lamotrigine and Dizziness studies

Dizziness: An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness.

Research Excerpts

Excerpt	Relevance	Reference
"This study assessed the comparative efficacy of pregabalin for refractory partial seizures."	9.14	A comparison of pregabalin, lamotrigine, and placebo as adjunctive therapy in patients with refractory partial-onset seizures. ( Barrett, J; Baulac, M; Leon, T; O'Brien, TJ; Whalen, E, 2010)
"To compare the pharmacokinetics (PK) of lamotrigine (LTG) when converting from twice-daily immediate-release (LTG-IR) to once-daily extended-release (LTG-XR) in subjects with epilepsy."	9.13	Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). ( Ali, I; Hammer, AE; Job, S; Lemme, F; Messenheimer, JA; Oliver-Willwong, R; Tompson, DJ; Vuong, A; Zhu, L, 2008)
"This randomised, double-blind study compared the newer antiepileptic drugs (AEDs) gabapentin (GBP) and lamotrigine (LTG) as monotherapy in newly diagnosed epilepsy."	9.10	Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002)
"To provide a qualitative, systematic update and review of the pharmacology, pharmacokinetics, efficacy in mood disorders, adverse effects, and costs of lamotrigine."	8.81	Lamotrigine update and its use in mood disorders. ( Hurley, SC, 2002)
"To examine the safety of lamotrigine (LTG) used in general practice to treat epilepsy."	7.69	Safety of long-term lamotrigine in epilepsy. ( Freemantle, SN; Mackay, FJ; Mann, RD; Pearce, GL; Wilton, LV, 1997)
"The objective was to assess the efficacy and safety of adjunctive brivaracetam (BRV) with concomitant use of lamotrigine (LTG) or topiramate (TPM) in patients with uncontrolled focal seizures."	5.27	Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. ( Benbadis, S; Diaz, A; Elmoufti, S; Klein, P; Schiemann, J; Whitesides, J, 2018)
"This study assessed the comparative efficacy of pregabalin for refractory partial seizures."	5.14	A comparison of pregabalin, lamotrigine, and placebo as adjunctive therapy in patients with refractory partial-onset seizures. ( Barrett, J; Baulac, M; Leon, T; O'Brien, TJ; Whalen, E, 2010)
"To compare the pharmacokinetics (PK) of lamotrigine (LTG) when converting from twice-daily immediate-release (LTG-IR) to once-daily extended-release (LTG-XR) in subjects with epilepsy."	5.13	Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). ( Ali, I; Hammer, AE; Job, S; Lemme, F; Messenheimer, JA; Oliver-Willwong, R; Tompson, DJ; Vuong, A; Zhu, L, 2008)
"This randomised, double-blind study compared the newer antiepileptic drugs (AEDs) gabapentin (GBP) and lamotrigine (LTG) as monotherapy in newly diagnosed epilepsy."	5.10	Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002)
"To determine the effects of lamotrigine on (1) seizures, (2) adverse-effect profile, and (3) cognition and quality of life, compared to placebo, when used as an add-on treatment for people with drug-resistant focal epilepsy."	5.05	Lamotrigine add-on therapy for drug-resistant focal epilepsy. ( Bresnahan, R; Marson, AG; Panebianco, M; Ramaratnam, S, 2020)
"To provide a qualitative, systematic update and review of the pharmacology, pharmacokinetics, efficacy in mood disorders, adverse effects, and costs of lamotrigine."	4.81	Lamotrigine update and its use in mood disorders. ( Hurley, SC, 2002)
" Although the sample size is small, this study suggests that lamotrigine may induce less disequilibrium than does carbamazepine in older people on monotherapy for epilepsy."	3.73	Measuring the effects of antiepileptic medications on balance in older people. ( Blum, D; Fife, TD; Fisher, RS, 2006)
"To examine the safety of lamotrigine (LTG) used in general practice to treat epilepsy."	3.69	Safety of long-term lamotrigine in epilepsy. ( Freemantle, SN; Mackay, FJ; Mann, RD; Pearce, GL; Wilton, LV, 1997)
" The adverse effect (AE) profile of this combination needs clarification."	2.69	Adding lamotrigine to valproate: incidence of rash and other adverse effects. Postmarketing Antiepileptic Drug Survey (PADS) Group. ( Faught, E; French, J; Harden, C; Jacobson, M; Montouris, G; Morris, G; Rosenfeld, W, 1999)
"Rash was the most common ADR of lamotrigine and the most common reason for treatment discontinuation."	2.52	Safety of lamotrigine in paediatrics: a systematic review. ( Choonara, I; Egunsola, O; Sammons, HM, 2015)
" LEV has milder adverse events than OXC and LTG in clinical practice."	1.56	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)
"05) change in the serum concentrations of either CBZ or its epoxide metabolite when LTG was added either to the group as a whole or to the nine patients who experienced adverse CNS effects."	1.30	Carbamazepine toxicity with lamotrigine: pharmacokinetic or pharmacodynamic interaction? ( Berry, DJ; Besag, FM; Newbery, JE; Pool, F; Subel, B, 1998)

Research

Studies (20)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	4 (20.00)	18.2507
2000's	6 (30.00)	29.6817
2010's	6 (30.00)	24.3611
2020's	4 (20.00)	2.80

Authors	Studies
Panebianco, M	2
Bresnahan, R	2
Ramaratnam, S	1
Marson, AG	3
Ramey, P	2
Osborn, M	1
Kirshner, H	1
Abou-Khalil, B	2
Li, R	1
Zhou, Q	1
Ou, S	1
Wang, Y	1
Li, Y	1
Xia, L	1
Pan, S	1
Androsova, G	1
Krause, R	1
Borghei, M	1
Wassenaar, M	1
Auce, P	1
Avbersek, A	1
Becker, F	1
Berghuis, B	1
Campbell, E	1
Coppola, A	1
Francis, B	1
Wolking, S	1
Cavalleri, GL	1
Craig, J	1
Delanty, N	1
Koeleman, BPC	1
Kunz, WS	1
Lerche, H	1
Sander, JW	1
Sills, GJ	1
Striano, P	1
Zara, F	1
Sisodiya, SM	1
Depondt, C	1
Benbadis, S	1
Klein, P	1
Schiemann, J	1
Diaz, A	1
Elmoufti, S	1
Whitesides, J	1
Egunsola, O	1
Choonara, I	1
Sammons, HM	1
Osborn, MR	1
Lowen, KM	1
Reed, RC	1
Welsh, L	1
Binder, W	1
Miller, ES	1
Baulac, M	1
Leon, T	1
O'Brien, TJ	1
Whalen, E	1
Barrett, J	1
Brodie, MJ	1
Chadwick, DW	1
Anhut, H	1
Otte, A	1
Messmer, SL	1
Maton, S	1
Sauermann, W	1
Murray, G	1
Garofalo, EA	1
Biton, V	1
Sackellares, JC	1
Vuong, A	2
Hammer, AE	2
Barrett, PS	1
Messenheimer, JA	2
Fife, TD	1
Blum, D	1
Fisher, RS	1
Tompson, DJ	1
Ali, I	1
Oliver-Willwong, R	1
Job, S	1
Zhu, L	1
Lemme, F	1
Besag, FM	1
Berry, DJ	1
Pool, F	1
Newbery, JE	1
Subel, B	1
Mackay, FJ	1
Wilton, LV	1
Pearce, GL	1
Freemantle, SN	1
Mann, RD	1
Faught, E	1
Morris, G	1
Jacobson, M	1
French, J	1
Harden, C	1
Montouris, G	1
Rosenfeld, W	1
Matsuo, F	1
Hurley, SC	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures[NCT00464269]	Phase 3	400 participants (Actual)	Interventional	2007-09-30	Completed
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures[NCT01261325]	Phase 3	768 participants (Actual)	Interventional	2010-12-31	Completed
A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.[NCT00490035]	Phase 3	399 participants (Actual)	Interventional	2007-09-30	Completed
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 4	361 participants (Actual)	Interventional	2007-01-31	Completed
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures[NCT00043901]	Phase 4	141 participants (Actual)	Interventional	2000-12-01	Completed
An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa[NCT00264615]	Phase 3	45 participants	Interventional	2005-10-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures.~All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	seizures per week (Median)
Modified Intention-to-Treat (Placebo Treated Subjects)	2.15
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	1.80
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	1.96
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	1.77

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	2.79
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	4.26
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	6.36
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	3.37

"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	1.97
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	7.03
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	7.73
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	2.06

Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	2.14
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	1.69
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	2.07
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	1.97

Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	6.41
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	2.24
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	3.94
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	0.45

Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	8.1
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	6.9
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	7.3
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	5.5

The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Hospital Depression Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	7.44
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	7.32
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	6.55
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	7.99

Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	5.36
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	4.97
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	4.82
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	5.81

Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	1.02
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	-2.61
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	0.73
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	6.07

Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	5.49
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	3.39
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	3.66
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	2.33

Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	9.36
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	3.34
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	3.69
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	5.97

Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

Intervention	units on a scale (Mean)
Modified Intention-to-Treat (Placebo Treated Subjects)	3.88
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	4.07
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	5.19
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	2.88

"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week

Intervention	seizures per week (Median)
Modified Intention-to-Treat (Placebo Treated Subjects)	2.15
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	1.80
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	1.96
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	1.70

"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period

Intervention	Percent change in POS frequency (Median)
Modified Intention-to-Treat (Placebo Treated Subjects)	17.75
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	19.95
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	22.52
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	30.47

The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Time to Fifth Type I Seizure During the 12-week Treatment Period

Intervention	percentage of participants (Number)
Modified Intention-to-Treat (Placebo Treated Subjects)	56.3
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	50.0
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	77.8
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	63.6

The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Time to First Type I Seizure During the 12-week Treatment Period

Intervention	days (Median)
Modified Intention-to-Treat (Placebo Treated Subjects)	15
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	14
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	17
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	19

The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Time to Tenth Type I Seizure During the 12-week Treatment Period

Intervention	days (Median)
Modified Intention-to-Treat (Placebo Treated Subjects)	3
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	4
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	5
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	4

The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period

Intervention	days (Median)
Modified Intention-to-Treat (Placebo Treated Subjects)	28
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	30
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	34
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	37

"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit

Intervention	percentage of participants (Number)
	<-25 %	-25 % to < 25 %	25 % to < 50 %	50 % to < 75 %	75 % to < 100 %	100 %
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	14.1	38.4	24.2	15.2	6.1	2.0
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	21.9	31.3	25.0	12.5	8.3	1.0
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	9.9	31.7	25.7	19.8	8.9	4.0
Modified Intention-to-Treat (Placebo Treated Subjects)	14.6	44.8	24.0	12.5	4.2	0

The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.' (NCT00464269)
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit

Intervention	percentage of participants (Number)
	Marked improvement	Moderate improvement	Slight improvement	No change	Slight worsening	Moderate worsening	Marked worsening
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	17.2	18.2	31.3	32.3	1.0	0	0
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	12.2	18.9	24.4	34.4	2.2	7.8	0
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	16.3	27.6	24.5	25.5	2.0	3.1	1.0
Modified Intention-to-Treat (Placebo Treated Subjects)	12.6	20.0	21.1	41.1	3.2	1.1	1.1

Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?' (NCT00464269)
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

Intervention	percentage of participants (Number)
	Marked improvement	Moderate improvement	Slight improvement	No change	Slight worsening	Moderate worsening	Marked worsening
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	18.8	26.3	21.3	27.5	1.3	3.8	1.3
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	19.8	24.7	18.5	23.5	6.2	7.4	0
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	26.7	19.8	22.1	23.3	4.7	1.2	2.3
Modified Intention-to-Treat (Placebo Treated Subjects)	15.5	25.0	23.8	28.6	4.8	1.2	1.2

The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period

Intervention	participants (Number)
	Responders	Non-responders
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	23	76
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	21	75
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	33	68
Modified Intention-to-Treat (Placebo Treated Subjects)	16	80

"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period

Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period

Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration

Intervention	percentage of participants (Number)
	Seizure-free	No seizures but non-completer	Not seizure-free
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	1.0	1.0	98.0
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	1.0	0	99.0
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)	4.0	0	96.0
Modified Intention-to-Treat (Placebo Treated Subjects)	0	0	100.0

Intervention	number of seizures/ 28-day (Median)
Placebo	8.7
Brivaracetam 100 mg/Day	6.3
Brivaracetam 200 mg/Day	5.8

Intervention	percentage of change (Median)
Placebo	17.6
Brivaracetam 100 mg/Day	37.2
Brivaracetam 200 mg/Day	35.6

Primary endpoint: United States of America (FDA) (NCT01261325)
Timeframe: 12 week Treatment Period

Time to the Fifth Type I Seizure During the Treatment Period

Time to the First Type I Seizure During the Treatment Period

Time to the Tenth Type I Seizure During the Treatment Period

50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration

Intervention	Percentage of reduction (Number)
Brivaracetam 100 mg/Day	22.8
Brivaracetam 200 mg/Day	23.2
Placebo	0

Intervention	days (Median)
Placebo	16
Brivaracetam 100 mg/Day	21
Brivaracetam 200 mg/Day	23

Intervention	days (Median)
Placebo	3
Brivaracetam 100 mg/Day	5
Brivaracetam 200 mg/Day	6

Intervention	days (Median)
Placebo	32
Brivaracetam 100 mg/Day	37
Brivaracetam 200 mg/Day	43

Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration. (NCT01261325)
Timeframe: Baseline to 12 week Treatment Period

Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period

Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period

All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period

Intervention	Percentage of subjects (Number)
	Responders	Non-Responders
Brivaracetam 100 mg/Day	38.9	61.1
Brivaracetam 200 mg/Day	37.8	62.2
Placebo	21.6	78.4

Intervention	percentage of subjects (Number)
	<-25 %	-25 % to <25 %	25 % to <50 %	50 % to <75 %	75 % to <100 %	100 %
Brivaracetam 100 mg/Day	14.3	28.6	18.3	19.0	13.9	6.0
Brivaracetam 200 mg/Day	10.8	29.3	22.1	18.1	13.7	6.0
Placebo	16.6	40.5	21.2	13.9	6.9	0.8

Intervention	percentage of subjects (Number)
	Seizure free	No seizures but discontinued	Not seizure free
Brivaracetam 100 mg/Day	5.2	1.2	93.7
Brivaracetam 200 mg/Day	4.0	1.2	94.8
Placebo	0.8	0.4	98.8

There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III). (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	Times per week (Median)
Placebo	1.75
Brivaracetam 20 mg/Day	1.34
Brivaracetam 50 mg/Day	1.49
Brivaracetam 100 mg/Day	1.26

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	1.80
Brivaracetam 20 mg/Day	5.36
Brivaracetam 50 mg/Day	1.02
Brivaracetam 100 mg/Day	0.69

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	-2.09
Brivaracetam 20 mg/Day	3.35
Brivaracetam 50 mg/Day	3.09
Brivaracetam 100 mg/Day	3.50

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	3.80
Brivaracetam 20 mg/Day	3.75
Brivaracetam 50 mg/Day	3.13
Brivaracetam 100 mg/Day	-2.45

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	3.49
Brivaracetam 20 mg/Day	3.53
Brivaracetam 50 mg/Day	1.95
Brivaracetam 100 mg/Day	1.99

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score

Intervention	units on a scale (Mean)
Placebo	6.6
Brivaracetam 20 mg/Day	6.9
Brivaracetam 50 mg/Day	9.7
Brivaracetam 100 mg/Day	4.9

The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Hospital Depression Score

Intervention	units on a scale (Mean)
Placebo	-1.54
Brivaracetam 20 mg/Day	-0.59
Brivaracetam 50 mg/Day	-0.41
Brivaracetam 100 mg/Day	0.08

Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	-0.65
Brivaracetam 20 mg/Day	-0.10
Brivaracetam 50 mg/Day	0.26
Brivaracetam 100 mg/Day	-0.24

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	0.92
Brivaracetam 20 mg/Day	3.64
Brivaracetam 50 mg/Day	-0.85
Brivaracetam 100 mg/Day	3.00

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	5.11
Brivaracetam 20 mg/Day	4.52
Brivaracetam 50 mg/Day	4.55
Brivaracetam 100 mg/Day	2.24

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Intervention	units on a scale (Mean)
Placebo	8.25
Brivaracetam 20 mg/Day	6.23
Brivaracetam 50 mg/Day	5.34
Brivaracetam 100 mg/Day	8.04

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit

Intervention	units on a scale (Mean)
Placebo	2.29
Brivaracetam 20 mg/Day	4.50
Brivaracetam 50 mg/Day	3.09
Brivaracetam 100 mg/Day	1.78

"The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: Assess the Overall change in the severity of patient's illness, compared to start of study medication." (NCT00490035)
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

Intervention	units on a scale (Mean)
Placebo	4.78
Brivaracetam 20 mg/Day	4.99
Brivaracetam 50 mg/Day	4.99
Brivaracetam 100 mg/Day	5.34

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. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit

Intervention	Seizure Frequency per Week (Median)
Placebo	1.75
Brivaracetam 20 mg/Day	1.34
Brivaracetam 50 mg/Day	1.49
Brivaracetam 100 mg/Day	1.26

"The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject not mentally impaired had to complete it by answering the following question: Overall, has there been a change in your seizures since the start of the study medication?" (NCT00490035)
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week

The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.

The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Time to Fifth Type I Seizure During the 12-week Treatment Period

The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Time to First Type I Seizure During the 12-week Treatment Period

The time to first Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Time to Tenth Type I Seizure During the 12-week Treatment Period

The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period

"The categories are:~<= 25 %~- 25 % to < 25 %~25 % to < 50 %~50 % to < 75 %~75 % to < 100 %~100 %" (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period

"Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.~The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline." (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period

Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

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

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

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

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

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

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

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

Time to Drop Out

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

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

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

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

"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

Intervention	units on a scale (Mean)
Placebo	4.93
Brivaracetam 20 mg/Day	5.17
Brivaracetam 50 mg/Day	5.04
Brivaracetam 100 mg/Day	5.47

Intervention	Percent change in seizures per week (Median)
Placebo	-17.03
Brivaracetam 20 mg/Day	-30.03
Brivaracetam 50 mg/Day	-26.83
Brivaracetam 100 mg/Day	-32.45

Intervention	percentage of participants (Number)
Placebo	45.9
Brivaracetam 20 mg/Day	47.2
Brivaracetam 50 mg/Day	62.5
Brivaracetam 100 mg/Day	41.0

Intervention	Percentage of Participants (Number)
	<= 25 %	- 25 % to < 25 %	25 % to < 50 %	50 % to < 75 %	75 % to < 100 %	100 %
Brivaracetam 100 mg/Day	10.0	33.0	21.0	14.0	18.0	4.0
Brivaracetam 20 mg/Day	10.1	35.4	27.3	18.2	7.1	2.0
Brivaracetam 50 mg/Day	15.2	33.3	24.2	17.2	9.1	1.0
Placebo	19.0	41.0	20.0	12.0	8.0	0

Intervention	units on a scale (Mean)
	Cognitive toxicity subscore	Somatomotor subscore	Total Score
Carbamazepine	27.3	11.4	38.7
Lamotrigine	23.7	10.8	34.5
Levetiracetam	22.2	10.5	32.7

Intervention	units on a scale (Mean)
	Seizure worry	Overall quality of life	Emotional well-being	Energy/fatigue	Cognitive functioning	Medication effects	Social functioning	Total Score	Health Scale
Carbamazepine	75.4	65.0	69.8	54.5	68.9	70.6	76.3	68.9	65.7
Lamotrigine	75.0	67.1	67.4	59.8	68.0	72.6	76.7	69.1	67.5
Levetiracetam	85.1	67.2	72.0	60.8	75.1	77.6	81.1	73.9	69.5

Intervention	participants (Number)
	Without pathological findings	Borderline	Impaired
Carbamazepine	34	17	33
Lamotrigine	31	15	39
Levetiracetam	38	10	36

Intervention	participants (Number)
	Improved	Unchanged	Worsened
Carbamazepine	16	56	8
Lamotrigine	15	53	13
Levetiracetam	15	61	6

Article	Year
Lamotrigine add-on therapy for drug-resistant focal epilepsy. The Cochrane database of systematic reviews, 2020, 03-20, Volume: 3 Topics: Adult; Anticonvulsants; Ataxia; Child; Cognition; Cross-Over Studies; Diplopia; Dizziness; Drug Resi	2020
Lamotrigine add-on therapy for drug-resistant generalised tonic-clonic seizures. The Cochrane database of systematic reviews, 2020, 07-01, Volume: 7 Topics: Anticonvulsants; Chemotherapy, Adjuvant; Dizziness; Drug Eruptions; Drug Resistant Epilepsy; Epileps	2020
Safety of lamotrigine in paediatrics: a systematic review. BMJ open, 2015, Jun-12, Volume: 5, Issue:6 Topics: Abdominal Pain; Anticonvulsants; Child; Dizziness; Drug Therapy, Combination; Exanthema; Headache; H	2015
Lamotrigine. Epilepsia, 1999, Volume: 40 Suppl 5 Topics: Adolescent; Adult; Animals; Anticonvulsants; Child; Clinical Trials as Topic; Diplopia; Dizziness; D	1999
Lamotrigine update and its use in mood disorders. The Annals of pharmacotherapy, 2002, Volume: 36, Issue:5 Topics: Acetates; Aggression; Amines; Antidepressive Agents; Bipolar Disorder; Cyclohexanecarboxylic Acids;	2002

Article	Year
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy & behavior : E&B, 2018, Volume: 80 Topics: Adult; Anticonvulsants; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Drug Thera	2018
A comparison of pregabalin, lamotrigine, and placebo as adjunctive therapy in patients with refractory partial-onset seizures. Epilepsy research, 2010, Volume: 91, Issue:1 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Dizziness; Double-Blind Method; Epilepsies, Partial; Fem	2010
Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. Epilepsia, 2002, Volume: 43, Issue:9 Topics: Acetates; Adolescent; Adult; Aged; Amines; Anticonvulsants; Asthenia; Clinical Protocols; Cyclohexan	2002
Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology, 2005, Dec-13, Volume: 65, Issue:11 Topics: Adolescent; Adult; Anticonvulsants; Child; Child, Preschool; Disorders of Excessive Somnolence; Dizz	2005
Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). Epilepsia, 2008, Volume: 49, Issue:3 Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anticonvulsants; Area Under Curve;	2008
Adding lamotrigine to valproate: incidence of rash and other adverse effects. Postmarketing Antiepileptic Drug Survey (PADS) Group. Epilepsia, 1999, Volume: 40, Issue:8 Topics: Adolescent; Adult; Child; Dizziness; Drug Eruptions; Drug Hypersensitivity; Drug Therapy, Combinatio	1999

Article	Year
Misdiagnosis of lamotrigine toxicity as posterior circulation transient ischemic attack or stroke. Epilepsy & behavior : E&B, 2020, Volume: 111 Topics: Adult; Aged; Anticonvulsants; Ataxia; Diagnostic Errors; Dizziness; Dose-Response Relationship, Drug	2020
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. Epilepsy research, 2020, Volume: 166 Topics: Adolescent; Adult; Aged; Anticonvulsants; Child; Child, Preschool; Cohort Studies; Dizziness; Drug A	2020
Comparative effectiveness of antiepileptic drugs in patients with mesial temporal lobe epilepsy with hippocampal sclerosis. Epilepsia, 2017, Volume: 58, Issue:10 Topics: Adolescent; Adult; Aged; Amines; Anticonvulsants; Ataxia; Benzodiazepines; Carbamazepine; Clobazam;	2017
Unexplained spikes in lamotrigine serum concentration: nonlinear elimination? Acta neurologica Scandinavica, 2017, Volume: 135, Issue:2 Topics: Adult; Aged; Anticonvulsants; Ataxia; Dizziness; Dose-Response Relationship, Drug; Drug Interactions	2017
Unsteady Gait and Dizziness. The Journal of emergency medicine, 2016, Volume: 50, Issue:6 Topics: Accidental Falls; Anticonvulsants; Cervical Cord; Clonazepam; Dizziness; Epidural Neoplasms; Gait Di	2016
Measuring the effects of antiepileptic medications on balance in older people. Epilepsy research, 2006, Volume: 70, Issue:2-3 Topics: Aged; Amines; Anticonvulsants; Ataxia; Carbamazepine; Cyclohexanecarboxylic Acids; Dizziness; Epilep	2006
Carbamazepine toxicity with lamotrigine: pharmacokinetic or pharmacodynamic interaction? Epilepsia, 1998, Volume: 39, Issue:2 Topics: Anticonvulsants; Carbamazepine; Child; Diplopia; Dizziness; Dose-Response Relationship, Drug; Drug A	1998
Safety of long-term lamotrigine in epilepsy. Epilepsia, 1997, Volume: 38, Issue:8 Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Age Factors; Aged; Anticonvulsants; Chil	1997
Valproate and other anticonvulsants for psychiatric disorders. The Medical letter on drugs and therapeutics, 2000, Dec-11, Volume: 42, Issue:1094 Topics: Abnormalities, Drug-Induced; Acetates; Adult; Amines; Anti-Anxiety Agents; Anticonvulsants; Bipolar	2000

lamotrigine and Dizziness

Research Excerpts

Research

Studies (20)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score

Change From Baseline to the 12-week Treatment Period in Hospital Depression Score

Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week

Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period

Time to Fifth Type I Seizure During the 12-week Treatment Period

Time to First Type I Seizure During the 12-week Treatment Period

Time to Tenth Type I Seizure During the 12-week Treatment Period

Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period

Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit

Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit

Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period

All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period

Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period

Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration

Time to the Fifth Type I Seizure During the Treatment Period

Time to the First Type I Seizure During the Treatment Period

Time to the Tenth Type I Seizure During the Treatment Period

50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration

Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period

Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period

All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score

Change From Baseline to the 12-week Treatment Period in Hospital Depression Score

Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit

Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit

Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week

Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.

Time to Fifth Type I Seizure During the 12-week Treatment Period

Time to First Type I Seizure During the 12-week Treatment Period

Time to Tenth Type I Seizure During the 12-week Treatment Period

Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period

Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period

Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period

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

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

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

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

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

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

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

Time to Drop Out

Portland Neurotoxicity Scale (PNS) at V6

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

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

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

Reviews

Trials

Other Studies