 mA current-induced seizure after 15 mins by 6 Hz psychomotor test2017Journal of natural products, 08-25, Volume: 80, Issue:8
Modulating the Serotonin Receptor Spectrum of Pulicatin Natural Products.
AID626716Neurotoxicity in ip dosed albino Carworth Farms No.1 mouse assessed as motor impairment after 0.25 hrs by rotarod test2011European journal of medicinal chemistry, Oct, Volume: 46, Issue:10
Synthesis and anticonvulsant activity of novel 2,6-diketopiperazine derivatives. Part 1: perhydropyrrole[1,2-a]pyrazines.
AID539470Solubility of the compound in water2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID1863977Antiseizure activity against electrical stimulus induced seizure in ip dosed CD-1 mouse model assessed as reduction in hindlimb tonic extension pretreated for 1 hr by maximal electroshock seizure test
AID623234Neurotoxicity in ip dosed CF1 albino mouse assessed as impair in motor coordination by rotarod test2011Bioorganic & medicinal chemistry, Oct-15, Volume: 19, Issue:20
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 5-cyclopropyl-5-phenyl- and 5-cyclopropyl-5-(4-chlorophenyl)-imidazolidine-2,4-diones.
AID780692Protective index, ratio of TD50 for albino mouse minimal clonic seizure model to ED50 for albino mouse assessed as protection against 6 Hz psychomotor seizure2013Bioorganic & medicinal chemistry letters, Nov-15, Volume: 23, Issue:22
Structure-activity relationships of the aromatic site in novel anticonvulsant pyrrolo[1,2-a]pyrazine derivatives.
AID1229810Anticonvulsant activity in ip dosed Swiss mouse assessed as protection against seizures measured at 1 hr of time to peak effect by subcutaneous pentylenetetrazole seizure test2015Journal of medicinal chemistry, Jul-09, Volume: 58, Issue:13
Design, synthesis, and anticonvulsant activity of new hybrid compounds derived from 2-(2,5-dioxopyrrolidin-1-yl)propanamides and 2-(2,5-dioxopyrrolidin-1-yl)butanamides.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1161078Anticonvulsant activity in ip dosed corneal kindled albino CF1 mouse seizure model2014Bioorganic & medicinal chemistry, Oct-01, Volume: 22, Issue:19
Novel fluorinated pyrrolo[1,2-a]pyrazine-2,6-dione derivatives: synthesis and anticonvulsant evaluation in animal models of epilepsy.
AID1285361Anticonvulsant activity in ip dosed CD1 albino mouse assessed as protection against 32 mA-current- for 3 secs induced seizure by 6Hz psychomotor seizure test2016Bioorganic & medicinal chemistry, Apr-15, Volume: 24, Issue:8
Synthesis, and anticonvulsant activity of new amides derived from 3-methyl- or 3-ethyl-3-methyl-2,5-dioxo-pyrrolidin-1-yl-acetic acids.
AID1452171Protection index, ratio of TD50 for neurotoxicity in ip dosed Albino Swiss CD-1 mouse to ED50 for ip dosed Albino Swiss CD-1 mouse model of 6 Hz-induced siezures
AID717844Inhibition of mouse Ido2 transfected in HEK293T cells using L-tryptophan as substrate assessed as kynurenine formation at 20 uM after 45 mins by spectrophotometric analysis relative to control2012Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24
Identification of selective inhibitors of indoleamine 2,3-dioxygenase 2.
AID471572Anticonvulsant activity against bicuculline-induced seizure in ip dosed CF1 mouse after 0.25 hrs2009Journal of medicinal chemistry, Dec-10, Volume: 52, Issue:23
Novel, broad-spectrum anticonvulsants containing a sulfamide group: advancement of N-((benzo[b]thien-3-yl)methyl)sulfamide (JNJ-26990990) into human clinical studies.
AID1304290Anticonvulsant activity in albino Swiss mouse assessed as protection against electrically-induced seizure by 6Hz psychomotor seizure test2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Design, synthesis and anticonvulsant activity of new hybrid compounds derived from N-phenyl-2-(2,5-dioxopyrrolidin-1-yl)-propanamides and -butanamides.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1285358Neurotoxicity in ip dosed CD1 albino mouse assessed as acute motor impairment by rotarod test2016Bioorganic & medicinal chemistry, Apr-15, Volume: 24, Issue:8
Synthesis, and anticonvulsant activity of new amides derived from 3-methyl- or 3-ethyl-3-methyl-2,5-dioxo-pyrrolidin-1-yl-acetic acids.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID113200In vivo dose required to protect 50% audiogenic seizure prone mice against clonic convulsions; value ranges from 143 to 2832004Journal of medicinal chemistry, Jan-29, Volume: 47, Issue:3
Discovery of 4-substituted pyrrolidone butanamides as new agents with significant antiepileptic activity.
AID1229811Anticonvulsant activity in ip dosed Swiss mouse assessed as protection against seizures measured at 1 hr of time to peak effect by 6 Hz test by 6 Hz psychomotor seizure test2015Journal of medicinal chemistry, Jul-09, Volume: 58, Issue:13
Design, synthesis, and anticonvulsant activity of new hybrid compounds derived from 2-(2,5-dioxopyrrolidin-1-yl)propanamides and 2-(2,5-dioxopyrrolidin-1-yl)butanamides.
AID780693Anticonvulsant activity in ip dosed albino mouse assessed as time of peak effect for protection against 6 Hz psychomotor seizure by minimal clonic seizure test2013Bioorganic & medicinal chemistry letters, Nov-15, Volume: 23, Issue:22
Structure-activity relationships of the aromatic site in novel anticonvulsant pyrrolo[1,2-a]pyrazine derivatives.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1863998Antiseizure activity against electrical stimulus induced seizure in ip dosed CD-1 mouse model assessed as normal behavior within 10 seconds after stimulation at 6 Hz and 44 mA for 3 secs pretreated for 1 hr by psychomotor seizure test
AID1432534Neurotoxicity in ip dosed albino CD1 mouse assessed as motor impairment by rotarod test2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Synthesis and evaluation of anticonvulsant properties of new N-Mannich bases derived from pyrrolidine-2,5-dione and its 3-methyl-, 3-isopropyl, and 3-benzhydryl analogs.
AID1269479Protective index, ratio of TD50 for neurotoxicity in ip dosed Swiss mouse to ED50 for anticonvulsant activity in ip dosed Swiss mouse 6 Hz psychomotor seizure model at 1 hr2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
New hybrid molecules with anticonvulsant and antinociceptive activity derived from 3-methyl- or 3,3-dimethyl-1-[1-oxo-1-(4-phenylpiperazin-1-yl)propan-2-yl]pyrrolidine-2,5-diones.
AID643350Anticonvulsant activity in ip dosed Carworth farms No.1 albino mouse assessed as protection against 6 Hz electric current-induced seizure measured after 0.25 hrs2012European journal of medicinal chemistry, Feb, Volume: 48Synthesis and anticonvulsant activity of novel 2,6-diketopiperazine derivatives. Part 2: Perhydropyrido[1,2-a]pyrazines.
AID1269473Anticonvulsant activity against ip dosed Swiss mouse seizure model assessed as protection at 1 hr by 6 Hz psychomotor seizure test2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
New hybrid molecules with anticonvulsant and antinociceptive activity derived from 3-methyl- or 3,3-dimethyl-1-[1-oxo-1-(4-phenylpiperazin-1-yl)propan-2-yl]pyrrolidine-2,5-diones.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1173470Anticonvulsant activity against ip dosed CF1 albino mouse seizure model after 4 hrs by 6 Hz psychomotor seizure test2014Bioorganic & medicinal chemistry letters, Dec-01, Volume: 24, Issue:23
Seizure prevention by the naturally occurring phenols, carvacrol and thymol in a partial seizure-psychomotor model.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID623235Protective index, ratio of TD50 for neurotoxicity in CF1 albino mouse to ED50 for inhibition of 6Hz electric shock-induced seizures in CF1 albino mouse2011Bioorganic & medicinal chemistry, Oct-15, Volume: 19, Issue:20
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 5-cyclopropyl-5-phenyl- and 5-cyclopropyl-5-(4-chlorophenyl)-imidazolidine-2,4-diones.
AID1649358Anti-seizure activity in ip dosed CF1 mouse assessed as attenuation of psychomotor seizures at stimulus intensities of 42 mA at pre-treated at 1 hr before test by 6 Hz limbic seizure test relative to control
AID683969Neurotoxicity in ip dosed CF-1 albino mouse assessed as motor impairment by rotarod test2012Bioorganic & medicinal chemistry, Aug-01, Volume: 20, Issue:15
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 3-(2-fluorophenyl)- and 3-(2-bromophenyl)-pyrrolidine-2,5-diones. Part II.
AID1711722Neurotoxicity activity in ip dosed mouse assessed as induction of motor impairment by rotarod test2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
Synthesis and evaluation of anticonvulsant properties of new N-Mannich bases derived from 3-(1-phenylethyl)- and 3-benzyl-pyrrolidine-2,5-dione.
AID1452168Anticonvulsant activity in ip dosed Albino Swiss CD-1 mouse assessed as protection against 32 mA current-induced seizure treated up to 2 hrs prior to 6-Hz current induction measured at time to peak effect
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID322672Antihyperalgesic activity in Sprague-Dawley rat assessed as lesioned paw pressure threshold at 500 ug/kg, icv after 60 mins2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
Synthesis and biological evaluation of novel dimiracetam derivatives useful for the treatment of neuropathic pain.
AID778984Neurotoxicity in ip dosed albino CF1 mouse by rotorod test2013Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21
Design, synthesis and anticonvulsant properties of new N-Mannich bases derived from 3-phenylpyrrolidine-2,5-diones.
AID1649367Toxicity in CF1 mouse assessed as induction of motor impairment during acute (1 hr) observation period by rotarod assay
AID102959In vitro inhibitory activity against [3H](2S)-2-[4-(3-azidophenyl)-2-oxopyrrolidin-1-yl]butanamide binding to levetiracetam binding site2004Journal of medicinal chemistry, Jan-29, Volume: 47, Issue:3
Discovery of 4-substituted pyrrolidone butanamides as new agents with significant antiepileptic activity.
AID1711736Protection index, ratio of TD50 for neurotoxicity in ip dosed mouse to ED50 for anticonvulsant activity in ip dosed mouse measured after 1 hr by 6 Hz limbic seizure test2016Bioorganic & medicinal chemistry letters, May-01, Volume: 26, Issue:9
Synthesis and evaluation of anticonvulsant properties of new N-Mannich bases derived from 3-(1-phenylethyl)- and 3-benzyl-pyrrolidine-2,5-dione.
AID1161079Anticonvulsant activity in ip dosed corneal kindled albino CF1 mouse seizure model assessed as time to peak effect2014Bioorganic & medicinal chemistry, Oct-01, Volume: 22, Issue:19
Novel fluorinated pyrrolo[1,2-a]pyrazine-2,6-dione derivatives: synthesis and anticonvulsant evaluation in animal models of epilepsy.
AID1432538Anticonvulsant in ip dosed CD1 mouse assessed as time to peak effect2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Synthesis and evaluation of anticonvulsant properties of new N-Mannich bases derived from pyrrolidine-2,5-dione and its 3-methyl-, 3-isopropyl, and 3-benzhydryl analogs.
AID683984Anticonvulsant activity in ip dosed 6 Hz psychomotor-induced seizure in CF-1 albino mouse assessed as time of peak effect2012Bioorganic & medicinal chemistry, Aug-01, Volume: 20, Issue:15
Synthesis and anticonvulsant activity of new N-Mannich bases derived from 3-(2-fluorophenyl)- and 3-(2-bromophenyl)-pyrrolidine-2,5-diones. Part II.
AID778986Neurotoxicity in ip dosed albino CF1 mouse assessed as time to peak effect by rotorod test2013Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21
Design, synthesis and anticonvulsant properties of new N-Mannich bases derived from 3-phenylpyrrolidine-2,5-diones.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1161071Anticonvulsant activity in ip dosed albino CF1 mouse assessed as protection against 6 Hz current-induced seizures2014Bioorganic & medicinal chemistry, Oct-01, Volume: 22, Issue:19
Novel fluorinated pyrrolo[1,2-a]pyrazine-2,6-dione derivatives: synthesis and anticonvulsant evaluation in animal models of epilepsy.
AID1173473Protective index, ratio of TD50 for CF1 albino mouse neurotoxicity to ED50 for protection against 6 Hz electroshock-induced seizure in CF1 albino mouse2014Bioorganic & medicinal chemistry letters, Dec-01, Volume: 24, Issue:23
Seizure prevention by the naturally occurring phenols, carvacrol and thymol in a partial seizure-psychomotor model.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID679302TP_TRANSPORTER: transcellular transport in MRP2-expressing MDCKII cells2007Neuropharmacology, Feb, Volume: 52, Issue:2
Differences in the transport of the antiepileptic drugs phenytoin, levetiracetam and carbamazepine by human and mouse P-glycoprotein.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1346078Rat synaptic vesicle glycoprotein 2A (Atypical major facilitator superfamily (MSF) proteins)2004Journal of medicinal chemistry, Jan-29, Volume: 47, Issue:3
Discovery of 4-substituted pyrrolidone butanamides as new agents with significant antiepileptic activity.
AID1346078Rat synaptic vesicle glycoprotein 2A (Atypical major facilitator superfamily (MSF) proteins)1995European journal of pharmacology, Nov-14, Volume: 286, Issue:2
The novel antiepileptic drug levetiracetam (ucb L059) appears to act via a specific binding site in CNS membranes.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).2014Journal of biomolecular screening, Jul, Volume: 19, Issue:6
A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,706)

TimeframeStudies, This Drug (%)All Drugs %
pre-19906 (0.22)18.7374
1990's20 (0.74)18.2507
2000's737 (27.24)29.6817
2010's1288 (47.60)24.3611
2020's655 (24.21)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 121.47

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index121.47 (24.57)
Research Supply Index8.09 (2.92)
Research Growth Index6.21 (4.65)
Search Engine Demand Index226.90 (26.88)
Search Engine Supply Index2.01 (0.95)

This Compound (121.47)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials417 (14.61%)5.53%
Reviews362 (12.68%)6.00%
Case Studies585 (20.50%)4.05%
Observational84 (2.94%)0.25%
Other1,406 (49.26%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (221)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Levetiracetam Efficacy and Safety as First-line Treatment of Neonatal Seizures Occuring in Hypoxic-ischemic Encephalopathy Context [NCT02229123]Phase 230 participants (Anticipated)Interventional2018-02-27Recruiting
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fed Conditions [NCT01132352]Phase 124 participants (Actual)Interventional2003-09-30Completed
A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures. [NCT00368069]Phase 3158 participants (Actual)Interventional2006-08-31Completed
Open-Label Study of Levetiracetam in Body Dysmorphic Disorder [NCT00265109]Phase 417 participants (Actual)Interventional2004-12-31Completed
Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates [NCT01261416]18 participants (Actual)Observational2008-10-31Completed
A Multicenter, Open-label, Parallel-group Study in Study Participants With Epilepsy, to Evaluate the Effect of Oxcarbazepine on the Pharmacokinetics, Safety, and Tolerability of Padsevonil [NCT03695094]Phase 131 participants (Actual)Interventional2018-09-18Completed
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Levetiracetam 750 mg Tablet and Keppra® (Reference) Following a 750 mg Dose in Healthy Subjects Under Fasting Conditions [NCT00849862]Phase 122 participants (Actual)Interventional2005-10-31Completed
Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Newly Diagnosed Epileptic Males [NCT03953781]50 participants (Actual)Observational2016-06-01Completed
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fasting Conditions. [NCT01131897]Phase 124 participants (Actual)Interventional2003-09-30Completed
A Randomized, Double-blind, Placebo-controlled Trial Investigating the Effects of Levetiracetam in Early Psychosis [NCT03129360]Phase 248 participants (Actual)Interventional2017-08-18Completed
Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial [NCT03689114]Phase 4374 participants (Anticipated)Interventional2020-01-07Not yet recruiting
Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder [NCT01345058]Phase 356 participants (Actual)Interventional2011-08-01Completed
Seizure Treatment IN Glioma (STING): Comparing a Treatment Strategy With Levetiracetam Versus Treatment With Valproic Acid in Glioma Patients With a First Seizure [NCT03048084]Phase 4120 participants (Anticipated)Interventional2018-02-01Recruiting
An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs [NCT01063764]Phase 373 participants (Actual)Interventional2010-01-31Completed
Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure [NCT03436433]Phase 24 participants (Actual)Interventional2019-01-31Terminated(stopped due to Did not enroll as planned)
Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy [NCT03632915]18 participants (Actual)Observational2017-11-20Completed
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures. [NCT00152516]Phase 3255 participants (Actual)Interventional2004-10-31Completed
An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures [NCT00419393]Phase 3190 participants (Actual)Interventional2007-12-31Completed
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Levetiracetam 1000 mg Tablet Under Fasting Conditions [NCT00859521]Phase 130 participants (Actual)Interventional2007-01-31Completed
A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From [NCT00150813]Phase 366 participants (Actual)Interventional2005-08-10Completed
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Levetiracetam 1000 mg Tablet Under Fed Conditions [NCT00859430]Phase 122 participants (Actual)Interventional2007-01-31Completed
An Investigation of Levetiracetam in Alzheimer's Disease (ILiAD): a Proof of Concept Study [NCT03489044]Phase 230 participants (Anticipated)Interventional2018-10-28Active, not recruiting
[NCT02208492]Phase 475 participants (Actual)Interventional2011-09-30Completed
A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial [NCT02334722]Phase 481 participants (Actual)Interventional2015-08-05Completed
Effect of Antiseizure Medication in Seizure Networks at Early Stages of Acute Brain Injury. The Rs-fMRI, Open-label Pilot Trial [NCT06081283]Phase 454 participants (Anticipated)Interventional2023-11-20Recruiting
Drugs in Breast Milk [NCT05543122]304 participants (Anticipated)Observational2022-03-09Recruiting
Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia [NCT03034356]Phase 1/Phase 267 participants (Actual)Interventional2018-09-01Active, not recruiting
Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus [NCT01150331]Phase 3203 participants (Actual)Interventional2009-07-31Completed
Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Patients With Schizophrenia [NCT02647437]30 participants (Anticipated)Interventional2013-06-30Recruiting
Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies [NCT05735717]Phase 2150 participants (Anticipated)Interventional2023-05-11Recruiting
A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting [NCT00627133]Phase 20 participants (Actual)Interventional2008-02-29Withdrawn
Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method [NCT00600509]Phase 2216 participants (Actual)Interventional2001-01-31Completed
Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy [NCT00630968]Phase 41,541 participants (Actual)Interventional2000-08-31Completed
Study on the Population Pharmacokinetics and Individualized Administration of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease [NCT05330390]50 participants (Anticipated)Observational2022-04-04Enrolling by invitation
Trial Evaluating the Safety and Tolerability of Levetiracetam Intravenous 15-minute Infusion, Administered in b.i.d. Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 65 Years Suffering From Partial Onset Seizures [NCT00610454]Phase 225 participants (Actual)Interventional2004-06-30Completed
The Prospective Trial for Validation of the Role of Levetiracetam as a Sensitizer of Temozolomide in the Treatment of Newly Diagnosed Glioblastoma Patients [NCT02815410]Phase 273 participants (Anticipated)Interventional2016-07-31Not yet recruiting
A Randomised Controlled Trial of the Ketogenic Diet in the Treatment of Epilepsy in Children Under the Age of Two Years [NCT02205931]Phase 4160 participants (Anticipated)Interventional2015-01-31Recruiting
Pharmacological Modulation of Hippocampal Activity in Psychosis 2 [NCT04559529]Phase 262 participants (Actual)Interventional2020-09-23Active, not recruiting
SUPER-refractory Status Epilepticus After Cardiac Arrest: a Multicenter, Retrospective, Cohort Study of Dual Anti-glutamate Therapy With Ketamine and Perampanel [NCT05756621]80 participants (Anticipated)Observational2022-01-15Recruiting
Effectiveness of Combined Levetiracetam and Midazolam in Treatment of Generalized Convulsive Status Epilepticus in Children [NCT04926844]Phase 2144 participants (Actual)Interventional2021-06-20Completed
Characterization of Epilepsy Patients At-risk for Adverse Outcomes Related to Switching Antiepileptic Drug Products: BEEP 2b Study [NCT02707965]Phase 121 participants (Actual)Interventional2017-06-08Completed
The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy [NCT05450822]550 participants (Anticipated)Observational2022-02-18Recruiting
A Clinical Study Exploring Lacosamide and Levetiracetam in Improving Cognitive in Patients With Alzheimer's Disease and Epilepsy [NCT05969054]Phase 4140 participants (Anticipated)Interventional2023-07-05Recruiting
A Multicenter, Open, Long-term Follow-up Study to Evaluate the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering Fro [NCT00367432]Phase 3398 participants (Actual)Interventional2006-07-31Completed
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures [NCT00510783]Phase 4158 participants (Actual)Interventional2007-07-31Completed
Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects [NCT00736931]Phase 120 participants (Actual)Interventional2008-07-31Completed
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study [NCT00223223]Phase 430 participants Interventional2005-02-28Completed
Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE) - A Phase II Exploratory Study [NCT04004702]Phase 265 participants (Anticipated)Interventional2020-01-31Not yet recruiting
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions [NCT00826787]29 participants (Actual)Interventional2005-08-31Completed
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions [NCT00826865]27 participants (Actual)Interventional2005-08-31Completed
Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE) [NCT02603991]1 participants (Anticipated)Observational2016-06-30Recruiting
Assessment of Bone Mineral Density and Periodontal Status in Patients With Epilepsy on Mono- and Combination Therapy of Antiepileptic Drug: A Cross-sectional Study. [NCT04262999]140 participants (Anticipated)Observational2020-01-01Recruiting
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy [NCT00643500]Phase 4342 participants (Actual)Interventional2002-01-31Completed
Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage [NCT02631759]Phase 350 participants (Actual)Interventional2016-10-31Completed
Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection [NCT05897658]Phase 370 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy [NCT00505934]Phase 219 participants (Actual)Interventional2008-05-31Completed
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions [NCT00946751]Phase 120 participants (Actual)Interventional2004-03-31Completed
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions [NCT00827320]26 participants (Actual)Interventional2007-06-30Completed
Efficacy of Levetiracetam in Patients With Essential Tremor [NCT00620165]Phase 1/Phase 210 participants (Actual)Interventional2005-01-31Completed
The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage [NCT00774306]52 participants (Actual)Interventional2009-04-30Terminated(stopped due to study no longer consistent with current clinical practice)
A Single-center, Open-label Positron Emission Tomography Study to Evaluate the Time-course of Displacement of [11C]UCB-J by Brivaracetam and Levetiracetam in Healthy Volunteers [NCT02602860]Phase 113 participants (Actual)Interventional2015-11-30Completed
Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus: a Randomized Clinical Trial [NCT04176887]Phase 460 participants (Anticipated)Interventional2019-01-01Recruiting
Prospective Double Blind Evaluation of Levetiracetam (Keppra) for the Treatment of Cervical Dystonia [NCT00760318]Phase 217 participants (Actual)Interventional2005-11-30Terminated(stopped due to Sponsor decided to stop enrollment to review data.)
Levetiracetam (Keppra) Treatment for Cocaine Dependence in Methadone-Maintained Patients [NCT00577005]Phase 228 participants (Actual)Interventional2007-07-31Completed
Levetiracetam (Keppra) Tolerability and Efficacy in Cocaine Abusing Methadone-maintained Patients. [NCT00593125]Phase 215 participants (Actual)Interventional2007-01-31Completed
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients [NCT00758277]Phase 3201 participants (Actual)Interventional2007-05-31Completed
Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study. [NCT00629889]Phase 252 participants (Actual)Interventional2008-02-29Completed
Modified Atkins Diet Versus Levetiracetam for Refractory Epilepsy in Children: A Randomized Open-Label Study [NCT04172311]Phase 2/Phase 390 participants (Anticipated)Interventional2019-11-14Recruiting
A Phase IV, Open-label, Multi-center Trial to Evaluate the Safety and Efficacy of Keppra® After Conversion to Mono-therapy in Adult Subjects With Partial Epilepsy [NCT00630357]Phase 414 participants (Actual)Interventional2003-03-31Completed
Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial [NCT00894010]Phase 26 participants (Actual)Interventional2009-05-31Completed
Efficacy and Safety of Generic Substitution of Original Levetiracetam in Patients With Epilepsy [NCT04132063]75 participants (Actual)Observational2018-11-01Completed
A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject [NCT00926302]26 participants (Actual)Interventional2008-01-31Completed
Intravenous Levetiracetam as First-line Anticonvulsive Treatment in Patients With Non-convulsive Status Epilepticus [NCT00603135]Phase 20 participants (Actual)Interventional2008-01-31Withdrawn
A 30-month Safety and Efficacy Follow-up Study With Levetiracetam at Individualized Optimal Dose in Children (4-17 Years Old at Inclusion) Suffering From Typical Absences in Childhood Absence Epilepsy (CAE) or Juvenile Absence Epilepsy (JAE) [NCT00545012]Phase 24 participants (Actual)Interventional2000-05-31Completed
A Double-blind, Phase III, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam as Adjunctive Therapy, in Partial Seizures Control Associated With Refractory Focal Epilepsy [NCT01392768]Phase 3126 participants (Actual)Interventional2013-01-31Completed
A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion [NCT01394224]Phase 125 participants (Actual)Interventional2011-06-30Completed
Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects [NCT00985348]Phase 126 participants (Actual)Interventional2009-09-30Completed
Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding [NCT05450978]60 participants (Anticipated)Observational [Patient Registry]2022-07-20Recruiting
A Randomized, Double-Blind, Cross-over Study of the Cognitive and Mood Effects of KEPPRA (Levetiracetam) Tablets in Healthy Older Adults. [NCT00221988]40 participants (Anticipated)Interventional2004-03-31Completed
Phase 1/2, Open Label, Sequential Cohort Study of a Single Intracranial Dose of AVASPA Gene Therapy for Treatment of Children With Typical Canavan Disease [NCT04833907]Phase 1/Phase 224 participants (Anticipated)Interventional2021-04-01Active, not recruiting
A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures [NCT00537238]Phase 3509 participants (Actual)Interventional2007-10-31Completed
Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial [NCT00615615]Phase 3216 participants (Actual)Interventional1999-09-30Completed
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fasting Conditions [NCT00826722]30 participants (Actual)Interventional2007-06-30Completed
Pilot Evaluation of Levetiracetam (Keppra® (Registered Trademark)) in Bipolar Illness [NCT00015769]Phase 230 participants Interventional2001-04-30Completed
Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome [Sicherheit Und Wirksamkeit Von Levetiracetam (Keppra) für Die Behandlung Des stationären Alkoholentzugsyndroms] [NCT00146471]Phase 3120 participants (Actual)Interventional2006-01-31Completed
A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From [NCT00175890]Phase 3116 participants (Actual)Interventional2004-10-31Completed
Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study [NCT02920060]Phase 280 participants (Actual)Interventional2015-01-31Completed
Efficacy of Levetiracetam for Language Dysfunction Associated With Benign Epilepsy With Centrotemporal Spikes [NCT00181116]Phase 46 participants Interventional2005-03-31Completed
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method [NCT00160615]Phase 3154 participants (Actual)Interventional2001-09-12Completed
A Pilot Study in a Double Blind, Randomized, Placebo-Controlled, Parallel-Group, 16 Week, Trial Design Evaluating the Efficacy and Safety of Levetiracetam 500 mg Tablets in Bid Administration (Daily Dose Ranging From 1000 mg to 3000 mg), in Adults (>18 Ye [NCT00156689]Phase 230 participants (Actual)Interventional2005-08-31Completed
A Double-blind, Randomized, Placebo-controlled, Parallel-group, 16 Week, Multicenter Trial Evaluating the Efficacy and Safety of Levetiracetam 500 mg Tablets in Bid Administration (Daily Dose Ranging From 1000 mg to 3000 mg), in Adults (≥ 18 Years of Age) [NCT00160511]Phase 2170 participants Interventional2004-04-30Completed
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiracetam (LEV) (166, 250, and 500mg Tablets), in Adult and Ped [NCT00160550]Phase 3154 participants Interventional2001-09-30Completed
A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subject [NCT00160628]Phase 3100 participants Interventional2004-03-31Completed
A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures [NCT00419094]Phase 3228 participants (Actual)Interventional2007-08-31Completed
A Phase IV, Open-label, Multi-center, Community-based Trial in Asia Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy. [NCT00160654]Phase 4251 participants (Actual)Interventional2003-11-24Completed
Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage [NCT01935908]Phase 40 participants (Actual)Interventional2013-05-31Withdrawn(stopped due to no funding)
Second-Line Treatment Choice for Epilepsy [NCT00208520]60 participants Interventional2003-07-31Active, not recruiting
Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study [NCT00252954]Phase 436 participants (Actual)Interventional2005-11-30Completed
An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Anti [NCT01292837]Phase 313 participants (Actual)Interventional2011-02-28Completed
Levetiracetam Treatment of Neonatal Seizures: A Multi-Centre Randomized Blinded Controlled Study of the Efficacy of Oral Levetiracetam as First Line Treatment for Neonatal Seizures in China [NCT02550028]Phase 1/Phase 260 participants (Actual)Interventional2015-09-01Terminated(stopped due to The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.)
Prospective, Randomized, Double-blind Study Assessing the Effects of Levetiracetam Compared to Placebo in the Prevention of Early Epileptic Seizures and Late Epilepsy in Patients With Severe Traumatic Brain Injury [NCT00566046]Phase 323 participants (Actual)Interventional2007-11-30Terminated(stopped due to Sponsor decision because of to small enrollment)
Randomised Factorial Design Controlled Trial Comparing Carbamazepine, Levetiracetam or Active Monitoring Combined With or Without Sleep Behaviour Intervention in Treatment Naive Children With Rolandic Epilepsy [NCT04610879]Phase 45 participants (Actual)Interventional2019-08-02Terminated(stopped due to Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation.)
Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study) [NCT00571155]Phase 430 participants (Anticipated)Interventional2007-12-31Completed
Pharmacological Management of Seizures Post Traumatic Brain Injury (MAST) [NCT04573803]Phase 31,649 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis [NCT05824728]Phase 230 participants (Anticipated)Interventional2023-09-28Recruiting
The Effect of Levetiracetam on the Postmastectomy Pain Syndrome [NCT00262262]25 participants (Actual)Interventional2004-03-31Completed
Evaluation of Efficacy and Safety of Levetiracetam, Lacosamide and Ketamine as Adjunctive Treatment of Refractory Status Epilepticus [NCT02726867]Phase 30 participants (Actual)Interventional2014-02-28Withdrawn(stopped due to No participants enrolled)
Liceo Study: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice [NCT00855738]Phase 4111 participants (Actual)Interventional2007-05-31Completed
A Multicenter, Randomized, Double-Blind, PBO-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Levetiracetam Versus PBO for the Treatment of Social Anxiety Disorder (Generalized Type) [NCT00612859]Phase 2217 participants (Actual)Interventional2003-09-30Completed
Cognitive Effects of Treatment of Interictal Discharges [NCT00916149]31 participants (Actual)Interventional2007-01-31Completed
A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures [NCT01229735]Phase 4343 participants (Actual)Interventional2010-11-30Completed
A Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Adult Female Subjects (18 to 40 Years of Age) With C1 Catamenial Epilepsy [NCT00630630]Phase 43 participants (Actual)Interventional2002-11-30Completed
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy [NCT00631150]Phase 435 participants (Actual)Interventional2003-03-31Completed
A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maxi [NCT00150735]Phase 3580 participants Interventional2002-06-30Completed
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam (LEV) (Oral Tablets of 500 mg b.i.d.) at a Dose of 3000 mg/Day as Adjunctive Treatment in Adolescents (≥ 12 Years) and Adults (≤ 65 Year [NCT00150774]Phase 3116 participants Interventional2001-11-30Completed
Intermittent Levetricetam in Treatment of Febrile Convulsions [NCT05860153]100 participants (Anticipated)Interventional2023-06-01Not yet recruiting
HEAD-TO-HEAD Evaluation of the Antiepileptic Drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German Multi-Centre, Doubleblind Controlled Trial in Children With Benign Epilepsy With Centro-Temporal Spikes [NCT00471744]Phase 344 participants (Actual)Interventional2006-06-30Terminated(stopped due to low patient number after 2 years recruiting)
A Pilot Study: Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder [NCT00518570]7 participants (Actual)Interventional2003-11-30Completed
Multicenter, Comparative, Randomized, Open Trial to Evaluate Efficacy and Safety of Levetiracetam Versus Carbamazepine in Post Stroke Late Onset Crisis [NCT00542802]Phase 3630 participants (Anticipated)Interventional2007-09-30Recruiting
An Open-Label, Single Dose, Pharmacokinetic Study of 20 mg/kg of Levetiracetam Oral Solution in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old [NCT00544050]Phase 213 participants (Actual)Interventional2002-09-30Completed
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures [NCT01228747]Phase 3361 participants (Actual)Interventional2010-10-31Completed
A Double-Blind, Placebo-Controlled, Parallel Group Design Trial of; Levetiracetam, Zonisamide, Topiramate, and Placebo Control for the Treatment of Alcohol Dependent Subjects. [NCT00862563]Phase 285 participants (Actual)Interventional2009-05-31Terminated(stopped due to Recruitment goals could not be met before ending of funding for this project.)
Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures [NCT03940326]Phase 4103 participants (Actual)Interventional2018-04-01Completed
A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects [NCT01725009]Phase 132 participants (Actual)Interventional2012-10-31Completed
Safety, Tolerability, and Efficacy of Levetiracetam for Neonatal Seizures [NCT01475656]2 participants (Actual)Observational2011-11-30Terminated(stopped due to difficulty with recruitment)
9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug. [NCT00245713]Phase 440 participants Interventional2003-03-31Completed
Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety [NCT00141115]Phase 23 participants (Actual)Interventional2004-03-31Completed
A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Un [NCT00280696]Phase 3352 participants (Actual)Interventional2005-11-30Completed
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial [NCT00291733]Phase 250 participants (Anticipated)Interventional2006-05-31Active, not recruiting
A Double-Blind Augmentation Study of LEvetiracetam in Obsessive Compulsive Disorder [NCT00299611]Phase 2/Phase 312 participants (Actual)Interventional2005-11-30Terminated(stopped due to Sponsor decided to terminate the study due to budget consideration)
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study [NCT00307450]Phase 434 participants (Anticipated)Interventional2006-03-31Completed
A Pilot Trial of Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron Disease [NCT00324454]Phase 220 participants (Actual)Interventional2006-05-31Completed
Pilot Study of Perampanel on Peritumoral Hyperexcitability and Seizure Control in Newly Diagnosed High Grade Glioma [NCT04497142]Phase 1/Phase 212 participants (Actual)Interventional2020-11-05Completed
Seizure Therapy With Intravenous Levetiracetam and Lorazepam [NCT00465244]Phase 2/Phase 30 participants (Actual)Interventional2008-01-31Withdrawn(stopped due to Inability to recruit subjects)
A Double-blind, Placebo-controlled, Randomized Study: 16-week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as add-on Therapy in Adults and Adolescents Older Than 16 Years Suffering From Partial Seizures. [NCT00152373]Phase 3192 participants Interventional2004-07-31Completed
Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy. [NCT00535392]Phase 233 participants (Actual)Interventional2007-09-30Completed
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures [NCT00884052]Phase 1/Phase 218 participants (Actual)Interventional2007-04-30Completed
An 8-week Exploratory, Double-blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-induced Tardive Dyskinesia in Subjects Wi [NCT00175955]Phase 270 participants Interventional2005-05-31Completed
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC) [NCT01666080]30 participants (Anticipated)Interventional2012-08-31Recruiting
A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures [NCT05610085]Phase 2133 participants (Anticipated)Interventional2023-03-24Recruiting
Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study [NCT04643327]Phase 228 participants (Anticipated)Interventional2021-02-09Recruiting
Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children [NCT01521130]Phase 1108 participants (Actual)Interventional2012-01-31Completed
A 19-week, Randomized, Double-blind, Multicenter, Placebo-controlled Safety Study to Evaluate the Cognitive and Neuropsychological Effects of Levetiracetam 20 - 60 mg/kg/Day, Divided in Twice Daily Dosing, as Adjunctive Treatment in Children 4 - 16 Years [NCT00105040]Phase 287 participants (Actual)Interventional2004-09-30Completed
Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study [NCT00393614]Phase 430 participants (Anticipated)Interventional2007-05-31Active, not recruiting
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy [NCT00150709]Phase 3238 participants Interventional1998-02-28Completed
An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less T [NCT00150748]Phase 3217 participants (Actual)Interventional2001-11-30Completed
A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial. [NCT00150787]Phase 3250 participants Interventional2003-07-31Completed
A Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's Disease [NCT00160576]Phase 230 participants Interventional2003-07-31Completed
A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/ [NCT00175903]Phase 31,701 participants (Actual)Interventional2005-02-28Completed
Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis [NCT00423527]Phase 430 participants (Anticipated)Interventional2007-01-31Completed
A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder [NCT00413296]Phase 2/Phase 316 participants (Actual)Interventional2005-11-30Completed
Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients. [NCT00227461]Phase 150 participants (Anticipated)Interventional2005-09-30Active, not recruiting
A Multicentre, Double-blind, Randomized, Phase IV Clinical Trial Comparing the Safety, Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epileps [NCT00438451]Phase 4361 participants (Actual)Interventional2007-01-31Completed
An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures [NCT01398956]Phase 344 participants (Actual)Interventional2011-06-30Completed
A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched and HLA-Matched Bone Marrow for Patients With Sickle Cell Anemia and Other Hemoglobinopathies [NCT00489281]Phase 243 participants (Actual)Interventional2008-06-23Terminated(stopped due to Initiation of CMS BMT study for sickle-cell disease operating under NCT01166009 made further accrual to this study impossible.)
Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy [NCT00612235]80 participants (Actual)Observational2008-04-30Completed
TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation [NCT02056236]172 participants (Actual)Interventional2014-04-30Completed
Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy: An Open, Prospective, Multicenter, Randomized Phase III Study [NCT00242606]Phase 3409 participants (Actual)Interventional2005-03-31Completed
A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS) [NCT00247364]Phase 220 participants Interventional2003-11-30Completed
Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy [NCT00286260]Phase 440 participants (Anticipated)Interventional2006-01-31Completed
Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates [NCT01239212]Phase 1/Phase 27 participants (Actual)Interventional2010-09-30Completed
A Randomized, Double-Blind, Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia [NCT00254657]66 participants (Actual)Interventional2004-03-31Completed
[NCT00291213]Phase 350 participants (Actual)InterventionalCompleted
A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases [NCT00415376]0 participants (Actual)Interventional2007-02-28Withdrawn(stopped due to Unable to accrue subjects)
Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks [NCT00279617]Phase 315 participants (Actual)Interventional2006-01-31Completed
Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam (Keppra®) (SOLUCION Study) [NCT00319605]600 participants (Anticipated)Observational2006-04-30Completed
The Effects of Levetiracetam on Alcohol Dependent Subjects [NCT00325182]Phase 440 participants (Actual)Interventional2006-01-31Completed
A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-con [NCT01618877]Phase 124 participants (Actual)Interventional2012-05-31Completed
A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-con [NCT01618903]Phase 124 participants (Actual)Interventional2012-05-31Completed
Seizure Prophylaxis in Aneurysm Repair [NCT01801072]Phase 479 participants (Actual)Interventional2013-02-28Completed
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of Carisbamate, Topiramate and Levetiracetam as Adjunctive Therapy in Subjects With Partial Onset Seizures [NCT00563459]Phase 389 participants (Actual)Interventional2007-11-30Terminated(stopped due to Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.)
A 12-week Randomized, Double-blind, Placebo-controlled Trial Investigating the Effects of Levetiracetam in Early Psychosis [NCT04317807]Phase 284 participants (Anticipated)Interventional2020-08-01Recruiting
Safety and Tolerability of Add-on Levetiracetam in Status Epilepticus [NCT00362141]Phase 212 participants Interventional2006-10-31Recruiting
An Open-Label, Multicenter, Parallel-Group, Two-Arm Study Comparing the Pharmacokinetics of Keppra XR in Children (Aged 12 - 16 Years Old) With Epilepsy and in Adults (Aged 18 - 55 Years Old) With Epilepsy [NCT00961441]Phase 225 participants (Actual)Interventional2009-09-30Completed
Placebo-Controlled Crossover Trial of Levetiracetam on Ethanol Intake [NCT01168687]46 participants (Actual)Interventional2008-11-30Completed
Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas [NCT04759196]Phase 456 participants (Anticipated)Interventional2021-03-01Recruiting
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Levetiracetam 750 mg Tablet and Keppra® (Reference) Following a 750 mg Dose in Healthy Subjects Under Fed Conditions [NCT00849485]Phase 122 participants (Actual)Interventional2005-11-30Completed
Phase 2a Levetiracetam Trial for AD-Associated Network Hyperexcitability [NCT02002819]Phase 234 participants (Actual)Interventional2014-10-16Completed
An Open-label, Multicenter Study to Evaluate the Safety of Adjunctive Treatment With Intravenous Levetiracetam (L059 IV) in Epilepsy Patients Aged ≥ 16 Years With Partial Onset Seizures [NCT01407523]Phase 216 participants (Actual)Interventional2011-07-31Completed
A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903). [NCT00291655]Phase 3130 participants (Actual)Interventional2006-06-30Completed
Modification of Epilepsy Screen Questionnaire and Treatment Feasibility Evaluation [NCT04939675]40 participants (Anticipated)Interventional2021-07-01Not yet recruiting
A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy [NCT02201251]Phase 363 participants (Actual)Interventional2014-10-06Completed
A Prospective, Phase 4, Open-Label, Twelve-Week Study to Examine the Cognitive Impact and Tolerability of Levetiracetam (Keppra) in Elderly Patients With Seizures of Partial Onset [NCT01318408]Phase 424 participants (Actual)Interventional2006-11-30Completed
A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus. [NCT01960075]Phase 3478 participants (Actual)Interventional2015-10-31Completed
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy [NCT00361010]20 participants (Anticipated)Interventional2006-12-31Completed
Metformin Efficacy and Safety in Epileptic Patients [NCT05722951]Phase 360 participants (Anticipated)Interventional2022-10-18Recruiting
Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures. [NCT00376766]Phase 3112 participants (Anticipated)Interventional2007-02-28Terminated(stopped due to recruitment recruitment recruitment recruitment difficulties)
Pharmacologic Modulation of Hippocampal Activity in Psychosis [NCT04277936]Phase 21 participants (Actual)Interventional2020-05-11Terminated(stopped due to Study was redesigned and submitted as a new protocol (NCT04559529).)
Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy [NCT01463033]Phase 2126 participants (Actual)Interventional2005-04-30Completed
Efficacy of Levetiracetam in Control of Neonatal Seizures [NCT03107507]Phase 440 participants (Anticipated)Interventional2017-03-25Recruiting
Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates? [NCT03054285]Phase 42,300 participants (Anticipated)Interventional2017-07-01Recruiting
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511]Phase 480 participants (Anticipated)Interventional2023-12-30Not yet recruiting
A Safety and Feasibility Study of Enteral Levetiracetam vs. Phenobarbital for Seizure Control in Pediatric Cerebral Malaria [NCT01982812]Phase 244 participants (Actual)Interventional2014-01-31Completed
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
A Single-Center, Open-Label Trial Examining the Efficacy and Safety of Levetiracetam for the Prophylactic Treatment of Migraine, With or Without Aura [NCT00203216]31 participants (Actual)Interventional2002-09-30Completed
Seizure-like Hippocampal Activity in Alzheimer's Disease Neurodegeneration [NCT01554683]12 participants (Actual)Interventional2012-02-29Completed
T-Cell Depleted Double UCB With Post Transplant IL-2 for Refractory Myeloid Leukemia [NCT01464359]Phase 23 participants (Actual)Interventional2011-10-31Terminated(stopped due to Slow accrual)
Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies [NCT01685411]5 participants (Actual)Interventional2013-01-31Terminated
A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers [NCT00970814]Phase 2130 participants (Actual)Interventional2009-10-31Completed
Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic MCI [NCT01044758]Phase 296 participants (Actual)Interventional2009-12-31Completed
Population Pharmacokinetics of Antiepileptic in Pediatrics [NCT03196466]1,000 participants (Anticipated)Observational2017-06-19Recruiting
Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit [NCT00618436]Phase 452 participants (Actual)Interventional2007-08-31Completed
An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures [NCT01954121]Phase 3436 participants (Actual)Interventional2013-09-30Completed
Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma [NCT01857934]Phase 2153 participants (Actual)Interventional2013-07-05Active, not recruiting
Treating Hyperexcitability in Alzheimer's Disease With Levetiracetam to Improve Brain Function and Cognition [NCT03875638]Phase 285 participants (Anticipated)Interventional2019-08-22Recruiting
Efficacy of Intravenous Levetiracetam in Neonatal Seizures: A Phase 2 Randomized Blinded Controlled Study of the Efficacy of Intravenous Levetiracetam (LEV) as First Line Treatment for Neonatal Seizures [NCT01720667]Phase 1/Phase 2280 participants (Actual)Interventional2013-03-31Completed
The Primary Prevention Study of Post-Ischemic Stroke Epilepsy [NCT04858841]180 participants (Anticipated)Interventional2020-08-01Recruiting
Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) [NCT01891890]Phase 372 participants (Actual)Interventional2013-08-31Terminated(stopped due to Poor recruitment)
Comparison of Keppra and Clonidine in the Treatment of Tics in Children With Tourette Syndrome [NCT00370838]Phase 412 participants (Actual)Interventional2007-02-28Completed
Levetiracetam in the Management of Bipolar Depression [NCT00566150]35 participants (Actual)Interventional2005-10-31Completed
Single-Dose Pharmacokinetics of Orally Administered Levetiracetam (LEV) in Japanese Subjects With Normal Renal Function and Various Degrees of Renal Impairment Using a Dosing Regimen Adjusted to Renal Function (250 mg or 500 mg) [NCT01491113]Phase 430 participants (Actual)Interventional2011-11-30Completed
A Dose-Escalation, Safety And Feasibility Study Of Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria [NCT01660672]Phase 1/Phase 27 participants (Actual)Interventional2013-01-31Completed
An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures [NCT01506882]Phase 371 participants (Actual)Interventional2011-12-31Completed
Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes [NCT03490487]Phase 4100 participants (Anticipated)Interventional2018-06-20Recruiting
[NCT00584025]Phase 40 participants (Actual)Interventional2007-12-31Withdrawn(stopped due to Study withdrawn due to personnel limitations.)
An Open-Label, Single-Arm, Multicenter Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age [NCT03340064]Phase 338 participants (Actual)Interventional2017-11-30Completed
Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia: A Randomized, Double-Blind Placebo-Controlled Cross-Over Study [NCT02199509]Phase 28 participants (Actual)Interventional2014-07-31Completed
A Multi-Center, Open-label, Randomized Study to Evaluate the Long Term Effectiveness of Levetiracetam as Monotherapy in Comparison With Oxcarbazepine in Subjects With Newly or Recently Diagnosed Partial Epilepsy [NCT01498822]Phase 4353 participants (Actual)Interventional2011-06-30Completed
Efficacy of Phenytoin vs Levetiracetam in Status Epilepticus at Institute of Child Health,Faisalabad [NCT06067412]70 participants (Actual)Interventional2022-08-01Completed
Seizure Prophylaxis in Aneurysm Repair [NCT01974700]Phase 417 participants (Actual)Interventional2013-07-31Terminated(stopped due to Lack of enrollment - since the start of the study in 2013, only 17 subjects have consented. Of those, only 8 completed the study.)
Multicenter, Open-label, Single-arm Study to Evaluate Hormone and Lipid Levels in Male Subjects With Partial-onset Seizures After a Switch of Treatment From Carbamazepine as Adjunctive Treatment to Levetiracetam to Lacosamide as Adjunctive Treatment to Le [NCT01375374]Phase 311 participants (Actual)Interventional2011-07-31Terminated(stopped due to Slow progress despite recruitment boosting efforts e.g., expert advice obtained from leading study center Investigators; decision thus made to terminate.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00141115 (2) [back to overview]Percent of Drinking Days
NCT00141115 (2) [back to overview]Participants Who Reported Reductions in Alcohol Consumption
NCT00150813 (1) [back to overview]Percentage Participants With Treatment Emergent Adverse Events
NCT00152516 (21) [back to overview]Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
NCT00152516 (21) [back to overview]Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
NCT00152516 (21) [back to overview]Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
NCT00152516 (21) [back to overview]Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
NCT00152516 (21) [back to overview]Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
NCT00152516 (21) [back to overview]Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
NCT00152516 (21) [back to overview]Investigator Global Evaluation Scale
NCT00152516 (21) [back to overview]Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
NCT00152516 (21) [back to overview]Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
NCT00152516 (21) [back to overview]Subject (>=8 Years Old) Global Evaluation Scale
NCT00152516 (21) [back to overview]Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
NCT00152516 (21) [back to overview]Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
NCT00152516 (21) [back to overview]Percent of Subjects With Each Seizure Type During the Evaluation Period
NCT00152516 (21) [back to overview]Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
NCT00152516 (21) [back to overview]Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
NCT00152516 (21) [back to overview]Parent/Guardian Global Evaluation Scale
NCT00152516 (21) [back to overview]Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
NCT00152516 (21) [back to overview]Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
NCT00152516 (21) [back to overview]Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
NCT00152516 (21) [back to overview]Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
NCT00152516 (21) [back to overview]Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
NCT00160615 (8) [back to overview]Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
NCT00160615 (8) [back to overview]Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
NCT00160615 (8) [back to overview]Partial (Type I) Seizure Frequency Per Week by Analysis Visit
NCT00160615 (8) [back to overview]Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
NCT00160615 (8) [back to overview]Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
NCT00160615 (8) [back to overview]Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
NCT00160615 (8) [back to overview]Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
NCT00160615 (8) [back to overview]Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
NCT00160654 (7) [back to overview]Percentage of Patients With Categorized Change From Baseline in Severity of Illness
NCT00160654 (7) [back to overview]Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16
NCT00160654 (7) [back to overview]Retention Rate at Week 16
NCT00160654 (7) [back to overview]Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period
NCT00160654 (7) [back to overview]Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period
NCT00160654 (7) [back to overview]Number of Patients With Adverse Events (AEs)
NCT00160654 (7) [back to overview]Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16
NCT00203216 (1) [back to overview]The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.
NCT00265109 (13) [back to overview]Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms
NCT00265109 (13) [back to overview]Scores on Clinical Global Severity
NCT00265109 (13) [back to overview]Scores on Brown Assessment of Beliefs Scale
NCT00265109 (13) [back to overview]Scores on Beck Anxiety Inventory
NCT00265109 (13) [back to overview]Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.
NCT00265109 (13) [back to overview]Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form
NCT00265109 (13) [back to overview]Scores on Social Phobia Inventory
NCT00265109 (13) [back to overview]Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.
NCT00265109 (13) [back to overview]Scores on Social and Occupational Functioning Scale (SOFAS)
NCT00265109 (13) [back to overview]Scores on Hamilton Depression Rating Scale
NCT00265109 (13) [back to overview]Scores on Global Assessment of Functioning
NCT00265109 (13) [back to overview]Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms
NCT00265109 (13) [back to overview]Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
NCT00291655 (2) [back to overview]Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
NCT00291655 (2) [back to overview]Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
NCT00367432 (9) [back to overview]Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study
NCT00367432 (9) [back to overview]Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)
NCT00367432 (9) [back to overview]Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
NCT00367432 (9) [back to overview]Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study
NCT00367432 (9) [back to overview]Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study
NCT00367432 (9) [back to overview]Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study
NCT00367432 (9) [back to overview]Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
NCT00367432 (9) [back to overview]Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study
NCT00367432 (9) [back to overview]Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)
NCT00368069 (6) [back to overview]Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
NCT00368069 (6) [back to overview]Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
NCT00368069 (6) [back to overview]50% Response in Weekly POS Frequency
NCT00368069 (6) [back to overview]POS Seizure Frequency Per Week Over Baseline and Treatment Period
NCT00368069 (6) [back to overview]Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
NCT00368069 (6) [back to overview]All (Type I+II+III) Seizures Frequency Per Week
NCT00370838 (7) [back to overview]Clinical Global Impression-Improvement (CGI-I):
NCT00370838 (7) [back to overview]Yale Global Tic Severity Scale (YGTSS):
NCT00370838 (7) [back to overview]Modified Pittsburgh Side Effect Scale
NCT00370838 (7) [back to overview]DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale:
NCT00370838 (7) [back to overview]Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS):
NCT00370838 (7) [back to overview]Multidimensional Anxiety Scale for Children (MASC):
NCT00370838 (7) [back to overview]Total Tic Score
NCT00419094 (4) [back to overview]The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
NCT00419094 (4) [back to overview]The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
NCT00419094 (4) [back to overview]The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
NCT00419094 (4) [back to overview]The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
NCT00419393 (5) [back to overview]Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
NCT00419393 (5) [back to overview]Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
NCT00419393 (5) [back to overview]Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
NCT00419393 (5) [back to overview]Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
NCT00419393 (5) [back to overview]Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
NCT00438451 (12) [back to overview]Portland Neurotoxicity Scale (PNS) at V6
NCT00438451 (12) [back to overview]Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)
NCT00438451 (12) [back to overview]Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)
NCT00438451 (12) [back to overview]58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment
NCT00438451 (12) [back to overview]Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)
NCT00438451 (12) [back to overview]The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)
NCT00438451 (12) [back to overview]The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)
NCT00438451 (12) [back to overview]Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase
NCT00438451 (12) [back to overview]QOLIE-31 (Quality Of Life In Epilepsy) Results at V6
NCT00438451 (12) [back to overview]Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6
NCT00438451 (12) [back to overview]Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6
NCT00438451 (12) [back to overview]Time to Drop Out
NCT00489281 (3) [back to overview]Donor Chimerism at 30 Days
NCT00489281 (3) [back to overview]Donor Chimerism at 1 Year
NCT00489281 (3) [back to overview]Transplant-related Mortality
NCT00505934 (3) [back to overview]Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
NCT00505934 (3) [back to overview]Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
NCT00505934 (3) [back to overview]Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)
NCT00510783 (1) [back to overview]Number of Participants Who Experienced a Recurrent Seizure After Treatment.
NCT00535392 (3) [back to overview]Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
NCT00535392 (3) [back to overview]Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
NCT00535392 (3) [back to overview]Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)
NCT00537238 (8) [back to overview]Hospital Anxiety and Depression Scale (HADS) Score
NCT00537238 (8) [back to overview]Medical Outcomes Study Sleep Scale (MOS-SS) Score
NCT00537238 (8) [back to overview]Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score
NCT00537238 (8) [back to overview]Percentage of Participants Without Seizures
NCT00537238 (8) [back to overview]Percent Change From Baseline in 28 Day Seizure Frequency at Week 16
NCT00537238 (8) [back to overview]Proportion of Participants With Response to Treatment
NCT00537238 (8) [back to overview]Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up
NCT00537238 (8) [back to overview]Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16
NCT00566150 (4) [back to overview]Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
NCT00566150 (4) [back to overview]Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.
NCT00566150 (4) [back to overview]Number of Subjects Who Achieve Remission.
NCT00566150 (4) [back to overview]Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.
NCT00577005 (4) [back to overview]Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13
NCT00577005 (4) [back to overview]Cocaine Craving
NCT00577005 (4) [back to overview]Change of Thrice Weekly Opioid Free Urine Toxicology From Week 1 to 13
NCT00577005 (4) [back to overview]Treatment Retention
NCT00618436 (3) [back to overview]Disability Rating Scale (DRS)
NCT00618436 (3) [back to overview]Seizure Incidence
NCT00618436 (3) [back to overview]Extended Glasgow Outcome Score
NCT00849485 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00849485 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00849485 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00849862 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00849862 (3) [back to overview]AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00849862 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00855738 (17) [back to overview]Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment
NCT00855738 (17) [back to overview]Percent of Participants Classified as Responders
NCT00855738 (17) [back to overview]Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)
NCT00855738 (17) [back to overview]Percent of Participants Reaching Monotherapy
NCT00855738 (17) [back to overview]Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy
NCT00855738 (17) [back to overview]Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)
NCT00855738 (17) [back to overview]Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit
NCT00855738 (17) [back to overview]Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation
NCT00855738 (17) [back to overview]Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment
NCT00855738 (17) [back to overview]Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy
NCT00855738 (17) [back to overview]Percent of Participants Who Continued on Study Medication to Month 6
NCT00855738 (17) [back to overview]Time to First Seizure
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy
NCT00855738 (17) [back to overview]Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)
NCT00859430 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00859430 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00859430 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00859521 (3) [back to overview]AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
NCT00859521 (3) [back to overview]Cmax - Maximum Observed Concentration
NCT00859521 (3) [back to overview]AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT00862563 (8) [back to overview]Controlled Word Association Test (COWAT)- Letter Fluency
NCT00862563 (8) [back to overview]COWAT-Category
NCT00862563 (8) [back to overview]Percent Days Drinking
NCT00862563 (8) [back to overview]Mean Percent Days Heavy Drinking
NCT00862563 (8) [back to overview]AB-Neurotoxicity Scale.
NCT00862563 (8) [back to overview]Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total
NCT00862563 (8) [back to overview]Wechsler Memory Scale-3rd Ed. Spatial Span
NCT00862563 (8) [back to overview]The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties.
NCT00884052 (3) [back to overview]Levetiracetam Treated Number of Participants With Serious Adverse Events
NCT00884052 (3) [back to overview]Drug Half Life
NCT00884052 (3) [back to overview]Drug Clearance
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)
NCT00916149 (32) [back to overview]Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall
NCT00916149 (32) [back to overview]Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning
NCT00961441 (5) [back to overview]Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration
NCT00961441 (5) [back to overview]Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration
NCT00961441 (5) [back to overview]Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days
NCT00961441 (5) [back to overview]Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration
NCT00961441 (5) [back to overview]Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration
NCT00970814 (3) [back to overview]The Number of Drinks Per Drinking Day Study Weeks 5-14.
NCT00970814 (3) [back to overview]The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
NCT00970814 (3) [back to overview]The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
NCT01044758 (2) [back to overview]Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI
NCT01044758 (2) [back to overview]Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task
NCT01063764 (11) [back to overview]Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period
NCT01063764 (11) [back to overview]Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)
NCT01063764 (11) [back to overview]Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
NCT01063764 (11) [back to overview]Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
NCT01063764 (11) [back to overview]Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)
NCT01063764 (11) [back to overview]Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
NCT01063764 (11) [back to overview]Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period
NCT01063764 (11) [back to overview]Number of Seizure-free Subjects Over the 14-weeks Treatment Period
NCT01063764 (11) [back to overview]Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
NCT01063764 (11) [back to overview]Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period
NCT01063764 (11) [back to overview]Number of Seizure-free Subjects Over the 10-weeks Evaluation Period
NCT01168687 (1) [back to overview]Standard Alcoholic Drinks Per Treatment Period
NCT01228747 (5) [back to overview]Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)
NCT01228747 (5) [back to overview]Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
NCT01228747 (5) [back to overview]Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period
NCT01228747 (5) [back to overview]Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
NCT01228747 (5) [back to overview]The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period
NCT01229735 (5) [back to overview]Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
NCT01229735 (5) [back to overview]Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate
NCT01229735 (5) [back to overview]Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)
NCT01229735 (5) [back to overview]Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52
NCT01229735 (5) [back to overview]Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52
NCT01239212 (1) [back to overview]Pharmacokinetic Profile
NCT01292837 (6) [back to overview]Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
NCT01292837 (6) [back to overview]Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
NCT01292837 (6) [back to overview]Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
NCT01292837 (6) [back to overview]The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)
NCT01292837 (6) [back to overview]Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
NCT01292837 (6) [back to overview]The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
NCT01318408 (2) [back to overview]ADAS-cog at Baseline and at 3 Months.
NCT01318408 (2) [back to overview]MMSE at Baseline and at Three (3) Months.
NCT01345058 (5) [back to overview]Retention Rate
NCT01345058 (5) [back to overview]Time to First Seizure After Therapeutic Dose is Reached
NCT01345058 (5) [back to overview]Percentage of Participants Achieving Six Month Seizure Freedom
NCT01345058 (5) [back to overview]Number of Seizure-Free Days
NCT01345058 (5) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAE)
NCT01375374 (4) [back to overview]Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
NCT01375374 (4) [back to overview]Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
NCT01375374 (4) [back to overview]Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
NCT01375374 (4) [back to overview]Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
NCT01398956 (3) [back to overview]Incidence of Treatment Emergent Adverse Events During the Entire Study Period
NCT01398956 (3) [back to overview]The Incidence of Adverse Drug Reactions During the Entire Study Period
NCT01398956 (3) [back to overview]The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).
NCT01407523 (7) [back to overview]Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
NCT01407523 (7) [back to overview]Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
NCT01407523 (7) [back to overview]Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)
NCT01407523 (7) [back to overview]Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
NCT01407523 (7) [back to overview]Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period
NCT01407523 (7) [back to overview]Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
NCT01407523 (7) [back to overview]Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
NCT01463033 (2) [back to overview]Post-Traumatic Epilepsy
NCT01463033 (2) [back to overview]Adverse Events
NCT01464359 (9) [back to overview]Duration of Survival
NCT01464359 (9) [back to overview]Disease Free Survival
NCT01464359 (9) [back to overview]Incidence of Acute Graft-Versus-Host Disease
NCT01464359 (9) [back to overview]Clinical Disease Response
NCT01464359 (9) [back to overview]Duration of Survival
NCT01464359 (9) [back to overview]Duration of Survival
NCT01464359 (9) [back to overview]Clinical Disease Response
NCT01464359 (9) [back to overview]Incidence of Graft Failure
NCT01464359 (9) [back to overview]Transplant-Related Mortality
NCT01491113 (29) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
NCT01491113 (29) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
NCT01491113 (29) [back to overview]Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
NCT01491113 (29) [back to overview]Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
NCT01491113 (29) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
NCT01491113 (29) [back to overview]Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
NCT01491113 (29) [back to overview]Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
NCT01491113 (29) [back to overview]Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
NCT01491113 (29) [back to overview]Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
NCT01491113 (29) [back to overview]Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D
NCT01491113 (29) [back to overview]Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
NCT01491113 (29) [back to overview]Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
NCT01491113 (29) [back to overview]Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
NCT01491113 (29) [back to overview]Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
NCT01491113 (29) [back to overview]Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Renal Clearance (CLR) of Ucb L057 for Groups A to D
NCT01491113 (29) [back to overview]Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
NCT01491113 (29) [back to overview]Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
NCT01491113 (29) [back to overview]Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
NCT01491113 (29) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
NCT01491113 (29) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
NCT01491113 (29) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
NCT01491113 (29) [back to overview]Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
NCT01498822 (4) [back to overview]Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period
NCT01498822 (4) [back to overview]Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time
NCT01498822 (4) [back to overview]Percentage of Subjects With a Treatment Failure
NCT01498822 (4) [back to overview]Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period
NCT01506882 (8) [back to overview]Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
NCT01506882 (8) [back to overview]Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
NCT01506882 (8) [back to overview]Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
NCT01506882 (8) [back to overview]Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
NCT01506882 (8) [back to overview]Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
NCT01506882 (8) [back to overview]Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
NCT01506882 (8) [back to overview]Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
NCT01506882 (8) [back to overview]Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
NCT01554683 (5) [back to overview]Free and Cued Selective Reminding Test
NCT01554683 (5) [back to overview]Montreal Cognitive Assessment (MoCA)
NCT01554683 (5) [back to overview]Number of Participants With Evaluable fMRI Scans
NCT01554683 (5) [back to overview]Trial Making Test Parts A & B
NCT01554683 (5) [back to overview]Phonemic & Category Fluency Test
NCT01660672 (8) [back to overview]Toxicity Related to LVT
NCT01660672 (8) [back to overview]Number of Participants With Neurologic Sequelae at Discharge
NCT01660672 (8) [back to overview]Freedom From Seizure
NCT01660672 (8) [back to overview]Mean Time to Return to a BCS Score Greater Than or Equal to 4
NCT01660672 (8) [back to overview]Number of Participants Requiring AED During Admission
NCT01660672 (8) [back to overview]Number of Subjects Exposed to Phenobarbitone Prior to Enrollment
NCT01660672 (8) [back to overview]Number of Subjects With Retinopathy at Enrollment
NCT01660672 (8) [back to overview]Range of Plasma Concentration of LVT Across All Individuals
NCT01685411 (15) [back to overview]Count of Participants With Disease Free Survival
NCT01685411 (15) [back to overview]Number of Participant Who Were Alive at 2 Years Post Transplant
NCT01685411 (15) [back to overview]Percentage of Participants With Acute Graft-Versus-Host Disease by Grade
NCT01685411 (15) [back to overview]Count of Participants Who Achieved Neutrophil Engraftment
NCT01685411 (15) [back to overview]Counts of Participants With Disease Free Survival
NCT01685411 (15) [back to overview]Percentage of Participants With Chronic Graft-Versus-Host Disease
NCT01685411 (15) [back to overview]Percentage of Participants With Treatment-Related Toxicity
NCT01685411 (15) [back to overview]Percentage of Participants With Treatment-Related Toxicity
NCT01685411 (15) [back to overview]Percentage of Participants With Relapse
NCT01685411 (15) [back to overview]Percentage of Participants With Relapse
NCT01685411 (15) [back to overview]Percentage of Participants With Engraftment Failure
NCT01685411 (15) [back to overview]Count of Participants With Disease Free Survival
NCT01685411 (15) [back to overview]Percentage of Participants With Chronic Graft-Versus-Host Disease
NCT01685411 (15) [back to overview]Number of Participant Who Were Alive at 7 Years Post Transplant
NCT01685411 (15) [back to overview]Number of Participant Who Were Alive at 5 Years Post Transplant
NCT01720667 (5) [back to overview]Number of Neonates With Seizure Termination at 1 Hour After Treatment
NCT01720667 (5) [back to overview]LEV Dose Escalation Component
NCT01720667 (5) [back to overview]Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)
NCT01720667 (5) [back to overview]Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment
NCT01720667 (5) [back to overview]Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia
NCT01857934 (6) [back to overview]Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy
NCT01857934 (6) [back to overview]Event-free Survival (EFS)
NCT01857934 (6) [back to overview]Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation
NCT01857934 (6) [back to overview]Dose Limiting Toxicity (DLT)
NCT01857934 (6) [back to overview]Local Failure Rate and Pattern of Failure
NCT01857934 (6) [back to overview]Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]
NCT01891890 (11) [back to overview]Affective Reactivity Scale
NCT01891890 (11) [back to overview]Child Behavior Checklist
NCT01891890 (11) [back to overview]Conners' Continuous Performance Test II (CPT-II) Confidence Index
NCT01891890 (11) [back to overview]Grooved Pegboard
NCT01891890 (11) [back to overview]Parenting Stress Inventory Short Form (PSI-4-SF)
NCT01891890 (11) [back to overview]Pediatric Inventory for Parents
NCT01891890 (11) [back to overview]Pediatric Neuro-QOL Score
NCT01891890 (11) [back to overview]Story Memory
NCT01891890 (11) [back to overview]Symbol Digit Modalities Test
NCT01891890 (11) [back to overview]The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT01891890 (11) [back to overview]Wechsler Intelligence Scale for Children-IV Processing Speed
NCT01954121 (5) [back to overview]Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
NCT01954121 (5) [back to overview]Time to First Seizure During the Evaluation Period
NCT01954121 (5) [back to overview]Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug
NCT01954121 (5) [back to overview]Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period
NCT01954121 (5) [back to overview]Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
NCT01960075 (17) [back to overview]Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Purple Glove Syndrome
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Life-threatening Cardiac Arrhythmia
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Life Threatening Hypotension
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Hepatic Transaminase or Ammonia Elevations
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Death
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Endotracheal Intubation
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Acute Seizure Recurrence
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Acute Respiratory Depression
NCT01960075 (17) [back to overview]Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success
NCT01960075 (17) [back to overview]Number of Participants With Safety Outcome: Acute Anaphylaxis
NCT01960075 (17) [back to overview]Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat
NCT01960075 (17) [back to overview]Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis
NCT01960075 (17) [back to overview]Number of Participants With Admission to Intensive Care Unit
NCT01960075 (17) [back to overview]Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success
NCT01960075 (17) [back to overview]Length of Hospital Stay
NCT01960075 (17) [back to overview]Length of ICU Stay
NCT01974700 (3) [back to overview]Number of Participants Who Returned to Work
NCT01974700 (3) [back to overview]Number of Participants Who Returned to Daily Activities.
NCT01974700 (3) [back to overview]Incidence of Seizure
NCT01982812 (4) [back to overview]Mean Time From Admission to BCS >/= 4
NCT01982812 (4) [back to overview]Minutes With Seizure on EEG
NCT01982812 (4) [back to overview]Required Additional AED
NCT01982812 (4) [back to overview]Sequelae
NCT02002819 (15) [back to overview]ADAS-cog in AD With Epileptiform Activity
NCT02002819 (15) [back to overview]Blood Serum Prolactin Level
NCT02002819 (15) [back to overview]Changes in ADAS-cog
NCT02002819 (15) [back to overview]Changes in Behavior and Level of Disability - ADCS-ADL
NCT02002819 (15) [back to overview]Changes in Behavior and Level of Disability - ADCS-CGIC
NCT02002819 (15) [back to overview]Changes in Behavior and Level of Disability - Neuropsychiatric Inventory (NPI)
NCT02002819 (15) [back to overview]NIH EXAMINER in AD With Epileptiform Activity
NCT02002819 (15) [back to overview]Changes in Epileptiform Events
NCT02002819 (15) [back to overview]Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery
NCT02002819 (15) [back to overview]Changes in Cognitive Function as Measured by a Virtual Route Learning Test
NCT02002819 (15) [back to overview]Clinical Dementia Rating Sum of Boxes (CDR-SOB)
NCT02002819 (15) [back to overview]Standardized Assessments of Clinical Fluctuations - One Day Fluctuation Assessment Scale
NCT02002819 (15) [back to overview]Standardized Assessments of Clinical Fluctuations -The Clinician Assessment of Fluctuation
NCT02002819 (15) [back to overview]Stroop Interference in AD With Epileptiform Activity
NCT02002819 (15) [back to overview]Changes in Stroop Interference Naming
NCT02199509 (3) [back to overview]Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of Burke-Fahn-Marsten Dystonia Rating Scale (BFM)
NCT02199509 (3) [back to overview]Percent Change of the Sum of Eyes and Upper Face, Lower Face and Jaw and Tongue Subscores of the GDS Rating Scale
NCT02199509 (3) [back to overview]Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of the Burke-Fahn-Marsden (BFM) Dystonia Scale.
NCT02201251 (16) [back to overview]Change From Baseline in Height Z-score up to Month 1
NCT02201251 (16) [back to overview]Change From Baseline in Height Z-score up to Month 12
NCT02201251 (16) [back to overview]Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6
NCT02201251 (16) [back to overview]Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6
NCT02201251 (16) [back to overview]Change From Baseline in BMD Z-score up to Month 12
NCT02201251 (16) [back to overview]Change From Baseline in BMC-Z Score up to Month 12
NCT02201251 (16) [back to overview]Percentage of Participants With Kidney Stones
NCT02201251 (16) [back to overview]Change From Baseline in Weight Z-score up to Month 9
NCT02201251 (16) [back to overview]Change From Baseline in Weight Z-score up to Month 6
NCT02201251 (16) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAE)
NCT02201251 (16) [back to overview]Change From Baseline in Weight Z-score up to Month 3
NCT02201251 (16) [back to overview]Change From Baseline in Weight Z-score up to Month 12
NCT02201251 (16) [back to overview]Change From Baseline in Weight Z-score up to Month 1
NCT02201251 (16) [back to overview]Change From Baseline in Height Z-score up to Month 9
NCT02201251 (16) [back to overview]Change From Baseline in Height Z-score up to Month 6
NCT02201251 (16) [back to overview]Change From Baseline in Height Z-score up to Month 3
NCT02334722 (1) [back to overview]Change in Neurotoxicity Scale Scores
NCT02707965 (5) [back to overview]Number of Seizures Reported
NCT02707965 (5) [back to overview]Number of Adverse Events
NCT02707965 (5) [back to overview]Mean AUC0-last_ss (Test vs. Reference)
NCT02707965 (5) [back to overview]Mean Cmax_ss (Test vs. Reference)
NCT02707965 (5) [back to overview]Mean Cmin_ss (Test vs. Reference)
NCT03129360 (1) [back to overview]Change in Cerebral Blood Flow (CBF)
NCT03436433 (2) [back to overview]Percentage of Patients With an ED Visit/Hospital Readmission Within 30 Days of Craniotomy
NCT03436433 (2) [back to overview]Number of Participants With an Adverse Event Within First 30 Days After Craniotomy
NCT03695094 (15) [back to overview]Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
NCT03695094 (15) [back to overview]Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
NCT03695094 (15) [back to overview]The Apparent Total Plasma Clearance at Steady-state (CL/Fss) for PSL During the Study
NCT03695094 (15) [back to overview]The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1431322-000 During the Study
NCT03695094 (15) [back to overview]The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1447499-000 During the Study
NCT03695094 (15) [back to overview]The Area Under the Plasma Concentration Time Curve (AUCtau) Over a Dosing Interval for PSL
NCT03695094 (15) [back to overview]The Maximum Observed Plasma Concentration (Cmax) for UCB1431322-000 During the Study
NCT03695094 (15) [back to overview]The Maximum Observed Plasma Concentration (Cmax) for UCB1447499-000 During the Study
NCT03695094 (15) [back to overview]The Maximum Observed Plasma Concentration (Cmax) of Padsevonil (PSL) During the Study
NCT03695094 (15) [back to overview]The Ratio of PSL Metabolite UCB1447499-000 to PSL Based on the Area Under the Curve (AUCtau)
NCT03695094 (15) [back to overview]The Ratio of PSL Metabolite UCB1431322-000 to PSL Based on the Area Under the Curve (AUCtau) During the Study
NCT03695094 (15) [back to overview]Percentage of Participants With at Least One Adverse Event (AE) During the Study
NCT03695094 (15) [back to overview]The Time to Reach Maximum Concentration (Tmax) for Padsevonil During the Study
NCT03695094 (15) [back to overview]The Time to Reach Maximum Concentration (Tmax) for UCB1431322-000 During the Study
NCT03695094 (15) [back to overview]The Time to Reach Maximum Concentration (Tmax) for UCB1447499-000 During the Study
NCT03940326 (4) [back to overview]Withdrawal Rate
NCT03940326 (4) [back to overview]Time to Withdrawal
NCT03940326 (4) [back to overview]Time to First Seizure
NCT03940326 (4) [back to overview]Seizure Freedom Rate

Percent of Drinking Days

daily drinking assessed each of study participation, reported percent of drinking days for 28 days prior to study initiation compared to last 28 days of study participation-as reported on the Time line follow back (NCT00141115)
Timeframe: assessed daily, reported for baseline 28 days compared to last 28 days of study participation

Interventionpercentage of days (Mean)
Baseline percent of drinking daysLast 28 days percent of drinking days
Levetiracetam67.927.6

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Participants Who Reported Reductions in Alcohol Consumption

Number of participants who reduced drinking during the trial (NCT00141115)
Timeframe: over 9 weeks of study or length of participation

InterventionParticipants (Count of Participants)
Levetiracetam 1500 mg Twice Daily3

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Percentage Participants With Treatment Emergent Adverse Events

An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). (NCT00150813)
Timeframe: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks

Interventionpercentage of participants (Number)
Levetiracetam27.3

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Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

InterventionSeizures Per Week (Median)
Up-titration/Conversion PeriodMaintenance Period
Levetiracetam0.720.93

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Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

InterventionSeizures Per Week (Median)
Up-titration/Conversion PeriodMaintenance Period
Levetiracetam0.690.93

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Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with up to 24 weeks of exposure

InterventionPercentage of Days (Median)
Levetiracetam0.00

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Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with greater than 24 weeks of exposure

InterventionPercentage of Days (Median)
Levetiracetam58.41

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Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with up to 24 weeks of exposure

InterventionPercentage of Days (Median)
Levetiracetam0.00

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Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)

The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155. (NCT00152516)
Timeframe: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)

InterventionScore on a scale (Mean)
Visit 5 (week 24)Visit 7 (week 48)
Levetiracetam4.84.5

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Investigator Global Evaluation Scale

There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change). (NCT00152516)
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)

InterventionPercentage of Participants (Number)
ImprovedNo ChangeWorsened
Levetiracetam76.115.38.6

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Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period

"The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.~The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks." (NCT00152516)
Timeframe: greater than or equal to 24 weeks, greater than or equal to 40 weeks

InterventionPercentage of Participants (Number)
>= 24 Weeks>= 40 Weeks
Levetiracetam16.514.7

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Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.

(NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

InterventionSeizures Per Week (Median)
Up-titration/Conversion PeriodMaintenance Period
Levetiracetam3.151.91

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Subject (>=8 Years Old) Global Evaluation Scale

There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change). (NCT00152516)
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)

InterventionPercentage of Participants (Number)
ImprovedNo ChangeWorsened
Levetiracetam78.915.55.6

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Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

InterventionPercent Reduction in Seizures per Week (Median)
Up-titration/Conversion PeriodMaintenance Period
Levetiracetam47.4466.02

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Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Interventionpercent reduction in seizures Per Week (Median)
Up-titration/ConversionMaintenance
Levetiracetam51.0668.87

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Percent of Subjects With Each Seizure Type During the Evaluation Period

"Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).~Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).~Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).~A subject could experience more than one seizure type." (NCT00152516)
Timeframe: Evaluation period (48 weeks)

InterventionPercentage of Participants (Number)
Type IType IIType III
Levetiracetam88.612.97.1

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Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase

"The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.~Note: Rates were reported as percentages." (NCT00152516)
Timeframe: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)

InterventionPercentage of Participants (Number)
Up-titration/Conversion (4 weeks)Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16)Maint. Visits 4-5 (weeks 14-24, 15-24, or 16-24);Maintenance Visits 5-6 (weeks 24-36)Maintenance Visits 6-7 (weeks 36-48)
Levetiracetam50.659.865.568.271.8

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Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.

(NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

InterventionSeizures Per Week (Median)
Up-titration/Conversion PeriodMaintenance Period
Levetiracetam2.851.49

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Parent/Guardian Global Evaluation Scale

There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change). (NCT00152516)
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)

InterventionPercentage of Participants (Number)
ImprovedNo ChangeWorsened
Levetiracetam75.712.611.7

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Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 5 (Week 24)

InterventionNumber of subjects (Number)
WorsenedStableImproved
Levetiracetam5214

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Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with greater than 24 weeks of exposure

InterventionPercentage of days (Median)
Levetiracetam61.49

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Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 7 (week 48)

InterventionNumber of subjects (Number)
WorsenedStableImproved
Levetiracetam7171

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Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 5 (week 24)

InterventionNumber of subjects (Number)
WorsenedStableImproved
Levetiracetam1208

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Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 7 (week 48)

InterventionNumber of subjects (Number)
WorsenedStableImproved
Levetiracetam1158

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Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit

"Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline." (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionPercent change (Median)
>= 1 d - <= 3 m> 3 m - <= 6 m> 6 m - <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00-100.00
N165 Randomized Treatment PBO-100.00-93.96-88.73-100.00-88.33-100.00-90.42-80.56-91.92-92.11-77.02-74.30-85.67-83.23-79.75-95.81-95.98-100.00-100.00

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Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit

"Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline." (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionPercent change (Median)
>= 1 d - <= 3 m> 3 m - <= 6 m> 6 m - <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV (FAS)-26.77-31.35-47.61-43.56-51.20-45.80-52.04-52.96-49.71-48.18-46.86-42.03-46.25-49.85-46.51-54.05-77.08-74.58-86.61
N165 Randomized Treatment PBO (FAS)-21.41-21.95-28.30-34.97-21.12-33.18-32.78-20.12-28.75-8.84-15.85-11.73-15.06-20.13-23.76-37.52-42.175.383.55

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Partial (Type I) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type I) seizures over the treatment period standardized to 1 week period. (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionNumber of Seizures (Type I) per week (Median)
>= 1 day(d) - <= 3 months(m)> 3 m - <= 6 m> 6 m - <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV2.192.001.781.601.551.691.511.361.331.281.331.301.281.321.281.090.700.780.09
N165 Randomized Treatment PBO1.681.691.581.411.581.361.351.301.251.301.211.141.201.251.170.950.901.061.16

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Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit

"Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline." (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionPercent change (Median)
>= 1 d - <= 3 m> 3 m - <= 6 m> 6 m - <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV-31.24-34.74-43.03-43.11-46.38-43.17-49.61-52.96-53.78-47.71-43.09-39.01-44.42-47.69-71.96-80.02-78.28-81.81-90.00
N165 Randomized Treatment PBO-27.39-35.15-38.42-41.44-29.58-44.44-37.58-45.75-50.89-40.54-29.96-40.03-43.67-42.88-45.06-42.41-49.11-43.74-40.72

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Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit

"Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline." (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionPercent change (Median)
>= 1 d - <= 3 m> 3 m - <= 6 m> 6 m - <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV (FAS)-45.93-58.81-61.62-69.01-78.44-71.42-66.07-73.18-74.85-76.45-78.24-80.40-76.79-75.66-74.09-79.25-91.41-83.37-97.55
N165 Randomized Treatment PBO (FAS)-79.58-77.15-71.71-66.05-37.32-79.55-83.68-82.30-72.52-74.89-80.89-84.13-90.62-92.50-77.00-71.43-54.01-64.18-59.19

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Partial (Type IC) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period. (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionNumber of Seizures (Type IC) per week (Median)
>= 1 d - <= 3 m> 3 m - <= 6 m> 6 m - <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV0.000.000.000.000.000.000.000.000.000.000.000.000.000.000.000.000.000.000.00
N165 Randomized Treatment PBO0.000.000.050.060.060.000.000.050.020.040.090.060.040.080.040.020.000.000.00

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Partial (Type IB) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period. (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionNumber of Seizures (Type IB) per week (Median)
>= 1 d - <= 3 m> 3 m - <= 6 m> 6 m <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV1.271.130.920.720.810.810.580.730.850.980.790.961.040.770.890.270.220.190.09
N165 Randomized Treatment PBO1.561.511.301.391.341.251.251.261.211.211.251.151.281.401.220.870.740.800.72

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Partial (Type IA) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period. (NCT00160615)
Timeframe: From Baseline up to 54 months

,
InterventionNumber of Seizures (Type IA) per week (Median)
>= 1 d - <= 3 m> 3 m - <= 6 m> 6 m - <= 9 m> 9 m - <= 12 m> 12 m - <= 15 m> 15 m - <= 18 m> 18 m - <= 21 m> 21 m - <= 24 m> 24 m - <= 27 m> 27 m - <= 30 m> 30 m - <= 33 m> 33 m - <= 36 m> 36 m - <= 39 m> 39 m - <= 42 m> 42 m - <= 45 m> 45 m - <= 48 m> 48 m - <= 51 m> 51 m - <= 54 m> 54 m
N165 Randomized Treatment LEV0.680.830.630.500.220.300.420.430.250.170.250.290.130.280.440.480.180.170.08
N165 Randomized Treatment PBO0.860.320.240.260.570.270.100.170.290.440.240.170.140.170.090.200.440.620.87

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Percentage of Patients With Categorized Change From Baseline in Severity of Illness

The overall change in the severity of the subject's illness, compared to the subject's condition prior to the levetiracetam intake, was assessed by the Investigator using Investigator's Global Evaluation Scale (IGS). Categories are as following: Marked improvement; Moderate improvement; Slight improvement; No change; Slight worsening; Moderate worsening; Marked worsening. (NCT00160654)
Timeframe: Baseline, Week 16

Interventionpercentage of participants (Number)
Marked improvementModerate improvementSlight improvementNo changeSlight worseningModerate worseningMarked worsening
Levetiracetam34.125.316.517.73.22.80.4

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Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16

"100% response in seizure frequency per Week is defined as 100% reduction in seizure frequency from Baseline.~Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Interventionpercentage of participants (Number)
Partial (Type I) seizuresTotal (type I+II+III) seizures
Levetiracetam20.220.2

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Retention Rate at Week 16

Retention rate, defined as the number of subjects who were still on levetiracetam at Visit 5 (Week 16) or on the day before divided by the number of subjects in the ITT population. (NCT00160654)
Timeframe: Week 16

Interventionpercentage of participants (Number)
Levetiracetam85.3

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Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period

"Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period.~Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.~A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Interventionpercentage changes (Median)
Levetiracetam-46.43

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Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period

"Percentage change from baseline in partial (Type I) seizure frequency over the treatment period standardized to 1 week period.~Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.~A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Interventionpercentage changes (Median)
Levetiracetam-48.34

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Number of Patients With Adverse Events (AEs)

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. (NCT00160654)
Timeframe: From Baseline until Safety visit (two weeks after last dose; up to Week 18)

InterventionParticipants (Number)
Levetiracetam184

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Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16

"50% response in seizure frequency per Week is defined as >=50% reduction in seizure frequency from Baseline.~Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Interventionpercentage of participants (Number)
Partial (Type I) seizuresTotal (type I+II+III) seizures
Levetiracetam47.748.1

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The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.

"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:~visit_4 = first follow-up interval (0 to 28 days after starting study drug)~visit_5 = second follow-up interval (28 to 56 days)~visit_6 = third follow-up interval (56 to 84 days)~visit_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI" (NCT00203216)
Timeframe: Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).

Interventionmigraine attacks per month (Mean)
Levetiracetam/Transcranial Magnetic Stimulation-0.058

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Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms

"The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD." (NCT00265109)
Timeframe: Last week of treatment (week 12) or last week of treatment for early dropouts

InterventionParticipants (Count of Participants)
Open Label8

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Scores on Clinical Global Severity

The 7-point Clinical Global Severity Scale assessed current illness severity at study baseline (score of 1=normal, not at all ill, and score of 7=among the most extremely ill patients). (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam5.24.2

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Scores on Brown Assessment of Beliefs Scale

The Brown Assessment of Beliefs Scale (BABS) is a 7-item semi-structured clinician-administered scale that assesses seven components of delusionality (insight) during the past week. Scores range from 0-24, with higher scores indicating greater delusionality. Beliefs are also categorized as delusional or nondelusional using an empirically derived cutpoint. (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam14.610.4

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Scores on Beck Anxiety Inventory

The Beck Anxiety Inventory (BAI) is a reliable, valid, and widely used 21-item self-report measure of anxiety during the past week which focuses on somatic symptoms.44 The BAI has been shown to be sensitive to change. Scores range from 0-63, with higher scores reflecting more severe symptoms. (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam12.49.6

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Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.

"The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement." (NCT00265109)
Timeframe: Last week of treatment (week 12)

InterventionParticipants (Count of Participants)
Open Label8

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Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form

The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), Short Form, is a 14-item reliable and valid measure that is sensitive to change. Transformed scores range from 0 from 100, with lower scores reflecting poorer quality of life.The Short Form transformed score is reported. (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam49.557.4

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Scores on Social Phobia Inventory

The Social Phobia Inventory (SPIN) is a 17-item self-report questionnaire that assesses fear, avoidance, and physiological arousal associated with social anxiety during the past week. This scale is reliable, valid, and sensitive to change. Scores range from 0-68, with a score ≥19 distinguishing patients with social phobia from both healthy controls and psychiatric controls without social phobia. (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam32.929.4

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Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.

"The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement." (NCT00265109)
Timeframe: Last week of treatment (week 12)

InterventionParticipants (Count of Participants)
Open Label9

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Scores on Social and Occupational Functioning Scale (SOFAS)

The Social and Occupational Functioning Scale (SOFAS) is a global measure of psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam47.059.8

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Scores on Hamilton Depression Rating Scale

The 24-item Hamilton Rating Scale for Depression (HAM-D 24) is a widely used reliable and valid clinician-administered measure of current severity of depressive symptoms. Scores range from 0 to 76, with higher scores reflecting more severe depressive symptoms. (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam18.111.4

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Scores on Global Assessment of Functioning

The Global Assessment of Functioning (GAF) is a global measure of symptom severity and psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning (NCT00265109)
Timeframe: Pre- and post-treatment (week 12)

Interventionunits on a scale (Mean)
Pre-treatmentPost-treatment
Open-Label Levetiracetam46.155.8

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Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms

"The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD." (NCT00265109)
Timeframe: Last week of treatment (week 12) or last week of treatment for early dropouts

InterventionParticipants (Count of Participants)
Open Label8

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Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)

The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0-48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response. (NCT00265109)
Timeframe: Baseline to end week 12

InterventionParticipants (Count of Participants)
Open-Label Levetiracetam9

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Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months

(NCT00291655)
Timeframe: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months

Interventionkg (Mean)
Levetiracetam Open- Label Treatment0.71

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Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase

Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories). (NCT00291655)
Timeframe: during open-label therapy phase of 18 months

Interventionparticipants (Number)
Subjects with at least one AESubjects with AEs leading to dose changeSubjects with AEs leading to trial discontinuationSubjects with drug-related AEsSubjects with AEs of severe intensitySubjects with serious AEsSubjects with study drug-related serious AEsNumber of deaths
Levetiracetam Open- Label Treatment4081164600

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Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures. (NCT00367432)
Timeframe: First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)

InterventionSeizures Per Week (Median)
Levetiracetam2.13

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Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)

"The percent reduction from Baseline was computed as:~[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100.~Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures." (NCT00367432)
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

InterventionParticipants (Number)
RespondersNon-responders
Levetiracetam74239

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Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study

"Change in complex partial seizure frequency is given as a percent reduction computed as:~[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures." (NCT00367432)
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

InterventionPercent Reduction (Median)
Levetiracetam20.59

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Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study

"Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B):~[ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Other types of Seizures are all seizures except Partial Seizures (Type 1)." (NCT00367432)
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

InterventionPercent Reduction (Median)
Levetiracetam66.47

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Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study

"The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as:~[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures." (NCT00367432)
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

InterventionPercent Reduction (Median)
Levetiracetam22.00

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Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study

"Change in secondary generalized seizure frequency is given as a percent reduction computed as:~[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100.~Positive values in reduction means the value decreased from Baseline during the first 16-week Period.~Secondary generalized seizures belong to one of the 3 groups:~Simple partial sz evolving to gen sz~Complex partial sz evolving to gen sz~Simple partial sz evolving to Complex partial sz evolving to gen sz" (NCT00367432)
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

InterventionPercent Reduction (Median)
Levetiracetam76.56

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Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study

"Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A):~[ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures." (NCT00367432)
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

InterventionPercent Reduction (Median)
Levetiracetam20.71

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Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study

"Change in simple partial seizure frequency is given as a percent reduction computed as:~[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures." (NCT00367432)
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

InterventionPercent Reduction (Median)
Levetiracetam39.84

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Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)

"An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product.~Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE." (NCT00367432)
Timeframe: During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted

Interventionparticipants (Number)
Levetiracetam381

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Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population

Number of POS over the treatment period standardized to 1 week period. (NCT00368069)
Timeframe: Treatment period (12 weeks)

Interventionseizures per week (log-transformed data) (Least Squares Mean)
Keppra®0.912
Placebo1.067

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Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population

Number of POS over the treatment period standardized to 1 week period (NCT00368069)
Timeframe: Treatment Period (12 weeks)

Interventionseizures per week (log-transformed data) (Least Squares Mean)
Keppra®0.914
Placebo1.119

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50% Response in Weekly POS Frequency

A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period. (NCT00368069)
Timeframe: Treatment period (12 weeks)

,
InterventionParticipants (Number)
ResponseNon-Response
Keppra®3445
Placebo2356

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POS Seizure Frequency Per Week Over Baseline and Treatment Period

(NCT00368069)
Timeframe: Baseline Period (8 weeks) - Treatment Period (12 weeks)

,
Interventionseizures per week (Median)
Baseline POS frequency per weekTreatment POS frequency per week
Keppra®1.800.99
Placebo2.111.36

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Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks

The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration. (NCT00368069)
Timeframe: over the treatment period (12 weeks)

,
InterventionParticipants (Number)
< -25%-25% - <25%25% - <75%75% - <100%100%
Keppra®111435118
Placebo13233472

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All (Type I+II+III) Seizures Frequency Per Week

Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures) (NCT00368069)
Timeframe: Treatment period (12 weeks)

Interventionseizures per week (log-transformed data) (Least Squares Mean)
Keppra®0.928
Placebo1.086

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Clinical Global Impression-Improvement (CGI-I):

"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to very much improved; 2 equals much improved; 3 denotes minimal change; and 4 represents no change. Scores above 4 are used to indicate deterioration, i.e., 5 equals minimally worse; 6 is much worse; and 7 is very much worse." (NCT00370838)
Timeframe: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)

,
Interventionscores on a scale (Mean)
BaselineFinal
Clonidine4.14
Levetiracetam4.14.1

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Yale Global Tic Severity Scale (YGTSS):

The YGTSS is a semi-structured clinical interview designed to measure current tic severity [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). The YGTSS contains an impairment ranking, 0-50 points, based on the impact of the tic disorder on areas such as self esteem, family life, social acceptance, and school. 0=no tics present; 100=most severe tics. (NCT00370838)
Timeframe: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)

,
Interventionscores on a scale (Mean)
BaselineFinal
Clonidine48.743.1
Levetiracetam45.248.8

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Modified Pittsburgh Side Effect Scale

"Side effects will be assessed by an expanded (modified) Pittsburgh Side Effect Scale modified to include side effects of levetiracetam and clonidine. Significant adverse events will be reported to the UCB, JCCI, and FDA within 24 hours. Positive responses are tallied as number of side effects for the responding period." (NCT00370838)
Timeframe: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)

InterventionNumber of Side Effects (Mean)
Levetiracetam2.1
Clonidine3.4

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DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale:

The presence of Attention Deficit Hyperactivity Disorder (ADHD) symptoms are assessed using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) version of the DuPaul ADHD rating scale, which incorporates the symptom items for ADHD from the DSM into a rating scale format that quantifies symptom severity. Each item is rated as not at all, just a little, pretty much, and very much (0, 1, 2, and 3). There are 18 items in total are summed, with a minimum score of 0 (meaning no inattention or hyperactivity) with a maximum score of 54 (severe inattention and hyperactivity). (NCT00370838)
Timeframe: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)

,
Interventionscores on a scale (Mean)
BaselineFinal
Clonidine12.611.9
Levetiracetam12.512.7

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Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS):

The severity of obsessive-compulsive disorder (OCD) is evaluated using the CY-BOCS [Scahill et al 1997]. Obsessions and compulsions are rated on 5 separate scales yielding three summary scores: Obsessions (0-20), Compulsions (0-20) and Total score (0-40). The CY-BOCS is the most widely used instrument to assess the severity of OCD symptoms in research studies. It includes checklist of specific obsessions and compulsions followed by examiner ratings of time spent, interference, distress, resistance and control over the obsessions and compulsions.0=no obsessions or compulsions; 40=most severe OC (NCT00370838)
Timeframe: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)

,
Interventionscores on a scale (Mean)
BaselineFinal
Clonidine3.13.2
Levetiracetam4.72.2

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Multidimensional Anxiety Scale for Children (MASC):

"The child's anxiety will be followed using the multidimensional Anxiety Scale for Children (MASC) (Stallings and March, 1995) and is now considered the preferred instrument for rating childhood anxiety. It is a 39-item questionnaire, ranking each item as Never, Rarely, Sometimes, or Often (0, 1, 2, 3). The sum of all responses yeilds a score (maximum MASC score is 117). A score of 0 represents no anxiety, and a score of 117 represents severe anxiety." (NCT00370838)
Timeframe: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)

,
Interventionscores on a scale (Mean)
BaselineFinal
Clonidine25.225
Levetiracetam32.927.5

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Total Tic Score

The TTS is a portion of the YGTSS [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). A score of 0 represent no tics present, a score of 50 represents the most severe tics in each category listed. (NCT00370838)
Timeframe: Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)

,
Interventionscores on a scale (Mean)
BaselineFinal
Clonidine25.221.8
Levetiracetam22.723.6

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Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)

An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. (NCT00419393)
Timeframe: Duration of the Treatment Period (6 months-2 years)

Interventionnumber of subjects (Number)
Keppra XR126

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Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period

An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. (NCT00419393)
Timeframe: Duration of the Treatment Period (6 months-2 years)

Interventionnumber of subjects (Number)
Keppra XR5

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Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)

A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention. (NCT00419393)
Timeframe: Duration of the Treatment Period (6 months-2 years)

Interventionnumber of subjects (Number)
Keppra XR22

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Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months

Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months. (NCT00419393)
Timeframe: Study entry through 12 months

Interventionpercentage of subjects (Number)
Keppra XR65.3

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Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months

Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months. (NCT00419393)
Timeframe: Study entry through 6 months

Interventionpercentage of subjects (Number)
Keppra XR77.0

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Portland Neurotoxicity Scale (PNS) at V6

"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.~Lower values indicate better quality of life." (NCT00438451)
Timeframe: at week 58

,,
Interventionunits on a scale (Mean)
Cognitive toxicity subscoreSomatomotor subscoreTotal Score
Carbamazepine27.311.438.7
Lamotrigine23.710.834.5
Levetiracetam22.210.532.7

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Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)

Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30. (NCT00438451)
Timeframe: Week 30

Interventionpercentage of participants (Number)
Levetiracetam48
Carbamazepine39
Lamotrigine49

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Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)

Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58. (NCT00438451)
Timeframe: week 58

Interventionpercentage of participants (Number)
Levetiracetam43
Carbamazepine33
Lamotrigine38

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58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment

(NCT00438451)
Timeframe: 58 weeks

Interventionproportion of participants (Mean)
Levetiracetam0.61
Carbamazepine0.46
Lamotrigine0.56

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Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)

"Evaluation of Changes~Changes in the EpiTrack® Score were categorized as follows:~≥5 score points: Improved;~-3 to 4 score points: Unchanged;~≤-4 score points: Worsened" (NCT00438451)
Timeframe: week 58

,,
Interventionparticipants (Number)
ImprovedUnchangedWorsened
Carbamazepine16568
Lamotrigine155313
Levetiracetam15616

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The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)

"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.~The absolute seizure frequency during the maintenance phase was defined as the sum of those entries." (NCT00438451)
Timeframe: over 52 weeks

Interventionnumber of seizures (Number)
Levetiracetam168
Carbamazepine131
Lamotrigine130

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The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)

(NCT00438451)
Timeframe: over the whole duration of 58 weeks

Interventiondays (Median)
LevetiracetamNA
CarbamazepineNA
LamotrigineNA

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Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase

(NCT00438451)
Timeframe: 52 weeks

Interventionproportion of seizure-free days (Number)
Levetiracetam0.99
Carbamazepine0.99
Lamotrigine0.99

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QOLIE-31 (Quality Of Life In Epilepsy) Results at V6

The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100. (NCT00438451)
Timeframe: 58 weeks, final visit

,,
Interventionunits on a scale (Mean)
Seizure worryOverall quality of lifeEmotional well-beingEnergy/fatigueCognitive functioningMedication effectsSocial functioningTotal ScoreHealth Scale
Carbamazepine75.465.069.854.568.970.676.368.965.7
Lamotrigine75.067.167.459.868.072.676.769.167.5
Levetiracetam85.167.272.060.875.177.681.173.969.5

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Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6

"Evaluation of current testing at V6:~≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;~≤25 score points: Impaired" (NCT00438451)
Timeframe: 58 weeks

,,
Interventionparticipants (Number)
Without pathological findingsBorderlineImpaired
Carbamazepine341733
Lamotrigine311539
Levetiracetam381036

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Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6

EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45. (NCT00438451)
Timeframe: week 58

Interventionunits on a scale (Mean)
Levetiracetam26.0
Carbamazepine26.0
Lamotrigine25.4

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Time to Drop Out

number of days between randomization and premature discontinuation of the study (NCT00438451)
Timeframe: 58 weeks

Interventiondays (Median)
LevetiracetamNA
Carbamazepine265
LamotrigineNA

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Donor Chimerism at 30 Days

Number of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells. (NCT00489281)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Whole blood72092236Whole blood72092237T cells72092236T cells72092237
95-100%5-94%0-4%Unknown or not measured
Transplant - 200 cGy12
Transplant - 400 cGy8
Transplant - 200 cGy15
Transplant - 400 cGy3
Transplant - 200 cGy1
Transplant - 400 cGy1
Transplant - 200 cGy4
Transplant - 400 cGy4
Transplant - 200 cGy18
Transplant - 200 cGy5
Transplant - 400 cGy0
Transplant - 200 cGy2

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Donor Chimerism at 1 Year

Number of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells. (NCT00489281)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Whole blood72092237Whole blood72092236T cells72092237T cells72092236
95-100%Unknown or not measured5-94%0-4%
Transplant - 200 cGy6
Transplant - 400 cGy9
Transplant - 200 cGy9
Transplant - 400 cGy3
Transplant - 200 cGy1
Transplant - 400 cGy1
Transplant - 200 cGy7
Transplant - 400 cGy10
Transplant - 400 cGy2
Transplant - 200 cGy0
Transplant - 400 cGy0
Transplant - 200 cGy13

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Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received

(NCT00505934)
Timeframe: Treatment period (up to 4 days)

InterventionConsecutive doses (Mean)
Levetiracetam2.89

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Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)

(NCT00505934)
Timeframe: Treatment period (up to 4 days)

InterventionSubjects (Number)
Levetiracetam12

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Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)

(NCT00505934)
Timeframe: Treatment period (up to 4 days)

InterventionSubjects (Number)
Levetiracetam6

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Number of Participants Who Experienced a Recurrent Seizure After Treatment.

Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department. (NCT00510783)
Timeframe: 24 hours

Interventionparticipants (Number)
Phenytoin/Fosphenytoin2
Levetiracetam3

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Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received

(NCT00535392)
Timeframe: Treatment period (up to 4 days)

InterventionConsecutive doses (Mean)
Levetiracetam3.73

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Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)

(NCT00535392)
Timeframe: Treatment period (up to 4 days)

InterventionSubjects (Number)
Levetiracetam21

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Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)

(NCT00535392)
Timeframe: Treatment period (up to 4 days)

InterventionSubjects (Number)
Levetiracetam10

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Hospital Anxiety and Depression Scale (HADS) Score

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00537238)
Timeframe: Baseline, Week 16

,
Interventionunits on a scale (Least Squares Mean)
Baseline: HADS-A (n=253, 253)Baseline: HADS-D (n=253, 253)Week 16: HADS-A (n=228, 241)Week 16: HADS-D (n=228, 241)
Levetiracetam7.346.006.065.42
Pregabalin7.256.226.325.41

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Medical Outcomes Study Sleep Scale (MOS-SS) Score

Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute. (NCT00537238)
Timeframe: Baseline, Week 16

,
Interventionunits on a scale (Least Squares Mean)
Baseline: Sleep Disturbance (n=253, 253)Baseline: Snoring (n=253, 254)Baseline: Awaken Short of Breath (n=253, 254)Baseline: Quantity of Sleep (n=252, 252)Baseline: Adequacy of Sleep (n=253, 254)Baseline: Somnolence (n=253, 254)Baseline: Sleep Problem Index (9) (n=253, 253)Week 16: Sleep Disturbance (n=230, 241)Week 16: Snoring (n=230, 240)Week 16: Awaken Short of Breath (n=230, 241)Week 16: Quantity of Sleep (n=230, 241)Week 16: Adequacy of Sleep (n=230, 241)Week 16: Somnolence (n=230, 241)Week 16: Sleep Problem Index (9) (n=230, 241)
Levetiracetam28.1032.4217.267.8264.4033.7729.4923.6123.7514.277.7566.4632.2926.00
Pregabalin27.0630.7215.727.7762.9634.8529.6221.9733.7715.157.8963.4631.5626.64

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Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. (NCT00537238)
Timeframe: Baseline, Week 16

,
Interventionpercentage of participants (Number)
Baseline (n=252, 252)Week 16 (n=230, 241)
Levetiracetam55.650.2
Pregabalin56.058.3

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Percentage of Participants Without Seizures

Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. (NCT00537238)
Timeframe: Baseline up to Week 16

,
Interventionpercentage of participants (Number)
All Partial SeizureSimple Partial SeizureComplex Partial SeizureSGTC Seizure
Levetiracetam27.666.259.079.0
Pregabalin19.965.749.380.6

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Percent Change From Baseline in 28 Day Seizure Frequency at Week 16

The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. (NCT00537238)
Timeframe: Baseline, Week 16

Interventionpercent change (Median)
Pregabalin-53.93
Levetiracetam-57.28

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Proportion of Participants With Response to Treatment

Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28. (NCT00537238)
Timeframe: Baseline up to Week 16

Interventionproportion of participants (Number)
Pregabalin0.59
Levetiracetam0.59

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Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up

BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment. (NCT00537238)
Timeframe: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)

,
Interventionunits on a scale (Least Squares Mean)
Baseline: Total BPRS-A Score (n=253, 254)Baseline: Core BPRS-A Score (n=253, 254)Change at Week 7: Total BPRS-A Score (n=217, 225)Change at Week 7: Core BPRS-A Score (n=216, 225)Change at Week 10: Total BPRS-A Score (n=217, 219)Change at Week 10: Core BPRS-A Score (n=217, 219)Change at Week 13: Total BPRS-A Score (n=209, 214)Change at Week 13: Core BPRS-A Score (n=209, 214)Change at Week 16: Total BPRS-A Score (n=235, 241)Change at Week 16: Core BPRS-A Score (n=235, 241)Change at Follow-up: Total BPRS-A Score(n=178,189)Change at Follow-up: Core BPRS-A Score(n=178,189)
Levetiracetam26.095.01-1.70-0.22-2.42-0.34-2.68-0.38-1.92-0.26-1.42-0.11
Pregabalin27.265.18-2.16-0.34-2.64-0.40-2.99-0.51-2.70-0.40-2.77-0.37

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Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16

Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures. (NCT00537238)
Timeframe: Baseline, Week 16

,
Interventionpercentage of all partial seizure/28days (Mean)
Baseline (n=107, 111)Change at Week 16 (n=102, 101)
Levetiracetam38.946.33
Pregabalin39.413.93

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Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.

Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60. (NCT00566150)
Timeframe: Baseline to week 6

,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=17, n=15)Week 2 (n=15, n=14)Week 3 (n=13, n=14)Week 4 (n=11, n=13)Week 5 (n=11, n=13)Week 6 (n=10, n=11)
Levetiracetam-2.7647-3.4259-2.1243-4.3534-6.952-4.8136
Placebo-4-6.5875-6.3625-6.3851-6.4368-7.0712

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Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.

Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. (NCT00566150)
Timeframe: Baseline to week 6

,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=17, n=15)Week 2 (n=15, n=14)Week 3 (n=13, n=14)Week 4 (n=11, n=13)Week 5 (n=11, n=12)Week 6 (n=10, n=11)
Levetiracetam-3.2941-5.2319-3.384-5.5505-9.9142-6.5208
Placebo-2.7333-7.256-9.0417-8.7608-6.6591-4.5153

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Number of Subjects Who Achieve Remission.

"Remission response is measured as an HDRS-21 total score is less than or equal to 7.~HDRS-21 measures range of depressive symptoms. Endpoint is LOCF." (NCT00566150)
Timeframe: Week 6

,
InterventionParticipants (Number)
RemittedNot remitted
Levetiracetam017
Placebo411

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Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.

Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill (NCT00566150)
Timeframe: Baseline to week 6

,
Interventionscore on scale (Least Squares Mean)
Week 1 (n=17, n=15)Week 2 (n=14, n=14)Week 3 (n=13, n=14)Week 4 (n=11, n=13)Week 5 (n=11, n=12)Week 6 (n=10, n=10)
Levetiracetam-0.2941-0.3186-0.1984-0.3729-0.7325-0.5742
Placebo-0.4667-0.6956-0.7753-0.8403-0.8739-0.9294

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Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13

The primary outcome variable was the change from baseline to week 13 of the thrice weekly cocaine-free urine scores. In this repeated ordinal variable, 0 represented all 3 urine samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urine samples submitted by the subjects were negative for cocaine. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data is summarized as number of participant that were cocaine free urine (score 2) per week by group. (NCT00577005)
Timeframe: Weekly from baseline to week 12

,
Interventionparticipants that were cocaine free (Number)
Baselineweek 1week 2week 3week 4week 5week 6week 7week 8week 9week 10week 11week 12
Levetiracetam 0mg + Methadone0234424334455
Levetiracetam 3000mg + Methadone6365553344555

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Cocaine Craving

Weekly cocaine craving was measure at intake and weekly after with the Visual Analog Scale (VAS) of the Cocaine Selective Severity Assessment. The VAS measures the intensity of cocaine craving with a scale from 0 (No desire at all) to 7 (Unable to resist), and frequency of cocaine craving in the previous 24 hours with a scale from 0 ( never) to 7 ( all the time). The scale is totaled for a maximum number of 14, the minimum is 0. (Kampman et al., 1998; Mulvaney et al., 1999). (NCT00577005)
Timeframe: Weekly from baseline to week 12

,
Interventionunits on a scale (Mean)
Baselineweek 1week 2week 3week 4week 5week 6week 7week 8week 9week 10week 11week 12
Levetiracetam7.194.132.642.132.132.533.002.672.802.332.182.093.27
Placebo6.505.752.833.423.173.272.183.183.603.093.554.204.22

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Change of Thrice Weekly Opioid Free Urine Toxicology From Week 1 to 13

The secondary outcome variable was the change from baseline to week 13 of the thrice weekly opioid-free urine scores. In this repeated ordinal variable, 0 represented all 3 urines samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urines samples submitted by the subjects were negative for opioids excluding methadone. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data summarized by number of participants who were had opioid free urine samples (score 2) per week by group. (NCT00577005)
Timeframe: Weekly from baseline to week 12

,
Interventionparticipants with opioid free urine (Number)
Baselineweek 1week 2week 3week 4week 5week 6week 7week 8week 9week 10week 11week 12
Levetiracetam 0mg + Methadone4346344644555
Levetiracetam 3000mg + Methadone4575687556685

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Treatment Retention

Weekly from week 1 to 13 (NCT00577005)
Timeframe: Week 13

Interventionparticipants (Number)
Levetiracetam 3000mg + Methadone13
Levetiracetam 0mg + Methadone9

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Disability Rating Scale (DRS)

The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable. (NCT00618436)
Timeframe: Discharge; 3 and 6 months following injury

,
Interventionunits on a scale (Mean)
At DischargeAt 3 monthsAt 6 months
Levetiracetam241517
Phenytoin23139

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Seizure Incidence

This was the number of patients in each group who demonstrated seizure activity during the course of the study (NCT00618436)
Timeframe: Duration of study, up to 6 months after the injury

InterventionParticipants (Number)
Levetiracetam5
Phenytoin3

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Extended Glasgow Outcome Score

This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls. (NCT00618436)
Timeframe: at discharge; 3 and 6 months following injury

,
Interventionunits on a scale (Mean)
At DischargeAt 3 monthsAt 6 months
Levetiracetam233
Phenytoin233

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00849485)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam176.267
Keppra®174.729

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00849485)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam186.758
Keppra®186.899

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00849485)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg/mL (Mean)
Levetiracetam19.635
Keppra®20.054

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00849862)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg/mL (Mean)
Levetiracetam21.625
Keppra®23.501

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AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00849862)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam173.932
Keppra®174.275

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00849862)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam186.097
Keppra®185.293

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Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment

(NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)

Interventionpercent change (Median)
All Antiepileptic Drugs-75.0

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Percent of Participants Classified as Responders

Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline). (NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)

Interventionpercent of participants (Number)
Month 3Month 6
All Antiepileptic Drugs76.780.0

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Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)

MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night. (NCT00855738)
Timeframe: Baseline, Month 6

Interventionpercent of participants (Number)
BaselineMonth 6
All Antiepileptic Drugs56.565.7

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Percent of Participants Reaching Monotherapy

Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study. (NCT00855738)
Timeframe: Baseline through Month 6 (or end of study)

Interventionpercent of partipants (Number)
All Antiepileptic Drugs2.9

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Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy

(NCT00855738)
Timeframe: Baseline through Month 6 (or end of treatment)

Interventionpercent of participants (Number)
ReducedMaintainedIncreased
All Antiepileptic Drugs0.0100.00.0

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Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)

(NCT00855738)
Timeframe: Baseline to Month 6 (or end of treatment)

Interventionpercent of participants (Number)
ReducedMaintainedIncreased
All Antiepileptic Drugs0.968.530.6

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Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit

Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU). (NCT00855738)
Timeframe: Month 6

Interventionpercent of participants (Number)
Stopped Usual OccupationRequired Informal CaregiverRequired Admission to ICU
All Antiepileptic Drugs16.26.60.0

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Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation

(NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)

Interventionpercent of participants (Number)
Month 3Month 6
All Antiepileptic Drugs10.020.0

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Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment

Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit. (NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)

Interventionpercent of participants (Number)
Month 3: >=25%Month 3: >=75%Month 6: >= 25%Month 6: >=75%
All Antiepileptic Drugs86.727.886.754.4

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Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)

Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night). (NCT00855738)
Timeframe: Baseline to Month 6

Interventionscores on scale (Mean)
Sleep disturbanceSnoringAwake short of breathQuantityAdequacySomnolenceSleep problems (summary 6)Sleep problems (summary 9)
All Antiepileptic Drugs-1.70.01.10.22.80.6-0.9-0.9

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Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy

Numerical assessment of change in total number of days hospitalized because of epilepsy during the study. (NCT00855738)
Timeframe: Baseline to Month 6

InterventionDays (Mean)
All Antiepileptic Drugs-8.0

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Percent of Participants Who Continued on Study Medication to Month 6

Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study. (NCT00855738)
Timeframe: Baseline to Month 6

Interventionpercent of participants (Number)
All Antiepileptic Drugs97.1

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Time to First Seizure

Number of days to first seizure after baseline. (NCT00855738)
Timeframe: Baseline to Month 6 (or end of treatment)

Interventiondays (Mean)
All Antiepileptic Drugs35.9

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Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)

QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life. (NCT00855738)
Timeframe: Baseline to Month 6

Interventionscores on scale (Mean)
EnergyEmotions (mood)Daily activitiesMental functionMedication effects (physical/ mental)Worry about seizures (impact of seizures)Overall quality of life
All Antiepileptic Drugs0.40.70.61.2-1.19.03.8

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Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)

HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00855738)
Timeframe: Baseline to Month 6

Interventionscores on scale (Mean)
DepressionAnxiety
All Antiepileptic Drugs-0.5-0.6

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Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy

Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study. (NCT00855738)
Timeframe: Baseline to Month 6

Interventionvisits (Mean)
Number of visits to a specialist (n=94)Number of visits to the emergency room (n=79)
All Antiepileptic Drugs-0.6-0.3

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Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)

Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. (NCT00855738)
Timeframe: Baseline, Month 3, Month 6

Interventionscores on scale (Mean)
Month 3Month 6
All Antiepileptic Drugs-0.41.2

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00859430)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg/mL (Mean)
Levetiracetam26.320
Keppra®24.927

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00859430)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam249.260
Keppra®252.523

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00859430)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam261.018
Keppra®263.968

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AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t (NCT00859521)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam269.172
Keppra®272.498

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Cmax - Maximum Observed Concentration

Bioequivalence based on Cmax (NCT00859521)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg/mL (Mean)
Levetiracetam30.281
Keppra®31.512

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AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT00859521)
Timeframe: Blood samples collected over 36 hour period

Interventionmcg*h/mL (Mean)
Levetiracetam281.155
Keppra®285.645

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Controlled Word Association Test (COWAT)- Letter Fluency

Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown. (NCT00862563)
Timeframe: Baseline & Week 12

,,,
InterventionNumber of Words Produced (Mean)
BaselineWeek 12
Levetiracetam46.245.4
Sugar Pill47.450.5
Topiramate43.428.1
Zonisamide46.532.5

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COWAT-Category

Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced. (NCT00862563)
Timeframe: Baseline, Week12

,,,
InterventionNumber of Words Produced (Mean)
BaselineWeek 12
Levetiracetam20.921.2
Sugar Pill21.620.8
Topiramate21.917.0
Zonisamide22.617.4

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Percent Days Drinking

Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor. (NCT00862563)
Timeframe: Weeks 10, 11, 12

,,,
InterventionPercentage of Days/ Week (Mean)
Week 10Week 11Week 12
Levetiracetam72.268.973.1
Sugar Pill83.687.278.2
Topiramate51.843.851.4
Zonisamide61.662.161.3

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Mean Percent Days Heavy Drinking

Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men. (NCT00862563)
Timeframe: Weeks 10, 11, 12

,,,
InterventionPercentage of Days/Week (Mean)
Week 10Week 11Week 12
Levetiracetam49.647.944.5
Sugar Pill65.761.760.9
Topiramate32.129.521.0
Zonisamide38.436.634.3

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AB-Neurotoxicity Scale.

Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. (NCT00862563)
Timeframe: Week 12

InterventionScale Scores (Mean)
Zonisamide7.1
Levetiracetam11.3
Topiramate15.4
Sugar Pill5.8

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Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total

WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task. (NCT00862563)
Timeframe: Baseline, Week 12

,,,
Interventionunits on a scale (Mean)
BaselineWeek 12
Levetiracetam11.912.2
Sugar Pill12.613.0
Topiramate12.17.7
Zonisamide11.810.0

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Wechsler Memory Scale-3rd Ed. Spatial Span

WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance. (NCT00862563)
Timeframe: Baseline, Week 12

,,,
Interventionunits on a scale (Mean)
BaselineWeek 12
Levetiracetam10.510.9
Sugar Pill10.810.4
Topiramate12.08.4
Zonisamide10.87.9

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The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties.

Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor. (NCT00862563)
Timeframe: Weeks 10, 11, 12

,,,
InterventionStandard Drinks per day (Mean)
Week 10Week 11Week 12
Levetiracetam4.64.34.3
Sugar Pill6.36.86.0
Topiramate3.22.72.5
Zonisamide3.83.42.5

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Levetiracetam Treated Number of Participants With Serious Adverse Events

(NCT00884052)
Timeframe: 7 Days

InterventionParticipants (Count of Participants)
Levetiracetam Low Dose0
Levetiracetam High Dose1

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Drug Half Life

(NCT00884052)
Timeframe: Day 1 and Day 7

Interventionhr (Mean)
Day 1Day 7
All Participants18.59.1

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Drug Clearance

(NCT00884052)
Timeframe: Day 1 and Day 7

Interventionml/min/kg (Mean)
Day 1Day 7
All Participants0.711.31

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionnumber recalled (Mean)
No Treatment1.09
Levetiracetam.17

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy

Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionpercentage of correct responses (Mean)
No Treatment.02
Levetiracetam.1

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time

Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment34.96
Levetiracetam.45

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy

Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionpercentage of correct responses (Mean)
No Treatment-0.01
Levetiracetam.01

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay

Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionnumber recalled (Mean)
No Treatment1.55
Levetiracetam2.67

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay

Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionnumber recalled (Mean)
No Treatment1.27
Levetiracetam-0.4

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning

Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled. (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionnumber recalled (Mean)
No Treatment8.09
Levetiracetam5.5

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score

Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
No Treatment2.45
Levetiracetam2.5

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency

Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
No Treatment2.8
Levetiracetam.83

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span

Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards. (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionnumber recalled (Mean)
No Treatment.73
Levetiracetam-.33

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol

Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
No Treatment3.2
Levetiracetam1.5

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy

Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionpercentage of correct responses (Mean)
No Treatment.01
Levetiracetam.03

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time

Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment-66.76
Levetiracetam.61

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard

Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment-4.73
Levetiracetam-4.36

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS

Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence. (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
No Treatment.18
Levetiracetam-0.5

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE

Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
No Treatment0.18
Levetiracetam1.5

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy

Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionpercentage of correct responses (Mean)
No Treatment-.01
Levetiracetam0

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time

Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment-31.99
Levetiracetam-25.54

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE

Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
Levetiracetam19.6

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span

Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards. (NCT00916149)
Timeframe: 1 and 11 Weeks

Interventionnumber recalled (Mean)
No Treatment.36
Levetiracetam-1.67

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop

Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment.98
Levetiracetam-7.3

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test

Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment-9.51
Levetiracetam11.29

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency

Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
No Treatment-1.55
Levetiracetam-.83

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy

Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionpercentage of correct responses (Mean)
No Treatment.02
Levetiracetam.14

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time

Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment2.98
Levetiracetam-6.1

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy

Change in Verbal Working Memory Accuracy Score (range 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionpercentage of correct responses (Mean)
No Treatment0
Levetiracetam-.02

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time

Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment-54.76
Levetiracetam-9.36

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)

Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionseconds (Mean)
No Treatment1.04
Levetiracetam-11.33

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Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment

This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls. (NCT00916149)
Timeframe: 1 and 11 weeks

InterventionIEDs/hour (Mean)
No Treatment-28.8
Levetiracetam.54

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)

Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionscores on a scale (Mean)
No Treatment-1.27
Levetiracetam1

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionnumber recalled (Mean)
No Treatment.36
Levetiracetam.33

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Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial) (NCT00916149)
Timeframe: 1 and 11 weeks

Interventionnumber recalled (Mean)
No Treatment.45
Levetiracetam.33

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Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration

The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. (NCT00961441)
Timeframe: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.

InterventionL/h (Geometric Mean)
Keppra XR in Children (12-16 Years Old)3.78
Keppra XR in Adults (18-55 Years Old)4.23

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Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration

"AUCtau normalized by 1000 mg dose was calculated as:~AUCtau/(mg dose taken/ 1000 mg Keppra XR).~AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken).~6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau." (NCT00961441)
Timeframe: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.

,
Interventionµg*h/mL (Geometric Mean)
Dose norm. (Keppra XR 1000mg)Dose and weight norm. (Keppra XR 1 mg/kg)
Keppra XR in Adults (18-55 Years Old)23619.6
Keppra XR in Children (12-16 Years Old)26519.4

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Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days

An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration. (NCT00961441)
Timeframe: From Starting Study Drug Treatment (Day 1) to up to 14 days

,
InterventionCount (Number)
Total number of AEsPatients with at least 1 AEPatients with severe AEsPatients with serious AEs
Keppra XR in Adults (18-55 Years Old)11310
Keppra XR in Children (12-16 Years Old)7300

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Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration

"The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose.~Cmax normalized by 1000 mg dose was calculated as:~Cmax/(mg dose taken/ 1000 mg Keppra XR).~Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~Cmax/(bodyweight (kg)/ mg dose Keppra XR taken).~Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration." (NCT00961441)
Timeframe: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.

,
Interventionµg/mL (Geometric Mean)
Dose norm. ( Keppra XR 1000mg)Dose and weight norm. ( Keppra XR 1 mg/kg)
Keppra XR in Adults (18-55 Years Old)14.91.24
Keppra XR in Children (12-16 Years Old)17.31.27

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Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration

The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. (NCT00961441)
Timeframe: 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.

Interventionhours (h) (Median)
Keppra XR in Children (12-16 Years Old)5.90
Keppra XR in Adults (18-55 Years Old)5.93

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The Number of Drinks Per Drinking Day Study Weeks 5-14.

based on self report (NCT00970814)
Timeframe: Study Weeks 5-14

Interventiondrinks per day (Least Squares Mean)
Sugar Pill and BBCET6.3
Levetiracetam and BBCET7.1

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The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.

A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report. (NCT00970814)
Timeframe: Weeks 5-14

Interventionpercentage of subjects (Number)
Sugar Pill and BBCET18.2
Levetiracetam and BBCET14.1

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The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.

A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report. (NCT00970814)
Timeframe: Study Weeks 5-14

Interventionpercentage of heavy drinking days (Least Squares Mean)
Sugar Pill and BBCET41.2
Levetiracetam and BBCET45.8

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Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI

Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects. (NCT01044758)
Timeframe: 2 weeks

Interventionmean beta coefficient (Mean)
aMCI_62.5-0.1203
aMCI_62.5 Placebo0.4353
aMCI_125-0.2238
aMCI_125 Placebo0.8814
aMCI_2500.3928
aMCI_250 Placebo0.4825
Age Matched Control-.02507

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Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task

Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance. (NCT01044758)
Timeframe: 2 weeks

Interventionpercent correct recalled (Mean)
aMCI_62.538
aMCI_62.5 Placebo33
aMCI_12533
aMCI_125 Placebo28
aMCI_25034
aMCI_250 Placebo31
Age Matched Control44

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Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period

"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))

Interventionpercentage of participants (Number)
Levetiracetam38.4

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Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period

"The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:~(B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)

InterventionPercent reduction (Median)
Levetiracetam39.02

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Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period

"The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:~(B values- T values) / B values x 100.~Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22

InterventionPercent reduction (Median)
Levetiracetam43.21

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Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)

An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR. (NCT01063764)
Timeframe: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)

Interventionparticipants (Number)
Levetiracetam15

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Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)

An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE. (NCT01063764)
Timeframe: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)

Interventionpercentage of participants (Number)
Levetiracetam98.2

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Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period

"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)

InterventionSeizures per week (Median)
Levetiracetam3.90

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Number of Seizure-free Subjects Over the 14-weeks Treatment Period

"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))

Interventionparticipants (Number)
Levetiracetam2

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Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period

"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))

InterventionSeizures per week (Median)
Levetiracetam3.92

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Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period

"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)

Interventionpercentage of participants (Number)
Levetiracetam38.2

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Number of Seizure-free Subjects Over the 10-weeks Evaluation Period

"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures." (NCT01063764)
Timeframe: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)

Interventionparticipants (Number)
Levetiracetam3

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Standard Alcoholic Drinks Per Treatment Period

The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period. (NCT01168687)
Timeframe: During each 14 day treatment period

Interventionnumber of drinks per treatment period (Mean)
All Subjects (n = 46) Placebo41.2
All Subjects (n = 46) Levetiracetam45.4

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Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)

"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline" (NCT01228747)
Timeframe: From Baseline to Week 28

InterventionPercentage Change (Mean)
Placebo-13.19
Levetiracetam-68.22

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Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period

"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline" (NCT01228747)
Timeframe: From Baseline to Week 28

Interventionparticipants (Number)
Placebo31
Levetiracetam91

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Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period

"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline" (NCT01228747)
Timeframe: From Baseline to Evaluation Period (Week 12 to Week 28)

Interventionparticipants (Number)
Placebo33
Levetiracetam82

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Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period

A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period. (NCT01228747)
Timeframe: Evaluation Period (Week 12 to Week 28)

Interventionparticipants (Number)
Placebo3
Levetiracetam32

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The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period

"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline." (NCT01228747)
Timeframe: From Baseline to Evaluation Period (Week 12 to Week 28)

InterventionPercentage Change (Mean)
Placebo-4.44
Levetiracetam-68.27

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Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52

(NCT01229735)
Timeframe: From Baseline to Week 52

Interventionresponders (Number)
Levetiracetam (Full Analysis Set)120
Topiramate (Full Analysis Set)107

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Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate

(NCT01229735)
Timeframe: From Baseline to Week 52

Interventionpercentage of subjects (Number)
Levetiracetam (Full Analysis Set)59.1
Topiramate (Full Analysis Set)56.6

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Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)

(NCT01229735)
Timeframe: From Baseline to Week 52

Interventionmonth (Median)
LevetiracetamNA
TopiramateNA

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Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52

(NCT01229735)
Timeframe: From Baseline to Week 52

InterventionParticipants (Number)
Levetiracetam125
Topiramate128

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Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52

Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value. (NCT01229735)
Timeframe: From Baseline to Week 52

Interventionpercent reduction (Median)
Levetiracetam (Full Analysis Set)74.47
Topiramate (Full Analysis Set)67.86

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Pharmacokinetic Profile

3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm. (NCT01239212)
Timeframe: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)

Interventionml/min/kg (Median)
Single Arm, 50 mg/kg of Levetiracetam0.51

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Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period

The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period. (NCT01292837)
Timeframe: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)

Interventionpercentage of participants (Number)
Levetiracetam53.8

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Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period

A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period. (NCT01292837)
Timeframe: Evaluation Period (Week 4 to Week 24)

Interventionparticipants (Number)
Levetiracetam2

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Generalized Tonic-clonic Seizure Freedom Over the Treatment Period

A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period. (NCT01292837)
Timeframe: Treatment Period (Week 0 to Week 24)

Interventionparticipants (Number)
Levetiracetam2

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The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)

"The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - T)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7" (NCT01292837)
Timeframe: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)

Interventionpercent change (Mean)
Levetiracetam45.47

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Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period

The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period. (NCT01292837)
Timeframe: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)

Interventionpercentage of participants (Number)
Levetiracetam58.3

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The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period

"The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - E)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7" (NCT01292837)
Timeframe: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)

Interventionpercent change (Mean)
Levetiracetam44.93

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ADAS-cog at Baseline and at 3 Months.

"ADAScog (Alzheimer's Disease Assessment Scale-cognitive subscale) consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Score ranges from 0 - 70.~Lower scores (negative change) indicate improvements on the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog)." (NCT01318408)
Timeframe: Baseline and Three (3) months

Interventionunits on a scale (Mean)
BaselineChange at 3 months
Open Label25.5-4.3

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MMSE at Baseline and at Three (3) Months.

The MMSE (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of Food and Drug Administration (FDA) products approved for the treatment of AD. The MMSE consists of five components; 1) orientation to time and place, 2) registration of three words, 3) attention and calculation, 4) recall of three words, and 5) language. The scores from each of the five components are summed to obtain the overall MMSE score. The score can range from 0 to 30, with lower scores indicating greater impairment in function. (NCT01318408)
Timeframe: Baseline and Three months

Interventionunits on a scale (Mean)
BaselineChange at 3 Months
Open Label18.22.2

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Retention Rate

Retention rate is defined as the percentage of participants who remained on the study drug after study completion. (NCT01345058)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
Lacosamide + Low-Dose Levetiracetam89
Control Group (High-Dose Levetiracetam)80

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Time to First Seizure After Therapeutic Dose is Reached

Time in days until the first seizure after the therapeutic dose is reached occurs. (NCT01345058)
Timeframe: 6 Months

Interventiondays (Median)
Lacosamide + Low-Dose Levetiracetam162.0
Control Group (High-Dose Levetiracetam)116.5

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Percentage of Participants Achieving Six Month Seizure Freedom

Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug. (NCT01345058)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
Lacosamide + Low-Dose Levetiracetam47.4
Control Group (High-Dose Levetiracetam)41.7

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Number of Seizure-Free Days

(NCT01345058)
Timeframe: 6 Months

Interventiondays (Mean)
Lacosamide + Low-Dose Levetiracetam118.11
Control Group (High-Dose Levetiracetam)114.0

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Number of Participants With Treatment-Emergent Adverse Events (TEAE)

An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug. (NCT01345058)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
Lacosamide + Low-Dose Levetiracetam11
Control Group (High-Dose Levetiracetam)26

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Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

Interventionmmol/L (Median)
Lacosamide-0.540

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Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

Interventionnmol/L (Median)
Lacosamide-12.80

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Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

InterventionFree Androgen Index (Median)
Lacosamide9.493

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Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

Interventionpmol/L (Median)
Lacosamide2.70

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Incidence of Treatment Emergent Adverse Events During the Entire Study Period

(NCT01398956)
Timeframe: Through study completion, an average of 3 years

InterventionTreatment Emergent Adverse Events (Number)
Levetiracetam (SS)626

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The Incidence of Adverse Drug Reactions During the Entire Study Period

Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug. (NCT01398956)
Timeframe: Through study completion, an average of 3 years

InterventionAdverse Drug Reactions (Number)
Levetiracetam (SS)46

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Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4

"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg." (NCT01407523)
Timeframe: Day 4

Interventionmicrograms per milliliter (µg/mL) (Geometric Mean)
Levetiracetam5.492

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Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)

An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (NCT01407523)
Timeframe: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)

Interventionparticipants (Number)
Levetiracetam5

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Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)

A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention. (NCT01407523)
Timeframe: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)

Interventionparticipants (Number)
Levetiracetam0

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Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4

Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. (NCT01407523)
Timeframe: Day 4

Interventionmicrograms per milliliter (µg/mL) (Geometric Mean)
Levetiracetam11.632

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Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures. (NCT01407523)
Timeframe: During the Evaluation Period (Day 1 to Day 4)

InterventionSeizures per day (Median)
Levetiracetam0.38

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Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1

Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. (NCT01407523)
Timeframe: Day 1

Interventionmicrograms per milliliter (µg/mL) (Geometric Mean)
Levetiracetam11.732

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Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1

"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg." (NCT01407523)
Timeframe: Day 1

Interventionmicrograms per milliliter (µg/mL) (Geometric Mean)
Levetiracetam6.611

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Post-Traumatic Epilepsy

occurrence of PTE (Post-Traumatic Epilepsy) (NCT01463033)
Timeframe: 2 years

Interventionparticipants (Number)
Levetiracetam6
Observational8

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Adverse Events

The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. (NCT01463033)
Timeframe: 30 day treatment period

InterventionEvents (Number)
HeadacheFatigueDrowsinessMemory ImpairmentAmnesiaPainIrritabilityDizzinessAnorexiaEmotional labilityInsomniaCognitive changesAtaxiaDepressionHostilityVertigoNauseaCoughNervousnessParaesthesiaWeight gainHallucinationsOtherDiplopiaSuicidalityPsychosis
Participants28282098151010675767312253152333

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Duration of Survival

(NCT01464359)
Timeframe: 6 months after Transplantation.

InterventionParticipants (Count of Participants)
Patients With Acute Myelogenous Leukemia1

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Disease Free Survival

The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo. (NCT01464359)
Timeframe: At 3 months

Interventionparticipants (Number)
Patients With Acute Myelogenous Leukemia1

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Incidence of Acute Graft-Versus-Host Disease

(NCT01464359)
Timeframe: Day 60

InterventionParticipants (Count of Participants)
Patients With Acute Myelogenous Leukemia0

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Clinical Disease Response

Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 2 years from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only untilthe resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care. (NCT01464359)
Timeframe: 2 Years from Transplantation

InterventionParticipants (Count of Participants)
Patients With Acute Myelogenous Leukemia2

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Duration of Survival

(NCT01464359)
Timeframe: 2 years after Transplantation.

InterventionParticipants (Count of Participants)
Patients With Acute Myelogenous Leukemia0

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Duration of Survival

(NCT01464359)
Timeframe: 1 year after Transplantation.

InterventionParticipants (Count of Participants)
Patients With Acute Myelogenous Leukemia0

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Clinical Disease Response

Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 1 year from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only until the resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care. (NCT01464359)
Timeframe: 1 Year from Transplantation

InterventionParticipants (Count of Participants)
Patients With Acute Myelogenous Leukemia2

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Incidence of Graft Failure

Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) (NCT01464359)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Patients With Acute Myelogenous Leukemia0

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Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D

"Cmax refers to the maximum observed concentration of ucb L057.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionµg/mL (Geometric Mean)
Group A: Normal Renal Function0.3620
Group B: Mild Renal Impairment0.7503
Group C: Moderate Renal Impairment0.5674
Group D: Severe Renal Impairment1.0640

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Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period

Cmax refers to the maximum observed concentration of ucb L057. (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

Interventionµg/mL (Geometric Mean)
Group E: End-stage Renal Disease8.8435

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Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E

Calculated according: CLHD=CLD+CLUF. (NCT01491113)
Timeframe: From 44 hours to 48 hours post first dose

InterventionmL/min (Geometric Mean)
Group E: End-stage Renal Disease115.3702

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Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E

Calculated by the Arterio - Venous difference method and cumulative dialysate method. (NCT01491113)
Timeframe: From 44 hours to 48 hours post first dose

InterventionmL/min (Geometric Mean)
Group E: End-stage Renal Disease113.9665

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Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D

"Cmax refers to the maximum observed concentration of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionµg/mL (Geometric Mean)
Group A: Normal Renal Function21.9357
Group B: Mild Renal Impairment15.5334
Group C: Moderate Renal Impairment10.7767
Group D: Severe Renal Impairment9.1754

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Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period

Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam). (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

Interventionµg/mL (Geometric Mean)
Group E: End-stage Renal Disease18.6810

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Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D

"Ae refers to the total amount of ucb L059 (Levetiracetam) excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionmg (Geometric Mean)
Group A: Normal Renal Function304.7321
Group B: Mild Renal Impairment247.6562
Group C: Moderate Renal Impairment98.7182
Group D: Severe Renal Impairment74.3761

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Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D

"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

InterventionL/h (Geometric Mean)
Group A: Normal Renal Function2.9359
Group B: Mild Renal Impairment1.9826
Group C: Moderate Renal Impairment1.4362
Group D: Severe Renal Impairment1.1484

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Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period

"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Geometric mean and Coefficient of Variation (CV) was not calculated since the extrapolated part of the AUC was greater than 20 %." (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

InterventionL/h (Median)
Group E: End-stage Renal Disease0.629

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Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E

AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

Interventionh*µg/mL (Geometric Mean)
Group E: End-stage Renal Disease230.4393

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Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D

"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionh*µg/mL (Geometric Mean)
Group A: Normal Renal Function5.8607
Group B: Mild Renal Impairment22.5573
Group C: Moderate Renal Impairment18.6675
Group D: Severe Renal Impairment57.7773

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Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E

AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

Interventionh*µg/mL (Geometric Mean)
Group E: End-stage Renal Disease462.4883

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Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D

"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionh*µg/mL (Geometric Mean)
Group A: Normal Renal Function165.9996
Group B: Mild Renal Impairment247.6430
Group C: Moderate Renal Impairment169.3392
Group D: Severe Renal Impairment212.1193

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Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D

"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionh*µg/mL (Median)
Group A: Normal Renal Function8.176
Group B: Mild Renal Impairment32.401
Group C: Moderate Renal Impairment27.441
Group D: Severe Renal Impairment63.126

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Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E

Calculated by the Arterio - Venous difference method and cumulative dialysate method. (NCT01491113)
Timeframe: From 44 hours to 48 hours post first dose

InterventionmL/min (Geometric Mean)
Group E: End-stage Renal Disease1.3271

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Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D

"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionh*µg/mL (Geometric Mean)
Group A: Normal Renal Function170.3045
Group B: Mild Renal Impairment252.1923
Group C: Moderate Renal Impairment174.0764
Group D: Severe Renal Impairment217.6854

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Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D

"fe refers to the fraction of dose excreted in urine of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

InterventionPercentage of Dose Administered (Geometric Mean)
Group A: Normal Renal Function60.9464
Group B: Mild Renal Impairment49.5312
Group C: Moderate Renal Impairment39.4873
Group D: Severe Renal Impairment29.7504

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Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E

"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %." (NCT01491113)
Timeframe: From Baseline to 140 hours post first dose

Interventionh*µg/mL (Median)
Group E: End-stage Renal Disease794.588

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Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D

"The Non-Renal Clearance (CLNR) describes the removal of drug by organs other than the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

InterventionL/h (Geometric Mean)
Group A: Normal Renal Function1.0712
Group B: Mild Renal Impairment0.9873
Group C: Moderate Renal Impairment0.8636
Group D: Severe Renal Impairment0.7848

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Renal Clearance (CLR) of Ucb L057 for Groups A to D

"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

InterventionL/h (Geometric Mean)
Group A: Normal Renal Function14.6937
Group B: Mild Renal Impairment6.8015
Group C: Moderate Renal Impairment4.6828
Group D: Severe Renal Impairment1.6475

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Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D

"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

InterventionL/h (Geometric Mean)
Group A: Normal Renal Function1.8622
Group B: Mild Renal Impairment0.9820
Group C: Moderate Renal Impairment0.5671
Group D: Severe Renal Impairment0.3417

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Terminal Half-life (t1/2) of Ucb L057 for Groups A to D

"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionhours (Median)
Group A: Normal Renal Function12.351
Group B: Mild Renal Impairment19.030
Group C: Moderate Renal Impairment20.303
Group D: Severe Renal Impairment26.769

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Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period

"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %." (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

Interventionhours (Median)
Group E: End-stage Renal Disease34.669

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Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D

"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionhours (Geometric Mean)
Group A: Normal Renal Function7.6164
Group B: Mild Renal Impairment12.6214
Group C: Moderate Renal Impairment15.5033
Group D: Severe Renal Impairment19.7320

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Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period

tmax refers to the time to reach maximum plasma concentration (tmax). (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

Interventionhours (Median)
Group E: End-stage Renal Disease44.020

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Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D

"tmax refers to the time to reach maximum plasma concentration (tmax).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionhours (Median)
Group A: Normal Renal Function5.000
Group B: Mild Renal Impairment8.000
Group C: Moderate Renal Impairment12.000
Group D: Severe Renal Impairment24.000

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Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D

"tmax refers to the time to reach maximum plasma concentration of ucb L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionhours (Median)
Group A: Normal Renal Function0.500
Group B: Mild Renal Impairment1.000
Group C: Moderate Renal Impairment0.500
Group D: Severe Renal Impairment0.500

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Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period

tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam). (NCT01491113)
Timeframe: From Baseline to 44 hours post first dose

Interventionhours (Median)
Group E: End-stage Renal Disease0.720

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Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D

"Ae refers to the total amount of ucb L057 excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours" (NCT01491113)
Timeframe: From Baseline up to 144 hours post first dose

Interventionmg (Geometric Mean)
Group A: Normal Renal Function83.5936
Group B: Mild Renal Impairment169.3395
Group C: Moderate Renal Impairment93.1346
Group D: Severe Renal Impairment100.7489

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Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period

48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period (NCT01498822)
Timeframe: From Week 2 to Week 50 (During Treatment Period )

Interventionpercentage of subjects (Number)
Full Analysis Set (LEV Treated Subjects)34.7
Full Analysis Set (OXC Treated Subjects)40.9

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Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time

24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time (NCT01498822)
Timeframe: From Week 2 to Week 50 (During Treatment Period )

Interventionpercentage of subjects (Number)
Full Analysis Set (LEV Treated Subjects)53.8
Full Analysis Set (OXC Treated Subjects)58.5

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Percentage of Subjects With a Treatment Failure

Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication. (NCT01498822)
Timeframe: Week 0 (First Dose) to Week 50

Interventionpercentage of subjects (Number)
Per Protocol Set (LEV Treated Subjects)12.7
Per Protocol Set (OXC Treated Subjects)23.4

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Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period

(NCT01498822)
Timeframe: From Week 2 to Week 50 (During Treatment Period )

Interventionmonths (Median)
Full Analysis Set (LEV Treated Subjects)7.556
Full Analysis Set (OXC Treated Subjects)NA

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Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period

Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs. (NCT01506882)
Timeframe: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

Interventionpercentage of participants (Number)
Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)59.0

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Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period

"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period." (NCT01506882)
Timeframe: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

Interventionpercentage of participants (Number)
Levetiracetam 3000 mg/Day Group22.2

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Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period

Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs. (NCT01506882)
Timeframe: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

Interventionpercentage of participants (Number)
Full Analysis Set (LEV 3000 mg/Day Group)11.1

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Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve." (NCT01506882)
Timeframe: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year

Interventiondays (Median)
Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)NA

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Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group

"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve." (NCT01506882)
Timeframe: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year

Interventiondays (Median)
Full Analysis Set (LEV 3000 mg/Day Group)106

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Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

Median time to withdrawal will be estimated from the Kaplan-Meier curve. (NCT01506882)
Timeframe: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year

Interventiondays (Median)
Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)NA

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Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group

Median time to withdrawal will be estimated from the Kaplan-Meier curve. (NCT01506882)
Timeframe: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year

Interventiondays (Median)
Levetiracetam 3000 mg/Day Group91

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Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period

"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period." (NCT01506882)
Timeframe: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

Interventionpercentage of participants (Number)
Levetiracetam 1000 mg/Day to 2000 mg/Day Group73.8

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Free and Cued Selective Reminding Test

Evaluate memory changes, the free and cued selective reminding test lists the number of items recalled from a possibility of 16, adding free recall at two time points, yielding a score on a 0-32 scale per participant. A higher score is better, representing better recall. (NCT01554683)
Timeframe: At visits 2,3,4 in weeks 1-6 (one visit per intervention, visits spaced 2 weeks apart)

Interventionscore on a scale (Mean)
High Dose Levetiracetam13.4
Low Dose Levetiracetam14.3
Placebo Administration15

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Montreal Cognitive Assessment (MoCA)

Evaluate AD severity, this is a 30 point scale from 0-30, with higher scores representing better performance. (NCT01554683)
Timeframe: At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart

Interventionscore on a scale (Mean)
High Dose Levetiracetam21.4
Low Dose Levetiracetam21.4
Placebo Administration20.4

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Number of Participants With Evaluable fMRI Scans

Number of participants who had evaluable fMRI scans with arterial spin labeling to measure brain perfusion blood flow changes in specific brain regions, including the hippocampus (NCT01554683)
Timeframe: 3 MRIs acquired at visit 2,3 and 4 between weeks 1 and 6

,,
Interventionparticipants (Number)
temporal lobe perfusionFrontal lobe perfusion
High Dose Levetiracetam99
Low Dose Levetiracetam99
Placebo Administration99

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Trial Making Test Parts A & B

Evaluate visuo-spatial changes, outcome is total time to complete a task of connecting items (either numbers in trails A, or numbers alternating with letters in Trails B). A longer time indicates worse performance. (NCT01554683)
Timeframe: At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*

,,
Interventionseconds (Geometric Mean)
Trails ATrails B
High Dose Levetiracetam44.1147.3
Low Dose Levetiracetam47.1138.9
Placebo Administration48.9153.5

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Phonemic & Category Fluency Test

Evaluate memory changes in AD. Phonemic fluency refers to the number of items generated in one minute beginning with a specific letter. A higher score indicates more items and better performance. There is no maximum score. Category fluency refers to the number of items generated belonging to a specific category (such as animals), again, more items generated indicates better performance. (NCT01554683)
Timeframe: At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*

,,
InterventionCorrect Items (Mean)
Phonemic fluencyAnimal fluency
High Dose Levetiracetam34.413.4
Low Dose Levetiracetam3413.1
Placebo Administration34.412.4

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Number of Participants With Neurologic Sequelae at Discharge

Number of participants with neurologic sequelae at discharge (NCT01660672)
Timeframe: day 7

Interventionparticipants (Number)
LEVETIRACETAM2

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Freedom From Seizure

Number of subjects free of seizure at 24 hours after initiation of treatment (NCT01660672)
Timeframe: 24 hours

Interventionindividuals (Number)
LEVETIRACETAM7

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Mean Time to Return to a BCS Score Greater Than or Equal to 4

Mean time from admission to a BCS score greater than or equal to 4. The BCS (Blantyre Coma Scale) is a 0-5 scale measuring motor response, verbal response and eye movement assessing the severity of coma in children with cerebral malaria. Lower scores correspond to more profound coma. (NCT01660672)
Timeframe: 7 days

Interventionhours (Mean)
LEVETIRACETAM35.3

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Number of Participants Requiring AED During Admission

Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission. (NCT01660672)
Timeframe: 7 days

Interventionparticipants (Number)
LEVETIRACETAM6

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Number of Subjects Exposed to Phenobarbitone Prior to Enrollment

Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated. (NCT01660672)
Timeframe: 0 hour

Interventionparticipants (Number)
LEVETIRACETAM3

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Number of Subjects With Retinopathy at Enrollment

Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic. (NCT01660672)
Timeframe: Upon admission

Interventionparticipants (Number)
LEVETIRACETAM4

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Range of Plasma Concentration of LVT Across All Individuals

Range of plasma LVT concentrations will be determined through HPLC method at eight timepoints post administration to evaluate LVT absorption and elimination in pediatric CM. (NCT01660672)
Timeframe: 72 hours

Interventionmcg/ml (Mean)
LEVETIRACETAM35

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Count of Participants With Disease Free Survival

The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 7 Years

InterventionParticipants (Count of Participants)
Allogeneic Hematopoietic Stem Cell Transplant1

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Number of Participant Who Were Alive at 2 Years Post Transplant

Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive. (NCT01685411)
Timeframe: 2 Years

InterventionParticipants (Count of Participants)
Allogeneic Hematopoietic Stem Cell Transplant4

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Percentage of Participants With Acute Graft-Versus-Host Disease by Grade

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT01685411)
Timeframe: Day 100

Interventionpercentage of participants (Number)
Grade 2-4Grade 3-4
Allogeneic Hematopoietic Stem Cell Transplant4020

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Count of Participants Who Achieved Neutrophil Engraftment

Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater. (NCT01685411)
Timeframe: By Day 42

InterventionParticipants (Count of Participants)
Allogeneic Hematopoietic Stem Cell Transplant5

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Counts of Participants With Disease Free Survival

The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 2 Years

InterventionParticipants (Count of Participants)
Allogeneic Hematopoietic Stem Cell Transplant3

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Percentage of Participants With Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT01685411)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Stem Cell Transplant0

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Percentage of Participants With Relapse

The return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 2 Years

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Stem Cell Transplant40

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Percentage of Participants With Relapse

The return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 1 Year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Stem Cell Transplant40

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Percentage of Participants With Engraftment Failure

Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets. (NCT01685411)
Timeframe: Day 42

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Stem Cell Transplant0

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Count of Participants With Disease Free Survival

The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. (NCT01685411)
Timeframe: 5 Years

InterventionParticipants (Count of Participants)
Allogeneic Hematopoietic Stem Cell Transplant1

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Percentage of Participants With Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT01685411)
Timeframe: 1 Year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Stem Cell Transplant0

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Number of Participant Who Were Alive at 7 Years Post Transplant

Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive. (NCT01685411)
Timeframe: 7 Years

InterventionParticipants (Count of Participants)
Allogeneic Hematopoietic Stem Cell Transplant1

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Number of Participant Who Were Alive at 5 Years Post Transplant

Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive. (NCT01685411)
Timeframe: 5 Years

InterventionParticipants (Count of Participants)
Allogeneic Hematopoietic Stem Cell Transplant3

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Number of Neonates With Seizure Termination at 1 Hour After Treatment

A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures. (NCT01720667)
Timeframe: 1 hour

InterventionParticipants (Count of Participants)
Intravenous Levetiracetam26
Intravenous Phenobarbital28

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LEV Dose Escalation Component

Number of babies with seizure control at levetiracetam (60 mg/Kg load) who had not responded to 40 mg/kg load and number of babies with seizure control at 40 mg/kg who had not responded to 20 mg/kg. (NCT01720667)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Intravenous Levetiracetam4
Intravenous Phenobarbital3

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Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)

"A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.~Seizure cessation from 15 minutes after completion of infusion for 24 hours as assessed by continuous EEG reviewed by neurophysiologists." (NCT01720667)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Intravenous Levetiracetam15
Intravenous Phenobarbital24

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Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment

A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures. (NCT01720667)
Timeframe: 48 hours

InterventionParticipants (Count of Participants)
Intravenous Levetiracetam8
Intravenous Phenobarbital18

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Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia

(NCT01720667)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Intravenous Levetiracetam6
Intravenous Phenobarbital9

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Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy

"The study is designed to monitor the feasibility of delivering hu14.18K332A to 6 cycles of Induction chemotherapy. The feasibility of Induction therapy for this study will be to target no worse than 75%. A patient was considered as a failure for the 6 cycles of Induction therapy if the patient failed to complete Induction therapy within 155 days since treatment initiation due to toxicity or disease progression, unless the delay was a result of non-medical issues (e.g. not due to protocol toxicity). The proportion of patients who successfully received hu14.18K322A with 6 cycles of induction chemotherapy was estimated together with a 95% confidence interval. The response rate (CR + VGPR + PR) to 6 cycles of Induction chemoimmunotherapy was estimated together with the 95% confidence intervals" (NCT01857934)
Timeframe: After 6 cycles of induction therapy (approximately 24 weeks after enrollment)

Interventionpercentage of participants (Number)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)96.8

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Event-free Survival (EFS)

EFS was estimated as time to relapse, progressive disease, secondary neoplasm, or death from any cause from enrollment. The EFS was estimated by Kaplan-Meier method (NCT01857934)
Timeframe: 3 years, from time of enrollment

Interventionpercent of probability (Number)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)73.7

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Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation

Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding in any subject receiving the hu14.18K322A with NK cell combination; 4) Failure of recovery of ANC > 500/mm3 by day 35 after PBSC infusion. Number of patients who experience Grade 3 or Grade 4 (per Common Toxicity Criteria v 4.0) veno occlusive disease (VOD). (NCT01857934)
Timeframe: During the recovery phase after busulfan/melphalan and PBSC rescue (approximately 24-26 weeks after enrollment)

InterventionParticipants (Count of Participants)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)0

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Dose Limiting Toxicity (DLT)

Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) Toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade 3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding. (NCT01857934)
Timeframe: During MRD treatment cycle (approximately 8-12 months after enrollment)

InterventionParticipants (Count of Participants)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)1

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Local Failure Rate and Pattern of Failure

Local failure is defined as relapse or progression of disease at the primary site. The cumulative incidence of local failure will be estimated; competing events will include distant failure or death prior to local failure. (NCT01857934)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody Antibody (hu14.18K322A)1.56

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Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]

Per the 1993 INRC: measurable tumor defined as product of the longest x widest perpendicular diameter, elevated catecholamine levels and tumor cels in bone marrow. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in an any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive. (NCT01857934)
Timeframe: After two initial courses of chemotherapy (approximately 6 weeks after enrollment)

InterventionParticipants (Count of Participants)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A)42

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Affective Reactivity Scale

"The Affective Reactivity Scale is a 7-item survey completed by the child participants which asks questions concerning their level of agreement with statements about anger and irritability. Respondents select between not true (scored as 0), somewhat true (scored as 1), and certainly true (scored as 2). Total scores range from 0 to 14 with higher values indicating increased feelings of annoyance and anger." (NCT01891890)
Timeframe: Baseline, Month 3, Month 6

,,
Interventionunits on a scale (Mean)
BaselineAfter 3 months of treatmentAfter 6 months of treatment
Lamotrigine9.28.88.8
Levetiracetam8.610.310.3
Oxcarbazepine8.68.58.2

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Child Behavior Checklist

The Child Behavior Checklist is a measure of specific behavioral and emotional problems are rated by the child's parent or guardian. The Child Behavior Checklist examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 118 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True). Total raw scores are converted to t-scores with a mean of 50 and standard deviation of 10. A t-score of 67 or greater is considered to be in the clinical range for problematic behavior. (NCT01891890)
Timeframe: Baseline, Month 6

,,
Interventiont-scores (Mean)
BaselineAfter 6 months of treatment
Lamotrigine37.637.5
Levetiracetam38.233.3
Oxcarbazepine39.836.7

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Conners' Continuous Performance Test II (CPT-II) Confidence Index

"The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter X. For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness." (NCT01891890)
Timeframe: Baseline, Month 6

,,
InterventionConfidence Index (Mean)
BaselineAfter 6 months of treatment
Lamotrigine58.458.1
Levetiracetam56.954.0
Oxcarbazepine56.754.2

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Grooved Pegboard

The Grooved Pegboard assesses fine motor speed and dexterity. The participant fits keyhole-shaped pegs into similarly shaped holes on a square board. The pegs, which have an edge along one side, must be rotated to match the holes before they can be inserted. The scores represent the number of seconds it took for the participant to correctly insert the pegs into the require number of grooves, using their dominant hand. (NCT01891890)
Timeframe: Baseline, Month 6

,,
InterventionSeconds (Mean)
BaselineAfter 6 months of treatment
Lamotrigine99.990.3
Levetiracetam114.294.9
Oxcarbazepine96.390.1

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Parenting Stress Inventory Short Form (PSI-4-SF)

The Parenting Stress Inventory-4-Short Form is a 36 item questionnaire, completed by the parent/guardian, designed to evaluate parenting and family characteristics based upon child characteristics (behavioral and emotional problems), parent characteristics, and situational/demographic life stress. Respondents indicate the degree to which they agree with a variety of statements by selecting 1=strongly agree, 2=agree, 3=not sure, 4=disagree, or 5=strongly disagree. Raw scores range from 36 to 180 and higher scores are associated with higher parental stress. (NCT01891890)
Timeframe: Baseline, Month 6

,,
Interventionunits on a scale (Mean)
BaselineAfter 6 months of treatment
Lamotrigine138.2147.4
Levetiracetam143.9146.8
Oxcarbazepine138.3137.6

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Pediatric Inventory for Parents

"The Pediatric Inventory for Parents consists of 42 items involving communication, medical care, emotional disturbance, and change in role function. Parents respond to a list of difficult events (such as difficulty sleeping) that are often experienced by parents of children who are seriously ill. Parents indicated how frequently an event occurred by selecting 1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Very often. Raw score values range from 4 to 210 with higher scores indicating increased frequency of difficult events." (NCT01891890)
Timeframe: Baseline, Month 6

,,
Interventionunits on a scale (Mean)
BaselineAfter 6 months of treatment
Lamotrigine93.074.2
Levetiracetam91.174.8
Oxcarbazepine98.476.5

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Pediatric Neuro-QOL Score

The Pediatric Neuro-QOL is a Quality of Life instrument developed in conjunction with NIH with a pediatric specific form utilized in this protocol. Pediatric Neuro-QOL assesses the domains of Anger, Anxiety, Cognition, Depression, Fatigue, Pain, Social Relations, and Stigma. Each domain has 8 to 10 items and respondents indicate how often they experienced feelings and circumstances related to each domain on a scale of 1 to 5 (such as 1=never, 2=almost never, 3=sometimes, 4=often, 5=almost always). Higher values indicate increased difficulty for most of the scales but this pattern is reversed for two of the domains. Raw scores are rescaled to standardized scores with a mean of 50 and a standard deviation of 10. Higher values for the standardized scores indicate more problematic characteristics while scores below 50 indicate that the child is experiencing less trouble in the domains measured by the Pediatric Neuro-QOL. (NCT01891890)
Timeframe: Baseline, Month 6

,,
Interventiont-scores (Mean)
BaselineAfter 6 months of treatment
Lamotrigine37.036.7
Levetiracetam38.836.9
Oxcarbazepine39.935.2

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Story Memory

"Story Memory will be measured at baseline with the Children's Memory Scale (CMS) and then with the Wide Range Assessment of Memory and Learning-2 (WRAML-2) at the 6 month follow up visit. Two different tests are used to avoid practice effects in memory assessment associated with repeated assessments using the same stimulus material. The Story Memory sub-test of the CMS and the WRAML-2 Story Memory are measures of prose passage recall. Stories are read to the subject for recall, with different stories presented based upon participant age. Scores are converted to percentile ranks for both measurements of story memory. Possible scores can fall between the 1st and 99th percentile and higher values indicate better performance with story recall. Values between the 9th and 25 percentiles are considered low average, values between the 25th and 75th percentiles are average, while values between the 75th and 91st percentile are high average." (NCT01891890)
Timeframe: Baseline, Month 6

,,
Interventionpercentiles (Mean)
Baseline (CMS)After 6 months of treatment (WRAML-2)
Lamotrigine29.623.1
Levetiracetam29.426.5
Oxcarbazepine31.226.1

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Symbol Digit Modalities Test

Symbol Digit Modalities Test (SDMT) is a test of graphomotor speed using numbers as the response rather than copying symbols, and is timed at 90 seconds. The SDMT is designed for people who are 8 years of age and older and detects brain dysfunction as well as measures function over time. Possible total scores range from 0 to 110; where 110 indicates that all values were entered within the 90 second limit. An increase between initial and retest scores indicates that the respondent is correctly matching numbers to symbols at a faster speed. The SDMT was administered at the Month 3 and Month 6 visits for this study. (NCT01891890)
Timeframe: Month 3, Month 6

,,
Interventionnumber of correct responses (Mean)
After 3 months of treatmentAfter 6 months of treatment
Lamotrigine25.926.4
Levetiracetam23.028.3
Oxcarbazepine28.530.4

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The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)

"Suicidal behaviors and suicidal ideation were assessed through an interview using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS guides interviewers to ask a series of simple questions in order to identify people at risk for suicide, as well as the severity and urgency of suicidal thoughts and behaviors. The Children's Baseline/Screening C-SSRS was used at the initial study visit while the Children's Since Last Visit C-SSRS was used for subsequent study visits. Any responses of yes to the C-SSRS questions are considered a positive response, indicating that the participant is experiencing thoughts of suicide or has exhibited suicidal behaviors." (NCT01891890)
Timeframe: Baseline, Month 3, Month 6

,,
InterventionParticipants (Count of Participants)
BaselineAfter 3 months of treatmentAfter 6 months of treatment
Lamotrigine000
Levetiracetam000
Oxcarbazepine000

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Wechsler Intelligence Scale for Children-IV Processing Speed

Coding and Symbol Search subtests from the Wechsler Intelligence Scale for Children (WISC)-IV are measures of processing speed and combine to form the Processing Speed Index. Processing speed refers to how quickly the child understands and responds to information. Coding presents children with a row of boxes containing a numeral in the top line and a symbol in the bottom line with the task of copying the symbol corresponding to each numeral as quickly as possible in 120 seconds. In Symbol Search, children are given rows of symbols and target symbols and are asked to mark whether or not the target symbols appear in each row as quickly as possible during 120 seconds. Composite scores compare the test-taker to peers with a mean score of 100 and a standard deviation of 15. Possible scores range from 40 to 160 with higher scores indicating increased processing speeds. Scores between 85 and 115 are considered average, with 2/3 of test takers falling between these values. (NCT01891890)
Timeframe: Baseline, Month 3, Month 6

,,
Interventionunits on a scale (Mean)
BaselineAfter 3 months of treatmentAfter 6 months of treatment
Lamotrigine87.895.797.3
Levetiracetam102.196.9102.6
Oxcarbazepine97.990.4101.22

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Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period

(NCT01954121)
Timeframe: 6-months Evaluation Period (From Week 4 to Week 30)

Interventionpercentage of subjects (Number)
Levetiracetam (Per Protocol Set)47.3
Carbamazepine-IR (Per Protocol Set)68.4

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Time to First Seizure During the Evaluation Period

Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. (NCT01954121)
Timeframe: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)

Interventionevents (Number)
Levetiracetam (Per Protocol Set)87
Carbamazepine-IR (Per Protocol Set)39

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Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug

Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. (NCT01954121)
Timeframe: From Randomization (Week 1) up to Evaluation Visit (Week 30)

Interventionevents (Number)
Levetiracetam (Per Protocol Set)97
Carbamazepine-IR (Per Protocol Set)57

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Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period

Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. (NCT01954121)
Timeframe: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)

Interventionevents (Number)
Levetiracetam (Per Protocol Set)88
Carbamazepine-IR (Per Protocol Set)45

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Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period

(NCT01954121)
Timeframe: From Week 1 to Week 30

Interventionpercentage of subjects (Number)
Levetiracetam (Per Protocol Set)48.4
Carbamazepine-IR (Per Protocol Set)70.2

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Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis

Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Per-protocol analysis (NCT01960075)
Timeframe: Within 60 minutes after the start of study drug infusion

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)37
Valproic Acid43
Levetiracetam51

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Number of Participants With Safety Outcome: Purple Glove Syndrome

Purple glove syndrome is defined as the presence of all three of the findings of the objective edema: discoloration, and pain in the distal extremity in which study drug was administered, with or without known extravasation, and for which there is no other evident etiology. (NCT01960075)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)0
Valproic Acid0
Levetiracetam0

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Number of Participants With Safety Outcome: Life-threatening Cardiac Arrhythmia

Life-threatening cardiac arrhythmia within 60 minutes of the start of study drug infusion (NCT01960075)
Timeframe: within 60 minutes of the start of study drug infusion

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)0
Valproic Acid0
Levetiracetam1

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Number of Participants With Safety Outcome: Life Threatening Hypotension

Life-threatening hypotension within 60 minutes of the start of study drug infusion (NCT01960075)
Timeframe: within 60 minutes of the start of study drug infusion

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)4
Valproic Acid2
Levetiracetam1

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Number of Participants With Safety Outcome: Hepatic Transaminase or Ammonia Elevations

Safety outcome: Hepatic transaminase or ammonia elevations (NCT01960075)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)0
Valproic Acid1
Levetiracetam1

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Number of Participants With Safety Outcome: Death

Safety outcome: Death (NCT01960075)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)3
Valproic Acid2
Levetiracetam7

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Number of Participants With Safety Outcome: Endotracheal Intubation

Endotracheal intubation within 60 minutes of start of study drug infusion (NCT01960075)
Timeframe: within 60 minutes of start of study drug infusion

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)33
Valproic Acid21
Levetiracetam30

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Number of Participants With Safety Outcome: Acute Seizure Recurrence

acute seizure recurrence 60 minutes to 12 hours after start of study drug infusion (NCT01960075)
Timeframe: 60 minutes to 12 hours after start of study drug infusion

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)14
Valproic Acid14
Levetiracetam16

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Number of Participants With Safety Outcome: Acute Respiratory Depression

Respiratory depression is defined as impairment of ventilation or oxygenation necessitating definitive endotracheal intubation and mechanical ventilation. It is distinct from intubations performed only for airway protection in those with decreased levels of consciousness. It does not include those getting only supraglottic airways or transient bag-valve-mask support. (NCT01960075)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)16
Valproic Acid10
Levetiracetam12

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Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success

Number of participants with seizure cessation within 20 minutes of study drug initiation for patients with treatment success. This outcome measure was only reported in the Supplementary materials to the Primary Paper. (NCT01960075)
Timeframe: within 20 minutes

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)43
Valproic Acid43
Levetiracetam53

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Number of Participants With Safety Outcome: Acute Anaphylaxis

Acute anaphylaxis is defined as a clinical presentation consistent with life threatening allergic reaction occurring within 6 hours of the start of study drug infusions and manifested as urticaria in combination with either (1) a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes, or (2) objective evidence of airway obstruction, and for which the patient was treated with antihistamines and/or steroids. (NCT01960075)
Timeframe: within 6 hours of the start of study drug infusions

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)0
Valproic Acid0
Levetiracetam0

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Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat

Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Intention to treat (NCT01960075)
Timeframe: Within 60 minutes after the start of study drug infusion

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)53
Valproic Acid56
Levetiracetam68

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Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis

Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. The Adjudicated outcomes analysis is different from Outcome measure 1 because a central clinical phenomenology core of four neurologists adjudicated from the medical records the time to seizure cessation, the time in status epilepticus before trial-drug initiation, and the cause of the seizure. For each enrollment, two neurologists from this core group conducted independent initial reviews and then determined a consensus or consulted a third adjudicator, as needed. Adjudicators were unaware of the treatment assignments and made determinations by medical record review. (NCT01960075)
Timeframe: Within 60 minutes after the start of study drug infusion

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)57
Valproic Acid60
Levetiracetam67

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Number of Participants With Admission to Intensive Care Unit

ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient. (NCT01960075)
Timeframe: Admission to intensive care unit after start of study drug infusion, where the ICU is the initial inpatient unit for the patient

InterventionParticipants (Count of Participants)
Fosphenytoin (FOS)70
Valproic Acid71
Levetiracetam87

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Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success

The time to termination of seizures is the interval from the start of study drug infusion to cessation of clinically apparent seizure in those who meet the primary outcome. (NCT01960075)
Timeframe: start of drug infusion to seizure cessation

Interventionminutes (Median)
Fosphenytoin (FOS)11.7
Valproic Acid7.0
Levetiracetam10.5

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Length of Hospital Stay

Length of hospital stay in days (NCT01960075)
Timeframe: length of hospital stay

Interventiondays (Median)
Fosphenytoin (FOS)3
Valproic Acid3
Levetiracetam3

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Length of ICU Stay

Length of stay is determined by the number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study. (NCT01960075)
Timeframe: number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study

Interventiondays (Median)
Fosphenytoin (FOS)1
Valproic Acid1
Levetiracetam1

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Number of Participants Who Returned to Work

The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time. (NCT01974700)
Timeframe: 6 months - 12 months

Interventionparticipants (Number)
Levetiracetam1
No Anti-epileptic Treatment1

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Number of Participants Who Returned to Daily Activities.

The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities. (NCT01974700)
Timeframe: 6 months - 12 months

Interventionparticipants (Number)
Levetiracetam5
No Anti-epileptic Treatment1

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Incidence of Seizure

Reported via patient in follow-up phone call. (NCT01974700)
Timeframe: 6 mo - 1 Year from Operative Procedure

Interventionparticipants (Number)
Levetiracetam0
No Anti-epileptic Treatment1

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Mean Time From Admission to BCS >/= 4

"The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis.~The Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement~1 - Watches or follows 0 - Fails to watch or follow~Best motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response~Best verbal response 2 - Cries appropriately with pain, or, if verbal, speaks~1 - Moan or abnormal cry with pain 0 - No vocal response to pain" (NCT01982812)
Timeframe: 7 days

Interventionhours of coma from admission (Mean)
Oral Levetiracetam35.4
Comparison Group34.6

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Minutes With Seizure on EEG

Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation. (NCT01982812)
Timeframe: 72 hours

Interventionminutes with seizure (Mean)
Oral Levetiracetam165.2
Comparison Group464.8

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Required Additional AED

Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no) (NCT01982812)
Timeframe: 7 days

InterventionParticipants requiring additional AEDs (Number)
Oral Levetiracetam18
Comparison Group18

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Sequelae

"Neurologic outcome in 3 categories--~Neurologically intact at discharge~Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge~Died during admission, never discharged" (NCT01982812)
Timeframe: 7 days

,
Interventionparticipants (Number)
Neurologically intact at dischargeNeurologic sequelae at dischargeDied during admission
Comparison Group1425
Oral Levetiracetam1931

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ADAS-cog in AD With Epileptiform Activity

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) - The ADAS-cog rating instrument (Rosen et al. 1984) will be used to evaluate the global cognitive functioning. The ADAS-cog is a 70-point scale that includes an assessment of verbal memory, language, orientation, reasoning, and praxis.The score is derived from adding point values from each of its subsections. The higher your score on the ADAS-cog, the better you do. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam (Epileptiform Activity)-1.0
Placebo (Epileptiform Activity)1.5

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Blood Serum Prolactin Level

Blood samples intended for Quest Diagnostics LEV and prolactin serum levels (one 6 mL tube) will be processed in the following manner, as outlined in the Quest Diagnostics lab manual. The whole blood will be allowed to clot for 60 minutes and centrifuged at 2200 - 2500 revolutions per minute (RPM) for at least 15 minutes. The resulting serum will be split into 2 cryovials which will be stored at -20°C and immediately shipped for external assessment of LEV and prolactin levels. Prolactin will be assessed via immunoassay. The concentration of LEV in serum will be measured using validated liquid chromatography/tandem mass spectrometry (LC/MS-MS) methods. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionng/mL (Mean)
Levetiracetam0.1
Placebo0.2

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Changes in ADAS-cog

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) - The ADAS-cog rating instrument (Rosen et al. 1984) will be used to evaluate the global cognitive functioning. The ADAS-cog is a 70-point scale that includes an assessment of verbal memory, language, orientation, reasoning, and praxis.The score is derived from adding point values from each of its subsections. The higher your score on the ADAS-cog, the better you do. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam-0.2
Placebo0.8

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Changes in Behavior and Level of Disability - ADCS-ADL

Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) - The ADCS-ADL rating instrument (Galasko et al. 1997) will be used to evaluate functional capacity. The ADCS-ADL is a caregiver rated questionnaire. Scores on the 24-item ADCS-ADL range from 0 to 78. A higher score indicates less severity while a lower score indicates greater severity. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam0.4
Placebo0.3

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Changes in Behavior and Level of Disability - ADCS-CGIC

ADCS-Clinical Global Impression of Change (ADCS-CGIC) - The ADCS-CGIC is a seven-point scale that gives a global rating of change from baseline (Schneider et al. 1997). The baseline and follow up assessments are based on interviews with the subject and the informant. The ADCS-CGIC is a clinician-rated measure of: global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); and global change at follow-up scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam4.0
Placebo4.0

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Changes in Behavior and Level of Disability - Neuropsychiatric Inventory (NPI)

Neuropsychiatric Inventory (NPI) - The NPI (Cummings et al. 1994) will be used to evaluate the severity of behavioral symptoms. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress). (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam-0.8
Placebo0.2

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NIH EXAMINER in AD With Epileptiform Activity

Changes in executive function will be measured using the NIH EXAMINER, a 1-hour computer-based battery of various executive function tasks. The subject's performance after the study treatment will be compared with results from a baseline assessment done before the study treatment, using statistical tests to assess whether there was any significant change. The Examiner assessment consists of the following scales: NIH EXAMINER - antisaccade , NIH EXAMINER - set shifting , NIH EXAMINER - flanker task, NIH EXAMINER - dot counting, NIH EXAMINER - spatial 1-back, NIH EXAMINER - category fluency, and NIH EXAMINER - letter fluency. Scores for this task have an indefinite range. Higher scores however do indicate better performance. Scores for this scale were generated using item response theory (Kramer et al. J Int Neuropsychol Soc. 2014;20(1):11-19. doi:10.1017/S1355617713001094). (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
No Epileptiform Activity-0.01
Epileptiform Activity0.22

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Changes in Epileptiform Events

"Epileptiform activity will be measured using a 1-hr resting magnetoencephalogram/electroencephalogram (M/EEG). M/EEG can detect abnormal epileptiform findings called spikes. The M/EEG will be read by an epileptologist with specialized training to assess whether there are any spikes. If spikes are observed during the M/EEG they will be counted to determine their frequency (e.g., 5 spikes per 1 hour recording). The frequency of spikes will then be compared to baseline values from before beginning the study treatment, using statistical tests to determine if the frequency changed with treatment." (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

InterventionEpileptiform events (Mean)
Levetiracetam-0.1
Placebo-0.2

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Changes in Executive Function as Measured by the NIH EXAMINER Computer Battery

Changes in executive function were measured using the NIH EXAMINER, a 1-hour computer-based battery of various executive function tasks. The subject's performance after the study treatment will be compared with results from a baseline assessment done before the study treatment, using statistical tests to assess whether there was any significant change. The Examiner assessment consists of the following scales: antisaccade , set shifting , flanker task, dot counting, spatial 1-back, category fluency, and letter fluency. Scores for this task have an indefinite range. Higher scores however do indicate better performance. Scores for this scale were generated using item response theory. For this study, scores with SEs greater than 0.55 were classified as unreliable and excluded from analysis. Composite scores from 2 participants were excluded on this basis.The EXAMINER ranges for the participants in the study were -2.59 to 1.33. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam-0.06
Placebo-0.14

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Changes in Cognitive Function as Measured by a Virtual Route Learning Test

A 20-minute computer-based virtual navigation test will be used to assess how well a subject can navigate a virtual community to reach a goal destination. The subjects will then be measured on their ability to accurately navigate the virtual community after a period of a few hours. The subject's performance after the study treatment will be compared with results from a baseline assessment done before the study treatment, using statistical tests to assess whether there was any significant change. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventioncorrect turns (Mean)
No Epileptiform Activity-6.0
Epileptic Activity17.4

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Clinical Dementia Rating Sum of Boxes (CDR-SOB)

Clinical Dementia Rating Sum of Boxes (CDR-SOB) - The CDR will be used as a global measure of dementia severity (Morris 1993). The CDR consists of questions addressed to the caregiver/informant. The lowest score one can receive is a 0 and the highest is a 3. Score is measured by getting the mean of the individual scores in each category. Lower scores equate to less dementia severity. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam0.1
Placebo0.1

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Standardized Assessments of Clinical Fluctuations - One Day Fluctuation Assessment Scale

The One Day Fluctuation Assessment Scale will be used to quantitate fluctuations of dementia symptoms (Walker et al. 2000). The One Day Fluctuation Assessment Scale has a score range of 0-21 points,with higher scores indicatingmore fluctuations. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam0.3
Placebo-0.4

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Standardized Assessments of Clinical Fluctuations -The Clinician Assessment of Fluctuation

Two standardized methods will be used to quantitate fluctuations of dementia symptoms: The Clinician Assessment of Fluctuation and the One Day Fluctuation Assessment Scale (Walker et al. 2000). : The Clinician Assessment of Fluctuation (score range,0-12 points, with higher scores indicating more fluctuations),26 the One Day Fluctuation Assessment Scale (score range,0-21 points, with higher scores indicatingmore fluctuations). (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam0.9
Placebo0.1

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Stroop Interference in AD With Epileptiform Activity

Stroop Test - The Stroop Test (Stroop 1935) will be used to assess executive functions including selective attention, cognitive flexibility and processing speed. Subtasks include Stroop color naming and Stroop interference naming, and each subtask is restricted to 1 minute. The minimum score is 0 and the maximum score is 126. The higher the score the better a participant does. The mean below represents the average change in score between the timepoints for all participants. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam (Epileptiform Activity)4.7
Placebo (Epileptiform Activity)-2.6

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Changes in Stroop Interference Naming

Stroop Test - The Stroop Test (Stroop 1935) will be used to assess executive functions including selective attention, cognitive flexibility and processing speed. Subtasks include Stroop color naming and Stroop interference naming, and each subtask is restricted to 1 minute. The minimum score is 0 and the maximum score is 126. The higher the score the better a participant does. (NCT02002819)
Timeframe: Difference between weeks 0-4 (Baseline) and weeks 8-12 (Treatment)

Interventionscore on a scale (Mean)
Levetiracetam1.5
Placebo-1.4

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Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of Burke-Fahn-Marsten Dystonia Rating Scale (BFM)

The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of ten body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The secondary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 3 weeks or 11 weeks (representing the end of the three week titration period up to the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia. (NCT02199509)
Timeframe: 3 and 11 weeks compared to baseline

Interventionpercent change (Mean)
Levetiracetam Group14.80
Placebo Group6.78

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Percent Change of the Sum of Eyes and Upper Face, Lower Face and Jaw and Tongue Subscores of the GDS Rating Scale

The Global Dystonia Severity Scale provides a severity rating for ten body regions, i.e.,1) eyes and upper face, 2) lower face, 3) jaw and tongue, 4) larynx, 5) neck, 6) shoulder and proximal arm, 7) distal arm and hand including elbow, 8) pelvis and upper leg, 9) distal leg and foot, and 10) trunk. Each body area is rated from 0 to 10, with 0 representing no dystonia present in that body area and 10 representing severe dystonia. The secondary outcome measure includes the sum of the eyes and upper face, lower face and jaw and tongue subscores of the GDS rating scale and represents the percent change from baseline to either 3 and 6 weeks or 11 and 14 weeks (representing the end of the three week titration period (3 weeks and 11 weeks) and the post-3 week period (6 weeks and 14 weeks) at the maximum tolerated dose for Levetiracetam or Placebo). The total range of these combined sub scores is 0-30, with higher scores indicating more severe dystonia and 0 indicating absence of (NCT02199509)
Timeframe: 3, 6, 11 and 14 compared to baseline

InterventionPercentage of change (Mean)
Levetiracetam Group at 3 or 11 Weeks-10.36
Levetiracetam Group at 6 or 14 Weeks4.11
Placebo Group at 3 or 11 Weeks-16.93
Placebo Group at 6 or 14 Weeks-3.83

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Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of the Burke-Fahn-Marsden (BFM) Dystonia Scale.

The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of nine body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The primary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 6 weeks or 14 weeks (representing the end of the 3 week period at the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia. (NCT02199509)
Timeframe: 6 and 14 weeks compared to baseline

Interventionpercent change (Mean)
Levetiracetam Group12.16
Placebo Group31.25

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Change From Baseline in Height Z-score up to Month 1

Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from minus (-) 3 to plus (+) 3; 0 equal to (=) same mean, greater than (>) 0 a greater mean, and less than (<) 0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 1 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 1

InterventionZ-score (Mean)
Topiramate0.004
Levetiracetam-0.015

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Change From Baseline in Height Z-score up to Month 12

Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 12 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 12

InterventionZ-score (Mean)
Topiramate-0.057
Levetiracetam0.088

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Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6

"The BMD was measured by dual energy X-ray absorptiometry (DEXA) for the posterior-anterior lumbar spine (L1_L4) and total body less head area. The Z-Score is the number of standard deviations a participant's BMD differs from the average BMD of their age, sex and ethnicity. Positive scores indicate BMD above the mean; positive values are best values and negative values are worst values. Positive changes from baseline indicated an improvement in condition." (NCT02201251)
Timeframe: Baseline up to Month 6

,
InterventionZ-score (Mean)
Lumbar spineTotal body less head
Levetiracetam0.0350.102
Topiramate-0.181-0.180

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Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6

The BMC is an estimate of the amount of mineral (such as calcium) in the bone, which was assessed by DEXA scan for the posterior-anterior lumbar spine (L1_L4) and total body less head area. Positive changes from baseline indicated an improvement in condition. (NCT02201251)
Timeframe: Baseline up to Month 6

,
InterventionZ-score (Mean)
Lumbar spineTotal body less head
Levetiracetam0.0750.151
Topiramate-0.141-0.242

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Change From Baseline in BMD Z-score up to Month 12

"The BMD was measured by DEXA for the posterior-anterior lumbar spine (L1_L4) and total body less head area. The Z-Score is the number of standard deviations a participant's BMD differs from the average BMD of their age, sex and ethnicity. Positive scores indicate BMD above the mean; positive values are best values and negative values are worst values. Positive changes from baseline indicated an improvement in condition." (NCT02201251)
Timeframe: Baseline up to Month 12

,
InterventionZ-score (Mean)
Lumbar spineTotal body less head
Levetiracetam0.0840.054
Topiramate-0.346-0.367

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Change From Baseline in BMC-Z Score up to Month 12

The BMC is an estimate of the amount of mineral (such as calcium) in the bone, which was assessed by DEXA scan for the posterior-anterior lumbar spine (L1_L4) and total body less head area. Positive changes from baseline indicated an improvement in condition. (NCT02201251)
Timeframe: Baseline up to Month 12

,
InterventionZ-score (Mean)
Lumbar spineTotal body less head
Levetiracetam0.1240.017
Topiramate-0.274-0.266

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Percentage of Participants With Kidney Stones

Percentage of participants with kidney stones were reported. (NCT02201251)
Timeframe: Up to Day 390

Interventionpercentage of participants (Number)
Topiramate0
Levetiracetam0

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Change From Baseline in Weight Z-score up to Month 9

The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up yo Month 9 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 9

InterventionZ-score (Mean)
Topiramate-0.326
Levetiracetam-0.110

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Change From Baseline in Weight Z-score up to Month 6

The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 6 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 6

InterventionZ-score (Mean)
Topiramate-0.319
Levetiracetam-0.070

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Number of Participants With Treatment-emergent Adverse Events (TEAE)

An adverse event (AE) is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. (NCT02201251)
Timeframe: Up to Day 390

InterventionParticipants (Count of Participants)
Topiramate25
Levetiracetam29

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Change From Baseline in Weight Z-score up to Month 3

The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 3 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 3

InterventionZ-score (Mean)
Topiramate-0.201
Levetiracetam-0.027

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Change From Baseline in Weight Z-score up to Month 12

The Z-Score indicates how many SD a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the SAS programs provided by the CDC for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline to Month 12 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 12

InterventionZ-score (Mean)
Topiramate-0.351
Levetiracetam-0.065

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Change From Baseline in Weight Z-score up to Month 1

The Z-Score indicates how many standard deviations (SD) a participant has from the population normal values. The body weight z-scores were designed to take into account the amount of weight gain that was expected due to normal growth in children and adolescents. Body weight data were converted to Z-scores using the Statistical Analysis System (SAS) programs provided by the Centers for Disease Control (CDC) for the calculation of the 2000 CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 1 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 1

InterventionZ-score (Mean)
Topiramate-0.112
Levetiracetam-0.014

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Change From Baseline in Height Z-score up to Month 9

Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 9 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 9

InterventionZ-score (Mean)
Topiramate-0.059
Levetiracetam0.086

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Change From Baseline in Height Z-score up to Month 6

Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 6 for the total safety population for all age cohorts combined were presented. (NCT02201251)
Timeframe: Baseline up to Month 6

InterventionZ-score (Mean)
Topiramate-0.008
Levetiracetam0.077

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Change From Baseline in Height Z-score up to Month 3

Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by CDC growth charts. The mean (SD) change in Z scores from baseline up to Month 3 for the total safety population for all age cohorts combined were presented. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. (NCT02201251)
Timeframe: Baseline up to Month 3

InterventionZ-score (Mean)
Topiramate-0.036
Levetiracetam0.017

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Change in Neurotoxicity Scale Scores

"The Neurotoxicity Scale is as a validated 27 question, patient-reported measure for assessing the adverse effects of antiepileptic drugs on cognitive function. Patients self-report no problem, a mild problem, a moderate problem or a serious problem for each question corresponding to a score of 0, 1, 2, and 3, respectively. For each patient, the overall score was formed by summing scores in all 27 questions. The minimum possible score is 0 and the maximum possible total score is 81. A lower score indicates less toxicity when taking an antiepileptic drug. The outcome is a score change from baseline at the 6 week follow-up and is calculated by subtracting the baseline score from the 6 week follow-up score for each patient." (NCT02334722)
Timeframe: Baseline to 6 weeks

Interventionscore on scale (Median)
1 Week Levetiracetam-1
6 Week Levetiracetam-3.5

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Number of Seizures Reported

Number of seizures reported in all groups (NCT02707965)
Timeframe: Through the approximately 2 week period when the treatment is given.

,,,,,,,,
InterventionNumber of Seizures (Number)
Reference ProductTest (Generic)
Carbamazepine ER Capsule31
Carbamazepine ER Tablet00
Lamotrigine ER Tablet Group4425
Lamotrigine IR Tablet Group00
Levetiracetam ER Tablet Group4272
Levetiracetam IR Tablet Group165
Topiramate Tablet Group95
Valproic Acid ER Tablet Group120
Zonisamide Capsule Group00

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Number of Adverse Events

summed for each anti-epileptic drug from when taking brand and generic. (NCT02707965)
Timeframe: Through the approximately 2 week period when the treatment is given.

Interventionevents (Number)
Topiramate29
Lamotrigine ER9
Levetiracetam IR17
Levetiracetam ER4
Carbamazepine ER Capsule15
Zonisamide6
Carbamazepine ER Tablet10
Valproic Acid10

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Mean AUC0-last_ss (Test vs. Reference)

Average AUC (area under the drug plasma curve. (NCT02707965)
Timeframe: For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.

,,,,,,
Interventionmicro/mL/hr (Mean)
Test ProductReference Product
Carbamazepine ER Capsule114.96106.45
Carbamazepine ER Tablet104.6115.16
Lamotrigine ER Tablet62.7666666767.19333333
Levetiracetam ER Tablet260.3262.305
Levetiracetam IR Tablet419.97445.2
Topiramate Tablet92.88494.456
Zonisamide Capsule233.16226.14

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Mean Cmax_ss (Test vs. Reference)

Average maximum drug plasma concentration; (NCT02707965)
Timeframe: For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.

,,,,,,
Interventionmicrog/mL (Mean)
Test ProductReference Product
Carbamazepine ER Capsule10.959.91
Carbamazepine ER Tablet10.0010.6
Lamotrigine ER Tablet6.246.903333333
Levetiracetam ER Tablet31.0528.04
Levetiracetam IR Tablet71.0233333369.29333333
Topiramate Tablet9.8749.646
Zonisamide Capsule12.2911.68

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Mean Cmin_ss (Test vs. Reference)

Average minimum drug plasma concentration (Cmin); (NCT02707965)
Timeframe: For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.

,,,,,,
Interventionmicrog/mL (Mean)
Test ProductReference Product
Carbamazepine ER Capsule8.567.66
Carbamazepine ER Tablet7.377.97
Lamotrigine ER Tablet4.0533333334.21
Levetiracetam ER Tablet12.60514.395
Levetiracetam IR Tablet15.4533333317.45666667
Topiramate Tablet6.3266.53
Zonisamide Capsule8.468.34

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Change in Cerebral Blood Flow (CBF)

CBF will be measured by Arterial Spin Labeling (ASL) (NCT03129360)
Timeframe: Baseline, 2 Hours Post-Treatment

InterventionmL / (100g * min) (Mean)
Levetiracetam 185 mg-2.21
Levetiracetam 500mg-3.83
Placebo-1.29

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Percentage of Patients With an ED Visit/Hospital Readmission Within 30 Days of Craniotomy

The primary objective of this study is to assess the impact of LCM, LEV or, no AED in patients undergoing craniotomy for suspected new, recurrent or transformed glioma (WHO Gr I-IV) or brain metastasis on ED visits and readmissions within 30 days of craniotomy. (NCT03436433)
Timeframe: 30 days following surgery

InterventionParticipants (Count of Participants)
Lacosamide0
Levetiracetam0
No Anti-epileptic1

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Number of Participants With an Adverse Event Within First 30 Days After Craniotomy

Adverse events related to LCM, LEV, and no drug within first 30 days after craniotomy. (NCT03436433)
Timeframe: 30 days following surgery

,,
InterventionParticipants (Count of Participants)
DizzinessSomnolenceCognitive disturbanceNauseaVomitingAtaxiaSuicide thoughtSuicide attemptAnxietyDepressionIrritabilityPsychosisPersonality change
Lacosamide1111110010100
Levetiracetam1201000010100
No Anti-epileptic1110000000000

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Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL

"The trough plasma concentration of MHD with PSL was expressed in micrograms per milliliter (µg/mL).~Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged)." (NCT03695094)
Timeframe: Trough plasma samples were taken prior to the morning dose of OXC on Day -1, Day 1 through Day 20 (+/-1)

Interventionµg/mL (Geometric Mean)
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13
Group 1 (Inducers) (PK-PPS)14.914.014.915.515.215.415.416.315.415.515.413.811.3

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Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study

A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that requires treatment parenteral antibiotics or other important medical events which based on medical or scientific judgement could jeopardize the patients, or could require medical or surgical intervention to prevent any of the above. (NCT03695094)
Timeframe: From screening (Day -28 to Day -2) up to end of study (EOS) visit day 20 (+/-1)

Interventionpercentage of participants (Number)
Group 1 (Inducers) (FAS)0
Group 2 (Neutral [Control]) (FAS)0

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The Apparent Total Plasma Clearance at Steady-state (CL/Fss) for PSL During the Study

The CL/Fss for Padsevonil in plasma was expressed in liters per hour (L/hr). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

InterventionL/hr (Geometric Mean)
Group 1 (Inducers) (PK-PPS)75.44
Group 2 (Neutral [Control]) (PK-PPS)47.94

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The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1431322-000 During the Study

"The AUCtau for UCB1431322-000 in plasma in was expressed in hours times nanograms per milliliter (hr*ng/mL).~Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged)." (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionhr*ng/mL (Geometric Mean)
Group 1 (Inducers) (PK-PPS)11720
Group 2 (Neutral [Control]) (PK-PPS)11200

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The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1447499-000 During the Study

The AUCtau for UCB1447499-000 in plasma was expressed in hr*ng/mL. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionhr*ng/mL (Geometric Mean)
Group 1 (Inducers) (PK-PPS)1854
Group 2 (Neutral [Control]) (PK-PPS)1678

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The Area Under the Plasma Concentration Time Curve (AUCtau) Over a Dosing Interval for PSL

The AUCtau for Padsevonil in plasma was expressed in hours times nanograms per milliliter (hr*ng/mL). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionhr*ng/mL (Least Squares Mean)
Group 1 (Inducers) (PK-PPS)5301
Group 2 (Neutral [Control]) (PK-PPS)8339

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The Maximum Observed Plasma Concentration (Cmax) for UCB1431322-000 During the Study

"The Cmax for UCB1431322-000 in plasma was expressed in nanograms per milliliter (ng/mL).~Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged)." (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionng/mL (Geometric Mean)
Group 1 (Inducers) (PK-PPS)1753
Group 2 (Neutral [Control]) (PK-PPS)1700

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The Maximum Observed Plasma Concentration (Cmax) for UCB1447499-000 During the Study

The Cmax for UCB1447499-000 in plasma was expressed in ng/mL. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionng/mL (Geometric Mean)
Group 1 (Inducers) (PK-PPS)380.1
Group 2 (Neutral [Control]) (PK-PPS)307.2

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The Maximum Observed Plasma Concentration (Cmax) of Padsevonil (PSL) During the Study

The Cmax for Padsevonil in plasma was expressed in nanograms per milliliter (ng/mL). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionng/mL (Least Squares Mean)
Group 1 (Inducers) (PK-PPS)1210
Group 2 (Neutral [Control]) (PK-PPS)1670

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The Ratio of PSL Metabolite UCB1447499-000 to PSL Based on the Area Under the Curve (AUCtau)

Metabolite-to-Parent Ratios were corrected for differences in molecular weight. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionratio (Geometric Mean)
Group 1 (Inducers) (PK-PPS)0.3492
Group 2 (Neutral [Control]) (PK-PPS)0.2011

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The Ratio of PSL Metabolite UCB1431322-000 to PSL Based on the Area Under the Curve (AUCtau) During the Study

Metabolite-to-Parent Ratios were corrected for differences in molecular weight. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionratio (Geometric Mean)
Group 1 (Inducers) (PK-PPS)2.283
Group 2 (Neutral [Control]) (PK-PPS)1.386

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Percentage of Participants With at Least One Adverse Event (AE) During the Study

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (NCT03695094)
Timeframe: From screening (Day -28 to Day -2) up to end of study (EOS) visit day 20 (+/-1)

Interventionpercentage of participants (Number)
Group 1 (Inducers) (FAS)100
Group 2 (Neutral [Control]) (FAS)100

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The Time to Reach Maximum Concentration (Tmax) for Padsevonil During the Study

The tmax for Padsevonil in plasma was expressed in hours (hr). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionhr (Median)
Group 1 (Inducers) (PK-PPS)1.500
Group 2 (Neutral [Control]) (PK-PPS)2.000

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The Time to Reach Maximum Concentration (Tmax) for UCB1431322-000 During the Study

The tmax for UCB1431322-000 in plasma was expressed in hours (hr). (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionhr (Median)
Group 1 (Inducers) (PK-PPS)3.500
Group 2 (Neutral [Control]) (PK-PPS)3.500

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The Time to Reach Maximum Concentration (Tmax) for UCB1447499-000 During the Study

The tmax for UCB1447499-000 in plasma was expressed in hr. (NCT03695094)
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose

Interventionhr (Median)
Group 1 (Inducers) (PK-PPS)2.000
Group 2 (Neutral [Control]) (PK-PPS)2.000

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Withdrawal Rate

(NCT03940326)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Levetiracetam4
Valproate6

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Time to Withdrawal

(NCT03940326)
Timeframe: 9 months

InterventionDays (Mean)
Levetiracetam220
Valproate172

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Time to First Seizure

The time interval from the beginning of the study to occurrence of the first seizure (NCT03940326)
Timeframe: 6 months

InterventionDays (Mean)
Levetiracetam169
Valproate178

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Seizure Freedom Rate

(NCT03940326)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Levetiracetam40
Valproate50

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