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pramipexole

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Description

Pramipexole is a dopamine agonist medication used to treat Parkinson's disease, restless legs syndrome, and other conditions. It works by stimulating dopamine receptors in the brain, which helps to improve motor function. Pramipexole is typically taken orally, and it can be effective in reducing symptoms of Parkinson's disease, such as tremors, rigidity, and slowness of movement. It can also help to improve sleep quality in people with restless legs syndrome. Pramipexole is a synthetic compound that was first synthesized in the 1990s. It has been extensively studied, and it is generally considered to be safe and effective for treating Parkinson's disease and restless legs syndrome. However, it can cause side effects, such as nausea, vomiting, dizziness, and sleepiness. It is important to talk to a doctor before taking pramipexole, as it may not be suitable for everyone. Pramipexole is a non-ergot dopamine agonist, meaning it does not have the same side effects as older dopamine agonists. It is often used as a first-line treatment for Parkinson's disease, and it can be effective in improving motor function and quality of life for people with this condition.'
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Pramipexole: A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

pramipexole : A member of the class of benzothiazoles that is 4,5,6,7-tetrahydro-1,3-benzothiazole in which the hydrogens at the 2 and 6-pro-S-positions are substituted by amino and propylamino groups, respectively. [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 CID119570
CHEMBL ID301265
CHEBI ID8356
SCHEMBL ID35376
MeSH IDM0170120

Synonyms (109)

Synonym
BIDD:GT0250
(6s)-n(6)-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
pramipexolum
CHEBI:8356 ,
AB00053772-12
AB00053772-13
gtpl953
(6s)-n'-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
DIVK1C_006916
mirapexin
u-98528e
(6s)-n6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
pramipexolum [latin]
2-amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole
(s)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole
2,6-benzothiazolediamine, 4,5,6,7-tetrahydro-n6-propyl-, (s)-
2,6-benzothiazolediamine, 4,5,6,7-tetrahydro-n(sup 6)-propyl-, (s)-
pramipexol [spanish]
sud919cl2y
SPECTRUM_001838
pramipexole (usan/inn)
D05575
104632-26-0
SPECTRUM5_001453
MLS001423952
pramipexole
smr000449298
MLS000758250
pramipexol
DB00413
(-)-pramipexole
(s)-n 6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
KBIO2_002340
KBIO1_001860
KBIO2_004908
KBIO2_007476
KBIOSS_002343
SPECPLUS_000820
NCGC00167441-01
4,5,6,7-tetrahydro-n6-propyl-2,6-benzothiazole-diamine
HMS2090C15
HMS2051A21
111GE001 ,
bdbm50116766
sud-919cl2y
nsc-760426
CHEMBL301265 ,
(6s)-6-n-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
n'-propyl-4,5,6,7-tetrahydrobenzothiazole-2,6-diamine; (s)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzthiazole;(s)-n6-propyl-4,5,6,7-tetrahydrobenzothiazole-2,6-diamine
A801025
hsdb 8253
unii-83619peu5t
83619peu5t ,
oprymea
(s)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzothiazole
sud 919cl2y
pramipexole [usan:inn:ban]
nsc 760426
snd 919
ec 600-593-1
dtxsid6023496 ,
dtxcid203496
tox21_112445
cas-104632-26-0
(s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine
HMS2232B03
CCG-100823
NCGC00167441-03
ctc-501
pramipexole [mi]
pramipexole [vandf]
pramipexole [who-dd]
pramipexole [inn]
pramipexole [usan]
(s)-pramipexole
S2460
CX1349
FASDKYOPVNHBLU-ZETCQYMHSA-N
(s)-(-)-2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole
(-) pramipexole
(6s)-4,5,6,7-tetrahydro-n6-propyl-2,6-benzothiazole-diamine
HY-B0410
NC00073
SCHEMBL35376
NCGC00167441-02
tox21_112445_1
2,6-benzothiazolediamine, 4,5,6,7-tetrahydro-n6-propyl-, (6s)-
AB00053772_16
AB00053772_14
J-001211
sr-01000763219
SR-01000763219-6
SR-01000763219-5
SW197453-4
A901248
Q421304
(s)-4,5,6,7-tetrahydro-n6-propyl-2,6-benzothiazolediamine
pramipexole (mirapex)
DS-14807
AMY10837
EN300-150086
NCGC00167441-10
HMS3884L19
AKOS016843188
556801-24-2
P2879
(s)-n 6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
pramipexolum (latin)
n04bc05

Research Excerpts

Overview

Pramipexole is a dopamine agonist that is well-tolerated and effective at treating Parkinson’s disease symptoms. PramipeXole is used as a treatment in PD and restless legs syndrome to reduce motor symptoms, but it often induces impulse control disorders. Dexpramipe Xole was a great hope for the treatment of ALS.

ExcerptReferenceRelevance
"Pramipexole is a promising augmentation agent for TRD and may be a useful addition to existing treatment regimes. "( PAX-D: study protocol for a randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression.
Attenburrow, MJ; Au-Yeung, SK; Bogacz, R; Browning, M; Chan, F; Cipriani, A; Cleare, A; Cowen, P; Edwards, C; Evans, J; Geddes, J; Griffiths, J; Harmer, CJ; Harrison, PJ; Kessler, D; Lewis, G; Rendell, J; Roberts, S; Shanyinde, M; Simon, J; Singh, I; Watson, S; Yu, LM, 2022
)
2.38
"Pramipexole is a selective dopamine agonist applied for treating Parkinson's disease and has been recently claimed with neuroprotective capacity."( Pramipexole Protects Against Traumatic Brain Injury-Induced Blood-Brain Barrier (BBB) Dysfunction.
Chen, L; Huang, J; Huang, Z; Lan, H; Liu, Z; Wei, C; Xie, C; Zhou, Z, 2022
)
2.89
"Pramipexole is a dopamine agonist that is well-tolerated and effective at treating Parkinson’s disease symptoms."( Efficacy of pramipexole on quality of life in patients with Parkinson's disease: a systematic review and meta-analysis.
Li, T; Liang, Z; Liu, M; Zhang, Z; Zou, S, 2022
)
1.82
"Pramipexole is a dopamine agonist used as a treatment in PD and restless legs syndrome to reduce motor symptoms, but it often induces impulse control disorders. "( The anterior caudate nucleus supports impulsive choices triggered by pramipexole.
Martinez, E; Météreau, É; Pasquereau, B; Saga, Y; Tremblay, L, 2020
)
2.24
"Pramipexole is a selective dopamine receptor agonist which is used in the treatment of Parkinson's disease and restless legs syndrome. "( The convenient use of fluorescamine for spectrofluorimetric quantitation of pramipexole in pure form and pharmaceutical formulation; application to content uniformity testing.
Abdelrahman, MM; Abdelwahab, NS; Ahmed, AB; Derayea, SM; Omar, MA, 2020
)
2.23
"Dexpramipexole is a BTZ structural analog of riluzole and was a great hope for the treatment of ALS."( From Riluzole to Dexpramipexole via Substituted-Benzothiazole Derivatives for Amyotrophic Lateral Sclerosis Disease Treatment: Case Studies.
Desaphy, JF; Lentini, G; Majoral, JP; Mignani, S, 2020
)
1.4
"Pramipexole is an agonist, and the charge transfer process is similar to that of dopamine."( Interaction of graphene with antipsychotic drugs: Is there any charge transfer process?
Del Castillo, RM; Martínez, A; Ramos, E, 2021
)
1.34
"Pramipexole is a dopaminergic pharmacologic agent with reported adverse effects that include hypersexuality, shift in sexual interests, pathological gambling, compulsive shopping, and binge eating. "( Treatment of Pramipexole-Induced Problematic Sexual Behaviors.
DiMario, K; Fedoroff, JP; Ly, T; Mihowich, T; Murphy, L, 2021
)
2.43
"Pramipexole is a dopamine agonist with potential antidepressant, neuroprotective, antioxidant and anti-inflammatory activity. "( Efficacy and safety of 24-week pramipexole augmentation in patients with treatment resistant depression. A retrospective cohort study.
Betro', S; de Filippis, R; Iommi, M; Tundo, A, 2022
)
2.45
"Pramipexole is a dopamine D"( Pramipexole Overdose Associated with Visual Hallucinations, Agitation and Myoclonus.
Cardon-Dunbar, A; Isbister, GK; Roberts, MS; Robertson, T, 2017
)
3.34
"Pramipexole is a therapeutic option for MDD resistant to ECT. "( Pramipexole and Electroconvulsive Therapy in Treatment-Resistant Depression.
Advenier-Iakovlev, E; Gaillard, R; Gauthier, C; Souaiby, L,
)
3.02
"Dexpramipexole (DEX) is a drug with a good safety profile in humans, known for its ability to increase mitochondrial ATP production and prompt neuroprotection in adult rodents subjected to cerebral ischemia. "( Repurposing of dexpramipexole to treatment of neonatal hypoxic/ischemic encephalopathy.
Buonvicino, D; Chiarugi, A; Muzzi, M; Tofani, L; Urru, M, 2018
)
1.44
"Pramipexole (PPX) is a dopamine agonist developed for the symptomatic relief of PD."( Pramipexole reduces phosphorylation of α-synuclein at serine-129.
Chau, KY; Cooper, JM; Schapira, AH, 2013
)
2.55
"Pramipexole is a clinically important dopamine receptor agonist with reported selectivity for dopamine D3 receptors over other dopaminergic and non-dopaminergic sites. "( Low dose pramipexole causes D3 receptor-independent reduction of locomotion and responding for a conditioned reinforcer.
Browne, JD; Fletcher, PJ; McCormick, PN; Nobrega, JN; Remington, GJ; Wilson, VS, 2015
)
2.28
"Pramipexole is a D3 dopamine receptor-preferring agonist indicated for the treatment of Parkinson disease. "( Dopamine D3 receptor-preferring agonist enhances the subjective effects of cocaine in humans.
De La Garza, R; Haile, CN; Kosten, TR; Mahoney, JJ; Newton, TF; Shah, R; Verrico, CD, 2015
)
1.86
"Pramipexole is a dopaminergic agonist used in Parkinson's disease treatment. "( The adrenergic α2 antagonist atipamezole alters the behavioural effects of pramipexole and increases pramipexole concentration in blood plasma.
Fletcher, PJ; McCormick, PN; Remington, GJ; Wilson, VS, 2016
)
2.11
"Pramipexole is a dopamine D2 receptor agonist indicated for treating Parkinson disorder. "( Antidepressant effect of pramipexole in mice forced swimming test: A cross talk between dopamine receptor and NMDA/nitric oxide/cGMP pathway.
Dehpour, AR; Imran Khan, M; Norouzi-Javidan, A; Ostadhadi, S, 2016
)
2.18
"Pramipexole is a possible alternative, but limited literature on its effectiveness exists."( Pramipexole in the treatment of REM sleep behaviour disorder: A critical review.
Tan, SM; Wan, YM, 2016
)
2.6
"Pramipexole is a dopamine (DA) agonist (D2 subfamily receptors) that widely use in the treatment of Parkinson's diseases. "( Pramipexole reduces inflammation in the experimental animal models of inflammation.
Akbartabar Touri, M; Delaviz, H; Ghavamzadeh, M; Jafari Barmak, M; Parishani, M; Sadeghi, H; Zarezade, V, 2017
)
3.34
"Pramipexole (PPX) is a D(2)/D(3) receptor agonist that has been shown to be effective in the treatment of depression. "( Sustained administration of pramipexole modifies the spontaneous firing of dopamine, norepinephrine, and serotonin neurons in the rat brain.
Blier, P; Chernoloz, O; El Mansari, M, 2009
)
2.09
"Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. "( Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies.
Haertter, S; Jenner, P; Könen-Bergmann, M; Schepers, C, 2009
)
2.03
"Pramipexole (PRA) is a preferential D3R agonist that, in rats and humans, modifies prepulse inhibition (PPI) of the acoustic startle reflex, an operational measure of sensorimotor gating. "( The effects of pramipexole on prepulse inhibition and locomotor activity in C57BL/6J mice.
Buell, MR; Chang, WL; Geyer, MA; Swerdlow, NR; Weber, M, 2010
)
2.16
"Pramipexole is a hydrophilic, weakly basic drug, but exhibits high oral bioavailability in humans (>90%). "( Uptake of pramipexole by human organic cation transporters.
Diao, L; Polli, JE; Shu, Y, 2010
)
2.21
"Pramipexole (PPX) is a dopamine agonist approved for the treatment of the signs and symptoms of idiopathic Parkinson's disease as well as restless leg syndrome. "( Toxicity assessment of pramipexole in juvenile rhesus monkeys.
Deschl, U; Eddie, M; Greischel, A; Hotchkiss, CE; Li, M; Mauz, A; Patterson, TA; Paule, MG; Stierstorfer, B, 2010
)
2.11
"Pramipexole (PPX) is a dopamine agonist with an 8-fold higher affinity for D3 than D2 receptor, whose efficacy in the treatment of Parkinson's disease is based on dopamine agonistic activity. "( Distinct effects of pramipexole on the proliferation of adult mouse sub-ventricular zone-derived cells and the appearance of a neuronal phenotype.
Canonico, PL; Merlo, S; Sortino, MA, 2011
)
2.14
"Pramipexole is an effective treatment for restless legs syndrome (RLS), but no controlled studies have lasted >12 weeks."( Efficacy and augmentation during 6 months of double-blind pramipexole for restless legs syndrome.
Albrecht, S; Allen, RP; Brenner, SS; Busse, M; Ferini-Strambi, L; Fraessdorf, M; Garcia-Borreguero, D; Hening, W; Högl, B; Poewe, W; Trenkwalder, C, 2011
)
2.06
"Pramipexole is an effective agent against subjective tinnitus associated with presbycusis at a dose schedule used for the treatment of Parkinson's disease. "( Tinnitus control by dopamine agonist pramipexole in presbycusis patients: a randomized, placebo-controlled, double-blind study.
Sziklai, I; Szilvássy, J; Szilvássy, Z, 2011
)
2.08
"Pramipexole is a nonergolinic dopamine agonist, with high affinity for the D2 subfamily of dopamine receptors. "( Pramipexole for the treatment of early Parkinson's disease.
Perez Lloret, S; Perez-Lloret, S; Rascol, O; Ratti, L; Rey, MV, 2011
)
3.25
"Pramipexole is a non-ergot agonist with selective affinity for dopamine receptors of the D2 subfamily, in particular D3. "( Pharmacokinetic evaluation of pramipexole.
Antonini, A; Calandrella, D, 2011
)
2.1
"Pramipexole is a dopamine agonist that has been used to treat both motor and non-motor symptoms associated with PD."( The effect of pramipexole on depressive symptoms in Parkinson's disease.
Hamaguchi, H; Kanda, F; Sekiguchi, K; Yasui, N, 2011
)
1.45
"Pramipexole (PPX) is a dopamine agonist medication that has been implicated in the development of pathological gambling and other impulse control disorders. "( Effects of acute pramipexole on male rats' preference for gambling-like rewards II.
Johnson, PS; Madden, GJ; Stein, JS, 2012
)
2.16
"Pramipexole is a non-ergot dopamine agonist that is used frequently as a single therapy or in combination for the management of Parkinson's disease. "( Pramipexole-related chronic lower limb oedema in a patient with Parkinson's disease.
Munhoz, RP; Teive, HA; Zavala, JA, 2012
)
3.26
"Pramipexole (PPX) is a dopamine agonist that is FDA-approved for treatment of motor dysfunction in Parkinson's disease and restless leg syndrome. "( Pramipexole- and methamphetamine-induced reward-mediated behavior in a rodent model of Parkinson's disease and controls.
Napier, TC; Riddle, JL; Rokosik, SL, 2012
)
3.26
"Pramipexole is a novel, internationally available selective nonergot D2 dopamine agonist. "( [Pramipexole in Parkinson disease. Results of a treatment observation].
Brecht, HM; Kraus, PH; Lemke, MR; Reichmann, H, 2002
)
2.67
"Pramipexole is a dopamine agonist which binds selectively to dopamine D(3) and D(2) receptors. "( Potential antidepressant properties of pramipexole detected in locomotor and operant behavioral investigations in mice.
Lehr, E, 2002
)
2.03
"Pramipexole is a dopamine D2/D3 receptor agonist used to treat Parkinson's disease. "( Pramipexole increases vesicular dopamine uptake: implications for treatment of Parkinson's neurodegeneration.
Fleckenstein, AE; Hanson, GR; Rau, KS; Truong, JG, 2003
)
3.2
"Pramipexole is an effective and well-tolerated therapy, with or without concomitant levodopa, for Chinese patients with Parkinson's disease."( Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease.
Lu, CS; Mok, V; Shan, DE; Tsoi, TH; Wong, KS; Yang, CC, 2003
)
2.03
"Pramipexole is a nonergoline dopamine agonist with D2 and preferential D3 dopamine receptor activity. "( Conversion from dopamine agonists to pramipexole. An open-label trial in 227 patients with advanced Parkinson's disease.
Linazasoro, G, 2004
)
2.04
"Pramipexole (PRX) is a non-ergot dopamine (DA) D2/D3 receptor agonist. "( Biological effects of pramipexole on dopaminergic neuron-associated genes: relevance to neuroprotection.
Jankovic, J; Le, W; Pan, T; Xie, W, 2005
)
2.09
"Pramipexole is a D2/D3 dopamine receptor agonist used in the symptomatic treatment of PD, and which also protects neuronal cells against dopaminergic toxins in vitro."( Pramipexole protects against MPTP toxicity in non-human primates.
Cooper, JM; Haddon, CO; Iravani, MM; Jenner, P; Schapira, AH, 2006
)
2.5
"Pramipexole is a Food and Drug Administration-approved antiparkinsonian agent, which, when used to augment antidepressants, would be considered an off-label use and should be discussed with the patient."( Pramipexole: augmentation in the treatment of depressive symptoms.
Frank, B; Gupta, S; Vincent, JL, 2006
)
2.5
"Pramipexole is a D3 dopaminergic agonist that has shown a major effect on both sensory and motor manifestations of restless legs syndrome (RLS) in long-term trials. "( The acute effect of a low dosage of pramipexole on severe idiopathic restless legs syndrome: an open-label trial.
Cancelli, I; Canesin, R; Dolso, P; Gigli, GL; Merlino, G; Valente, M, 2006
)
2.05
"Pramipexole is an effective adjunctive antiparkinsonian therapy in PD patients of African, Asian, and Hispanic heritage. "( Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage.
,
)
3.02
"Pramipexole is an oral, non-ergoline dopamine agonist with selectivity for the dopamine D(3) receptor, which was recently approved in the EU and the US for the treatment of idiopathic restless legs syndrome (RLS) in adults. "( Pramipexole: in restless legs syndrome.
McCormack, PL; Siddiqui, MA, 2007
)
3.23
"Pramipexole is an important therapeutic option for treatment-resistant bipolar and unipolar depression; further studies are warranted to evaluate its safety in psychiatric patients."( Pramipexole in psychiatry: a systematic review of the literature.
Aiken, CB, 2007
)
3.23
"Pramipexole is a non-ergotic D2/D3 dopaminergic agonist that can be used to treat the symptoms of Parkinson's disease safely and effectively both as monotherapy in the early stages and in the advanced phases in association with levodopa, which improves the motor fluctuations and dyskinesias. "( [Pramipexole and Parkinson's disease, an update].
Kulisevsky, J; Martínez-Corral, M,
)
2.48
"Pramipexole is a non-ergoline dopamine agonist with a high selectivity for D(2) and D(3) receptors. "( Clinical experience with pramipexole in the treatment of restless legs syndrome.
Gigli, GL; Merlino, G; Robiony, F; Serafini, A; Valente, M, 2008
)
2.09
"R+ pramipexole (PPX) is a lipophilic cation that concentrates into brain and mitochondria and efficiently scavenges reactive oxygen and nitrogen species (RONS). "( R+ pramipexole as a mitochondrially focused neuroprotectant: initial early phase studies in ALS.
Bennett, JP; Burns, TM; Conaway, MA; Keller, KE; Lacomis, D; Larriviere, KS; Pattee, GL; Phillips, LH; Solenski, NJ; Wang, H; Ware, KA; Zivkovic, SA, 2008
)
1.59
"Pramipexole is a dopamine receptor agonist that has proved effective in the treatment of Parkinson's disease. "( Steady-state pharmacokinetic properties of pramipexole in healthy volunteers.
Ichhpurani, AK; Peters, GR; Sisson, TL; Wright, CE, 1997
)
2
"Pramipexole is a new, selective, nonergoline dopamine agonist that acts on D2 and preferentially on D3 dopamine receptors. "( Double-blind comparison of pramipexole and bromocriptine treatment with placebo in advanced Parkinson's disease. International Pramipexole-Bromocriptine Study Group.
Guttman, M, 1997
)
2.04
"Pramipexole is a clinically effective nonergot dopamine agonist. "( Pharmacology of pramipexole, a dopamine D3-preferring agonist useful in treating Parkinson's disease.
Piercey, MF,
)
1.92
"Pramipexole is an orally active non-ergoline dopamine agonist with selective activity at dopamine receptors belonging to the D2 receptor subfamily (D2, D3, D4 receptor subtypes) and with preferential affinity for the D3 receptor subtype. "( Pramipexole. A review of its use in the management of early and advanced Parkinson's disease.
Dooley, M; Markham, A, 1998
)
3.19
"Pramipexole (PPX) is a full intrinsic activity, direct-acting dopamine (DA) agonist possessing 7-fold higher affinity for D3 than for D2 receptors. "( Both the antioxidant and D3 agonist actions of pramipexole mediate its neuroprotective actions in mesencephalic cultures.
Carvey, PM; Ling, ZD; Robie, HC; Tong, CW, 1999
)
2
"Pramipexole is an aminothiazole dopamine agonist with selective actions at dopamine receptors belonging to the D2 subfamily, where it possesses full activity similar to dopamine itself."( Pramipexole--a new dopamine agonist for the treatment of Parkinson's disease.
Bennett, JP; Piercey, MF, 1999
)
2.47
"Pramipexole is a non-ergot dopamine agonist used to treat Parkinson's disease (PD). "( Pramipexole-induced somnolence and episodes of daytime sleep.
Anderson, WM; Gauger, L; Hauser, RA; Zesiewicz, TA, 2000
)
3.19
"Pramipexole is a potential therapy for primary orthostatic tremor. "( Pramipexole is a possible effective treatment for primary orthostatic tremor (shaky leg syndrome).
Finkel, MF, 2000
)
3.19
"Pramipexole is an aminobenzothiazole compound, recently introduced for the treatment of both early and advanced PD."( Pre-clinical studies of pramipexole: clinical relevance.
Hubble, JP, 2000
)
1.34
"Pramipexole is a novel nonergoline dopamine agonist with a preference for the dopamine D3 receptor subtype. "( Pramipexole in the treatment of advanced Parkinson's disease.
Möller, JC; Oertel, WH, 2000
)
3.19
"Pramipexole proved to be an effective agent for patients with Parkinson's disease and drug resistant tremor."( Pramipexole in patients with Parkinson's disease and marked drug resistant tremor: a randomised, double blind, placebo controlled multicentre study.
Gasser, T; Meier, D; Oertel, WH; Pogarell, O; Pollentier, S; Spieker, S; van Hilten, JJ, 2002
)
3.2
"Pramipexole (SND 919) is a dopamine D2 autoreceptor agonist which is structurally related to talipexole (B-HT 920), a potential antipsychotic agent. "( Pramipexole, a dopamine D2 autoreceptor agonist, decreases the extracellular concentration of dopamine in vivo.
Carter, AJ; Müller, RE, 1991
)
3.17

Effects

Pramipexole has a 5- to 7-fold greater affinity for the D3 receptor subtype. It has a low short-term rate of manic switching in bipolar patients (1% mania, 5% hypomania)

Pramipexole has been showed to protect cultured dopaminergic (DAergic) cells against free radical-induced cytotoxicity. DexpramipeXole (DEX) has been described as the first-in-class F1Fo ATP synthase activator.

ExcerptReferenceRelevance
"Pramipexole has a very low affinity for serotoninergic 5-HT2A and 5-HT2B receptors, as well as D1-type receptors."( Pharmacokinetic evaluation of pramipexole.
Antonini, A; Calandrella, D, 2011
)
1.38
"Pramipexole has a large effect size (0.6-1.1) in the treatment of both bipolar and unipolar depression with a low short-term rate of manic switching in bipolar patients (1% mania, 5% hypomania). "( Pramipexole in psychiatry: a systematic review of the literature.
Aiken, CB, 2007
)
3.23
"Pramipexole has a 5- to 7-fold greater affinity for the D3 receptor subtype with lower affinities for the D2 and D4 receptor subtypes."( Pre-clinical studies of pramipexole: clinical relevance.
Hubble, JP, 2000
)
1.34
"Pramipexole has a more potent blood pressure lowering effect in SHR than in WKY."( Effect of pramipexole, a dopamine-1/dopamine-2 receptor agonist, on sodium excretion and blood pressure in spontaneously hypertensive rats.
Eisner, GM; Jose, PA; Kaneko, S, 1990
)
1.4
"Dexpramipexole (DEX) has been described as the first-in-class F1Fo ATP synthase activator able to boost mitochondrial bioenergetics and provide neuroprotection in experimental models of ischemic brain injury. "( Dexpramipexole Enhances K
Buonvicino, D; Cherchi, F; Chiarugi, A; Coppi, E; Pugliese, AM; Ranieri, G; Venturini, M, 2021
)
1.86
"Pramipexole (PPX) has anti-inflammatory and antioxidant properties."( Pramipexole attenuates 6-OHDA-induced Parkinson's disease by mediating the Nurr1/NF-κB pathway.
Gao, H; Jiang, S; Mao, JP; Wang, D; Wang, YL; Yang, XL, 2021
)
2.79
"Pramipexole has been shown to improve mood symptoms in animal models of depression, in people with Parkinson's Disease and two proof of principle trials of pramipexole for people with BD who are currently depressed."( Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study).
Azim, L; Browne, G; Chadwick, T; Clare, E; Courtney, P; Dixon, L; Duffelen, N; Fouweather, T; Geddes, JR; Goudie, N; Harvey, S; Helter, T; Hindmarch, P; Holstein, EM; Martin, G; Mawson, P; McAllister-Williams, RH; McCaffery, J; Morriss, R; Simon, J; Smith, D; Stokes, PRA; Walker, J; Watson, S; Weetman, C; Wolstenhulme, F; Young, AH, 2021
)
1.58
"Pramipexole has demonstrated the efficacy in the treatment of persistent tremor and depression in double-blind placebo-controlled trials."( [A current view on dopamine receptor agonists in the treatment of Parkinson's disease].
Titova, NV, 2015
)
1.14
"Pramipexole has been proposed to exert a broad spectrum of neuroprotective properties, primarily through antioxidant effects, inhibiting apoptotic enzymes and preserving mitochondrial structure and activity."( Dexpramipexole, the R(+) enantiomer of pramipexole, for the potential treatment of amyotrophic lateral sclerosis.
Cheah, BC; Kiernan, MC, 2010
)
1.7
"Pramipexole has a very low affinity for serotoninergic 5-HT2A and 5-HT2B receptors, as well as D1-type receptors."( Pharmacokinetic evaluation of pramipexole.
Antonini, A; Calandrella, D, 2011
)
1.38
"Pramipexole in particular has shown efficacy in reducing toxicity to MPTP, MPP, rotenone and 6-hydroxydopamine."( Dopamine agonists and neuroprotection in Parkinson's disease.
Schapira, AH, 2002
)
1.04
"Pramipexole has been shown to reduce oxidative stress and be neuroprotective in cell and animal models of neurodegeneration."( Reduction of oxidative stress in amyotrophic lateral sclerosis following pramipexole treatment.
Bennett, JP; Gerber, RE; Pattee, GL; Post, GR, 2003
)
1.27
"Pramipexole has proven a suitable alternative in patients with moderate to severe RLS, particularly when their therapy has to be switched to a dopamine agonist."( Low-dose pramipexole in the management of restless legs syndrome. An open label trial.
Oertel, WH; Stiasny-Kolster, K, 2004
)
1.46
"Pramipexole has been shown to possess neuroprotective properties in vitro that are partly independent of its dopaminergic agonism. "( Targeted antioxidative and neuroprotective properties of the dopamine agonist pramipexole and its nondopaminergic enantiomer SND919CL2x [(+)2-amino-4,5,6,7-tetrahydro-6-Lpropylamino-benzathiazole dihydrochloride].
Buerger, E; Danzeisen, R; Dorner-Ciossek, C; Gillardon, F; Hengerer, B; Klinder, K; Krzykalla, V; Kussmaul, L; Ludolph, AC; Schild, L; Schwalenstoecker, B, 2006
)
2
"Pramipexole has been studied in the treatment of RLS since 1998."( Pramipexole for the treatment of restless legs syndrome.
Kushida, CA, 2006
)
2.5
"Pramipexole has a large effect size (0.6-1.1) in the treatment of both bipolar and unipolar depression with a low short-term rate of manic switching in bipolar patients (1% mania, 5% hypomania). "( Pramipexole in psychiatry: a systematic review of the literature.
Aiken, CB, 2007
)
3.23
"Pramipexole has similar effects, whereas bromocriptine seems to exhibit the former but not the latter effect."( Protective effects of the antiparkinsonian drugs talipexole and pramipexole against 1-methyl-4-phenylpyridinium-induced apoptotic death in human neuroblastoma SH-SY5Y cells.
Kakimura, JI; Kitamura, Y; Kohno, Y; Kosaka, T; Matsuoka, Y; Nomura, Y; Taniguchi, T, 1998
)
1.26
"Pramipexole has been showed to protect cultured dopaminergic (DAergic) cells against free radical-induced cytotoxicity. "( Pramipexole inhibits lipid peroxidation and reduces injury in the substantia nigra induced by the dopaminergic neurotoxin 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine in C57BL/6 mice.
Appel, SH; He, Y; Jankovic, J; Le, W; Xu, J; Zou, L, 2000
)
3.19
"Pramipexole has a 5- to 7-fold greater affinity for the D3 receptor subtype with lower affinities for the D2 and D4 receptor subtypes."( Pre-clinical studies of pramipexole: clinical relevance.
Hubble, JP, 2000
)
1.34
"Pramipexole has a more potent blood pressure lowering effect in SHR than in WKY."( Effect of pramipexole, a dopamine-1/dopamine-2 receptor agonist, on sodium excretion and blood pressure in spontaneously hypertensive rats.
Eisner, GM; Jose, PA; Kaneko, S, 1990
)
1.4

Actions

Pramipexole may produce neuroprotective effects by protecting neurons in the hippocampus and improving mitochondrial membrane potential after cerebral ischemia-reperfusion injury.

ExcerptReferenceRelevance
"Pramipexole may produce neuroprotective effects by protecting neurons in the hippocampus and improving the mitochondrial membrane potential after global cerebral ischemia-reperfusion injury."( Effects of different doses of dopamine receptor agonist pramipexole on neurobehaviors and changes of mitochondrial membrane potentials in rats with global cerebral ischemia-reperfusion injury.
Kang, X; Liu, L; Wang, W; Wang, Y, 2023
)
1.88
"pramipexole) known to produce compulsive behaviors in humans would increase marble burying."( Pharmacological evaluation of the adequacy of marble burying as an animal model of compulsion and/or anxiety.
Jimenez-Gomez, C; Osentoski, A; Woods, JH, 2011
)
1.09

Treatment

Pramipexole pretreatment in male C57BL/6 mice significantly reduced the myocardial infarction size, decreased the CK and LDH activities at the serum level and enhanced autophagy. PramipeXole treatment was associated with later occurrence of dyskinesias.

ExcerptReferenceRelevance
"Pramipexole treatment induced a physical interaction between D3R and DAT, as assessed by co-immunoprecipitation and in situ proximity ligation assay."( Prolonged treatment with pramipexole promotes physical interaction of striatal dopamine D3 autoreceptors with dopamine transporters to reduce dopamine uptake.
Afonso-Oramas, D; Barroso-Chinea, P; Castro-Hernández, J; Cruz-Muros, I; González-Hernández, T; Millan, MJ; Moratalla, R; Salas-Hernández, J, 2015
)
1.44
"Pramipexole pretreatment in male C57BL/6 mice significantly reduced the myocardial infarction size, decreased the CK and LDH activities at the serum level and enhanced autophagy."( Pramipexole pretreatment attenuates myocardial ischemia/reperfusion injury through upregulation of autophagy.
Ma, Y; Mo, Y; Tang, L; Wu, S, 2016
)
2.6
"Pramipexole treatment significantly reduced lactate dehydrogenase release (p<0.0001) as a measure of cellular injury."( Comparable Neuroprotective Effects of Pergolide and Pramipexole on Ferrous Sulfate-Induced Dopaminergic Cell Death in Cell Culture.
Gille, G; Moldzio, R; Radad, K; Rausch, WD; Reichelt, D; Reichmann, H, 2016
)
1.41
"For pramipexole in the treatment of Parkinson's disease, this means taking into account the available evidence regarding its symptomatic efficacy, effect on delaying long-term levodopa-related motor complications, beneficial effect on non-motor symptoms such as depression, and its safety and tolerability profile."( Role of pramipexole in the management of Parkinson's disease.
Abbruzzese, G; Antonini, A; Barone, P; Ceravolo, R; Fabbrini, G; Tinazzi, M, 2010
)
1.28
"Pramipexole treatment completely antagonized the neurotoxic effects of MPTP, as measured by substantia nigra and ventral tegmental area TH-immunoreactive cell counts. "( Low dose pramipexole is neuroprotective in the MPTP mouse model of Parkinson's disease, and downregulates the dopamine transporter via the D3 receptor.
Borwege, S; Hagner, D; Joyce, JN; Ryoo, H; Woolsey, C, 2004
)
2.18
"Pramipexole-treated subjects had significantly increased brain GABA levels compared to placebo (p=0.031)."( Prefrontal GABA levels in cocaine-dependent subjects increase with pramipexole and venlafaxine treatment.
Ciraulo, DA; Hennen, J; Jensen, JE; Ke, Y; Knapp, C; Kwak, T; Meyer, AA; Nassar, LE; Renshaw, PF; Sarid-Segal, O; Streeter, CC, 2005
)
1.29
"Pramipexole pretreatment also prevented degeneration of striatal dopamine terminals."( Pramipexole protects against MPTP toxicity in non-human primates.
Cooper, JM; Haddon, CO; Iravani, MM; Jenner, P; Schapira, AH, 2006
)
2.5
"Pramipexole treatment was associated with later occurrence of dyskinesias."( Factors associated with the development of motor fluctuations and dyskinesias in Parkinson disease.
Hauser, RA; McDermott, MP; Messing, S, 2006
)
1.06
"The pramipexole treated group experienced a significant improvement in "off" time functioning as measured by the activities of daily living portion of the United Parkinson's Disease Rating Scale."( The use of pramipexole, a novel dopamine (DA) agonist, in advanced Parkinson's disease.
Brown, D; Factor, SA; Molho, ES; Sanchez-Ramos, JR; Sheldon, C; Shulman, L; Singer, C; Weiner, WJ, 1995
)
1.16
"Pramipexole treated animals exhibited a 29% and a 27% reduction in striatal dopamine and THir cell counts, respectively."( Pramipexole attenuates the dopaminergic cell loss induced by intraventricular 6-hydroxydopamine.
Carvey, PM; Chen, EY; Ling, ZD; Lipton, JW; Ma, SY; Robie, HC; Tong, CW; Vu, TQ, 2000
)
2.47
"Pramipexole treatment also significantly attenuated the loss of tyrosine hydroxylase immunoreactive neurons (TH-IR) within the substantia nigra pars compacta (SNc) in both young and aged animals."( Neuroprotective effects of pramipexole in young and aged MPTP-treated mice.
Anderson, DW; Neavin, T; Schneider, JS; Smith, JA, 2001
)
1.33
"Treatment with pramipexole is used in restless legs syndrome."( PTPRD as a candidate druggable target for therapies for restless legs syndrome?
Esteves, AM; Franco, B; Holanda, ASS; Manconi, M; Morais, MA; Simino, LAP; Torsoni, A, 2021
)
0.96
"Pretreatment with pramipexole (PPX), a preferential D3R agonist, showed antidepressant effects on LPS-induced depression-like behavior through preventing changes in LPS-induced proinflammatory cytokines (tumour necrosis factor-α, interleukin-1β, and interleukin-6), BDNF, and ERK1/2-CREB signaling pathway in the VTA and NAc."( The Dopamine Receptor D3 Regulates Lipopolysaccharide-Induced Depressive-Like Behavior in Mice.
Chen, T; Chen, Y; Jia, Y; Li, G; Wang, B; Wang, J; Zhou, T; Zhu, L, 2018
)
0.8
"Treatment with pramipexole, a dopamine D(3)/D(2) receptor agonist, reduces depressive symptoms in patients suffering from Parkinson's disease. "( Antidepressant effects of pramipexole, a dopamine D3/D2 receptor agonist, and 7-OH-DPAT, a dopamine D3 receptor agonist, in olfactory bulbectomized rats.
Breuer, ME; Buerger, E; Ferger, B; Groenink, L; Korte, M; Olivier, B; Oosting, RS, 2009
)
1.01
"Treatment with pramipexole decreased the number of PLMS and normalized the increased PLMS-related HR response in RLS subjects."( Effects of acute dopamine-agonist treatment in restless legs syndrome on heart rate variability during sleep.
Clemens, S; Ferini-Strambi, L; Ferri, R; Manconi, M; Oldani, A; Rundo, F; Zucconi, M, 2011
)
0.71
"Treatment with pramipexole yielded significant score reduction as early as day 5."( Evaluation of painful sensory symptoms in restless legs syndrome: experience from two clinical trials.
Busse, M; Hornyak, M; Sohr, M, 2011
)
0.71
"The treatment with pramipexole was followed by a significant reduction in the rate of occurrence of ALMA, in reported insomnia, and in daytime sleepiness. "( The neurophysiology of the alternating leg muscle activation (ALMA) during sleep: study of one patient before and after treatment with pramipexole.
Cosentino, FI; Ferri, R; Iero, I; Lanuzza, B; Tripodi, M, 2006
)
0.87
"Treatment with pramipexole concurrently with MPTP or following MPTP did not prevent TH-positive cell loss."( Pramipexole protects against MPTP toxicity in non-human primates.
Cooper, JM; Haddon, CO; Iravani, MM; Jenner, P; Schapira, AH, 2006
)
2.12
"Treatment with pramipexole 0.25, 0.50 or 0.75 mg once daily for 12 weeks significantly reduced IRLS scores from baseline values (-13 to -14 vs -9) and produced significantly higher proportions of CGI-I responders (68-75% vs 51%) compared with placebo."( Pramipexole: in restless legs syndrome.
McCormack, PL; Siddiqui, MA, 2007
)
2.12
"Treatment with Pramipexole was associated with increased risk of gambling and this association approached significance (OR, 3.6; 95% CI, 0.9-14.9)."( Medications used to treat Parkinson's disease and the risk of gambling.
Brown, LA; Geda, YE; Imamura, A; Slowinski, J; Uitti, RJ; Wszolek, ZK, 2008
)
0.69
"Treatment with pramipexole and bromocriptine partially, but significantly (P < 0.01), prevented the loss of inferior olivary neurons."( Neuroprotective effects of the dopamine agonists pramipexole and bromocriptine in 3-acetylpyridine-treated rats.
Hall, ED; Oostveen, JA; Sethy, VH; Wu, H, 1997
)
0.89
"Pretreatment with pramipexole in a concentration range (4-100 microM) significantly attenuates DA- or L-DOPA-induced cytotoxicity and apoptosis, an action which is not blocked by D3 antagonist U-99194 A or D2 antagonist raclopride."( Neuroprotection by pramipexole against dopamine- and levodopa-induced cytotoxicity.
Appel, SH; Jankovic, J; Le, W; Rowe, DB; Xie, W; Zou, L, 1999
)
0.96

Toxicity

Pramipexole is effective and safe in the treatment of both objective and subjective facets of RLS. The most frequent adverse events with higher occurrence in the pramipexoles group were nausea (19%)

ExcerptReferenceRelevance
" Serious adverse events did not occur."( Pramipexole as adjunct to haloperidol in schizophrenia. Safety and efficacy.
Barnas, C; Heiden, A; Kasper, S; Laakmann, G; Pfolz, H; Volz, HP; Zeit, H, 1997
)
1.74
"Pramipexole was generally safe and well tolerated in this 10-week study."( Safety and efficacy of pramipexole in early Parkinson disease. A randomized dose-ranging study. Parkinson Study Group.
, 1997
)
2.05
"Pramipexole is safe and effective as short-term monotherapy in patients with early PD who are not receiving levodopa."( Safety and efficacy of pramipexole in early Parkinson disease. A randomized dose-ranging study. Parkinson Study Group.
, 1997
)
2.05
" Safety and tolerability were assessed on the basis of adverse events, vital signs, laboratory measurements, and ECG recordings."( Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study.
Oertel, WH; Pinter, MM; Pogarell, O, 1999
)
0.54
" The adverse event profile disclosed a high tolerability."( Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study.
Oertel, WH; Pinter, MM; Pogarell, O, 1999
)
0.54
" There is, however, uncertainty regarding differences in the adverse event profiles associated with each drug."( Comparison of the risk of adverse events with pramipexole and ropinirole in patients with Parkinson's disease: a meta-analysis.
Etminan, M; Gill, S; Samii, A, 2003
)
0.58
"To compare the adverse events of pramipexole and ropinirole as reported in the peer-reviewed medical literature."( Comparison of the risk of adverse events with pramipexole and ropinirole in patients with Parkinson's disease: a meta-analysis.
Etminan, M; Gill, S; Samii, A, 2003
)
0.86
" In the first analysis, we estimated the pooled relative risk (RR) of adverse events with either pramipexole or ropinirole as compared with levodopa."( Comparison of the risk of adverse events with pramipexole and ropinirole in patients with Parkinson's disease: a meta-analysis.
Etminan, M; Gill, S; Samii, A, 2003
)
0.79
" Safety and tolerability were evaluated by treatment-emergent adverse event reports, clinical laboratory test results (blood chemistry, hematology, and urinalysis), vital signs, and electrocardiograms."( Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease.
Lu, CS; Mok, V; Shan, DE; Tsoi, TH; Wong, KS; Yang, CC, 2003
)
0.59
"Pramipexole is effective and safe in the treatment of both objective and subjective facets of RLS."( Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study.
Alakuijala, A; Hirvonen, K; Hublin, C; Jama, L; Koester, J; Partinen, M; Reess, J; Tamminen, I, 2006
)
2.09
" Pramipexole was well tolerated: The most frequent adverse events with higher occurrence in the pramipexole group were nausea (19."( Efficacy and safety of pramipexole in restless legs syndrome.
Becker, PM; Cappola, JJ; Koester, J; Kushida, CA; Reess, J; Sethi, KD; Winkelman, JW, 2006
)
1.55
"As rated by patients and by clinicians, pramipexole was efficacious and safe in reducing the symptoms of restless legs syndrome."( Efficacy and safety of pramipexole in restless legs syndrome.
Becker, PM; Cappola, JJ; Koester, J; Kushida, CA; Reess, J; Sethi, KD; Winkelman, JW, 2006
)
0.91
" Adverse events, all of which were mild, occurred in 29."( Pramipexole safely replaces ergot dopamine agonists with either rapid or slow switching.
Abe, T; Hamada, T; Kashihara, K; Kawamura, J; Kowa, H; Nogawa, S; Ogino, Y; Tachibana, H; Takahashi, H,
)
1.57
" Safety was documented by Adverse Events reported in >5% of patients."( Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study).
Alakuijala, A; Hirvonen, K; Hublin, C; Jama, L; Koester, J; Partinen, M; Reess, J; Tamminen, I, 2008
)
0.59
" The most frequent Adverse Events were influenza (17."( Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study).
Alakuijala, A; Hirvonen, K; Hublin, C; Jama, L; Koester, J; Partinen, M; Reess, J; Tamminen, I, 2008
)
0.59
"To determine whether adding orally disintegrating selegiline (ODS) while decreasing dopamine agonist (DA) dosages would reduce DA-related adverse effects (AEs) of excessive daytime sleepiness (EDS), pedal edema, hallucinations, and impulse control disorders (ICDs) without compromising efficacy in Parkinson disease (PD) patients."( Orally disintegrating selegiline in Parkinson patients with dopamine agonist-related adverse effects.
Elmer, LW; Friedman, JH; Hauser, RA; Hermanowicz, N; Hersh, BP; Isaacson, SH; Lew, MF; Lyons, KE; Pahwa, R; Parashos, SA; Silver, DE; Struck, LK; Tetrud, JW,
)
0.13
" Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug-related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment."( Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease.
Barone, P; Debieuvre, C; Hauser, RA; Mizuno, Y; Poewe, W; Rascol, O; Salin, L; Schapira, AH; Sohr, M, 2010
)
0.57
"0 mg/kg/day for 30 weeks to juvenile rhesus monkeys produced adverse findings which were attributable to its pharmacological properties, including hypoprolactinemia."( Toxicity assessment of pramipexole in juvenile rhesus monkeys.
Deschl, U; Eddie, M; Greischel, A; Hotchkiss, CE; Li, M; Mauz, A; Patterson, TA; Paule, MG; Stierstorfer, B, 2010
)
0.67
"5 days were safe and well tolerated."( Safety, tolerability, and pharmacokinetics of KNS-760704 (dexpramipexole) in healthy adult subjects.
Bozik, ME; Gribkoff, VK; Ingersoll, EW; Kramer, WG; Mather, JL, 2011
)
0.61
" The type and frequency of adverse events were consistent with the known safety profile for dopamine agonists in RLS."( Efficacy, safety and dose-response of pramipexole in Japanese patients with primary restless legs syndrome: randomized trial.
Hirata, K; Inoue, Y; Kagimura, T; Kuroda, K; Shimizu, T; Uchimura, N, 2011
)
0.64
"75 mg/day is efficacious, safe and well tolerated in Japanese patients with primary RLS."( Efficacy, safety and dose-response of pramipexole in Japanese patients with primary restless legs syndrome: randomized trial.
Hirata, K; Inoue, Y; Kagimura, T; Kuroda, K; Shimizu, T; Uchimura, N, 2011
)
0.64
" The proportion of adverse events was 62."( Efficacy and safety of pramipexole in chinese patients with restless legs syndrome: results from a multi-center, randomized, double-blind, placebo-controlled trial.
Chen, SD; Hu, XY; Jiang, YP; Li, JM; Liu, CF; Ma, JF; Sun, SG; Wan, Q; Wang, WZ; Wang, YJ; Zhao, ZX, 2012
)
0.69
" The objective of this study was to perform an indirect comparison of Adverse Events (AEs) and Dropout Rates (DRs) among clinical trials of pramipexole, ropinirole, and rasagiline."( Indirect comparisons of adverse events and dropout rates in early Parkinson's disease trials of pramipexole, ropinirole, and rasagiline.
Tarrants, ML; Zagmutt, FJ, 2012
)
0.8
"9%) reported adverse events (AEs), requiring withdrawal of 3 ER patients (5."( Efficacy and safety of extended- versus immediate-release pramipexole in Japanese patients with advanced and L-dopa-undertreated Parkinson disease: a double-blind, randomized trial.
Barone, P; Hasegawa, K; Hattori, N; Hauser, RA; Kagimura, T; Kuno, S; Mizuno, Y; Poewe, W; Rascol, O; Sarashina, A; Schapira, AH; Yamamoto, M,
)
0.38
" The primary outcome was the number of patients experiencing a 'clinically important adverse event' (classified as a serious adverse event, an event leading to withdrawal or severe according to the patient)."( Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.
Blin, O; Lancrenon, S; Pitel, S; Viallet, F, 2013
)
0.39
"6% reported at least one 'clinically important' adverse event compared to 32."( Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.
Blin, O; Lancrenon, S; Pitel, S; Viallet, F, 2013
)
0.39
"In this study, the safety profile of rasagiline had clinically favorable differences in gastrointestinal and sleep adverse events compared to pramipexole, whilst showing comparable clinician and patient-rated clinical effectiveness as a monotherapy for the treatment of early idiopathic PD."( Evaluation of the safety and tolerability of rasagiline in the treatment of the early stages of Parkinson's disease.
Blin, O; Lancrenon, S; Pitel, S; Viallet, F, 2013
)
0.59
" A non-serious drug-related adverse event (diarrhea) was observed in one patient."( Efficacy and safety of a once-daily extended-release formulation of pramipexole switched from an immediate-release formulation in patients with advanced Parkinson's disease: results from an open-label study.
Hatano, T; Hattori, N; Oyama, G; Shimo, Y; Takanashi, M, 2013
)
0.63
" However, long-acting NEDA were also associated with a higher incidence of adverse events, especially in early PD patients, compared with placebo."( Meta-analysis of the efficacy and safety of long-acting non-ergot dopamine agonists in Parkinson's disease.
Peng, GG; Wang, M; Zhang, JW; Zhou, CQ, 2014
)
0.4
" Reported adverse events (AEs) with incidence ≥10."( Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease.
Barone, P; Busse, M; Debieuvre, C; Fraessdorf, M; Hauser, RA; Mizuno, Y; Poewe, W; Rascol, O; Schapira, AH, 2014
)
0.64
" 56 mild-moderate adverse events occurred, 26 probably/definitely related to R(+)PPX use, with 4 withdrawals."( Safety and Tolerability of R(+) Pramipexole in Mild-to-Moderate Alzheimer's Disease.
Bennett, J; Bothwell, R; Burns, J; Welch, P, 2016
)
0.72
" We assessed differences in Unified Parkinson's Disease Rating Scale (UPDRS) scores, percentage of 'on' time or 'off' time, withdrawals, adverse events (AEs) and life quality between pramipexole ER and pramipexole IR or placebo."( Efficacy and safety of pramipexole extended-release in Parkinson's disease: a review based on meta-analysis of randomized controlled trials.
Shen, T; Ye, R; Zhang, B, 2017
)
0.96
"Pramipexole ER is as safe and effective as pramipexole IR in the treatment of Parkinson's disease."( Efficacy and safety of pramipexole extended-release in Parkinson's disease: a review based on meta-analysis of randomized controlled trials.
Shen, T; Ye, R; Zhang, B, 2017
)
2.21
"In order to increase treatment choices for patients with Parkinson disease (PD), we performed a retrospective assessment of adverse events associated with a novel once-daily extended-release (ER) formulation versus the standard immediate-release (IR) of the nonergolinic dopamine agonist, pramipexole."( Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease.
Kong, D; Shen, Z, 2018
)
0.87
" The relative risks (RR) of various adverse events with 95% confidence intervals (95% CIs) were generated."( Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease.
Kong, D; Shen, Z, 2018
)
0.7
" We evaluated common adverse events associated with pramipexole in the gastrointestinal and nervous systems."( Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease.
Kong, D; Shen, Z, 2018
)
0.95
"Patients with PD treated with 2 different pramipexole formulations (ER and IR) had similar incidences of common adverse events."( Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease.
Kong, D; Shen, Z, 2018
)
0.96
" The outcomes of interest were as follows: the efficacy, unified Parkinson disease rating scale (UPDRS) scores, Hamilton depression rating scale score or adverse events."( Efficacy and safety of combination therapy with pramipexole and levodopa vs levodopa monotherapy in patients with Parkinson disease: A systematic review and meta-analysis.
Jiang, DQ; Jiang, LL; Li, MX; Lu, CS; Wang, Y, 2021
)
0.88
"Pathologic gambling is a rare but severe side effect of dopamine agonists (DA)."( [Gambling addiction as a side effect of low dose pramipexole in the treatment of restless legs syndrome].
Ibsen, JD; Lindström, ES; Skovbølling, SL, 2022
)
0.98
" Pramipexole ER ranked first in overall withdrawals, and rotigotine transdermal patch ranked first in the incidence of adverse events (≥1 AEs)."( Efficacy and safety of non-ergot dopamine-receptor agonists as an adjunct to levodopa in advanced Parkinson's disease: A network meta-analysis.
Chen, FF; Chen, XT; Wen, SY; Zhang, Q; Zhou, CQ, 2023
)
1.82

Pharmacokinetics

The pharmacokinetic analyses demonstrated relatively low bioavailability for L-dopa and adequate plasma levels of pramipexole, even at baseline, on a stable daily dose. Dexpramipexoles area under the curves (AUCs), but not Cmax , were significantly increased with the severity of renal impairment after a single dose administration.

ExcerptReferenceRelevance
" The pharmacokinetic properties of pramipexole at steady-state concentrations were studied in 16 healthy men and women at four dose levels throughout the range recommended for Parkinson's patients."( Steady-state pharmacokinetic properties of pramipexole in healthy volunteers.
Ichhpurani, AK; Peters, GR; Sisson, TL; Wright, CE, 1997
)
0.84
"These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation."( Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies.
Haertter, S; Jenner, P; Könen-Bergmann, M; Schepers, C, 2009
)
0.79
" In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC(0-24h), C(max), and C(min)."( Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies.
Haertter, S; Jenner, P; Könen-Bergmann, M; Schepers, C, 2009
)
0.59
"This review summarizes the overall pharmacokinetic profile of pramipexole for both the IR and ER formulations."( Pharmacokinetic evaluation of pramipexole.
Antonini, A; Calandrella, D, 2011
)
0.9
" The method was successfully applied to pharmacokinetic studies of PRX in rats."( LC-MS/MS determination of pramipexole on rat dried blood spots: a pharmacokinetic study.
Raju, B; Ramakrishna, K; Rao, RN; Sravan, B; Srinivas, R, 2013
)
0.69
" The pharmacokinetic analyses demonstrated relatively low bioavailability for L-dopa and adequate plasma levels of pramipexole, even at baseline, on a stable daily dose."( Therapeutic response to pramipexole in a patient with multiple system atrophy with predominant parkinsonism: positron emission tomography and pharmacokinetic assessments.
Ishii, K; Katayama, Y; Nagayama, H; Nakajima, N; Nishiyama, Y; Ueda, M, 2013
)
0.91
" Dexpramipexole area under the curves (AUCs), but not Cmax , were significantly increased with the severity of renal impairment after a single dose administration."( Pharmacokinetics of renally excreted drug dexpramipexole in subjects with impaired renal function.
Dong, Y; Farwell, W; He, P; Kerr, D; Marbury, T; Ries, D; Rogge, M; Stecher, S; Wei, D, 2014
)
1.22
" The aim was to develop a physiologically based pharmacokinetic (PBPK) model of pramipexole, providing a basis for its individualized administration."( Development of a Physiologically Based Pharmacokinetic Model for Prediction of Pramipexole Pharmacokinetics in Parkinson's Disease Patients With Renal Impairment.
Huang, P; Jiao, Z; Ke, M; Lin, C; Wu, W; Xu, J; You, X, 2020
)
1.01

Compound-Compound Interactions

Pramipexole combined with NGF therapy not only can effectively strengthen the cognitive impairment of patients with PD and promote clinical efficacy and high safety but also can inhibit inflammatory state, regulate brain neurotransmitters, and reduce urinary AD7c-NTP levels.

ExcerptReferenceRelevance
"The present experiments were performed to investigate the effects of dopamine D1 receptor agonists given alone or in combination with dopamine D2 receptor agonists on body temperature in rats."( Hyperthermia induced by the dopamine D1 receptor agonist SK&F38393 in combination with the dopamine D2 receptor agonist talipexole in the rat.
Furukawa, T; Kimura, H; Matsumoto, S; Nagashima, M; Yamada, K, 1992
)
0.28
" These results suggest that pramipexole could be administered with a reduced dose of levodopa to minimize dyskinesia in Parkinson's disease while maintaining therapeutic efficacy."( Pramipexole combined with levodopa improves motor function but reduces dyskinesia in MPTP-treated common marmosets.
Jackson, MJ; Jenner, P; Olanow, CW; Rose, S; Tayarani-Binazir, KA, 2010
)
2.1
"A simple, rapid and sensitive analytical method for preconcentration and determination of pramipexole in different biological samples has been developed using solvent bar microextraction (SBME) combined with HPLC-UV."( Solvent bar microextraction combined with high-performance liquid chromatography for preconcentration and determination of pramipexole in biological samples.
Ghasemi, E; Ghorban Dadrass, O; Kheradmand, S, 2014
)
0.83
"In total, 160 PD patients who were admitted to our hospital were equally randomized into a control treatment group (levodopa alone) and the study group (pramipexole combined with levodopa)."( Efficacy of pramipexole combined with levodopa for Parkinson's disease treatment and their effects on QOL and serum TNF-
Ding, J; Hong, W; Huang, J; Ren, Y; Yang, Z, 2020
)
1.14
"Pramipexole combined with levodopa relieved PD symptoms and improved the quality of life of PD patients, potentially by suppressing serum TNF-α levels."( Efficacy of pramipexole combined with levodopa for Parkinson's disease treatment and their effects on QOL and serum TNF-
Ding, J; Hong, W; Huang, J; Ren, Y; Yang, Z, 2020
)
2.38
"To explore the effects of pramipexole combined with nerve growth factor (NGF) on cognitive impairment and urinary Alzheimer-associated neural thread protein (AD7c-NTP) expression in patients with Parkinson's disease (PD)."( Effects of Pramipexole Combined with Nerve Growth Factor on Cognitive Impairment and Urinary AD7c-NTP Expression in Patients with Parkinson's Disease.
Cheng, S; Wang, Z, 2022
)
1.41
" The former was treated with pramipexole, and the latter was treated with pramipexole combined with NGF."( Effects of Pramipexole Combined with Nerve Growth Factor on Cognitive Impairment and Urinary AD7c-NTP Expression in Patients with Parkinson's Disease.
Cheng, S; Wang, Z, 2022
)
1.4
"Pramipexole combined with NGF therapy not only can effectively strengthen the cognitive impairment of patients with PD and promote clinical efficacy and high safety but also can inhibit inflammatory state, regulate brain neurotransmitters, and reduce urinary AD7c-NTP levels."( Effects of Pramipexole Combined with Nerve Growth Factor on Cognitive Impairment and Urinary AD7c-NTP Expression in Patients with Parkinson's Disease.
Cheng, S; Wang, Z, 2022
)
2.55
" The objectives of this study were to evaluate the efficacy, safety, and tolerability of ZPG combined with pramipexole in the treatment of depression in PD (dPD)."( Zishen pingchan granules combined with pramipexole in the improvement of depressive symptoms in Parkinson's disease: a prospective, multicenter, randomized, double-blind, controlled clinical study.
Chen, J; Liu, W; Liu, Z; Ning, H; Ren, J; Shen, L; Tian, Z; Wang, H; Wang, Z; Yang, N; Yuan, C; Zhao, Y; Zheng, H; Zhou, G; Zhou, H, 2022
)
1.2
"ZPG combined with pramipexole further reduced the depressive symptoms and improved the sleeping quality of PD patients."( Zishen pingchan granules combined with pramipexole in the improvement of depressive symptoms in Parkinson's disease: a prospective, multicenter, randomized, double-blind, controlled clinical study.
Chen, J; Liu, W; Liu, Z; Ning, H; Ren, J; Shen, L; Tian, Z; Wang, H; Wang, Z; Yang, N; Yuan, C; Zhao, Y; Zheng, H; Zhou, G; Zhou, H, 2022
)
1.32

Bioavailability

Dexpramipexole (KNS-760704), an orally bioavailable synthetic aminobenzothiazole, showed an excellent safety profile and was coincidentally noted to significantly decrease absolute eosinophil counts (AECs) in a phase 3 trial for amyotrophic lateral sclerosis.

ExcerptReferenceRelevance
" It has a high absolute bioavailability of > 90% and can be administered without regard to meals."( Pre-clinical studies of pramipexole: clinical relevance.
Hubble, JP, 2000
)
0.61
" The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies."( Quantification of pramipexole in human plasma by liquid chromatography tandem mass spectrometry using tamsulosin as internal standard.
Ajjala, D; Kandikere, V; Maurya, S; Mudigonda, K; Nirogi, RV; Shrivastava, W, 2007
)
0.67
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect."( Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies.
Haertter, S; Jenner, P; Könen-Bergmann, M; Schepers, C, 2009
)
0.59
"Pramipexole is a hydrophilic, weakly basic drug, but exhibits high oral bioavailability in humans (>90%)."( Uptake of pramipexole by human organic cation transporters.
Diao, L; Polli, JE; Shu, Y, 2010
)
2.21
" Preclinical studies have shown that dexpramipexole is neuroprotective in vitro and in vivo, is highly orally bioavailable and water soluble, and rapidly achieves and maintains high central nervous system concentrations relative to plasma."( Safety, tolerability, and pharmacokinetics of KNS-760704 (dexpramipexole) in healthy adult subjects.
Bozik, ME; Gribkoff, VK; Ingersoll, EW; Kramer, WG; Mather, JL, 2011
)
0.88
" The pharmacokinetic analyses demonstrated relatively low bioavailability for L-dopa and adequate plasma levels of pramipexole, even at baseline, on a stable daily dose."( Therapeutic response to pramipexole in a patient with multiple system atrophy with predominant parkinsonism: positron emission tomography and pharmacokinetic assessments.
Ishii, K; Katayama, Y; Nagayama, H; Nakajima, N; Nishiyama, Y; Ueda, M, 2013
)
0.91
"Dexpramipexole, an orally bioavailable small molecule previously under clinical development in amyotrophic lateral sclerosis, was observed during routine safety hematology monitoring to demonstrate pronounced, dose- and time-dependent eosinophil-lowering effects, with minor reductions on other leukocyte counts."( The targeted eosinophil-lowering effects of dexpramipexole in clinical studies.
Archibald, DG; Bozik, ME; Dworetzky, SI; Farwell, W; Hebrank, GT; Reynolds, IJ, 2017
)
1.33
" Dexpramipexole (KNS-760704), an orally bioavailable synthetic aminobenzothiazole, showed an excellent safety profile and was coincidentally noted to significantly decrease absolute eosinophil counts (AECs) in a phase 3 trial for amyotrophic lateral sclerosis."( Dexpramipexole as an oral steroid-sparing agent in hypereosinophilic syndromes.
Archibald, DG; Bozik, ME; Brown, T; Dunbar, CE; Dworetzky, SI; Fay, MP; Hebrank, GT; Khoury, P; Klion, AD; Makiya, M; Maric, I; Panch, SR; Prussin, C; Sullivan, M; Sun, X; Ware, J; Wetzler, L, 2018
)
1.66
"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

Dosage Studied

Pramipexole (Sifrol) was initiated at a dosage of 0.0 mg/kg. Cocaine-treated rats displayed an enhanced locomotor response to cocaine. 32 mg/ kg of the selective D3 antagonist PG01037 had little effect.

ExcerptRelevanceReference
" Its dose-response curve was bell-shaped with maximal effects at a dose of 100 micrograms/kg."( Occurrence of yawning and decrease of prolactin levels via stimulation of dopamine D2-receptors after administration of SND 919 in rats.
Domae, M; Furukawa, T; Matsumoto, S; Nagashima, M; Shirakawa, K; Yamada, K, 1989
)
0.28
"To evaluate dose-response relationships for tolerability, safety, and efficacy of the synthetic dopamine agonist pramipexole."( Safety and efficacy of pramipexole in early Parkinson disease. A randomized dose-ranging study. Parkinson Study Group.
, 1997
)
0.82
" A 6-week dosage escalation period was followed by a 4-week maintenance period and a 1-week period during which active treatment was withdrawn."( Safety and efficacy of pramipexole in early Parkinson disease. A randomized dose-ranging study. Parkinson Study Group.
, 1997
)
0.61
" Both drugs are relatively well-tolerated, with the exception of dyskinesias that require reduction of the levodopa dosage and occasional diarrhea."( New pharmacotherapy for Parkinson's disease.
Alldredge, BK; Aminoff, MJ; Bainbridge, JL; Dowling, GA; Gottwald, MD, 1997
)
0.3
" Patients were randomized to two titration schedules-either slow titration, following the package insert and taking up to 8 weeks to reach their equivalent dosage (8 patients), or rapid titration, receiving the full converted dose the day after stopping the former agonist (8 patients) with subsequent weekly dose adjustments."( Switching dopamine agonists in advanced Parkinson's disease: is rapid titration preferable to slow?
Blasucci, L; Goetz, CG; Stebbins, GT, 1999
)
0.3
" Also, when given as adjunctive therapy with levodopa, they can allow the levodopa maintenance dosage to be reduced without loss of symptom control."( Clinical pharmacology of dopamine agonists.
Lam, YW, 2000
)
0.31
" For patients with residual disability, the dosage was escalated during the first 10 weeks."( Pramipexole vs levodopa as initial treatment for Parkinson disease: A randomized controlled trial. Parkinson Study Group.
, 2000
)
1.75
" These findings suggest that pramipexole can markedly reduce the daily levodopa dosage without deterioration of motor response and support that this new selective D2/D3 receptor agonist also improves later levodopa-associated motor complications."( An open-label, multicentre clinical trial to determine the levodopa dose-sparing capacity of pramipexole in patients with idiopathic Parkinson's disease.
Hebenstreit, E; Pinter, MM; Rutgers, AW, 2000
)
0.82
" For patients with residual disability, the dosage was escalated during the first 10 weeks, and subsequently, open-label levodopa could be added."( Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression.
, 2002
)
0.56
"25-5 mg/kg) did not affect the cocaine dose-response curve or its ED50 values."( Does combined treatment with novel antidepressants and a dopamine D3 receptor agonist reproduce cocaine discrimination in rats?
Filip, M; Papla, I,
)
0.13
" However, 24-h dosing of dopamine (DA) agonists may induce side effects of insomnia and psychosis, as well as anergia and anhedonia which may actually potentiate abuse."( Effect of daily dosing duration of direct and indirect dopamine receptor agonists: cocaine cross-tolerance following chronic regimens.
Davidson, C; Ellinwood, EH; King, GR; Lee, TH; Yu, GZ, 2002
)
0.31
" Side-effects were assessed by the Dosage Record Treatment Emergent Symptom Scale (DOTES)."( Pramipexole in treatment-resistant depression: a 16-week naturalistic study.
Abelli, M; Bassi, A; Battistini, G; Cassano, GB; Cassano, P; Dell'Osso, L; Gemignani, A; Houck, PR; Lattanzi, L; Pini, S; Rucci, P, 2002
)
1.76
" The dose-response curve and duration of pramipexole's effects suggest that these rCBF responses indicate functional effects of a D3-preferring agonist."( A possible substrate for dopamine-related changes in mood and behavior: prefrontal and limbic effects of a D3-preferring dopamine agonist.
Black, KJ; Hershey, T; Koller, JM; Mintun, MA; Perlmutter, JS; Price, JL; Videen, TO, 2002
)
0.58
" Pramipexole dosing and clinical follow-up were performed in a standardized fashion."( Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS).
Johnston, L; Winkelman, JW, 2004
)
1.5
" However, these complications are generally manageable by earlier dosing or small dose increases of this agent, and only rarely require medication discontinuation."( Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS).
Johnston, L; Winkelman, JW, 2004
)
0.59
" The main risk factor associated with pathologic daytime sleep latency was high levodopa dosage equivalents (>867."( Predictors of impaired daytime sleep and wakefulness in patients with Parkinson disease treated with older (ergot) vs newer (nonergot) dopamine agonists.
Lang, AE; Razmy, A; Shapiro, CM, 2004
)
0.32
" Physicians concerned with daytime hypersomnolence in PD patients treated with dopamine agonists and receiving high levodopa dosage equivalents should consider polysomnographic monitoring for impaired daytime sleep latency."( Predictors of impaired daytime sleep and wakefulness in patients with Parkinson disease treated with older (ergot) vs newer (nonergot) dopamine agonists.
Lang, AE; Razmy, A; Shapiro, CM, 2004
)
0.32
"Twenty-two depressed outpatients with DSM-IV nonpsychotic bipolar disorder were randomly assigned to receive placebo or flexibly dosed pramipexole (mean maximum dose=1."( Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression.
Burdick, KE; Endick, CJ; Goldberg, JF, 2004
)
0.76
" Since pramipexole was well tolerated, an ideal dosage to control RLS symptoms could be reached rapidly."( Low-dose pramipexole in the management of restless legs syndrome. An open label trial.
Oertel, WH; Stiasny-Kolster, K, 2004
)
1.2
" Dosage was escalated during the first 10 weeks for patients with ongoing disability."( Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial.
Alexander-Brown, B; Atassi, F; Barclay, L; Bennett, S; Berry, D; Biglan, K; Borchert, L; Brocht, A; Brown, D; Daigneault, S; DeAngelis, M; Dillon, S; Dobson, J; Evans, S; Factor, S; Fahn, S; Fontaine, D; Ford, B; Fussell, B; Hall, J; Hammerstad, J; Harrigan, M; Hodgeman, K; Holloway, RG; Hubble, J; Jankovic, J; Kamp, C; Kieburtz, K; Kurlan, R; Lang, A; LeWitt, P; Marek, K; McDermott, M; Miyasaki, J; Montgomery, A; Musch, B; O'Connell, C; Pahwa, R; Panisset, M; Pantella, C; Petsinger, G; Pfeiffer, B; Pfeiffer, R; Rainey, P; Rajput, A; Richard, K; Riley, D; Rodnitzky, R; Ross, T; Rost-Ruffner, E; Russell, DS; Seibyl, J; Shinaman, A; Shirley, T; Shoulson, I; Shults, C; Sime, E; Stacy, M; Standaert, D; Suchowersky, O; Sutherland, L; Tennis, M; Waters, C; Watts, A; Weeks, C; Weiner, W; Welsh, M; Wood, S; Wooten, F, 2004
)
1.77
" Medication dosage was increased over 4 weeks, weaned over 2 weeks, and then discontinued."( Dopamine agonist therapy in low-response children following traumatic brain injury.
Blackman, JA; Buck, ML; Conaway, MR; Gurka, MJ; Mabry, JL; Patrick, PD, 2006
)
0.33
"To evaluate the acute effect of a low dosage of pramipexole (0."( The acute effect of a low dosage of pramipexole on severe idiopathic restless legs syndrome: an open-label trial.
Cancelli, I; Canesin, R; Dolso, P; Gigli, GL; Merlino, G; Valente, M, 2006
)
0.86
" Under the auspices of a Physician-Sponsor IND, R+PPX was dosed to small numbers of ALS patients for tolerability and safety while efficacy measures were also collected."( R+ pramipexole as a mitochondrially focused neuroprotectant: initial early phase studies in ALS.
Bennett, JP; Burns, TM; Conaway, MA; Keller, KE; Lacomis, D; Larriviere, KS; Pattee, GL; Phillips, LH; Solenski, NJ; Wang, H; Ware, KA; Zivkovic, SA, 2008
)
0.97
" Mirapex has been administered in addition to levodopa and other antiparkinsonian drugs in dosage 3,5+/-1,1 mg daily to 36 patients with emotional and cognitive disorders and in dosage 2,9+/-0,96 mg daily to 30 patients with sleep disorders."( [Mirapex (pramipexole) in the treatment of non-motor disturbances in Parkinson's disease].
Iakhno, NN; Nodel', MR, 2008
)
0.75
"0 mg/kg was more effective at shifting to the right the pramipexole dose-response curve in pramipexole-trained rats, while 32 mg/kg of the selective D3 antagonist PG01037 had little effect."( The discriminative stimulus effects of dopamine D2- and D3-preferring agonists in rats.
Greedy, B; Grundt, P; Husbands, SM; Koffarnus, MN; Newman, AH; Woods, JH, 2009
)
0.6
"70 depending on dosage group, vs."( A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: polysomnographic evaluation of periodic leg movements and sleep disturbance.
Alakuijala, A; Hirvonen, K; Hublin, C; Jama, L; Koester, J; Partinen, M; Reess, J; Tamminen, I, 2009
)
0.66
" The daily administrations of l-dopa were curtailed from 3 or 4 to 2, and the l-dopa dosage was reduced up to 40%."( Dopamine agonists in 6-pyruvoyl tetrahydropterin synthase deficiency.
Concolino, D; Mussa, A; Ponzone, A; Porta, F; Spada, M, 2009
)
0.35
" Seventy percents of patients received levodopa (mean dosage 351,2+/-279,4 mg); 62% had motor fluctuations and 43% - dyskinesias."( [Influence of dopamine agonist pramipexole (mirapex) on tremor, cognitive and affective impairment in patients with Parkinson's disease].
Artemova, IIu; Boĭko, AN; Ganzula, PA; Ismailov, AM; Ivanov, AK; Khozova, AA; Levin, OS; Lisenker, LN; Nesterova, OS; Otcheskaia, OV; Rotor, LD; Vdovichenko, TV; Zhuravleva, EIu, 2009
)
0.64
" Patients with RLS with mood and stress states may be at greater risk of developing compulsive behaviors while receiving standard dosage DA agonist treatment."( Compulsive habits in restless legs syndrome patients under dopaminergic treatment.
Cohen, H; Pourcher, E; Rémillard, S, 2010
)
0.36
"To measure behavioral and brain functional markers of drug-related attentional bias in stimulant-dependent individuals studied repeatedly after short-term dosing with dopamine D(2)/D(3) receptor antagonist and agonist challenges."( Influence of compulsivity of drug abuse on dopaminergic modulation of attentional bias in stimulant dependence.
Abbott, S; Barnes, A; Bullmore, ET; Craig, KJ; Ersche, KD; Merlo-Pich, EV; Müller, U; Ooi, C; Robbins, TW; Sahakian, BJ; Shabbir, SS; Suckling, J, 2010
)
0.36
" Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug-related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment."( Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease.
Barone, P; Debieuvre, C; Hauser, RA; Mizuno, Y; Poewe, W; Rascol, O; Salin, L; Schapira, AH; Sohr, M, 2010
)
0.57
" All subjects were dosed 3 times daily, with placebo if necessary, to maintain blinding."( Twice-daily, low-dose pramipexole in early Parkinson's disease: a randomized, placebo-controlled trial.
Kieburtz, K, 2011
)
0.68
"Cocaine-treated rats displayed an enhanced locomotor response to cocaine, as well as a progressive and persistent leftward/upward shift of the ascending limb (72 h-42 day) and leftward shift of the descending limb (42 days) of the pramipexole-induced yawning dose-response curve."( Behavioral sensitization to cocaine in rats: evidence for temporal differences in dopamine D3 and D2 receptor sensitivity.
Chen, J; Collins, GT; Levant, B; Truong, YN; Wang, S; Woods, JH, 2011
)
0.55
" Neither disease severity nor L-dopa dosage correlated with plasma AVP levels."( Increased plasma arginine vasopressin levels in dopamine agonist-treated Parkinson's disease patients.
Arai, M, 2011
)
0.37
" D(2) and D(3) antagonists differentially affected pramipexole-induced PR responding, with L: -741,626 and PG01037 producing rightward, and downward shifts in the dose-response curve for CS-maintained responding, respectively."( Effects of pramipexole on the reinforcing effectiveness of stimuli that were previously paired with cocaine reinforcement in rats.
Chen, J; Collins, GT; Cunningham, AR; Newman, AH; Wang, S; Woods, JH, 2012
)
1.02
"For a multicenter randomized, double-blind, parallel trial of extended- and immediate-release pramipexole vs placebo, patients experiencing motor fluctuations while taking levodopa underwent flexible study drug titration and then maintenance at optimized dosage (0."( Extended-release pramipexole in advanced Parkinson disease: a randomized controlled trial.
Barone, P; Busse, M; Hauser, RA; Juhel, N; Mizuno, Y; Poewe, W; Rascol, O; Salin, L; Schapira, AH, 2011
)
0.93
" BDNF levels were not affected by any dosage and treatment regime in any brain region investigated."( Pramipexole is active in depression tests and modulates monoaminergic transmission, but not brain levels of BDNF in mice.
Gass, P; Hellweg, R; Hörtnagl, H; Schulte-Herbrüggen, O; Vogt, MA, 2012
)
1.82
"To perform a pilot study assessing possible efficacy, safety, and optimal dosage of pramipexole in essential tremor."( Pramipexole may be an effective treatment option in essential tremor.
Herceg, M; Janszky, J; Késmárky, I; Komoly, S; Kovács, N; Nagy, F; Pál, E,
)
1.8
" Consequently, different L-dopa-sparing strategies have been successively introduced, with partial reduction of L-dopa dosage and amelioration of the clinical outcome."( Dopamine agonists in dihydropteridine reductase deficiency.
Concolino, D; Mussa, A; Ponzone, A; Porta, F; Spada, M, 2012
)
0.38
"  In chronic diseases including Parkinson's disease (PD), complex pharmacotherapy dosing schedules are reported to reduce adherence, perhaps leading to less-effective symptom control and, in PD, more erratic stimulation of dopamine receptors."( Patient-reported convenience of once-daily versus three-times-daily dosing during long-term studies of pramipexole in early and advanced Parkinson's disease.
Barone, P; Busse, M; Debieuvre, C; Fraessdorf, M; Hauser, RA; Mizuno, Y; Poewe, W; Rascol, O; Schapira, AH, 2013
)
0.6
" dosing preference was surveyed by questionnaire."( Patient-reported convenience of once-daily versus three-times-daily dosing during long-term studies of pramipexole in early and advanced Parkinson's disease.
Barone, P; Busse, M; Debieuvre, C; Fraessdorf, M; Hauser, RA; Mizuno, Y; Poewe, W; Rascol, O; Schapira, AH, 2013
)
0.6
" dosing (72."( Patient-reported convenience of once-daily versus three-times-daily dosing during long-term studies of pramipexole in early and advanced Parkinson's disease.
Barone, P; Busse, M; Debieuvre, C; Fraessdorf, M; Hauser, RA; Mizuno, Y; Poewe, W; Rascol, O; Schapira, AH, 2013
)
0.6
"The objective of this study is to assess the effect of smoking and caffeine intake in the dosage of dopaminergic replacement therapy."( Caffeine drinking, cigarette smoking, and dopaminergic replacement therapy dose in Parkinson's disease.
Cervantes-Arriaga, A; Corona, T; Ojeda-López, C; Rodríguez-Violante, M, 2013
)
0.39
"25 mg/day; escitalopram dosage remained at 10 mg/day."( Combining a dopamine agonist and selective serotonin reuptake inhibitor for the treatment of depression: a double-blind, randomized pilot study.
Franco-Chaves, JA; Luckenbaugh, DA; Mallinger, AG; Martinez, PE; Mateus, CF; Zarate, CA, 2013
)
0.39
" The full analysis set (FAS) comprised 564 patients (106 de novo; 458 pretreated [454 had complete rotigotine dosing data])."( Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany.
Bachmann, CG; Berg, D; Berkels, R; Grieger, F; Hofmann, WE; Lauterbach, T; Schollmayer, E; Stiasny-Kolster, K, 2013
)
0.39
" However, there may be individual pharmacokinetic differences so that multiple dosing may be preferred in some individuals."( Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease.
Jeon, BS; Kim, HJ; Kim, JM; Kim, JS; Kim, YE; Lee, JY; Yun, JY, 2013
)
0.39
" Subjects were consecutively enrolled into either once-daily first or twice-daily first groups, and received the same amount of RPR in a single and two divided dosing for 8 weeks respectively in a crossover manner without a washout period."( Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease.
Jeon, BS; Kim, HJ; Kim, JM; Kim, JS; Kim, YE; Lee, JY; Yun, JY, 2013
)
0.39
" PGI-improvement on wearing off defined was better in twice-daily dosing regimen."( Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease.
Jeon, BS; Kim, HJ; Kim, JM; Kim, JS; Kim, YE; Lee, JY; Yun, JY, 2013
)
0.39
"RPR is a once-daily formulation, but multiple dosing was preferred in many patients."( Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease.
Jeon, BS; Kim, HJ; Kim, JM; Kim, JS; Kim, YE; Lee, JY; Yun, JY, 2013
)
0.39
" Extensive drug accumulation may occur with repeated dosing in patients with significant renal impairment."( Pharmacokinetics of renally excreted drug dexpramipexole in subjects with impaired renal function.
Dong, Y; Farwell, W; He, P; Kerr, D; Marbury, T; Ries, D; Rogge, M; Stecher, S; Wei, D, 2014
)
0.66
" It may be related with using a similar dosage of dopaminergic drugs."( Augmentation in restless legs syndrome patients in Korea.
Cho, YW; Jeon, JY; Lee, HB; Moon, HJ; Song, ML, 2015
)
0.42
" The two formulations are bioequivalent; the majority (>80 %) of patients can be switched overnight from pramipexole IR to ER without the need for dosage adjustment."( Pramipexole extended-release: a review of its use in patients with Parkinson's disease.
Frampton, JE, 2014
)
2.06
" Dosage of levodopa and oral DA (pramipexole ≤1."( Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: an open-label study.
Bauer, L; Chung, SJ; Ikeda, J; Jeon, BS; Kim, JM; Kim, JW; Singh, P; Thierfelder, S, 2015
)
0.7
" Dose-response experiments were performed to select the appropriate pramipexole concentration and frequency of administration for induction of mild hypothermia (33-36 °C)."( Pramipexole-Induced Hypothermia Reduces Early Brain Injury via PI3K/AKT/GSK3β pathway in Subarachnoid Hemorrhage rats.
Chen, G; Chen, Z; Duan, X; Li, H; Liu, C; Ma, J; Shen, H; Wang, Z; Yin, J; Zuo, G, 2016
)
2.11
" Based on the projected dosing regimen in the clinical trial, a 5000-fold improvement in sensitivity was required for the (S)-enantiomer."( Development and validation of a highly sensitive gradient chiral separation of pramipexole in human plasma by LC-MS/MS.
Belardi, JK; Breda, M; Dworetzky, S; Michi, M; Solazzo, L, 2017
)
0.68
" Here we present a rare case of hypotension and bradycardia that is significantly related to the dosage of piribedil."( Hypotension and bradycardia, a serious adverse effect of piribedil, a case report and literature review.
Li, Y; Nie, K; Wang, L; Zhang, P; Zhang, Y, 2018
)
0.48
"Parkinson's disease (PD) is associated with symptoms such as tremor and bradykinesia which, together with a rigorous dosing regimen, can place an untenable burden on patients."( Near-infrared light-responsive, pramipexole-loaded biodegradable PLGA microspheres for therapeutic use in Parkinson's disease.
Fu, Z; Li, G; Li, S; Li, Y; Liu, J; Sun, F; Teng, L; Xu, F; Zhang, X, 2019
)
0.8
" The efficacy of MMF as an immunosuppressant and long-term safety in cats of this dosage regimen is unknown."(
Abrams, G; Adolfsson, E; Agarwal, PK; Akkan, AG; Al Alhareth, NS; Alves, VGL; Armentano, R; Bahroos, E; Baig, M; Baldridge, KK; Barman, S; Bartolucci, C; Basit, A; Bertoli, SV; Bian, L; Bigatti, G; Bobenko, AI; Boix, PP; Bokulic, T; Bolink, HJ; Borowiec, J; Bulski, W; Burciaga, J; Butt, NS; Cai, AL; Campos, AM; Cao, G; Cao, Y; Čapo, I; Caruso, ML; Chao, CT; Cheatum, CM; Chelminski, K; Chen, AJW; Chen, C; Chen, CH; Chen, D; Chen, G; Chen, H; Chen, LH; Chen, R; Chen, RX; Chen, X; Cherdtrakulkiat, R; Chirvony, VS; Cho, JG; Chu, K; Ciurlino, D; Coletta, S; Contaldo, G; Crispi, F; Cui, JF; D'Esposito, M; de Biase, S; Demir, B; Deng, W; Deng, Z; Di Pinto, F; Domenech-Ximenos, B; Dong, G; Drácz, L; Du, XJ; Duan, LJ; Duan, Y; Ekendahl, D; Fan, W; Fang, L; Feng, C; Followill, DS; Foreman, SC; Fortunato, G; Frew, R; Fu, M; Gaál, V; Ganzevoort, W; Gao, DM; Gao, X; Gao, ZW; Garcia-Alvarez, A; Garza, MS; Gauthier, L; Gazzaz, ZJ; Ge, RS; Geng, Y; Genovesi, S; Geoffroy, V; Georg, D; Gigli, GL; Gong, J; Gong, Q; Groeneveld, J; Guerra, V; Guo, Q; Guo, X; Güttinger, R; Guyo, U; Haldar, J; Han, DS; Han, S; Hao, W; Hayman, A; He, D; Heidari, A; Heller, S; Ho, CT; Ho, SL; Hong, SN; Hou, YJ; Hu, D; Hu, X; Hu, ZY; Huang, JW; Huang, KC; Huang, Q; Huang, T; Hwang, JK; Izewska, J; Jablonski, CL; Jameel, T; Jeong, HK; Ji, J; Jia, Z; Jiang, W; Jiang, Y; Kalumpha, M; Kang, JH; Kazantsev, P; Kazemier, BM; Kebede, B; Khan, SA; Kiss, J; Kohen, A; Kolbenheyer, E; Konai, MM; Koniarova, I; Kornblith, E; Krawetz, RJ; Kreouzis, T; Kry, SF; Laepple, T; Lalošević, D; Lan, Y; Lawung, R; Lechner, W; Lee, KH; Lee, YH; Leonard, C; Li, C; Li, CF; Li, CM; Li, F; Li, J; Li, L; Li, S; Li, X; Li, Y; Li, YB; Li, Z; Liang, C; Lin, J; Lin, XH; Ling, M; Link, TM; Liu, HH; Liu, J; Liu, M; Liu, W; Liu, YP; Lou, H; Lu, G; Lu, M; Lun, SM; Ma, Z; Mackensen, A; Majumdar, S; Martineau, C; Martínez-Pastor, JP; McQuaid, JR; Mehrabian, H; Meng, Y; Miao, T; Miljković, D; Mo, J; Mohamed, HSH; Mohtadi, M; Mol, BWJ; Moosavi, L; Mosdósi, B; Nabu, S; Nava, E; Ni, L; Novakovic-Agopian, T; Nyamunda, BC; Nyul, Z; Önal, B; Özen, D; Özyazgan, S; Pajkrt, E; Palazon, F; Park, HW; Patai, Á; Patai, ÁV; Patzke, GR; Payette, G; Pedoia, V; Peelen, MJCS; Pellitteri, G; Peng, J; Perea, RJ; Pérez-Del-Rey, D; Popović, DJ; Popović, JK; Popović, KJ; Posecion, L; Povall, J; Prachayasittikul, S; Prachayasittikul, V; Prat-González, S; Qi, B; Qu, B; Rakshit, S; Ravelli, ACJ; Ren, ZG; Rivera, SM; Salo, P; Samaddar, S; Samper, JLA; Samy El Gendy, NM; Schmitt, N; Sekerbayev, KS; Sepúlveda-Martínez, Á; Sessolo, M; Severi, S; Sha, Y; Shen, FF; Shen, X; Shen, Y; Singh, P; Sinthupoom, N; Siri, S; Sitges, M; Slovak, JE; Solymosi, N; Song, H; Song, J; Song, M; Spingler, B; Stewart, I; Su, BL; Su, JF; Suming, L; Sun, JX; Tantimavanich, S; Tashkandi, JM; Taurbayev, TI; Tedgren, AC; Tenhunen, M; Thwaites, DI; Tibrewala, R; Tomsejm, M; Triana, CA; Vakira, FM; Valdez, M; Valente, M; Valentini, AM; Van de Winckel, A; van der Lee, R; Varga, F; Varga, M; Villarino, NF; Villemur, R; Vinatha, SP; Vincenti, A; Voskamp, BJ; Wang, B; Wang, C; Wang, H; Wang, HT; Wang, J; Wang, M; Wang, N; Wang, NC; Wang, Q; Wang, S; Wang, X; Wang, Y; Wang, Z; Wen, N; Wesolowska, P; Willis, M; Wu, C; Wu, D; Wu, L; Wu, X; Wu, Z; Xia, JM; Xia, X; Xia, Y; Xiao, J; Xiao, Y; Xie, CL; Xie, LM; Xie, S; Xing, Z; Xu, C; Xu, J; Yan, D; Yan, K; Yang, S; Yang, X; Yang, XW; Ye, M; Yin, Z; Yoon, N; Yoon, Y; Yu, H; Yu, K; Yu, ZY; Zhang, B; Zhang, GY; Zhang, H; Zhang, J; Zhang, M; Zhang, Q; Zhang, S; Zhang, W; Zhang, X; Zhang, Y; Zhang, YW; Zhang, Z; Zhao, D; Zhao, F; Zhao, P; Zhao, W; Zhao, Z; Zheng, C; Zhi, D; Zhou, C; Zhou, FY; Zhu, D; Zhu, J; Zhu, Q; Zinyama, NP; Zou, M; Zou, Z, 2019
)
0.51
"05) and higher dosage (P<0."( Augmentation in patients with restless legs syndrome receiving pramipexole therapy: a retrospective study in a single center from China.
Wang, T; Ying, M; Zhang, L; Zhao, R; Zhu, D, 2022
)
0.96
"75]) taking one of three types of non-ergot extended-release DAs (rotigotine 32; pramipexole 44; ropinirole 36) with or without L-dopa (median daily total dosage of antiparkinsonian drugs 525."( Antiparkinsonian drugs as potent contributors to nocturnal sleep in patients with Parkinson's disease.
Ando, H; Doyu, M; Fujikake, A; Fukuoka, T; Hayashi, M; Ito, C; Izumi, M; Kawagashira, Y; Koide, H; Nakashima, K; Niwa, JI; Ogawa, K; Oiwa, H; Okada, Y; Taguchi, S; Tokui, K; Tsunoda, Y; Yasumoto, A; Yuasa, T, 2021
)
0.85
"For the whole PD patient cohort, the PDSS-2 sleep disturbance domain score and the scores for item 1 assessing sleep quality and item 8 assessing nocturia were positively correlated with daily total dosage of antiparkinsonian drugs and dosage of L-dopa, but not with the dosage of DAs."( Antiparkinsonian drugs as potent contributors to nocturnal sleep in patients with Parkinson's disease.
Ando, H; Doyu, M; Fujikake, A; Fukuoka, T; Hayashi, M; Ito, C; Izumi, M; Kawagashira, Y; Koide, H; Nakashima, K; Niwa, JI; Ogawa, K; Oiwa, H; Okada, Y; Taguchi, S; Tokui, K; Tsunoda, Y; Yasumoto, A; Yuasa, T, 2021
)
0.62
" Thus, adjusting both the total dosage of antiparkinsonian drugs and the dose-ratio of L-dopa might be key actions for alleviating poor sleep quality in patients with PD."( Antiparkinsonian drugs as potent contributors to nocturnal sleep in patients with Parkinson's disease.
Ando, H; Doyu, M; Fujikake, A; Fukuoka, T; Hayashi, M; Ito, C; Izumi, M; Kawagashira, Y; Koide, H; Nakashima, K; Niwa, JI; Ogawa, K; Oiwa, H; Okada, Y; Taguchi, S; Tokui, K; Tsunoda, Y; Yasumoto, A; Yuasa, T, 2021
)
0.62
" Daily DA dosage was categorized: LOW/MID (US Food and Drug Administration [FDA]-approved/guideline or slightly above FDA-approved [pramipexole]); HIGH (101%-149%); VERY HIGH (>150%)."( High national rates of high-dose dopamine agonist prescribing for restless legs syndrome.
Winkelman, JW, 2022
)
0.93
" Rates of HIGH/VERY HIGH DA dosing increased with patient age."( High national rates of high-dose dopamine agonist prescribing for restless legs syndrome.
Winkelman, JW, 2022
)
0.72
" The P2B001 combination has the potential to provide greater efficacy than either pramipexole or rasagiline alone and a better tolerability profile compared to higher dosage dopamine agonist monotherapy, while maintaining the advantage of lower motor complication risk than levodopa."( P2B001 (Extended Release Pramipexole and Rasagiline): A New Treatment Option in Development for Parkinson's Disease.
Brotchie, J; Friedman, H; Giladi, N; Hauser, RA; Litman, P; Oren, S; Poewe, W, 2022
)
1.25
" The P2B001 combination has the potential to provide greater efficacy than either pramipexole or rasagiline alone and a better tolerability profile compared to higher dosage dopamine agonist monotherapy, while maintaining the advantage of lower motor complication risk than levodopa."( P2B001 (Extended Release Pramipexole and Rasagiline): A New Treatment Option in Development for Parkinson's Disease.
Brotchie, J; Friedman, H; Giladi, N; Hauser, RA; Litman, P; Oren, S; Poewe, W, 2022
)
1.25
" Low dosage DA, as given when treating restless legs syndrome (RLS), has been thought only to have mild side effects."( [Gambling addiction as a side effect of low dose pramipexole in the treatment of restless legs syndrome].
Ibsen, JD; Lindström, ES; Skovbølling, SL, 2022
)
0.98
" However, buccal patches can solve this problem because the patients do not have to swallow the dosage form, and during application, the API can absorb from the area of the buccal mucosa quickly without causing a foreign body sensation."( Formulation and characterization of pramipexole containing buccal films for using in Parkinson's disease.
Bácskay, I; Jójárt-Laczkovich, O; Kristó, K; Nemes, D; Pamlényi, K; Regdon, G, 2023
)
1.19
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
antiparkinson drugA drug used in the treatment of Parkinson's disease.
dopamine agonistA drug that binds to and activates dopamine receptors.
antidyskinesia agentAny compound which can be used to treat or alleviate the symptoms of dyskinesia.
radical scavengerA role played by a substance that can react readily with, and thereby eliminate, radicals.
[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 (2)

ClassDescription
benzothiazoles
diamineAny polyamine that contains two amino groups.
[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 (43)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
acetylcholinesteraseHomo sapiens (human)Potency27.54040.002541.796015,848.9004AID1347395
TDP1 proteinHomo sapiens (human)Potency23.32220.000811.382244.6684AID686978; AID686979
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency13.33320.001022.650876.6163AID1224839
cytochrome P450 2D6Homo sapiens (human)Potency24.54540.00108.379861.1304AID1645840
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency2.27940.005612.367736.1254AID624032
[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)133.00000.11007.190310.0000AID1473738
Beta-2 adrenergic receptorHomo sapiens (human)Ki55.00000.00000.66359.5499AID1298705; AID1607430
Muscarinic acetylcholine receptor M2Homo sapiens (human)Ki10.00000.00000.690210.0000AID1607446
5-hydroxytryptamine receptor 1AHomo sapiens (human)Ki6.51400.00010.532610.0000AID1607411
Alpha-2A adrenergic receptorHomo sapiens (human)Ki0.07570.00010.807410.0000AID1607425
Muscarinic acetylcholine receptor M1Homo sapiens (human)Ki10.00000.00000.59729.1201AID1607445
Beta-3 adrenergic receptorHomo sapiens (human)Ki10.00000.00302.30986.0450AID1607427
D(2) dopamine receptorHomo sapiens (human)IC50 (µMol)10.00000.00000.74728.0000AID727074
D(2) dopamine receptorHomo sapiens (human)Ki1.09030.00000.651810.0000AID1298708; AID1563552; AID1607341; AID1607433; AID1895203; AID1895205; AID239106; AID239107; AID239120; AID239121; AID254516; AID254517; AID254519; AID254520; AID61171; AID61487; AID64493
Alpha-2B adrenergic receptorHomo sapiens (human)Ki0.06770.00020.725710.0000AID1607426
Alpha-2C adrenergic receptorHomo sapiens (human)Ki0.05220.00030.483410.0000AID1607428
DRattus norvegicus (Norway rat)Ki50.01350.00010.610010.0000AID391641; AID61171
D(3) dopamine receptorRattus norvegicus (Norway rat)Ki0.00060.00010.25675.8000AID391639; AID711802
Muscarinic acetylcholine receptor M3Homo sapiens (human)Ki10.00000.00000.54057.7600AID1607447
D(1A) dopamine receptorHomo sapiens (human)Ki10.00000.00010.836310.0000AID1607432
D(4) dopamine receptorHomo sapiens (human)Ki0.04570.00000.436210.0000AID1607435; AID239128; AID239137; AID254504; AID254506; AID61810; AID63685; AID63686
D(1B) dopamine receptorHomo sapiens (human)Ki10.00000.00030.40177.9000AID1607436
Histamine H2 receptorHomo sapiens (human)Ki8.24340.00062.197310.0000AID1607441; AID1895194
5-hydroxytryptamine receptor 1DHomo sapiens (human)Ki10.00000.00010.808710.0000AID1607413
5-hydroxytryptamine receptor 1BHomo sapiens (human)Ki3.50800.00010.54859.2100AID1607412
5-hydroxytryptamine receptor 1EHomo sapiens (human)Ki10.00000.09304.770110.0000AID1607414
5-hydroxytryptamine receptor 7Homo sapiens (human)Ki1.18800.00030.380610.0000AID1607421
Alpha-1A adrenergic receptorHomo sapiens (human)Ki10.00000.00000.272610.0000AID1607422
D(3) dopamine receptorHomo sapiens (human)Ki0.00820.00000.602010.0000AID1563553; AID1607340; AID1607356; AID1607357; AID1607358; AID1607359; AID1607360; AID1607434; AID1895204; AID239087; AID239098; AID239943; AID254499; AID254501; AID64987; AID65291; AID773370
Delta-type opioid receptorHomo sapiens (human)Ki10.00000.00000.59789.9300AID1607438
5-hydroxytryptamine receptor 3AHomo sapiens (human)Ki10.00000.00000.74119.9000AID1607418
5-hydroxytryptamine receptor 5AHomo sapiens (human)Ki10.00000.00080.94335.1600AID1607419
5-hydroxytryptamine receptor 6Homo sapiens (human)Ki10.00000.00020.522910.0000AID1607420
D(2) dopamine receptorRattus norvegicus (Norway rat)Ki0.03900.00000.437510.0000AID711803
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
DBos taurus (cattle)Ki20.00000.00012.367610.0000AID254428
Sigma non-opioid intracellular receptor 1Homo sapiens (human)Ki4.44600.00000.490110.0000AID1607454
Histamine H4 receptorHomo sapiens (human)Ki10.00000.00060.478710.0000AID1607443
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
D(2) dopamine receptorHomo sapiens (human)EC50 (µMol)0.02600.00000.18743.9000AID1340444; AID1448003; AID1448005; AID1448008; AID1895218; AID310686; AID319299
D(2) dopamine receptorHomo sapiens (human)Kd0.00000.00000.64599.5000AID1895202; AID1895203
D(3) dopamine receptorRattus norvegicus (Norway rat)EC50 (µMol)0.00020.00020.02710.0800AID65468
D(1A) dopamine receptorHomo sapiens (human)EC50 (µMol)10.00000.00020.47959.5000AID319298
D(4) dopamine receptorHomo sapiens (human)EC50 (µMol)0.01500.00140.08892.2300AID240291; AID61802
Histamine H2 receptorHomo sapiens (human)EC50 (µMol)0.16600.11481.77695.4954AID1895211
Histamine H2 receptorHomo sapiens (human)Kd0.01220.01220.09190.2512AID1895194
5-hydroxytryptamine receptor 2AHomo sapiens (human)EC50 (µMol)1.17490.00000.22763.4750AID1340445
Histamine H1 receptorHomo sapiens (human)Kd0.00450.00010.40215.4000AID1895193
D(3) dopamine receptorHomo sapiens (human)EC50 (µMol)0.00200.00010.02470.6690AID1607335; AID1895221; AID240284; AID254617; AID310687; AID64816
D(3) dopamine receptorHomo sapiens (human)Kd0.00000.00000.07480.3162AID1895204
D(2) dopamine receptorRattus norvegicus (Norway rat)EC50 (µMol)0.00880.00040.32993.9100AID240276; AID240277; AID61304; AID61491; AID64640
Histamine H4 receptorHomo sapiens (human)Kd0.01600.00400.01940.0702AID1895197
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
D(3) dopamine receptorHomo sapiens (human)ED500.00370.00370.00370.0037AID1143585
Solute carrier family 22 member 1Rattus norvegicus (Norway rat)Km30.00000.27005.695010.0000AID679186; AID679194
Solute carrier family 22 member 2Rattus norvegicus (Norway rat)Km17.00009.40009.40009.4000AID681621; AID681629
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (387)

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)
diet induced thermogenesisBeta-2 adrenergic receptorHomo sapiens (human)
regulation of sodium ion transportBeta-2 adrenergic receptorHomo sapiens (human)
transcription by RNA polymerase IIBeta-2 adrenergic receptorHomo sapiens (human)
receptor-mediated endocytosisBeta-2 adrenergic receptorHomo sapiens (human)
smooth muscle contractionBeta-2 adrenergic receptorHomo sapiens (human)
cell surface receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
activation of transmembrane receptor protein tyrosine kinase activityBeta-2 adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
endosome to lysosome transportBeta-2 adrenergic receptorHomo sapiens (human)
response to coldBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of protein kinase A signalingBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of bone mineralizationBeta-2 adrenergic receptorHomo sapiens (human)
heat generationBeta-2 adrenergic receptorHomo sapiens (human)
negative regulation of multicellular organism growthBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeBeta-2 adrenergic receptorHomo sapiens (human)
bone resorptionBeta-2 adrenergic receptorHomo sapiens (human)
negative regulation of G protein-coupled receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIBeta-2 adrenergic receptorHomo sapiens (human)
negative regulation of smooth muscle contractionBeta-2 adrenergic receptorHomo sapiens (human)
brown fat cell differentiationBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of mini excitatory postsynaptic potentialBeta-2 adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of protein serine/threonine kinase activityBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of cold-induced thermogenesisBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of autophagosome maturationBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of lipophagyBeta-2 adrenergic receptorHomo sapiens (human)
cellular response to amyloid-betaBeta-2 adrenergic receptorHomo sapiens (human)
response to psychosocial stressBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of cAMP-dependent protein kinase activityBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of AMPA receptor activityBeta-2 adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine-mediated vasodilation involved in regulation of systemic arterial blood pressureBeta-2 adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of heart contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
response to virusMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M2Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M2Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M2Homo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
gamma-aminobutyric acid signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of serotonin secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of vasoconstriction5-hydroxytryptamine receptor 1AHomo sapiens (human)
exploration behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of dopamine metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of hormone secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1AHomo sapiens (human)
positive regulation of cytokine productionAlpha-2A adrenergic receptorHomo sapiens (human)
DNA replicationAlpha-2A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
Ras protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
Rho protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2A adrenergic receptorHomo sapiens (human)
actin cytoskeleton organizationAlpha-2A adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell migrationAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
cellular response to hormone stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2A adrenergic receptorHomo sapiens (human)
vasodilationAlpha-2A adrenergic receptorHomo sapiens (human)
glucose homeostasisAlpha-2A adrenergic receptorHomo sapiens (human)
fear responseAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of potassium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAP kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion-dependent exocytosisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2A adrenergic receptorHomo sapiens (human)
intestinal absorptionAlpha-2A adrenergic receptorHomo sapiens (human)
thermoceptionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of lipid catabolic processAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of membrane protein ectodomain proteolysisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretion involved in cellular response to glucose stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of uterine smooth muscle contractionAlpha-2A adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
phospholipase C-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of wound healingAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transmembrane transporter activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of monoatomic ion transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
neuromuscular synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M1Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M1Homo sapiens (human)
cognitionMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of postsynaptic membrane potentialMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of glial cell proliferationMuscarinic acetylcholine receptor M1Homo sapiens (human)
positive regulation of intracellular protein transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M1Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
receptor-mediated endocytosisBeta-3 adrenergic receptorHomo sapiens (human)
negative regulation of G protein-coupled receptor signaling pathwayBeta-3 adrenergic receptorHomo sapiens (human)
diet induced thermogenesisBeta-3 adrenergic receptorHomo sapiens (human)
carbohydrate metabolic processBeta-3 adrenergic receptorHomo sapiens (human)
generation of precursor metabolites and energyBeta-3 adrenergic receptorHomo sapiens (human)
energy reserve metabolic processBeta-3 adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerBeta-3 adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayBeta-3 adrenergic receptorHomo sapiens (human)
response to coldBeta-3 adrenergic receptorHomo sapiens (human)
heat generationBeta-3 adrenergic receptorHomo sapiens (human)
negative regulation of multicellular organism growthBeta-3 adrenergic receptorHomo sapiens (human)
eating behaviorBeta-3 adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeBeta-3 adrenergic receptorHomo sapiens (human)
brown fat cell differentiationBeta-3 adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayBeta-3 adrenergic receptorHomo sapiens (human)
positive regulation of cold-induced thermogenesisBeta-3 adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine-mediated vasodilation involved in regulation of systemic arterial blood pressureBeta-3 adrenergic receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
temperature homeostasisD(2) dopamine receptorHomo sapiens (human)
response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein phosphorylationD(2) dopamine receptorHomo sapiens (human)
response to amphetamineD(2) dopamine receptorHomo sapiens (human)
nervous system process involved in regulation of systemic arterial blood pressureD(2) dopamine receptorHomo sapiens (human)
regulation of heart rateD(2) dopamine receptorHomo sapiens (human)
regulation of sodium ion transportD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(2) dopamine receptorHomo sapiens (human)
positive regulation of neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
positive regulation of receptor internalizationD(2) dopamine receptorHomo sapiens (human)
autophagyD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
neuron-neuron synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
axonogenesisD(2) dopamine receptorHomo sapiens (human)
synapse assemblyD(2) dopamine receptorHomo sapiens (human)
sensory perception of smellD(2) dopamine receptorHomo sapiens (human)
long-term memoryD(2) dopamine receptorHomo sapiens (human)
grooming behaviorD(2) dopamine receptorHomo sapiens (human)
locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
adult walking behaviorD(2) dopamine receptorHomo sapiens (human)
protein localizationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell population proliferationD(2) dopamine receptorHomo sapiens (human)
associative learningD(2) dopamine receptorHomo sapiens (human)
visual learningD(2) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(2) dopamine receptorHomo sapiens (human)
response to light stimulusD(2) dopamine receptorHomo sapiens (human)
response to toxic substanceD(2) dopamine receptorHomo sapiens (human)
response to iron ionD(2) dopamine receptorHomo sapiens (human)
response to inactivityD(2) dopamine receptorHomo sapiens (human)
Wnt signaling pathwayD(2) dopamine receptorHomo sapiens (human)
striatum developmentD(2) dopamine receptorHomo sapiens (human)
orbitofrontal cortex developmentD(2) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(2) dopamine receptorHomo sapiens (human)
adenohypophysis developmentD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell migrationD(2) dopamine receptorHomo sapiens (human)
peristalsisD(2) dopamine receptorHomo sapiens (human)
auditory behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of synaptic transmission, GABAergicD(2) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(2) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
response to histamineD(2) dopamine receptorHomo sapiens (human)
response to nicotineD(2) dopamine receptorHomo sapiens (human)
positive regulation of urine volumeD(2) dopamine receptorHomo sapiens (human)
positive regulation of renal sodium excretionD(2) dopamine receptorHomo sapiens (human)
positive regulation of multicellular organism growthD(2) dopamine receptorHomo sapiens (human)
response to cocaineD(2) dopamine receptorHomo sapiens (human)
negative regulation of circadian sleep/wake cycle, sleepD(2) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(2) dopamine receptorHomo sapiens (human)
drinking behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(2) dopamine receptorHomo sapiens (human)
response to morphineD(2) dopamine receptorHomo sapiens (human)
pigmentationD(2) dopamine receptorHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
positive regulation of G protein-coupled receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(2) dopamine receptorHomo sapiens (human)
negative regulation of innate immune responseD(2) dopamine receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IID(2) dopamine receptorHomo sapiens (human)
negative regulation of insulin secretionD(2) dopamine receptorHomo sapiens (human)
acid secretionD(2) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(2) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(2) dopamine receptorHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityD(2) dopamine receptorHomo sapiens (human)
response to axon injuryD(2) dopamine receptorHomo sapiens (human)
branching morphogenesis of a nerveD(2) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(2) dopamine receptorHomo sapiens (human)
epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(2) dopamine receptorHomo sapiens (human)
release of sequestered calcium ion into cytosolD(2) dopamine receptorHomo sapiens (human)
dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of synapse structural plasticityD(2) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(2) dopamine receptorHomo sapiens (human)
excitatory postsynaptic potentialD(2) dopamine receptorHomo sapiens (human)
positive regulation of growth hormone secretionD(2) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeD(2) dopamine receptorHomo sapiens (human)
regulation of locomotion involved in locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
negative regulation of cellular response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
positive regulation of glial cell-derived neurotrophic factor productionD(2) dopamine receptorHomo sapiens (human)
positive regulation of long-term synaptic potentiationD(2) dopamine receptorHomo sapiens (human)
hyaloid vascular plexus regressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of neuron migrationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(2) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(2) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
angiogenesisAlpha-2B adrenergic receptorHomo sapiens (human)
regulation of vascular associated smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2B adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2B adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of blood pressureAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of uterine smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
regulation of smooth muscle contractionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2C adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2C adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2C adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2C adrenergic receptorHomo sapiens (human)
calcium-mediated signalingMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of monoatomic ion transmembrane transporter activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
synaptic transmission, cholinergicMuscarinic acetylcholine receptor M3Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of insulin secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein modification processMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ion channel modulating, G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ligand-gated ion channel signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M3Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M3Homo sapiens (human)
temperature homeostasisD(1A) dopamine receptorHomo sapiens (human)
conditioned taste aversionD(1A) dopamine receptorHomo sapiens (human)
behavioral fear responseD(1A) dopamine receptorHomo sapiens (human)
regulation of protein phosphorylationD(1A) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(1A) dopamine receptorHomo sapiens (human)
response to amphetamineD(1A) dopamine receptorHomo sapiens (human)
protein import into nucleusD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
activation of adenylate cyclase activityD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
synapse assemblyD(1A) dopamine receptorHomo sapiens (human)
memoryD(1A) dopamine receptorHomo sapiens (human)
mating behaviorD(1A) dopamine receptorHomo sapiens (human)
grooming behaviorD(1A) dopamine receptorHomo sapiens (human)
adult walking behaviorD(1A) dopamine receptorHomo sapiens (human)
visual learningD(1A) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(1A) dopamine receptorHomo sapiens (human)
astrocyte developmentD(1A) dopamine receptorHomo sapiens (human)
dopamine transportD(1A) dopamine receptorHomo sapiens (human)
transmission of nerve impulseD(1A) dopamine receptorHomo sapiens (human)
neuronal action potentialD(1A) dopamine receptorHomo sapiens (human)
dentate gyrus developmentD(1A) dopamine receptorHomo sapiens (human)
striatum developmentD(1A) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(1A) dopamine receptorHomo sapiens (human)
positive regulation of cell migrationD(1A) dopamine receptorHomo sapiens (human)
peristalsisD(1A) dopamine receptorHomo sapiens (human)
operant conditioningD(1A) dopamine receptorHomo sapiens (human)
synaptic transmission, glutamatergicD(1A) dopamine receptorHomo sapiens (human)
regulation of dopamine metabolic processD(1A) dopamine receptorHomo sapiens (human)
vasodilationD(1A) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(1A) dopamine receptorHomo sapiens (human)
maternal behaviorD(1A) dopamine receptorHomo sapiens (human)
positive regulation of potassium ion transportD(1A) dopamine receptorHomo sapiens (human)
glucose importD(1A) dopamine receptorHomo sapiens (human)
habituationD(1A) dopamine receptorHomo sapiens (human)
sensitizationD(1A) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(1A) dopamine receptorHomo sapiens (human)
positive regulation of release of sequestered calcium ion into cytosolD(1A) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(1A) dopamine receptorHomo sapiens (human)
positive regulation of synaptic transmission, glutamatergicD(1A) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(1A) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
long-term synaptic potentiationD(1A) dopamine receptorHomo sapiens (human)
long-term synaptic depressionD(1A) dopamine receptorHomo sapiens (human)
cellular response to catecholamine stimulusD(1A) dopamine receptorHomo sapiens (human)
modification of postsynaptic structureD(1A) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(1A) dopamine receptorHomo sapiens (human)
positive regulation of neuron migrationD(1A) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
positive regulation of MAP kinase activityD(4) dopamine receptorHomo sapiens (human)
behavioral fear responseD(4) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(4) dopamine receptorHomo sapiens (human)
response to amphetamineD(4) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(4) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
adult locomotory behaviorD(4) dopamine receptorHomo sapiens (human)
positive regulation of sodium:proton antiporter activityD(4) dopamine receptorHomo sapiens (human)
positive regulation of kinase activityD(4) dopamine receptorHomo sapiens (human)
response to histamineD(4) dopamine receptorHomo sapiens (human)
social behaviorD(4) dopamine receptorHomo sapiens (human)
regulation of dopamine metabolic processD(4) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(4) dopamine receptorHomo sapiens (human)
fear responseD(4) dopamine receptorHomo sapiens (human)
regulation of circadian rhythmD(4) dopamine receptorHomo sapiens (human)
positive regulation of MAP kinase activityD(4) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(4) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(4) dopamine receptorHomo sapiens (human)
rhythmic processD(4) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(4) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(4) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(4) dopamine receptorHomo sapiens (human)
inhibitory postsynaptic potentialD(4) dopamine receptorHomo sapiens (human)
regulation of postsynaptic neurotransmitter receptor internalizationD(4) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(4) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathwayD(4) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerD(4) dopamine receptorHomo sapiens (human)
chemical synaptic transmissionD(4) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(1B) dopamine receptorHomo sapiens (human)
response to amphetamineD(1B) dopamine receptorHomo sapiens (human)
regulation of systemic arterial blood pressure by vasopressinD(1B) dopamine receptorHomo sapiens (human)
norepinephrine-epinephrine vasoconstriction involved in regulation of systemic arterial blood pressureD(1B) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(1B) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
activation of adenylate cyclase activityD(1B) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
chemical synaptic transmissionD(1B) dopamine receptorHomo sapiens (human)
associative learningD(1B) dopamine receptorHomo sapiens (human)
transmission of nerve impulseD(1B) dopamine receptorHomo sapiens (human)
negative regulation of NAD(P)H oxidase activityD(1B) dopamine receptorHomo sapiens (human)
wound healingD(1B) dopamine receptorHomo sapiens (human)
response to cocaineD(1B) dopamine receptorHomo sapiens (human)
positive regulation of adenylate cyclase activityD(1B) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(1B) dopamine receptorHomo sapiens (human)
regulation of female receptivityD(1B) dopamine receptorHomo sapiens (human)
sensitizationD(1B) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
long-term synaptic depressionD(1B) dopamine receptorHomo sapiens (human)
cellular response to catecholamine stimulusD(1B) dopamine receptorHomo sapiens (human)
reactive oxygen species metabolic processD(1B) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(1B) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(1B) dopamine receptorHomo sapiens (human)
gastric acid secretionHistamine H2 receptorHomo sapiens (human)
immune responseHistamine H2 receptorHomo sapiens (human)
positive regulation of vasoconstrictionHistamine H2 receptorHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayHistamine H2 receptorHomo sapiens (human)
chemical synaptic transmissionHistamine H2 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerHistamine H2 receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1DHomo sapiens (human)
intestine smooth muscle contraction5-hydroxytryptamine receptor 1DHomo sapiens (human)
regulation of locomotion5-hydroxytryptamine receptor 1DHomo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 1DHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 1DHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1DHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1DHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1DHomo sapiens (human)
G protein-coupled receptor internalization5-hydroxytryptamine receptor 1BHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1BHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1BHomo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1BHomo sapiens (human)
negative regulation of gamma-aminobutyric acid secretion5-hydroxytryptamine receptor 1BHomo sapiens (human)
regulation of dopamine secretion5-hydroxytryptamine receptor 1BHomo sapiens (human)
negative regulation of serotonin secretion5-hydroxytryptamine receptor 1BHomo sapiens (human)
negative regulation of synaptic transmission, GABAergic5-hydroxytryptamine receptor 1BHomo sapiens (human)
response to cocaine5-hydroxytryptamine receptor 1BHomo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 1BHomo sapiens (human)
drinking behavior5-hydroxytryptamine receptor 1BHomo sapiens (human)
response to ethanol5-hydroxytryptamine receptor 1BHomo sapiens (human)
bone remodeling5-hydroxytryptamine receptor 1BHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 1BHomo sapiens (human)
response to mineralocorticoid5-hydroxytryptamine receptor 1BHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergic5-hydroxytryptamine receptor 1BHomo sapiens (human)
cellular response to alkaloid5-hydroxytryptamine receptor 1BHomo sapiens (human)
cellular response to xenobiotic stimulus5-hydroxytryptamine receptor 1BHomo sapiens (human)
cellular response to temperature stimulus5-hydroxytryptamine receptor 1BHomo sapiens (human)
presynaptic modulation of chemical synaptic transmission5-hydroxytryptamine receptor 1BHomo sapiens (human)
regulation of presynaptic cytosolic calcium ion concentration5-hydroxytryptamine receptor 1BHomo sapiens (human)
positive regulation of vascular associated smooth muscle cell proliferation5-hydroxytryptamine receptor 1BHomo sapiens (human)
regulation of synaptic vesicle exocytosis5-hydroxytryptamine receptor 1BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1BHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1BHomo sapiens (human)
temperature homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytokine production involved in immune response5-hydroxytryptamine receptor 2AHomo sapiens (human)
glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2AHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cytosolic calcium ion concentration5-hydroxytryptamine receptor 2AHomo sapiens (human)
memory5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2AHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
regulation of dopamine secretion5-hydroxytryptamine receptor 2AHomo sapiens (human)
artery smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
urinary bladder smooth muscle contraction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of heat generation5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of potassium ion transport5-hydroxytryptamine receptor 2AHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of neuron apoptotic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein localization to cytoskeleton5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of glycolytic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of vasoconstriction5-hydroxytryptamine receptor 2AHomo sapiens (human)
symbiont entry into host cell5-hydroxytryptamine receptor 2AHomo sapiens (human)
sensitization5-hydroxytryptamine receptor 2AHomo sapiens (human)
behavioral response to cocaine5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of inflammatory response5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylation5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of temperature stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of pain5-hydroxytryptamine receptor 2AHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2AHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergic5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic modulation of chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of execution phase of apoptosis5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of platelet aggregation5-hydroxytryptamine receptor 2AHomo sapiens (human)
positive regulation of DNA biosynthetic process5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2AHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1EHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1EHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1EHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1EHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1EHomo sapiens (human)
smooth muscle contraction5-hydroxytryptamine receptor 7Homo sapiens (human)
circadian rhythm5-hydroxytryptamine receptor 7Homo sapiens (human)
blood circulation5-hydroxytryptamine receptor 7Homo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 7Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 7Homo sapiens (human)
MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of heart rate involved in baroreceptor response to increased systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine vasoconstriction involved in regulation of systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of heart rate by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of the force of heart contraction by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
apoptotic processAlpha-1A adrenergic receptorHomo sapiens (human)
smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
activation of phospholipase C activityAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1A adrenergic receptorHomo sapiens (human)
adult heart developmentAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of cell population proliferationAlpha-1A adrenergic receptorHomo sapiens (human)
response to xenobiotic stimulusAlpha-1A adrenergic receptorHomo sapiens (human)
response to hormoneAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of autophagyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle hypertrophyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of synaptic transmission, GABAergicAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of action potentialAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of vasoconstrictionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
calcium ion transport into cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
cell growth involved in cardiac muscle cell developmentAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of protein kinase C signalingAlpha-1A adrenergic receptorHomo sapiens (human)
pilomotor reflexAlpha-1A adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
inflammatory responseHistamine H1 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayHistamine H1 receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayHistamine H1 receptorHomo sapiens (human)
memoryHistamine H1 receptorHomo sapiens (human)
visual learningHistamine H1 receptorHomo sapiens (human)
regulation of vascular permeabilityHistamine H1 receptorHomo sapiens (human)
positive regulation of vasoconstrictionHistamine H1 receptorHomo sapiens (human)
regulation of synaptic plasticityHistamine H1 receptorHomo sapiens (human)
cellular response to histamineHistamine H1 receptorHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayHistamine H1 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerHistamine H1 receptorHomo sapiens (human)
chemical synaptic transmissionHistamine H1 receptorHomo sapiens (human)
response to ethanolD(3) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(3) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
learning or memoryD(3) dopamine receptorHomo sapiens (human)
learningD(3) dopamine receptorHomo sapiens (human)
locomotory behaviorD(3) dopamine receptorHomo sapiens (human)
visual learningD(3) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(3) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(3) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(3) dopamine receptorHomo sapiens (human)
response to histamineD(3) dopamine receptorHomo sapiens (human)
social behaviorD(3) dopamine receptorHomo sapiens (human)
response to cocaineD(3) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(3) dopamine receptorHomo sapiens (human)
response to morphineD(3) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(3) dopamine receptorHomo sapiens (human)
positive regulation of mitotic nuclear divisionD(3) dopamine receptorHomo sapiens (human)
acid secretionD(3) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(3) dopamine receptorHomo sapiens (human)
negative regulation of oligodendrocyte differentiationD(3) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(3) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(3) dopamine receptorHomo sapiens (human)
musculoskeletal movement, spinal reflex actionD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(3) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(3) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(3) dopamine receptorHomo sapiens (human)
positive regulation of dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(3) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(3) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(3) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(3) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(3) dopamine receptorHomo sapiens (human)
immune responseDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerDelta-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
adult locomotory behaviorDelta-type opioid receptorHomo sapiens (human)
negative regulation of gene expressionDelta-type opioid receptorHomo sapiens (human)
negative regulation of protein-containing complex assemblyDelta-type opioid receptorHomo sapiens (human)
positive regulation of CREB transcription factor activityDelta-type opioid receptorHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationDelta-type opioid receptorHomo sapiens (human)
response to nicotineDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
eating behaviorDelta-type opioid receptorHomo sapiens (human)
regulation of mitochondrial membrane potentialDelta-type opioid receptorHomo sapiens (human)
regulation of calcium ion transportDelta-type opioid receptorHomo sapiens (human)
cellular response to growth factor stimulusDelta-type opioid receptorHomo sapiens (human)
cellular response to hypoxiaDelta-type opioid receptorHomo sapiens (human)
cellular response to toxic substanceDelta-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayDelta-type opioid receptorHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 3AHomo sapiens (human)
monoatomic ion transmembrane transport5-hydroxytryptamine receptor 3AHomo sapiens (human)
excitatory postsynaptic potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
inorganic cation transmembrane transport5-hydroxytryptamine receptor 3AHomo sapiens (human)
regulation of presynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 3AHomo sapiens (human)
regulation of membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 5AHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 5AHomo sapiens (human)
hippocampus development5-hydroxytryptamine receptor 5AHomo sapiens (human)
response to estradiol5-hydroxytryptamine receptor 5AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 5AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 5AHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 5AHomo sapiens (human)
cerebral cortex cell migration5-hydroxytryptamine receptor 6Homo sapiens (human)
positive regulation of TOR signaling5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 6Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 6Homo 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)
synaptic transmission, dopaminergicDBos taurus (cattle)
vasodilationDBos taurus (cattle)
lipid transportSigma non-opioid intracellular receptor 1Homo sapiens (human)
nervous system developmentSigma non-opioid intracellular receptor 1Homo sapiens (human)
G protein-coupled opioid receptor signaling pathwaySigma non-opioid intracellular receptor 1Homo sapiens (human)
regulation of neuron apoptotic processSigma non-opioid intracellular receptor 1Homo sapiens (human)
protein homotrimerizationSigma non-opioid intracellular receptor 1Homo sapiens (human)
inflammatory responseHistamine H4 receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationHistamine H4 receptorHomo sapiens (human)
biological_processHistamine H4 receptorHomo sapiens (human)
regulation of MAPK cascadeHistamine H4 receptorHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayHistamine H4 receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayHistamine H4 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerHistamine H4 receptorHomo sapiens (human)
chemical synaptic transmissionHistamine H4 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (79)

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)
amyloid-beta bindingBeta-2 adrenergic receptorHomo sapiens (human)
beta2-adrenergic receptor activityBeta-2 adrenergic receptorHomo sapiens (human)
protein bindingBeta-2 adrenergic receptorHomo sapiens (human)
adenylate cyclase bindingBeta-2 adrenergic receptorHomo sapiens (human)
potassium channel regulator activityBeta-2 adrenergic receptorHomo sapiens (human)
identical protein bindingBeta-2 adrenergic receptorHomo sapiens (human)
protein homodimerization activityBeta-2 adrenergic receptorHomo sapiens (human)
protein-containing complex bindingBeta-2 adrenergic receptorHomo sapiens (human)
norepinephrine bindingBeta-2 adrenergic receptorHomo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
arrestin family protein bindingMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M2Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
receptor-receptor interaction5-hydroxytryptamine receptor 1AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein kinase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-1B adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-2C adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
thioesterase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
heterotrimeric G-protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
norepinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2A adrenergic receptorHomo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
norepinephrine bindingBeta-3 adrenergic receptorHomo sapiens (human)
beta-adrenergic receptor activityBeta-3 adrenergic receptorHomo sapiens (human)
protein bindingBeta-3 adrenergic receptorHomo sapiens (human)
beta3-adrenergic receptor activityBeta-3 adrenergic receptorHomo sapiens (human)
beta-3 adrenergic receptor bindingBeta-3 adrenergic receptorHomo sapiens (human)
protein homodimerization activityBeta-3 adrenergic receptorHomo sapiens (human)
epinephrine bindingBeta-3 adrenergic receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(2) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(2) dopamine receptorHomo sapiens (human)
protein bindingD(2) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(2) dopamine receptorHomo sapiens (human)
dopamine bindingD(2) dopamine receptorHomo sapiens (human)
ionotropic glutamate receptor bindingD(2) dopamine receptorHomo sapiens (human)
identical protein bindingD(2) dopamine receptorHomo sapiens (human)
heterocyclic compound bindingD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(2) dopamine receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2B adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2B adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2B adrenergic receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2C adrenergic receptorHomo sapiens (human)
alpha-2A adrenergic receptor bindingAlpha-2C adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2C adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2C adrenergic receptorHomo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
signaling receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via GsD(1A) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(1A) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(1A) dopamine receptorHomo sapiens (human)
protein bindingD(1A) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(1A) dopamine receptorHomo sapiens (human)
dopamine bindingD(1A) dopamine receptorHomo sapiens (human)
arrestin family protein bindingD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(1A) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(4) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(4) dopamine receptorHomo sapiens (human)
protein bindingD(4) dopamine receptorHomo sapiens (human)
potassium channel regulator activityD(4) dopamine receptorHomo sapiens (human)
SH3 domain bindingD(4) dopamine receptorHomo sapiens (human)
dopamine bindingD(4) dopamine receptorHomo sapiens (human)
identical protein bindingD(4) dopamine receptorHomo sapiens (human)
metal ion bindingD(4) dopamine receptorHomo sapiens (human)
epinephrine bindingD(4) dopamine receptorHomo sapiens (human)
norepinephrine bindingD(4) dopamine receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityD(4) dopamine receptorHomo sapiens (human)
neurotransmitter receptor activityD(4) dopamine receptorHomo sapiens (human)
serotonin bindingD(4) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via GsD(1B) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(1B) dopamine receptorHomo sapiens (human)
protein bindingD(1B) dopamine receptorHomo sapiens (human)
dopamine bindingD(1B) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(1B) dopamine receptorHomo sapiens (human)
histamine receptor activityHistamine H2 receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityHistamine H2 receptorHomo sapiens (human)
neurotransmitter receptor activityHistamine H2 receptorHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1DHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1DHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1BHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 1BHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 1BHomo sapiens (human)
voltage-gated calcium channel activity involved in regulation of presynaptic cytosolic calcium levels5-hydroxytryptamine receptor 1BHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1BHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
virus receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein tyrosine kinase activator activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
protein-containing complex binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled receptor activity5-hydroxytryptamine receptor 1EHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1EHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 1EHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 1EHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1EHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1A adrenergic receptorHomo sapiens (human)
histamine receptor activityHistamine H1 receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityHistamine H1 receptorHomo sapiens (human)
neurotransmitter receptor activityHistamine H1 receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(3) dopamine receptorHomo sapiens (human)
protein bindingD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(3) dopamine receptorHomo sapiens (human)
G protein-coupled opioid receptor activityDelta-type opioid receptorHomo sapiens (human)
protein bindingDelta-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled enkephalin receptor activityDelta-type opioid receptorHomo sapiens (human)
neuropeptide bindingDelta-type opioid receptorHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin-gated monoatomic cation channel activity5-hydroxytryptamine receptor 3AHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 3AHomo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potential5-hydroxytryptamine receptor 3AHomo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activity5-hydroxytryptamine receptor 3AHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 5AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 5AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 5AHomo sapiens (human)
histamine receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 6Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 6Homo 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)
G protein-coupled opioid receptor activitySigma non-opioid intracellular receptor 1Homo sapiens (human)
protein bindingSigma non-opioid intracellular receptor 1Homo sapiens (human)
histamine receptor activityHistamine H4 receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityHistamine H4 receptorHomo sapiens (human)
G protein-coupled acetylcholine receptor activityHistamine H4 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (84)

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)
nucleusBeta-2 adrenergic receptorHomo sapiens (human)
lysosomeBeta-2 adrenergic receptorHomo sapiens (human)
endosomeBeta-2 adrenergic receptorHomo sapiens (human)
early endosomeBeta-2 adrenergic receptorHomo sapiens (human)
Golgi apparatusBeta-2 adrenergic receptorHomo sapiens (human)
plasma membraneBeta-2 adrenergic receptorHomo sapiens (human)
endosome membraneBeta-2 adrenergic receptorHomo sapiens (human)
membraneBeta-2 adrenergic receptorHomo sapiens (human)
apical plasma membraneBeta-2 adrenergic receptorHomo sapiens (human)
clathrin-coated endocytic vesicle membraneBeta-2 adrenergic receptorHomo sapiens (human)
neuronal dense core vesicleBeta-2 adrenergic receptorHomo sapiens (human)
receptor complexBeta-2 adrenergic receptorHomo sapiens (human)
plasma membraneBeta-2 adrenergic receptorHomo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
clathrin-coated endocytic vesicle membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
asymmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
symmetric synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
neuronal cell bodyMuscarinic acetylcholine receptor M2Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M2Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M2Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M2Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M2Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 1AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1AHomo sapiens (human)
cytoplasmAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
basolateral plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
neuronal cell bodyAlpha-2A adrenergic receptorHomo sapiens (human)
axon terminusAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic active zone membraneAlpha-2A adrenergic receptorHomo sapiens (human)
dopaminergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
postsynaptic density membraneAlpha-2A adrenergic receptorHomo sapiens (human)
glutamatergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
GABA-ergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
receptor complexAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M1Homo sapiens (human)
Schaffer collateral - CA1 synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic density membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneBeta-3 adrenergic receptorHomo sapiens (human)
receptor complexBeta-3 adrenergic receptorHomo sapiens (human)
plasma membraneBeta-3 adrenergic receptorHomo sapiens (human)
Golgi membraneD(2) dopamine receptorHomo sapiens (human)
acrosomal vesicleD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
ciliumD(2) dopamine receptorHomo sapiens (human)
lateral plasma membraneD(2) dopamine receptorHomo sapiens (human)
endocytic vesicleD(2) dopamine receptorHomo sapiens (human)
axonD(2) dopamine receptorHomo sapiens (human)
dendriteD(2) dopamine receptorHomo sapiens (human)
synaptic vesicle membraneD(2) dopamine receptorHomo sapiens (human)
sperm flagellumD(2) dopamine receptorHomo sapiens (human)
dendritic spineD(2) dopamine receptorHomo sapiens (human)
perikaryonD(2) dopamine receptorHomo sapiens (human)
axon terminusD(2) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(2) dopamine receptorHomo sapiens (human)
ciliary membraneD(2) dopamine receptorHomo sapiens (human)
non-motile ciliumD(2) dopamine receptorHomo sapiens (human)
dopaminergic synapseD(2) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(2) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(2) dopamine receptorHomo sapiens (human)
presynaptic membraneD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
cytosolAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic receptorHomo sapiens (human)
cell surfaceAlpha-2B adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-2C adrenergic receptorHomo sapiens (human)
endosomeAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
endoplasmic reticulum membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basal plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basolateral plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M3Homo sapiens (human)
nucleusD(1A) dopamine receptorHomo sapiens (human)
endoplasmic reticulum membraneD(1A) dopamine receptorHomo sapiens (human)
plasma membraneD(1A) dopamine receptorHomo sapiens (human)
ciliumD(1A) dopamine receptorHomo sapiens (human)
presynaptic membraneD(1A) dopamine receptorHomo sapiens (human)
dendritic spineD(1A) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(1A) dopamine receptorHomo sapiens (human)
ciliary membraneD(1A) dopamine receptorHomo sapiens (human)
non-motile ciliumD(1A) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(1A) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(1A) dopamine receptorHomo sapiens (human)
plasma membraneD(1A) dopamine receptorHomo sapiens (human)
centrosomeD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(4) dopamine receptorHomo sapiens (human)
membraneD(4) dopamine receptorHomo sapiens (human)
postsynapseD(4) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(4) dopamine receptorHomo sapiens (human)
dendriteD(4) dopamine receptorHomo sapiens (human)
plasma membraneD(1B) dopamine receptorHomo sapiens (human)
ciliumD(1B) dopamine receptorHomo sapiens (human)
brush border membraneD(1B) dopamine receptorHomo sapiens (human)
synapseD(1B) dopamine receptorHomo sapiens (human)
ciliary membraneD(1B) dopamine receptorHomo sapiens (human)
non-motile ciliumD(1B) dopamine receptorHomo sapiens (human)
plasma membraneD(1B) dopamine receptorHomo sapiens (human)
plasma membraneHistamine H2 receptorHomo sapiens (human)
synapseHistamine H2 receptorHomo sapiens (human)
plasma membraneHistamine H2 receptorHomo sapiens (human)
dendriteHistamine H2 receptorHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1DHomo sapiens (human)
synapse5-hydroxytryptamine receptor 1DHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1DHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1DHomo sapiens (human)
endoplasmic reticulum5-hydroxytryptamine receptor 1BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1BHomo sapiens (human)
presynaptic membrane5-hydroxytryptamine receptor 1BHomo sapiens (human)
calyx of Held5-hydroxytryptamine receptor 1BHomo sapiens (human)
serotonergic synapse5-hydroxytryptamine receptor 1BHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 1BHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1BHomo sapiens (human)
neurofilament5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
caveola5-hydroxytryptamine receptor 2AHomo sapiens (human)
axon5-hydroxytryptamine receptor 2AHomo sapiens (human)
cytoplasmic vesicle5-hydroxytryptamine receptor 2AHomo sapiens (human)
presynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
neuronal cell body5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendritic shaft5-hydroxytryptamine receptor 2AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
cell body fiber5-hydroxytryptamine receptor 2AHomo sapiens (human)
glutamatergic synapse5-hydroxytryptamine receptor 2AHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1EHomo sapiens (human)
synapse5-hydroxytryptamine receptor 1EHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1EHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1EHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
trans-Golgi network membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
synapse5-hydroxytryptamine receptor 7Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 7Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
nucleusAlpha-1A adrenergic receptorHomo sapiens (human)
nucleoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
caveolaAlpha-1A adrenergic receptorHomo sapiens (human)
nuclear membraneAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
cytosolHistamine H1 receptorHomo sapiens (human)
plasma membraneHistamine H1 receptorHomo sapiens (human)
synapseHistamine H1 receptorHomo sapiens (human)
dendriteHistamine H1 receptorHomo sapiens (human)
plasma membraneHistamine H1 receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
synapseD(3) dopamine receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneDelta-type opioid receptorHomo sapiens (human)
dendrite membraneDelta-type opioid receptorHomo sapiens (human)
presynaptic membraneDelta-type opioid receptorHomo sapiens (human)
axon terminusDelta-type opioid receptorHomo sapiens (human)
spine apparatusDelta-type opioid receptorHomo sapiens (human)
postsynaptic density membraneDelta-type opioid receptorHomo sapiens (human)
neuronal dense core vesicleDelta-type opioid receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
neuron projectionDelta-type opioid receptorHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
cleavage furrow5-hydroxytryptamine receptor 3AHomo sapiens (human)
postsynaptic membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
serotonin-activated cation-selective channel complex5-hydroxytryptamine receptor 3AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 3AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 3AHomo sapiens (human)
transmembrane transporter complex5-hydroxytryptamine receptor 3AHomo sapiens (human)
neuron projection5-hydroxytryptamine receptor 3AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 5AHomo sapiens (human)
perikaryon5-hydroxytryptamine receptor 5AHomo sapiens (human)
postsynaptic specialization membrane5-hydroxytryptamine receptor 5AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 5AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 5AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
cilium5-hydroxytryptamine receptor 6Homo sapiens (human)
synapse5-hydroxytryptamine receptor 6Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 6Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo 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)
endoplasmic reticulum membraneDBos taurus (cattle)
dendritic spineDBos taurus (cattle)
ciliary membraneDBos taurus (cattle)
nuclear envelopeSigma non-opioid intracellular receptor 1Homo sapiens (human)
nuclear inner membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
nuclear outer membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulumSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulum membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
lipid dropletSigma non-opioid intracellular receptor 1Homo sapiens (human)
cytosolSigma non-opioid intracellular receptor 1Homo sapiens (human)
postsynaptic densitySigma non-opioid intracellular receptor 1Homo sapiens (human)
membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
growth coneSigma non-opioid intracellular receptor 1Homo sapiens (human)
cytoplasmic vesicleSigma non-opioid intracellular receptor 1Homo sapiens (human)
anchoring junctionSigma non-opioid intracellular receptor 1Homo sapiens (human)
postsynaptic density membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulumSigma non-opioid intracellular receptor 1Homo sapiens (human)
plasma membraneHistamine H4 receptorHomo sapiens (human)
plasma membraneHistamine H4 receptorHomo sapiens (human)
dendriteHistamine H4 receptorHomo sapiens (human)
synapseHistamine H4 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (323)

Assay IDTitleYearJournalArticle
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.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID391646Inhibition of yawning in rat at >0.1 mg/kg, sc2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
AID679194TP_TRANSPORTER: uptake in OCT1 expressing oocytes2005Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 33, Issue:4
Transport of the dopamine D2 agonist pramipexole by rat organic cation transporters OCT1 and OCT2 in kidney.
AID1607432Displacement of [3H]-SCH23390 from recombinant human D1 receptor transiently expressed in HEKT cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1563555Selectivity ratio of Ki for displacement of [3H]-(R)-(+)-7-OH-DPAT from recombinant human D2L receptor expressed in HEK293 cell membranes to Ki for displacement of [3H]-(R)-(+)-7-OH-DPAT from recombinant human D3 receptor expressed in HEK293 cell membrane2019Journal of medicinal chemistry, 07-11, Volume: 62, Issue:13
The Significance of Chirality in Drug Design and Synthesis of Bitopic Ligands as D
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).
AID1607481Displacement of [3H]-SCH23390 from recombinant human D5 receptor transiently expressed in HEKT cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID773370Agonist activity at dopamine D3 receptor (unknown origin)2013Bioorganic & medicinal chemistry letters, Oct-15, Volume: 23, Issue:20
Synthesis and binding affinity of new 1,4-disubstituted triazoles as potential dopamine D(3) receptor ligands.
AID1607445Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M1 receptor expressed in stable CHO cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607451Displacement of [3H]-Nisoxetine from human NET receptor expressed in stable HEK cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID61487Binding affinity of compound measured using [3H]spiperone for the cloned human dopamine receptor D2 short (high/low affinity is given as 40/3600)2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID1607449Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M5 receptor expressed in stable CHO cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607487Displacement of [3H]-alpha-methylhistamine from recombinant human histamine H3 receptor expressed in HEK Flp-In cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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.
AID61802Effective concentration required for agonistic activity against human D4.2 receptor2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID773369Selectivity ratio of Ki for dopamine D2 receptor (unknown origin) to Ki for dopamine D3 receptor (unknown origin)2013Bioorganic & medicinal chemistry letters, Oct-15, Volume: 23, Issue:20
Synthesis and binding affinity of new 1,4-disubstituted triazoles as potential dopamine D(3) receptor ligands.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1607431Displacement of [3H]-Flunitrazepam from rat brain GABA(A)/BzR site measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID711822Induction of yawning in Sprague-Dawley rat at 0.1 mg/kg, sc pre-treated with 1 mg/kg D2 receptor antagonist L-741,626 measured 30 mins post dose2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1448010Ratio of EC50 for human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 to EC50 for human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 and GRK22017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1607444Displacement of [3H]-U69593 from KOR (unknown origin) measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607340Displacement of [3H]-methylspiperon from human D3R expressed in HEK293 cell membranes measured after 90 mins in EBSS buffer by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID711803Displacement of [3H]Spiperone from Sprague-Dawley rat dopamine D2-like receptor after 90 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1607493Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M4 receptor expressed in stable CHO cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID711818Induction of yawning in Sprague-Dawley rat at 0.1 mg/kg, sc pre-treated with 32 mg/kg D3 receptor antagonist SB-277011A measured 30 mins post dose2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID711808Induction of yawning in sc dosed Sprague-Dawley rat after 60 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1607425Displacement of [3H]-rauwolscine from recombinant human alpha2A adrenergic receptor stably expressed in MDCK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607430Displacement of [3H]-CGP12177 from recombinant human beta2 adrenergic receptor expressed in HEK Flp-In cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895221Agonist activity at human D3 receptor stably expressed in HEK293T cells co-expressing ElucN-betaarr2 hD3R-ElucC by beta-arrestin2 recruitment assay
AID1607459Displacement of [3H]5-HT from recombinant human 5HT1E receptor stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID391642Selectivity for Sprague-Dawley rat D3 receptor over Sprague-Dawley rat D2-like receptor2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
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).
AID688184Selectivity ratio of Ki for dopamine D2 like receptor in rat brain homogenates to Ki for dopamine D3 receptor in rat brain homogenates2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
High-affinity and selective dopamine D₃ receptor full agonists.
AID1895203Displacement of [3H]N-methylspiperone from human D2 long receptor stably expressed in HEK293T cells co-expressing luciferase and CEK at high concentration incubated for 140 mins by radioligand competition binding based assay
AID254428Binding affinity (low) towards bovine dopamine receptor 1 by using [3H]-SCH- 23390 (0.3 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID1607464Displacement of [3H]-LSD from recombinant human 5HT5A receptor stably expressed in Flp-In CHO cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID319301Intrinsic activity at human dopamine D2 receptor expressed in CHO cells assessed as inhibition of forskolin-stimulated cAMP production2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
A novel synthesis and pharmacological evaluation of a potential dopamine D1/D2 agonist: 1-propyl-1,2,3,4,4a,5,10,10a-octahydrobenzo[g]quinoline-6,7-diol.
AID63685in vitro high binding affinity was determined on human Dopamine receptor D4 expressed in chinese hamster ovary(CHO) K-1 cells using [3H]spiperone as radioligand.2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID61171Binding affinity of compound measured using [3H]-spiperone for the cloned human dopamine receptor D2 long (high/low affinity is given as 27/5400)2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID688183Displacement of [3H]SCH23390 from dopamine D1 like receptor in rat brain homogenates2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
High-affinity and selective dopamine D₃ receptor full agonists.
AID240276Effective concentration to stimulate rat Dopamine receptor D2L mediated [3H]thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID244409Intrinsic activity to stimulate rat Dopamine receptor D2S mediated [3H]-thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1607420Displacement of [3H]-LSD from recombinant human 5HT6 receptor stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607406Agonist activity at RLuc8-fused human D3R Y198A/Y365A double mutant expressed in HEK293 cells co-expressing N-terminal Venus-tagged beta-arrestin2 and GRK3 assessed as induction of beta-arrestin2 recruitment measured after 5 mins in presence of coelentera2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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.
AID254506High binding affinity towards human dopamine receptor 4.4 expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID391639Displacement of [3H]PD128907 from dopamine D3 receptor in Sprague-Dawley rat ventral striatum2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1607421Displacement of [3H]-LSD from recombinant human 5HT7A receptor stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1607446Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M2 receptor expressed in stable CHO cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607341Displacement of [3H]-methylspiperon from human D2RL expressed in HEK293 cell membranes measured after 90 mins by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607465Displacement of [3H]-LSD from recombinant human 5HT6 receptor stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607448Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M4 receptor expressed in stable CHO cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895218Agonist activity at human D2 long receptor stably expressed in HEK293T cells co-expressing ElucN-betaarr2 hD2longR-ElucC by beta-arrestin2 recruitment assay
AID1895197Displacement of [3H]-histamine from human histamine H4 receptor stably expressed in baculovirus infected Sf9 cell membrane co-expressing G-alphai2 and G-beta1gamma2 incubated for 60 mins by scintillation counting analysis
AID1607437Displacement of [3H]-Win35428 from human DAT expressed in stable HEK cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID688185Selectivity ratio of Ki for dopamine D1 like receptor in rat brain homogenates to Ki for dopamine D3 receptor in rat brain homogenates2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
High-affinity and selective dopamine D₃ receptor full agonists.
AID688179Selectivity ratio of dopamine D2 receptor to dopamine D3 receptor2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
High-affinity and selective dopamine D₃ receptor full agonists.
AID1607472Displacement of [3H]-rauwolscine from recombinant human alpha2C adrenergic receptor stably expressed in MDCK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607415Displacement of [3H]-Ketanserin from 5HT2A receptor (unknown origin) measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607466Displacement of [3H]-LSD from recombinant human 5HT7A receptor stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607424Displacement of [3H]-prazosin from recombinant human alpha1D adrenergic receptor measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID238979Inhibition constant against [3H]SCH-23390 binding to Dopamine receptor D1 in bovine striatal membranes2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID711815Induction of hypothermia in Sprague-Dawley rat at 0.32 mg/kg, sc after 60 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID319299Agonist activity at human dopamine D2 receptor expressed in CHO cells assessed as inhibition of forskolin-stimulated cAMP production2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
A novel synthesis and pharmacological evaluation of a potential dopamine D1/D2 agonist: 1-propyl-1,2,3,4,4a,5,10,10a-octahydrobenzo[g]quinoline-6,7-diol.
AID711805Selectivity ratio of Ki for Sprague-Dawley rat dopamine D2-like receptor to Ki for Sprague-Dawley rat dopamine D3 receptor2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1143585Agonist activity at human dopamine D3 receptor expressed in human U2OS cells assessed as stimulation of beta-arrestin recruitment2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Tranylcypromine substituted cis-hydroxycyclobutylnaphthamides as potent and selective dopamine D₃ receptor antagonists.
AID1607429Displacement of [125I]-pindolol from recombinant human beta1 adrenergic receptor expressed in CHO Flp-In cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895193Displacement of [3H] mepyramine from human histamine H1 receptor stably expressed in baculovirus infected Sf9 cell membrane co-expressing RGS4 incubated for 60 mins by scintillation counting analysis
AID1563556Selectivity ratio of Ki for displacement of [3H]-(R)-(+)-7-OH-DPAT from recombinant human D4.4 receptor expressed in HEK293 cell membranes to Ki for displacement of [3H]-(R)-(+)-7-OH-DPAT from recombinant human D3 receptor expressed in HEK293 cell membran2019Journal of medicinal chemistry, 07-11, Volume: 62, Issue:13
The Significance of Chirality in Drug Design and Synthesis of Bitopic Ligands as D
AID1607484Displacement of [3H]-Muscimol from rat brain GABAA at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID239943Inhibition constant against [3H]-spiperone binding to human Dopamine receptor D3 expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
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.
AID1895211Agonist activity at human histamine H2 receptor stably expressed in HEK293T cells co-expressing NlucN-mGs/hH2R-NlucC assessed as induction of mini-Gi protein recruitment using furimazine as substrate measured for 45 mins by luminescence assay
AID1895220Agonist activity at human D2 long receptor stably expressed in HEK293T cells co-expressing ElucN-betaarr2 hD2longR-ElucC assessed as maximum efficacy at 10 uM by beta-arrestin2 recruitment assay relative to control
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1298711Selectivity index, ratio of Ki for human beta2 receptor to Ki for human D2S receptor2016Bioorganic & medicinal chemistry, 06-15, Volume: 24, Issue:12
Structure-guided development of dual β2 adrenergic/dopamine D2 receptor agonists.
AID1607351Agonist activity at RLuc8-fused human D3R expressed in HEK293 cells co-expressing N-terminal Venus-tagged beta-arrestin2 and GRK3 assessed as induction of beta-arrestin2 recruitment measured after 5 mins in presence of coelenterazine H by BRET assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID391645Induction of yawning in rat at 0.01 to 0.1 mg/kg, sc2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
AID1607361Displacement of [3H]-7-OH-DPAT from human D3R expressed in HEK293 cell membranes measured after 90 mins in Tris buffer containing MgCl2 by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607442Displacement of [3H]-alpha-methylhistamine from recombinant human histamine H3 receptor expressed in HEK Flp-In cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607497Displacement of [3H]-PK11195 from rat brain GABA PBR at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607413Displacement of [3H]5-CT from recombinant human 5HT1D receptor transiently expressed in HEKT cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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).
AID1607471Displacement of [3H]-rauwolscine from recombinant human alpha2B adrenergic receptor transiently expressed in HEKT cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID310686Agonist activity at human recombinant dopamine D2 receptor expressed in rat pituitary cells assessed as inhibition of forskolin-stimulated cAMP accumulation2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Design and synthesis of a functionally selective D3 agonist and its in vivo delivery via the intranasal route.
AID1607488Displacement of [3H]-Histamine from recombinant human histamine H4 receptor expressed in HEKT cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607461Displacement of [3H]-LSD from recombinant human 5HT2B receptor stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607460Displacement of [3H]-Ketanserin from 5HT2A receptor (unknown origin) at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID255229Ligand efficacy towards dopamine D3 receptor2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID1607422Displacement of [3H]-prazosin from recombinant human alpha1A adrenergic receptor measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID254520High binding affinity towards human dopamine receptor 2 (short) expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID254504Low binding affinity towards human dopamine receptor 4.4 expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID1895194Displacement of [3H]UR-DE257 from human histamine H2 receptor stably expressed in baculovirus infected Sf9 cell membrane co-expressing RG-Salpha S incubated for 60 mins by scintillation counting analysis
AID711826Inhibition of hypothermia in Sprague-Dawley rat at 0.32 mg/kg, sc pre-treated with 1 mg/kg D2 receptor antagonist L-741,626 measured 30 mins post dose2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
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.
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.
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).
AID1563554Displacement of [3H]-(R)-(+)-7-OH-DPAT from recombinant human D4.4 receptor expressed in HEK293 cell membranes measured after 90 mins by microbeta scintillation counting analysis2019Journal of medicinal chemistry, 07-11, Volume: 62, Issue:13
The Significance of Chirality in Drug Design and Synthesis of Bitopic Ligands as D
AID1607486Displacement of [125I]-Iodo-aminopotentidine from human histamine H2 receptor expressed in stable HEK cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607480Displacement of [3H]-N-methylspiperone from recombinant human D4 receptor stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607359Displacement of [3H]-7-OH-DPAT from human D3R expressed in HEK293 cell membranes measured after 90 mins in Tris buffer by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607478Displacement of [3H]-N-methylspiperone from recombinant human D2 receptor stably expressed in fibroblast cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607473Displacement of [125I]-pindolol from recombinant human beta1 adrenergic receptor expressed in CHO Flp-In cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607411Displacement of [3H]-Way100635 from recombinant human 5HT1A receptor stably expressed in CHO cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID244410Intrinsic activity to stimulate human Dopamine receptor D3 mediated [3H]thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1607414Displacement of [3H]5-HT from recombinant human 5HT1E receptor stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID681621TP_TRANSPORTER: uptake in Xenopus laevis oocytes2005Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 33, Issue:4
Transport of the dopamine D2 agonist pramipexole by rat organic cation transporters OCT1 and OCT2 in kidney.
AID254516Low binding affinity towards human dopamine receptor 2 (long) expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID391641Displacement of [3H]SCH23390 from D1-like receptor in Sprague-Dawley rat striatum2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
AID1448003Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID310688Selectivity for human dopamine D3 receptor over human dopamine D2 receptor2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Design and synthesis of a functionally selective D3 agonist and its in vivo delivery via the intranasal route.
AID239121High inhibition constant against [3H]spiperone binding to human Dopamine receptor D2S expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
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).
AID1607491Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M2 receptor expressed in stable CHO cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895208Selectivity ratio of Ki for human D3 receptor receptor to Ki for human histamine H2 receptor
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).
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID711806Selectivity ratio of Ki for Sprague-Dawley rat dopamine D1-like receptor to Ki for Sprague-Dawley rat dopamine D3 receptor2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1607439Displacement of [3H]-Muscimol from rat brain GABAA measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID240284Effective concentration to stimulate human Dopamine receptor D3 mediated [3H]-thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
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).
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID239106Low inhibition constant against [3H]spiperone binding to human Dopamine receptor D2L expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1607419Displacement of [3H]-LSD from recombinant human 5HT5A receptor stably expressed in Flp-In CHO cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895212Agonist activity at human histamine H2 receptor stably expressed in HEK293T cells co-expressing NlucN-mGs/hH2R-NlucC assessed as induction of mini-Gi protein recruitment by measuring maximum efficacy at 100 uM using furimazine as substrate measured for 45
AID61491Effective concentration required for agonistic activity against rat D2 short receptor2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID65765compound was tested for intrinsic activity for thymidine uptake in CHO-L6 cells transfected with rat Dopamine receptor D32000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID1607489Displacement of [3H]-U69593 from KOR (unknown origin) at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID391640Displacement of [3H]Spiperone from D2 receptor in Sprague-Dawley rat caudate-putamen2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
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.
AID727074Antagonist activity at human D2 dopamine receptor expressed in CHO cell membrane by GTPgammaS-binding assay2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
Synthesis and SAR of aminothiazole fused benzazepines as selective dopamine D2 partial agonists.
AID1448008Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 and GRK2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID239087Low inhibition constant against [3H]spiperone binding to human Dopamine receptor D3 expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1607453Displacement of [3H]-citalopram from human SERT receptor expressed in stable HEK cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1607410Selectivity ratio of Ki for displacement of [3H]-methylspiperon from human D2RL expressed in HEK293 cell membranes to Ki for displacement of [3H]-methylspiperon from human D3R expressed in HEK293 cell membranes2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID65291in vitro low binding affinity was determined on human Dopamine receptor D3 expressed in chinese hamster ovary(CHO) K-1 cells using [3H]spiperone as radioligand.2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID688182Displacement of [3H]Spiperone from dopamine D2 like receptor in rat brain homogenates2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
High-affinity and selective dopamine D₃ receptor full agonists.
AID750039Selectivity ratio for human recombinant dopamine D2 receptor to human recombinant dopamine D3 receptor2013Bioorganic & medicinal chemistry, Jun-01, Volume: 21, Issue:11
Modification of agonist binding moiety in hybrid derivative 5/7-{[2-(4-aryl-piperazin-1-yl)-ethyl]-propyl-amino}-5,6,7,8-tetrahydro-naphthalen-1-ol/-2-amino versions: impact on functional activity and selectivity for dopamine D2/D3 receptors.
AID1448004Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay relative to quinpirole2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1607463Displacement of [3H]GR65630 from recombinant human 5HT3 receptor transiently expressed in HEKT cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID588992Inhibitors of transporters of clinical importance in the absorption and disposition of drugs, MATE2-K2010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID239120High inhibition constant against [3H]spiperone binding to human Dopamine receptor D2L expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1607384Neuroprotective activity against 6-OHDA-induced toxicity in differentiated human NSC stably expressing D3R assessed as reduction in cell damage at 500 nM pretreated for 24 hrs followed by 6-OHDA challenge and measured after 24 hrs by MTT assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID391647Induction of hypothermia in rat assessed as change in body temperature2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
AID1607433Displacement of [3H]-N-methylspiperone from recombinant human D2 receptor stably expressed in fibroblast cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895195Displacement of [3H]Nalpha-methylhistamine from human histamine H3 receptor stably expressed in baculovirus infected Sf9 cell membrane co-expressing G-alphai2 and G-beta1gamma2 incubated for 60 mins by scintillation counting analysis
AID65761Inhibition of quinpirole (30 nM)-stimulated [3H]thymidine uptake in CHO-L6 cells transfected with the rat Dopamine receptor D3;NT is not tested2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID711801Inhibition of hypothermia in Sprague-Dawley rat assessed as reduction in core body temperature at 0.32 mg/kg, sc pre-treated with 1 mg/kg D2 receptor antagonist L-741,626 measured 30 mins post dose2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1607455Displacement of [3H]-DTG from sigma 2 receptor (unknown origin) measured after 90 mins by microbeta counting analysis2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607468Displacement of [3H]-prazosin from recombinant human alpha1B adrenergic receptor transiently expressed in HEKT cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607356Displacement of [3H]-methylspiperon from human D3R expressed in HEK293 cell membranes measured after 90 mins in Tris buffer by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895205Displacement of [3H]N-methylspiperone from human D2 long receptor stably expressed in HEK293T cells co-expressing luciferase and CEK at low concentration incubated for 140 mins by radioligand competition binding based assay
AID254519Low binding affinity towards human dopamine receptor 2 (short) expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID63686in vitro low binding affinity was determined on human Dopamine receptor D4 expressed in chinese hamster ovary(CHO) K-1 cells using [3H]spiperone as radioligand.2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID1607502Selectivity ratio of Ki for displacement of [3H]-N-methylspiperone from recombinant human D4 receptor stably expressed in HEK cell membranes to Ki for displacement of [3H]-N-methylspiperone from D3 receptor (unknown origin)2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1448006Agonist activity at human D2S receptor expressed in HEK293T cell membranes coexpressing Galphao1 assessed as induction of nucleotide exchange at 0.1 pM to 100 uM preincubated for 30 mins followed by addition of [35S]GTPgammaS measured after 30 mins by [352017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID1607440Displacement of [3H]-pyrilamine from human histamine H1 receptor expressed in stable HEK cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607412Displacement of [3H]5-CT from recombinant human 5HT1B receptor stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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).
AID1298708Displacement of [3H]spiperone from human D2S receptor expressed in CHO cells2016Bioorganic & medicinal chemistry, 06-15, Volume: 24, Issue:12
Structure-guided development of dual β2 adrenergic/dopamine D2 receptor agonists.
AID1607357Displacement of [3H]-methylspiperon from human D3R expressed in HEK293 cell membranes measured after 90 mins in Tris buffer containing NaCl by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID688180Selectivity ratio of dopamine D1 like receptor to dopamine D3 receptor2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
High-affinity and selective dopamine D₃ receptor full agonists.
AID1607454Displacement of [3H]-pentazocine from sigma1 receptor (unknown origin) after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1607474Displacement of [3H]-CGP12177 from recombinant human beta2 adrenergic receptor expressed in HEK Flp-In cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607438Displacement of [3H]-DADLE from recombinant human DOR stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1448005Agonist activity at human D2S receptor expressed in HEK293T cell membranes coexpressing Galphao1 assessed as induction of nucleotide exchange preincubated for 30 mins followed by addition of [35S]GTPgammaS measured after 30 mins by [35S]GTPgammaS binding 2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID244411Intrinsic activity to stimulate human Dopamine receptor D4.2 mediated [3H]thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1607423Displacement of [3H]-prazosin from recombinant human alpha1B adrenergic receptor transiently expressed in HEKT cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607494Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M5 receptor expressed in stable CHO cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID254499Low binding affinity towards human dopamine receptor 3 expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1607498Displacement of [3H]-citalopram from human SERT receptor expressed in stable HEK cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895204Displacement of [3H]N-methylspiperone from human D3 receptor stably expressed in HEK293T cells co-expressing luciferase and CEK incubated for 140 mins by radioligand competition binding based assay
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).
AID711804Displacement of [3H]SCH 23390 from Sprague-Dawley rat dopamine D1-like receptor after 90 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID711810Induction of hypothermia in Sprague-Dawley rat at 10 mg/kg, sc after 60 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID64987Binding affinity of compound measured using [3H]-spiperone for the cloned human Dopamine receptor D3 (high/low affinity is given as 0.87/44)2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID688181Displacement of [3H]-R(+)-7-OHDPAT from dopamine D3 receptor in rat brain homogenates2012Bioorganic & medicinal chemistry letters, Sep-01, Volume: 22, Issue:17
High-affinity and selective dopamine D₃ receptor full agonists.
AID727076Intrinsic agonist activity at human D2 dopamine receptor expressed in CHO cell membrane using cellular CD spectroscopy by Cell-Key assay2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
Synthesis and SAR of aminothiazole fused benzazepines as selective dopamine D2 partial agonists.
AID64493in vitro low binding affinity was determined on human Dopamine receptor D2L expressed in chinese hamster ovary(CHO) K-1 cells using [3H]-spiperone as radioligand.2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID1607360Displacement of [3H]-7-OH-DPAT from human D3R expressed in HEK293 cell membranes measured after 90 mins in Tris buffer containing NaCl by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607417Displacement of [3H]-Mesulergine from recombinant human 5HT2C receptor expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID240277Effective concentration to stimulate rat Dopamine receptor D2S mediated [3H]thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1607469Displacement of [3H]-prazosin from recombinant human alpha1D adrenergic receptor at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID239128Low inhibition constant against [3H]spiperone binding to human Dopamine receptor D4.4 expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID727075Displacement of [3H]raclopride from human D2 dopamine receptor expressed in CHO cell membranes2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
Synthesis and SAR of aminothiazole fused benzazepines as selective dopamine D2 partial agonists.
AID1895207Selectivity ratio of Ki for human D2 long receptor receptor to Ki for human histamine H2 receptor
AID1607482Displacement of [3H]-Win35428 from human DAT expressed in stable HEK cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607452Displacement of [3H]-PK11195 from rat brain GABA PBR measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607458Displacement of [3H]5-CT from recombinant human 5HT1D receptor transiently expressed in HEKT cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607404Agonist activity at RLuc8-fused human D3R Y365A mutant expressed in HEK293 cells co-expressing N-terminal Venus-tagged beta-arrestin2 and GRK3 assessed as induction of beta-arrestin2 recruitment measured after 5 mins in presence of coelenterazine H by BRE2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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.
AID1607500Displacement of [3H]-DTG from sigma 2 receptor (unknown origin) at 10 uM measured after 90 mins by microbeta counting analysis relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID727073Agonist activity at human D2 dopamine receptor expressed in CHO cell membranes2013Bioorganic & medicinal chemistry letters, Jan-15, Volume: 23, Issue:2
Synthesis and SAR of aminothiazole fused benzazepines as selective dopamine D2 partial agonists.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID61810Binding affinity of compound measured using [3H]spiperone for the cloned human dopamine receptor D4.4 (high/low affinity is given as 8.5/130)2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID711824Induction of yawning in Sprague-Dawley rat at 0.32 mg/kg, sc pre-treated with 1 mg/kg D2 receptor antagonist L-741,626 measured 30 mins post dose2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1607492Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M3 receptor expressed in stable CHO cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID64640Effective concentration was determined as thymidine uptake in CHO-L6 cells transfected with the rat Dopamine receptor D2L by mitogenesis assay2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID64496in vitro binding affinity was determined on human Dopamine receptor D2L expressed in chinese hamster ovary(CHO) K-1 cells using [3H]NPA as radioligand; NA is not determined2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID681629TP_TRANSPORTER: uptake in OCT1 expressing oocytes2005Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 33, Issue:4
Transport of the dopamine D2 agonist pramipexole by rat organic cation transporters OCT1 and OCT2 in kidney.
AID711809Inhibition of yawning in Sprague-Dawley rat at 10 mg/kg, sc after 60 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1607402Agonist activity at RLuc8-fused human D3R Y198A mutant expressed in HEK293 cells co-expressing N-terminal Venus-tagged beta-arrestin2 and GRK3 assessed as induction of beta-arrestin2 recruitment measured after 5 mins in presence of coelenterazine H by BRE2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607501Selectivity ratio of Ki for displacement of [3H]-N-methylspiperone from recombinant human D2 receptor stably expressed in fibroblast cell membranes to Ki for displacement of [3H]-N-methylspiperone from D3 receptor (unknown origin)2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID310687Agonist activity at human recombinant dopamine D3 receptor expressed in CHO cells assessed as inhibition of forskolin-stimulated cAMP accumulation2007Bioorganic & medicinal chemistry letters, Dec-15, Volume: 17, Issue:24
Design and synthesis of a functionally selective D3 agonist and its in vivo delivery via the intranasal route.
AID254617Effective concentration against dopamine D3 receptor2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID1895202Displacement of [3H]N-methylspiperone from human D2 long receptor stably expressed in HEK293T cells co-expressing luciferase and CEK incubated for 140 mins by radioligand competition binding based assay
AID1143586Antagonist activity at human dopamine D3 receptor expressed in human U2OS cells assessed as inhibition of pramipexole-stimulated beta-arrestin recruitment2014Journal of medicinal chemistry, Jun-12, Volume: 57, Issue:11
Tranylcypromine substituted cis-hydroxycyclobutylnaphthamides as potent and selective dopamine D₃ receptor antagonists.
AID1607483Displacement of [3H]-DADLE from recombinant human DOR stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID239107Low inhibition constant against [3H]spiperone binding to human Dopamine receptor D2S expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
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).
AID1607476Displacement of [3H]-Flunitrazepam from rat brain GABA(A)/BzR site at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607427Displacement of [3H]-CGP12177 from recombinant human beta3 adrenergic receptor expressed in HEK Flp-In cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID254517High binding affinity towards human dopamine receptor 2 (long) expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID1607495Displacement of [3H]-DAMGO from recombinant human MOR stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1563552Displacement of [3H]-(R)-(+)-7-OH-DPAT from recombinant human D2L receptor expressed in HEK293 cell membranes measured after 90 mins by microbeta scintillation counting analysis2019Journal of medicinal chemistry, 07-11, Volume: 62, Issue:13
The Significance of Chirality in Drug Design and Synthesis of Bitopic Ligands as D
AID1607443Displacement of [3H]-Histamine from recombinant human histamine H4 receptor expressed in HEKT cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID240291Effective concentration to stimulate human Dopamine receptor D4.2 mediated [3H]thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID254501High binding affinity towards human dopamine receptor 3 expressed in Chinese hamster ovary cells using [3H]spiperone (0.5 nM) as radioligand2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Pharmacophore-guided drug discovery investigations leading to bioactive 5-aminotetrahydropyrazolopyridines. Implications for the binding mode of heterocyclic dopamine D3 receptor agonists.
AID1607477Displacement of [3H]-SCH23390 from recombinant human D1 receptor transiently expressed in HEKT cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID64816Effective concentration required for agonistic activity against human D3 receptor2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID63186Binding affinity of compound measured against Dopamine receptor D1 from bovine striatal membranes using radioligand [3H]-SCH- 23390; not determined2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID711816Induction of hypothermia in Sprague-Dawley rat at 1 mg/kg, sc after 60 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID239137High inhibition constant against [3H]spiperone binding to human Dopamine receptor D4.4 expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1607450Displacement of [3H]-DAMGO from recombinant human MOR stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1607467Displacement of [3H]-prazosin from recombinant human alpha1A adrenergic receptor at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID62318Binding affinity of compound against Dopamine receptor D2 was measured using [3H]pramipexole in Bovine striatal membranes2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID1607426Displacement of [3H]-rauwolscine from recombinant human alpha2B adrenergic receptor transiently expressed in HEKT cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID679186TP_TRANSPORTER: uptake in Xenopus laevis oocytes2005Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 33, Issue:4
Transport of the dopamine D2 agonist pramipexole by rat organic cation transporters OCT1 and OCT2 in kidney.
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).
AID1607456Displacement of [3H]-Way100635 from recombinant human 5HT1A receptor stably expressed in CHO cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID711802Displacement of [3H]R(+)-7-OH-DPAT from Sprague-Dawley rat dopamine D3 receptor after 90 mins2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1607499Displacement of [3H]-pentazocine from sigma1 receptor (unknown origin) at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607436Displacement of [3H]-SCH23390 from recombinant human D5 receptor transiently expressed in HEKT cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607416Displacement of [3H]-LSD from recombinant human 5HT2B receptor stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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).
AID1607479Displacement of [3H]-N-methylspiperone from D3 receptor (unknown origin) at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID1607475Displacement of [3H]-CGP12177 from recombinant human beta3 adrenergic receptor expressed in HEK Flp-In cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607418Displacement of [3H]GR65630 from recombinant human 5HT3 receptor transiently expressed in HEKT cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607335Agonist activity at human D3R expressed in CHOK1 cells assessed as induction of beta-arrestin recruitment measured after 90 mins by beta-galactosidase based PathHunter assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID239098High inhibition constant against [3H]spiperone binding to human Dopamine receptor D3 expressed in CHO cells2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID61304Effective concentration required for agonistic activity against rat D2 long receptor2002Bioorganic & medicinal chemistry letters, Sep-02, Volume: 12, Issue:17
Fused azaindole derivatives: molecular design, synthesis and in vitro pharmacology leading to the preferential dopamine D3 receptor agonist FAUC 725.
AID65468Effective concentration was determined as thymidine uptake in CHO-L6 cells transfected with the rat Dopamine receptor D3 by mitogenesis assay2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID1607485Displacement of [3H]-pyrilamine from human histamine H1 receptor expressed in stable HEK cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID319298Agonist activity at human recombinant dopamine D1 receptor expressed in CHO cells assessed as stimulation of cAMP production2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
A novel synthesis and pharmacological evaluation of a potential dopamine D1/D2 agonist: 1-propyl-1,2,3,4,4a,5,10,10a-octahydrobenzo[g]quinoline-6,7-diol.
AID1607447Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M3 receptor expressed in stable CHO cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607490Displacement of [3H]-QNB/[3H]-NMS from human muscarinic M1 receptor expressed in stable CHO cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID64651compound was tested for intrinsic activity for thymidine uptake in CHO-L6 cells transfected with rat Dopamine receptor D2L2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID64648Inhibition of quinpirole (30 nM)-stimulated [3H]thymidine uptake in CHO-L6 cells transfected with the rat Dopamine receptor D2L; NT is not tested2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID244408Intrinsic activity to sitmulate rat Dopamine receptor D2L mediated [3H]thymidine incorporation into growing cells using mitogenesis assay2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
CoMFA and CoMSIA investigations revealing novel insights into the binding modes of dopamine D3 receptor agonists.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1630286Induction of recombinant alphaSN (unknown origin) fibrillation at 120 uM after 6 days by ThT fluorescence assay
AID1607428Displacement of [3H]-rauwolscine from recombinant human alpha2C adrenergic receptor stably expressed in MDCK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607358Displacement of [3H]-7-OH-DPAT from human D3R expressed in HEK293 cell membranes measured after 90 mins in EBSS buffer by topcount assay2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1895222Agonist activity at human D3 receptor stably expressed in HEK293T cells co-expressing ElucN-betaarr2 hD3R-ElucC assessed as maximum efficacy by beta-arrestin2 recruitment assay relative to control
AID1607462Displacement of [3H]-Mesulergine from recombinant human 5HT2C receptor expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1448009Partial agonist activity at human D2SR expressed in HEK293T cells co-expressing (EA)beta-arrestin2 and GRK2 assessed as induction of beta-arrestin2 recruitment after 5 hrs by chemiluminescence assay relative to quinpirole2017Journal of medicinal chemistry, 06-08, Volume: 60, Issue:11
Hydroxy-Substituted Heteroarylpiperazines: Novel Scaffolds for β-Arrestin-Biased D
AID391643Selectivity for Sprague-Dawley rat D3 receptor over Sprague-Dawley rat D1-like receptor2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Design, synthesis, and evaluation of potent and selective ligands for the dopamine 3 (D3) receptor with a novel in vivo behavioral profile.
AID1607457Displacement of [3H]5-CT from recombinant human 5HT1B receptor stably expressed in HEK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607434Displacement of [3H]-N-methylspiperone from D3 receptor (unknown origin) measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1607496Displacement of [3H]-Nisoxetine from human NET receptor expressed in stable HEK cell membranes at 10 uM after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID1298705Displacement of [3H]CGP12177 from human beta2 receptor expressed in CHO cells2016Bioorganic & medicinal chemistry, 06-15, Volume: 24, Issue:12
Structure-guided development of dual β2 adrenergic/dopamine D2 receptor agonists.
AID1607470Displacement of [3H]-rauwolscine from recombinant human alpha2A adrenergic receptor stably expressed in MDCK cell membranes at 10 uM measured after 90 mins by microbeta scintillation counting method relative to control2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
AID101014Inhibitory concentration of lipid peroxidation (LPO); Neuroprotective against postischemic or methamphetamine-induced degeneration of nigrostriatal neurons2000Journal of medicinal chemistry, Sep-21, Volume: 43, Issue:19
Thiazoloindans and thiazolobenzopyrans: a novel class of orally active central dopamine (partial) agonists.
AID711819Induction of yawning in Sprague-Dawley rat at 0.32 mg/kg, sc pre-treated with 32 mg/kg D3 receptor antagonist SB-277011A measured 30 mins post dose2011ACS medicinal chemistry letters, Aug-11, Volume: 2, Issue:8
CJ-1639: A Potent and Highly Selective Dopamine D3 Receptor Full Agonist.
AID1607435Displacement of [3H]-N-methylspiperone from recombinant human D4 receptor stably expressed in HEK cell membranes measured after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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).
AID1563553Displacement of [3H]-(R)-(+)-7-OH-DPAT from recombinant human D3 receptor expressed in HEK293 cell membranes measured after 90 mins by microbeta scintillation counting analysis2019Journal of medicinal chemistry, 07-11, Volume: 62, Issue:13
The Significance of Chirality in Drug Design and Synthesis of Bitopic Ligands as D
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).
AID539466Solubility of the compound2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID1607441Displacement of [125I]-Iodo-aminopotentidine from human histamine H2 receptor expressed in stable HEK cell membranes after 90 mins by microbeta scintillation counting method2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
Discovery, Optimization, and Characterization of ML417: A Novel and Highly Selective D
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.
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.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical 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.
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.
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.
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.
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.
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.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
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.
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.
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.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
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.
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.
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.
AID1745845Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1345833Human D3 receptor (Dopamine receptors)1995Neuroreport, Jan-26, Volume: 6, Issue:2
A functional test identifies dopamine agonists selective for D3 versus D2 receptors.
AID1345788Human D2 receptor (Dopamine receptors)1995Neuroreport, Jan-26, Volume: 6, Issue:2
A functional test identifies dopamine agonists selective for D3 versus D2 receptors.
AID1345833Human D3 receptor (Dopamine receptors)1995European journal of pharmacology, Jun-23, Volume: 290, Issue:1
Pramipexole binding and activation of cloned and expressed dopamine D2, D3 and D4 receptors.
AID1345788Human D2 receptor (Dopamine receptors)1995European journal of pharmacology, Jun-23, Volume: 290, Issue:1
Pramipexole binding and activation of cloned and expressed dopamine D2, D3 and D4 receptors.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,041)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902 (0.19)18.7374
1990's101 (9.70)18.2507
2000's357 (34.29)29.6817
2010's467 (44.86)24.3611
2020's114 (10.95)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 110.52

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 Index110.52 (24.57)
Research Supply Index7.19 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index200.59 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (110.52)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials219 (19.85%)5.53%
Reviews141 (12.78%)6.00%
Case Studies186 (16.86%)4.05%
Observational3 (0.27%)0.25%
Other554 (50.23%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (131)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally [NCT00466167]Phase 3517 participants (Actual)Interventional2007-04-30Completed
Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease [NCT01048229]Phase 4112 participants (Actual)Interventional2008-10-31Terminated(stopped due to recruitment)
Combined Prolonged Exposure and Pramipexole Treatment for Patients With PTSD and Depression [NCT03765138]Phase 31 participants (Actual)Interventional2019-02-19Terminated(stopped due to Patient recruitment difficulties)
Combining a Dopamine Agonist and Selective Serotonin Reuptake Inhibitor for Treatment of Depression: A Double-Blind, Randomized Study [NCT00086307]Phase 239 participants (Actual)Interventional2004-06-30Completed
Neural Dimensions of Threat Reactivity and Regulation for Understanding Anxiety [NCT02220309]160 participants (Anticipated)Observational2013-08-31Enrolling by invitation
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma [NCT04046939]Phase 2534 participants (Actual)Interventional2019-08-15Completed
Adjuvant Treatment With Pramipexole to Reduce the Dose of Opioids Necessary for Analgesia in Acute Renal Colic [NCT04160520]Phase 1/Phase 219 participants (Actual)Interventional2019-10-28Completed
Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD) [NCT00349310]1,018 participants Observational2006-04-01Completed
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis [NCT01281189]Phase 3942 participants (Actual)Interventional2011-03-31Completed
A Single Dose Five-way Cross-over Study to Establish an in Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets With 0.375 mg Pramipexole in Healthy Male Volunteers [NCT02260024]Phase 115 participants (Actual)Interventional2005-10-31Completed
An Open-Label, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome [NCT02101138]Phase 215 participants (Actual)Interventional2014-03-14Active, not recruiting
Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP) [NCT02236728]497 participants (Actual)Observational2008-02-29Completed
A Multiple Dose Seven-way Cross-over Formulation-finding Study Comparing the Oral Bioavailability of Seven Prototype Slow-release Formulations With 0.75 mg Pramipexole (Four Days Each) to Immediate-release Tablets at Steady State in Healthy Male Volunteer [NCT02261090]Phase 114 participants (Actual)Interventional2004-06-30Completed
A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients [NCT00144300]Phase 4246 participants (Actual)Interventional2005-01-31Completed
A Randomized Trial Administering Minocycline, Acetylsalicylic Acid or Pramipexole vs Placebo as add-on to Antipsychotics in Patients With Schizophrenia or Schizoaffective Disorder [NCT01320982]Phase 3400 participants (Anticipated)Interventional2011-03-31Not yet recruiting
A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID) [NCT00402233]Phase 4312 participants (Actual)Interventional2006-11-30Completed
A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study [NCT00390689]Phase 3154 participants (Actual)Interventional2006-10-31Completed
A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease [NCT02172573]Phase 3315 participants (Actual)Interventional1999-04-30Completed
A Randomized Controlled Trial of Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients [NCT03817554]Phase 421 participants (Actual)Interventional2019-07-01Terminated(stopped due to The recruitment of participants in the study was difficulty.)
Matched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease [NCT02233023]Phase 4705 participants (Actual)Interventional1998-06-30Completed
The Effects of the Dopamine Receptor Agonist Pramipexole on Reward and Emotion Related Information Processing in Healthy Volunteers [NCT03681509]43 participants (Actual)Interventional2018-09-01Completed
Imaging the Nucleus Accumbens in Major Depressed Patients 'Treated With Pramipexole [NCT01066897]Phase 416 participants (Actual)Interventional2010-02-28Terminated(stopped due to Lack of funding prevented further recruitment)
The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia [NCT02236741]26,814 participants (Actual)Observational2009-11-30Completed
Gait Pattern Analysis in Neurological Disease [NCT02994719]120 participants (Anticipated)Observational2016-03-01Active, not recruiting
The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients. [NCT02231294]1,464 participants (Actual)Observational2000-07-31Completed
A Multiple Dose Study of Pramipexole With Increasing Doses (0.375 mg to 1.5 mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375 mg ER Tablet q.d. Versus 0.125 mg Immediate Release (IR) Tablet t.i.d. and 1.5 mg ER Tablet [NCT02264132]Phase 124 participants (Actual)Interventional2006-09-30Completed
Non-opioid Pramipexole Suppresses Immune NLRP3 Reactivity for Pain Control [NCT03842709]Early Phase 113 participants (Actual)Interventional2019-05-01Completed
A Double-blind, Randomised, Placebo Controlled Study With Two Sequential Two-way Cross-over Parts to Demonstrate That the Influence of Pramipexole up to 4.5 mg Daily on the QT Interval of the ECG in Healthy Male and Female Volunteers is Comparable With Pl [NCT02262546]Phase 160 participants (Actual)Interventional2007-05-31Completed
Long-term Efficacy and Tolerability of add-on Pramipexole for Anhedonic Depression - an Open Label Follow-up Study [NCT05825235]Phase 380 participants (Anticipated)Interventional2023-04-21Recruiting
Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months [NCT00600873]Phase 1/Phase 210 participants (Actual)Interventional2007-08-31Completed
A Multiple Dose Study With Increasing Pramipexole Doses (0.375 mg to 4.5 mg q.d.) of Oral Extended Release (ER) Tablets With a Three-way Cross Comparison of 4.5 mg Pramipexole ER q.d. Fasted Versus 4.5 mg Pramipexole ER q.d. Fed Versus 1.5 mg Pramipexole [NCT02261103]Phase 139 participants (Actual)Interventional2006-04-30Completed
An Exploration of the Effects of the Dopamine Agonist Pramipexole on Binge Antecedants, Binge Frequency, and Weight in Binge Eating Disorder [NCT01106053]Phase 30 participants (Actual)Interventional2010-04-30Withdrawn(stopped due to No participants were recruited and study has been closed.)
Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD): Randomized Controlled Trial [NCT05401019]Phase 252 participants (Anticipated)Interventional2022-06-30Not yet recruiting
A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease. [NCT03845387]Phase 274 participants (Actual)Interventional2019-02-26Completed
A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patie [NCT03521635]Phase 498 participants (Actual)Interventional2018-07-03Completed
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome: AUTOREST, a Case-control Study and a Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-week, Multicenter Study of 0.25mg Pramipexole vs. Placebo in Patients With RLS [NCT02025608]Phase 420 participants (Actual)Interventional2013-12-31Completed
Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole [NCT02231905]Phase 429 participants (Actual)Interventional2004-01-31Completed
Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study [NCT02177357]Phase 3150 participants (Actual)Interventional1998-11-30Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 52 Weeks in Participants With Severe Eosinophilic Asthma [NCT05813288]Phase 3930 participants (Anticipated)Interventional2023-03-27Recruiting
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 24 Weeks in Participants With Eosinophilic Asthma [NCT05748600]Phase 3550 participants (Anticipated)Interventional2023-01-30Recruiting
Cognitive and Neural Mechanisms of Impaired Social Decision-Making in Parkinson's Patients Taking Dopamine Agonists [NCT04249544]Phase 118 participants (Actual)Interventional2019-12-03Completed
Open Label Extension Study With Pramipexole (PPX) in Children With Tourette Syndrome [NCT00681863]Phase 345 participants (Actual)Interventional2008-05-31Terminated(stopped due to Terminated for slow enrollment.)
Comparative Efficacy of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment-resistant Unipolar Depression: A Randomized Controlled Trial. [NCT04936126]Phase 4150 participants (Anticipated)Interventional2021-08-07Recruiting
Bioequivalence Study of 0.25 mg Pramipexole Tablets Produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in Comparison With the Comparator Product (Sifrol® 0.25 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim [NCT02660060]23 participants (Actual)Interventional2015-05-31Completed
Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists [NCT01007864]Phase 380 participants (Actual)Interventional2010-01-31Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms [NCT00297778]Phase 4296 participants (Actual)Interventional2006-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's Disease [NCT03977441]Phase 4240 participants (Anticipated)Interventional2019-07-31Not yet recruiting
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD). [NCT00601523]Phase 3511 participants (Actual)Interventional2008-01-31Completed
Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease: a Double-Blind Placebo Controlled Crossover Study [NCT00666653]Phase 113 participants (Actual)Interventional2003-07-31Completed
A 2-Part, Randomized, Double-Blind, Safety and Tolerability Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS) [NCT00647296]Phase 2194 participants (Actual)Interventional2008-04-09Completed
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD) [NCT00577460]Phase 3391 participants (Actual)Interventional2007-12-31Completed
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment [NCT00651183]286 participants (Actual)ObservationalCompleted
A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia. [NCT00903838]Phase 237 participants (Actual)Interventional2009-09-30Terminated(stopped due to The study was terminated on 31 May, 2011, due to strategic considerations.)
A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patien [NCT01191944]Phase 3475 participants (Actual)Interventional2010-08-31Completed
A Randomized, Double-blind, Placebo-controlled, Dose Titration Efficacy and Safety Study of Pramipexole ER (0.75 to 4.5 mg) Administered Orally Once Daily Versus Placebo Over a 16-week Maintenance Phase in Patients Diagnosed With Fibromyalgia, as Assessed [NCT00689052]Phase 261 participants (Actual)Interventional2008-07-31Terminated
A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression [NCT00893841]Phase 296 participants (Actual)Interventional2009-02-28Completed
A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With [NCT00560508]Phase 2/Phase 3112 participants (Actual)Interventional2007-11-30Completed
An Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS) [NCT00931944]Phase 274 participants (Actual)Interventional2009-07-31Completed
A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease [NCT01968460]Phase 2/Phase 3149 participants (Actual)Interventional2013-12-31Completed
A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks [NCT00654498]Phase 3306 participants (Actual)Interventional2008-04-30Completed
Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS [NCT00721279]549 participants (Actual)Observational2007-09-30Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease. [NCT00321854]Phase 4535 participants (Actual)Interventional2006-05-31Completed
A Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy Volunteers [NCT01449578]Phase 163 participants (Actual)Interventional2011-11-30Completed
A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER. [NCT03329508]Phase 3544 participants (Actual)Interventional2018-01-19Completed
A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stab [NCT00605683]Phase 3679 participants (Actual)Interventional2007-11-30Completed
A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restl [NCT00472199]Phase 4331 participants (Actual)Interventional2007-05-31Completed
An Open-Label, Randomized, Crossover Study to Assess the Bioavailability of Dexpramipexole Administered in Soft Food and Water, and in Intact Tablet Form in the Fasted and Fed States in Healthy Volunteers [NCT01607034]Phase 124 participants (Actual)Interventional2012-06-30Completed
Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day [NCT00596115]0 participants Expanded AccessTemporarily not available
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome [NCT00991276]Phase 385 participants (Actual)Interventional2009-12-31Completed
A Relative Bioavailability Study of 0.25 mg Pramipexole Dihydrochloride Tablets Under Fasting Conditions [NCT01074450]Phase 124 participants (Actual)Interventional2005-02-28Completed
Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease [NCT01097421]329 participants (Actual)Observational2010-03-31Completed
Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome [NCT00806026]Phase 3731 participants (Actual)Interventional2008-12-31Completed
An Open-Label Study to Assess the Effect of Dexpramipexole (BIIB050) on the Pharmacokinetics of Warfarin in Healthy Volunteers [NCT01597310]Phase 115 participants (Actual)Interventional2012-05-31Completed
Dopamine D2/D3 Receptor Agonist and Antagonist Drug Effects on Fronto-striatal Systems Related to Compulsive Behaviour in Healthy Volunteers and Patients With Addictive and Compulsive Disorders [NCT00471588]Phase 152 participants (Actual)Interventional2006-08-31Completed
Adjunctive Treatment With Pramipexole for Anhedonic Depression Symptoms in Depression - PRIME-PRAXOL [NCT05355337]Phase 3120 participants (Anticipated)Interventional2023-02-08Recruiting
Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's [NCT00096720]Phase 2112 participants (Actual)Interventional2004-02-29Completed
A Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinson's Disease. [NCT00240409]Phase 3208 participants (Actual)Interventional2003-07-31Completed
Pramipexole as a Treatment for Cocaine Dependence [NCT01651377]Phase 110 participants (Actual)Interventional2011-10-31Completed
An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease. [NCT00275275]Phase 361 participants (Actual)Interventional2006-01-31Completed
A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-pat [NCT00349531]Phase 4369 participants (Actual)Interventional2006-07-31Completed
A Double-blind, Placebo-controlled, Randomised Withdrawal Study of 3 Month Duration in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, [NCT00152958]Phase 3224 participants Interventional2004-01-31Completed
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome. [NCT00152997]Phase 241 participants (Actual)Interventional2004-08-31Completed
Swiss Restless Legs Syndrome Trial (SRLS) A Double-blind, Randomised, Crossover Trial Investigating the Efficacy and Safety of the Dopamine Agonist Pramipexole (Sifrol®, 0.25-0.75 mg Per Day) Versus Levodopa / Benserazide (Madopar® DR, 125-375 mg Per Day) [NCT00144209]Phase 358 participants (Actual)Interventional2003-02-28Completed
An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease [NCT01515774]Phase 4200 participants (Anticipated)Interventional2011-09-30Recruiting
An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers [NCT01536249]Phase 114 participants (Actual)Interventional2012-03-31Completed
Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib) [NCT00102856]Phase 460 participants Interventional2005-01-31Suspended
An Investigation of the Antidepressant Efficacy of a Dopamine Agonist With Neurotrophic Properties in Bipolar Disorder [NCT00025792]Phase 2200 participants Interventional2001-10-31Completed
Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis [NCT00140218]Phase 1/Phase 230 participants (Actual)Interventional2005-08-31Completed
A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label o [NCT00275457]Phase 3346 participants Interventional2002-10-31Completed
a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics [NCT03430596]Early Phase 150 participants (Actual)Interventional2018-05-01Completed
Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD) [NCT00399477]Phase 4200 participants (Actual)Interventional2006-10-31Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs [NCT00133198]Phase 3345 participants (Actual)Interventional2004-04-30Completed
Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease [NCT01525641]615 participants (Actual)Observational2012-02-29Completed
A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Pa [NCT00479401]Phase 3539 participants (Actual)Interventional2007-05-31Completed
A Double-Blind Placebo-Controlled Trial of Adjunctive Pramipexole, a Dopamine Receptor Agonist, for Treatment Resistant Major Depressive Episodes [NCT00231959]Phase 465 participants (Actual)Interventional2003-09-30Completed
Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS). [NCT00239486]Phase 2109 participants Interventional2002-10-31Completed
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease [NCT00274131]Phase 3170 participants Interventional1998-12-31Completed
A Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal Impairment [NCT01424176]Phase 136 participants (Actual)Interventional2011-07-31Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 52 Weeks in Participants With Severe Eosinophilic Asthma [NCT05763121]Phase 31,395 participants (Anticipated)Interventional2023-01-30Recruiting
A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease. [NCT00335166]Phase 3330 participants (Anticipated)Interventional2006-11-30Completed
A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy Volunteers [NCT01511029]Phase 168 participants (Actual)Interventional2012-01-31Completed
Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy: A Key to Improving Sleep and Gait Performance [NCT05003648]Phase 424 participants (Anticipated)Interventional2023-04-01Recruiting
A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Diso [NCT00558467]Phase 263 participants (Actual)Interventional2008-01-31Completed
Sifrol® (Pramipexole) Impact on RLS: A 12-weeks Observational Study in Patients With Primary RLS [NCT02248142]1,029 participants (Actual)Observational2006-02-28Completed
Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease [NCT02248220]657 participants (Actual)Observational1998-10-31Completed
Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study [NCT01673724]Phase 4121 participants (Actual)Interventional2012-02-29Completed
Safety and Preliminary Efficacy of Dexpramipexole in Patients With Chronic Sinusitis With Nasal Polyps and Eosinophilia (CSNP-E) [NCT02217332]Phase 220 participants (Actual)Interventional2014-08-31Completed
A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associ [NCT00356096]Phase 4404 participants (Actual)Interventional2006-07-31Completed
Safety/Tolerability and Effects on Cognitive Impairment, Impaired Cerebral Cortical Metabolism and Oxidative Stress of R(+)Pramipexole Administered to Subjects With Early Alzheimer's Disease [NCT01388478]Phase 220 participants (Actual)Interventional2011-07-31Completed
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study [NCT01441284]Phase 30 participants (Actual)Interventional2017-12-31Withdrawn(stopped due to Lack of financial support)
A Relative Bioavailability Study of 0.25 mg Pramipexole Dihydrochloride Tablets Under Non-Fasting Conditions [NCT01074463]Phase 124 participants (Actual)Interventional2005-02-28Completed
Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease [NCT02231255]1,216 participants (Actual)Observational2002-02-28Completed
A Randomized, Single-blind Trial on the Efficacy and Safety of L-dopa Monotherapy Versus Dopamine Agonists Monotherapy After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease [NCT02347059]Phase 240 participants (Anticipated)Interventional2015-01-31Recruiting
A Multiple Dose Bioequivalence Study of Pramipexole With Increasing Doses (0.375mg to 1.5mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375mg Extended Release Tablet q.d. Versus 0.125mg Immediate Release (IR) Tablet t. [NCT01214109]Phase 124 participants (Actual)Interventional2010-12-31Completed
Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets [NCT04275492]30 participants (Actual)Interventional2020-07-24Terminated(stopped due to The sponsor terminated the clinical trial)
Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS [NCT02248155]2,644 participants (Actual)Observational2006-04-30Completed
Pramipexole in Bipolar Disorder: Targeting Cognition (PRAM-BD) [NCT02397837]Phase 4103 participants (Actual)Interventional2014-10-31Completed
An Open-Label Prospective Study of Restless Legs Patients Switched to Ropinirole From Pramipexole to Help Determine the Equipotent Dose [NCT00344994]Phase 420 participants (Anticipated)Interventional2006-05-31Completed
An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis [NCT01622088]Phase 3616 participants (Actual)Interventional2012-06-30Terminated(stopped due to The Initial Phase 3 Study (NCTO1281189) did not meet its primary efficacy endpoint.)
A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR [NCT00558025]Phase 3156 participants (Actual)Interventional2007-10-31Completed
A Phase IV Randomised, Double-blind, Active and Placebo-controlled, 6-week Trial to Investigate the Efficacy and Safety of a Starting (and Fixed) Dose 0.25 mg Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome [NCT00375284]Phase 4404 participants (Actual)Interventional2006-09-30Completed
Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance [NCT01361009]2,017 participants (Actual)Observational2011-05-31Completed
Cognitive Enhancement in Bipolar Disorder [NCT00597896]Phase 450 participants (Actual)Interventional2005-10-31Completed
Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease [NCT02248181]442 participants (Actual)Observational2004-02-29Completed
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD: A Pilot Double-blind, Randomized Clinical Trial [NCT04759703]Phase 2/Phase 380 participants (Anticipated)Interventional2022-01-24Recruiting
a Pilot Follow-up Study of Investigating the Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Chinese Patients With Early Parkinson's Disease [NCT01470859]30 participants (Actual)Interventional2011-12-31Completed
Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice [NCT02248207]1,293 participants (Actual)Observational2003-01-31Completed
Ventrostriatal Dopamine Release and Reward Motivation in MDD [NCT02033369]Phase 452 participants (Actual)Interventional2014-02-28Completed
Mirapex PMS Study Final Report [NCT02248168]1,449 participants (Actual)Observational2002-03-31Completed
Pramipexole Augmentation to Target Anhedonia in Depression - a Pilot Study [NCT04121091]Phase 213 participants (Actual)Interventional2019-10-04Completed
An Open-label Clinical Study to Investigate Pharmacokinetics (PK) of Different Doses (0.125 mg, 0.25 mg, 0.5 mg) of Pramipexole Administered Once Daily Orally in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatme [NCT02231918]Phase 226 participants (Actual)Interventional2006-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00086307 (1) [back to overview]Montgomery Asberg Depression Rating Scale (MADRS)
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline
NCT00144300 (21) [back to overview]Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
NCT00144300 (21) [back to overview]Expert Panel Overall Assessment Following 1 Year on Drug
NCT00144300 (21) [back to overview]Expert Panel Overall Assessment Following 2 Years on Drug
NCT00144300 (21) [back to overview]Hoehn and Yahr Scale at 1 Year
NCT00144300 (21) [back to overview]Hoehn and Yahr Scale at 2 Years
NCT00144300 (21) [back to overview]Hoehn and Yahr Scale at Baseline
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year
NCT00144300 (21) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years
NCT00275275 (2) [back to overview]Adverse Effects Experienced
NCT00275275 (2) [back to overview]Number of Dose Adjustments
NCT00297778 (15) [back to overview]Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
NCT00297778 (15) [back to overview]Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
NCT00297778 (15) [back to overview]Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
NCT00297778 (15) [back to overview]Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the UPDRS Part IV Total Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the UPDRS Part III Total Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the UPDRS Part II+III Total Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the UPDRS Part II Total Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the UPDRS Part I Total Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
NCT00297778 (15) [back to overview]Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
NCT00321854 (57) [back to overview]Percentage Change From Baseline in the Striatum Uptake at Month 15
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
NCT00321854 (57) [back to overview]Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
NCT00321854 (57) [back to overview]Clinically Significant Abnormalities in Vital Signs
NCT00321854 (57) [back to overview]Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
NCT00321854 (57) [back to overview]Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
NCT00321854 (57) [back to overview]Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
NCT00321854 (57) [back to overview]Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
NCT00321854 (57) [back to overview]Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
NCT00321854 (57) [back to overview]Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
NCT00321854 (57) [back to overview]Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
NCT00321854 (57) [back to overview]Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
NCT00321854 (57) [back to overview]Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
NCT00321854 (57) [back to overview]Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
NCT00390689 (14) [back to overview]Clinical Global Impression Global Improvement (CGI-I) Responder
NCT00390689 (14) [back to overview]Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period
NCT00390689 (14) [back to overview]Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.
NCT00390689 (14) [back to overview]Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period
NCT00390689 (14) [back to overview]Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks
NCT00390689 (14) [back to overview]Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period
NCT00390689 (14) [back to overview]Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period
NCT00390689 (14) [back to overview]IRLS Responder
NCT00390689 (14) [back to overview]Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks
NCT00390689 (14) [back to overview]IRLS Responder for Open-label Period
NCT00390689 (14) [back to overview]Patient Global Impression (PGI) Responder
NCT00390689 (14) [back to overview]Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period
NCT00390689 (14) [back to overview]Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
NCT00390689 (14) [back to overview]Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period
NCT00402233 (4) [back to overview]Modified Hoehn and Yahr Stage
NCT00402233 (4) [back to overview]Epworth Sleepiness Scale
NCT00402233 (4) [back to overview]Beck Depression Inventory II
NCT00402233 (4) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
NCT00466167 (17) [back to overview]Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks
NCT00466167 (17) [back to overview]Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks
NCT00466167 (17) [back to overview]Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks
NCT00466167 (17) [back to overview]Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18
NCT00466167 (17) [back to overview]Response in Patient Global Impression (PGI-I)
NCT00466167 (17) [back to overview]Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
NCT00466167 (17) [back to overview]Clinical Global Impression - Global Improvement (CGI-I) Responder
NCT00466167 (17) [back to overview]Change From Baseline in UPDRS IV Score After 18 Weeks
NCT00466167 (17) [back to overview]Change From Baseline in UPDRS III Score After 18 Weeks
NCT00466167 (17) [back to overview]Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period
NCT00466167 (17) [back to overview]Change From Baseline in UPDRS I Score After 18 Weeks
NCT00466167 (17) [back to overview]Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
NCT00466167 (17) [back to overview]Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
NCT00466167 (17) [back to overview]Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
NCT00466167 (17) [back to overview]Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
NCT00466167 (17) [back to overview]Change From Baseline in Percentage Off-time at Week 18
NCT00466167 (17) [back to overview]Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Vitality After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks
NCT00472199 (31) [back to overview]Diagnosis of Classified Augmentation According to Independent Expert Panel
NCT00472199 (31) [back to overview]Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation
NCT00472199 (31) [back to overview]Baseline, Week 26 Mean Standing Diastolic Blood Pressure
NCT00472199 (31) [back to overview]Baseline, Week 26 Mean Standing Pulse Rate
NCT00472199 (31) [back to overview]Baseline, Week 26 Mean Standing Systolic Blood Pressure
NCT00472199 (31) [back to overview]Baseline, Week 26 Mean Supine Diastolic Blood Pressure
NCT00472199 (31) [back to overview]Baseline, Week 26 Mean Supine Systolic Blood Pressure
NCT00472199 (31) [back to overview]Clinical Global Impression - Global Improvement (CGI-I) Responder Rate
NCT00472199 (31) [back to overview]International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate
NCT00472199 (31) [back to overview]Patient Global Impression (PGI) Responder Rate
NCT00472199 (31) [back to overview]Baseline, Week 26 Mean Supine Pulse Rate
NCT00472199 (31) [back to overview]"Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score Satisfaction With Sleep After 26 Weeks"
NCT00472199 (31) [back to overview]"Change From Baseline in RLS-6 Score Severity During the Day When at Rest After 26 Weeks"
NCT00472199 (31) [back to overview]"Change From Baseline in RLS-6 Score Severity During the Night After 26 Weeks"
NCT00472199 (31) [back to overview]"Change From Baseline in RLS-6 Score Severity Falling Asleep After 26 Weeks"
NCT00472199 (31) [back to overview]"Change From Baseline in RLS-6 Score Tired or Sleepy During the Day After 26 Weeks"
NCT00472199 (31) [back to overview]"Change From Baseline RLS-6 Score Severity During the Day Engaged in Activities After 26 Weeks"
NCT00472199 (31) [back to overview]Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension General Health After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks
NCT00472199 (31) [back to overview]Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks
NCT00479401 (16) [back to overview]Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale
NCT00479401 (16) [back to overview]UPDRS Part I Change From Baseline
NCT00479401 (16) [back to overview]UPDRS II+III Responder Rate (at Least 20% Improvement)
NCT00479401 (16) [back to overview]Change From Baseline in European Quality of Life Visual Analog Scale
NCT00479401 (16) [back to overview]Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score
NCT00479401 (16) [back to overview]Beck's Depression Inventory Version I A
NCT00479401 (16) [back to overview]Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score
NCT00479401 (16) [back to overview]Likert Scale for Pain Related to PD
NCT00479401 (16) [back to overview]Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)
NCT00479401 (16) [back to overview]Possible Clinically Significant Abnormal Laboratory Parameters
NCT00479401 (16) [back to overview]Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
NCT00479401 (16) [back to overview]UPDRS Part III Total Score
NCT00479401 (16) [back to overview]Parkinson's Disease Sleep Scale (PDSS)
NCT00479401 (16) [back to overview]Patients Who Started to Use L-Dopa Rescue Medication
NCT00479401 (16) [back to overview]Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale
NCT00479401 (16) [back to overview]UPDRS Part II Total Score
NCT00558025 (9) [back to overview]Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)
NCT00558025 (9) [back to overview]Pramipexole Dose Adaptation, FAS (LOCF)
NCT00558025 (9) [back to overview]Final Pramipexole Dose (mg) After 9 Weeks, Treated Set
NCT00558025 (9) [back to overview]Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)
NCT00558025 (9) [back to overview]Patient Global Impression - Improvement (PGI-I), FAS (LOCF)
NCT00558025 (9) [back to overview]Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)
NCT00558025 (9) [back to overview]Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)
NCT00558025 (9) [back to overview]Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)
NCT00558025 (9) [back to overview]Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)
NCT00558467 (26) [back to overview]Patient Global Impression at Week 1
NCT00558467 (26) [back to overview]Patient Global Impression at Week 2
NCT00558467 (26) [back to overview]Patient Global Impression at Week 3
NCT00558467 (26) [back to overview]Patient Global Impression at Week 4
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3
NCT00558467 (26) [back to overview]Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4
NCT00558467 (26) [back to overview]Clinical Global Impressions - Improvement at 1 Week
NCT00558467 (26) [back to overview]Clinical Global Impressions - Improvement at Week 2
NCT00558467 (26) [back to overview]Clinical Global Impressions - Improvement at Week 3
NCT00558467 (26) [back to overview]Clinical Global Impressions - Severity of Illness at Week 6
NCT00558467 (26) [back to overview]Patient Global Impression at Week 6
NCT00558467 (26) [back to overview]Clinical Global Impressions - Improvement at Week 4
NCT00558467 (26) [back to overview]Clinical Global Impressions - Improvement at Week 6
NCT00558467 (26) [back to overview]Clinical Global Impressions - Severity of Illness at Week 1
NCT00558467 (26) [back to overview]Clinical Global Impressions - Severity of Illness at Week 2
NCT00558467 (26) [back to overview]Clinical Global Impressions - Severity of Illness at Week 3
NCT00558467 (26) [back to overview]Clinical Global Impressions - Severity of Illness at Week 4
NCT00558467 (26) [back to overview]Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
NCT00560508 (33) [back to overview]Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)
NCT00560508 (33) [back to overview]UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)
NCT00560508 (33) [back to overview]Trough Plasma Concentration at Steady State
NCT00560508 (33) [back to overview]Responder Rate For Clinical Global Impression of Improvement (CGI-I)
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time Without Dyskinesia
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time With Troublesome Dyskinesia
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia
NCT00560508 (33) [back to overview]Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)
NCT00560508 (33) [back to overview]Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in L-dopa Daily Dose
NCT00560508 (33) [back to overview]Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part I Score
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part II Score
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part III Score
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part IV Score
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score
NCT00560508 (33) [back to overview]Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)
NCT00560508 (33) [back to overview]Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)
NCT00560508 (33) [back to overview]Percentage of Participants Who Experienced Adverse Events
NCT00560508 (33) [back to overview]Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia
NCT00560508 (33) [back to overview]Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)
NCT00560508 (33) [back to overview]Responder Rate For Patient Global Impression of Improvement (PGI-I)
NCT00560508 (33) [back to overview]Change From Baseline in Percentage Off-time
NCT00577460 (32) [back to overview]Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
NCT00577460 (32) [back to overview]Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
NCT00577460 (32) [back to overview]Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
NCT00577460 (32) [back to overview]Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
NCT00577460 (32) [back to overview]Number of Participants With Response in CGI-I
NCT00577460 (32) [back to overview]Number of Participants With Response in Percentage Off Time During Waking Hours
NCT00577460 (32) [back to overview]Number of Participants With Response in PGI-I
NCT00577460 (32) [back to overview]Number of Participants With Response in PGI-I for Early Morning Off Symptoms
NCT00577460 (32) [back to overview]Number of Participants With Serious Adverse Events
NCT00577460 (32) [back to overview]Number of Participants With UPDRS II+III Response
NCT00577460 (32) [back to overview]Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time
NCT00577460 (32) [back to overview]Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80
NCT00577460 (32) [back to overview]Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III
NCT00577460 (32) [back to overview]Percentage Off Time During Waking Hours Total Score: Change From Baseline
NCT00577460 (32) [back to overview]Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
NCT00577460 (32) [back to overview]Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
NCT00577460 (32) [back to overview]Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
NCT00577460 (32) [back to overview]Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
NCT00577460 (32) [back to overview]UPDRS I Total Score and Change From OL Baseline at Week 80
NCT00577460 (32) [back to overview]UPDRS II Total Score and Change From OL Baseline at Week 80
NCT00577460 (32) [back to overview]UPDRS II+III Change From Open Label (OL) Baseline
NCT00577460 (32) [back to overview]UPDRS III Total Score and Change From OL Baseline at Week 80
NCT00577460 (32) [back to overview]UPDRS IV Total Score and Change From OL Baseline at Week 80
NCT00577460 (32) [back to overview]Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
NCT00577460 (32) [back to overview]Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
NCT00577460 (32) [back to overview]Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
NCT00577460 (32) [back to overview]Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
NCT00577460 (32) [back to overview]Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
NCT00577460 (32) [back to overview]Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
NCT00577460 (32) [back to overview]Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
NCT00577460 (32) [back to overview]Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
NCT00577460 (32) [back to overview]Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Hopkins Verbal Learning Test
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in d2 Test of Attention
NCT00597896 (11) [back to overview]Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint
NCT00597896 (11) [back to overview]Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Stroop Color-Word Test
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Trail Making Test Part A
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Trail Making Test Part B
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)
NCT00597896 (11) [back to overview]Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test
NCT00601523 (14) [back to overview]Patient Rating of Convenience of Treatment Dosing
NCT00601523 (14) [back to overview]UPDRS I Total Score: Change From OL Baseline
NCT00601523 (14) [back to overview]UPDRS II Total Score: Change From OL Baseline
NCT00601523 (14) [back to overview]Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline
NCT00601523 (14) [back to overview]Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
NCT00601523 (14) [back to overview]Number of Patients Introducing L-Dopa Medication in OL Trial
NCT00601523 (14) [back to overview]Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
NCT00601523 (14) [back to overview]UPDRS III Total Score: Change From OL Baseline
NCT00601523 (14) [back to overview]L-Dopa Dose: Change From OL Baseline
NCT00601523 (14) [back to overview]Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
NCT00601523 (14) [back to overview]Response in Patient Global Impression of Improvement (PGI-I)
NCT00601523 (14) [back to overview]Response in Clinical Global Impression of Improvement (CGI-I)
NCT00601523 (14) [back to overview]Patient Preference Regarding Treatment Dosing
NCT00601523 (14) [back to overview]Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)
NCT00647296 (18) [back to overview]Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
NCT00647296 (18) [back to overview]Part 2 Double-Blind Treatment: Slope of the ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to Week 28 by Treatment Group
NCT00647296 (18) [back to overview]Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Hematology
NCT00647296 (18) [back to overview]Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
NCT00647296 (18) [back to overview]Part 2 Double-Blind Treatment: Slope of Percent Predicted Upright Vital Capacity From Baseline by Treatment Group
NCT00647296 (18) [back to overview]Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
NCT00647296 (18) [back to overview]Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
NCT00647296 (18) [back to overview]Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
NCT00647296 (18) [back to overview]Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
NCT00647296 (18) [back to overview]Part 1: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
NCT00647296 (18) [back to overview]Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
NCT00647296 (18) [back to overview]Part 2 Placebo Washout: Absolute Change in Upright Vital Capacity (Percent Predicted) From Baseline to End of Placebo Washout (Week 4)
NCT00647296 (18) [back to overview]Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
NCT00647296 (18) [back to overview]Part 2 Placebo Washout: Absolute Change in ALSFRS-R Total Score
NCT00647296 (18) [back to overview]Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
NCT00647296 (18) [back to overview]Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
NCT00647296 (18) [back to overview]Part 1: Slope of Upright Vital Capacity From Baseline to Week 12 by Treatment Group
NCT00647296 (18) [back to overview]Part 1: Slope of ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to Week 12 by Treatment Group
NCT00651183 (4) [back to overview]Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
NCT00651183 (4) [back to overview]Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
NCT00651183 (4) [back to overview]Change From Baseline in UPDRS Part III (Motor Examination)
NCT00651183 (4) [back to overview]Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
NCT00654498 (12) [back to overview]The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.
NCT00654498 (12) [back to overview]The Proportion of Patient Global Impression(PGI) Responders
NCT00654498 (12) [back to overview]The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10
NCT00654498 (12) [back to overview]"The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved"
NCT00654498 (12) [back to overview]The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.
NCT00654498 (12) [back to overview]The Change From Baseline in Visual Analogue Scales (VAS)
NCT00654498 (12) [back to overview]The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).
NCT00654498 (12) [back to overview]The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale
NCT00654498 (12) [back to overview]The Proportion of IRLS Responders
NCT00654498 (12) [back to overview]The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale
NCT00654498 (12) [back to overview]The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.
NCT00654498 (12) [back to overview]the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Patients With Adverse Events Leading to Discontinuation of Trial Drug
NCT00681863 (25) [back to overview]Clinical Global Impressions - Improvement
NCT00681863 (25) [back to overview]Clinical Global Impressions - Severity of Illness, Categorized
NCT00681863 (25) [back to overview]Patient Global Impression - Improvement
NCT00681863 (25) [back to overview]Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters
NCT00681863 (25) [back to overview]Clinical Global Impressions - Severity of Illness
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00681863 (25) [back to overview]Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
NCT00721279 (5) [back to overview]Change in Total Scores of IRLS (International Restless Legs Rating Scale)
NCT00721279 (5) [back to overview]Change in Global Clinical Impression - Improvement (CGI-I) Scale
NCT00721279 (5) [back to overview]Correlation of the Change in IRLS at End of Titration and at Final Visit
NCT00721279 (5) [back to overview]Frequency Analysis for Baseline Pattern of RLS Symptoms
NCT00721279 (5) [back to overview]Frequency of Adverse Events
NCT00806026 (21) [back to overview]Change From Baseline in RLS-NDI at Week 12
NCT00806026 (21) [back to overview]Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)
NCT00806026 (21) [back to overview]Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12
NCT00806026 (21) [back to overview]Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12
NCT00806026 (21) [back to overview]Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12
NCT00806026 (21) [back to overview]Severity of Augmentation Symptoms at Week 12
NCT00806026 (21) [back to overview]RLS-Next Day Impact (RLS-NDI)
NCT00806026 (21) [back to overview]Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12
NCT00806026 (21) [back to overview]Restless Legs Syndrome (RLS) Symptom Severity
NCT00806026 (21) [back to overview]Percentage of Participants With Augmentation
NCT00806026 (21) [back to overview]Medical Outcomes Study-Short Form 36 (SF-36) at Week 12
NCT00806026 (21) [back to overview]Percentage of Participants Responding to Treatment at Week 12
NCT00806026 (21) [back to overview]Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12
NCT00806026 (21) [back to overview]Limb Pain-Visual Analog Scale (Limb Pain-VAS)
NCT00806026 (21) [back to overview]Clinical Global Impressions-Severity (CGI-S) at Week 12
NCT00806026 (21) [back to overview]Change From Baseline in the RLS Symptom Severity at Week 12
NCT00806026 (21) [back to overview]Change From Baseline in SSQ: Subjective WASO at Week 12
NCT00806026 (21) [back to overview]Change From Baseline in Limb Pain-VAS at Week 12
NCT00806026 (21) [back to overview]Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12
NCT00806026 (21) [back to overview]Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12
NCT00806026 (21) [back to overview]Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12
NCT00931944 (14) [back to overview]Change in Upright Vital Capacity From Baseline to Week 12
NCT00931944 (14) [back to overview]Change in Upright Vital Capacity From Baseline to Week 24
NCT00931944 (14) [back to overview]Change in Upright Vital Capacity From Baseline to Week 48
NCT00931944 (14) [back to overview]Number of Subjects With Feeding Tube Placed During the Study.
NCT00931944 (14) [back to overview]Number of Participants With Potentially Clinically ECG Abnormalities
NCT00931944 (14) [back to overview]Number of Participants With Potentially Clinically Significant Hematology Results
NCT00931944 (14) [back to overview]Number of Participants With Potentially Clinically Significant Liver Enzyme Abnormalities
NCT00931944 (14) [back to overview]Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
NCT00931944 (14) [back to overview]Change in ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) Total Score From Baseline to Week 24
NCT00931944 (14) [back to overview]Change in McGill Single-Item Scale (SIS) From Baseline to Week 12
NCT00931944 (14) [back to overview]Change in McGill Single-Item Scale (SIS) From Baseline to Week 24
NCT00931944 (14) [back to overview]Change in McGill Single-Item Scale (SIS) From Baseline to Week 48
NCT00931944 (14) [back to overview]Change in ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) Total Score From Baseline to Week 12
NCT00931944 (14) [back to overview]Change in ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) Total Score From Baseline to Week 48
NCT00991276 (31) [back to overview]Medical Outcomes Study - Sleep Scale (MOS-SS)
NCT00991276 (31) [back to overview]Latency to Stage R Sleep (LREM)
NCT00991276 (31) [back to overview]Number of Arousals (NASO)
NCT00991276 (31) [back to overview]Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)
NCT00991276 (31) [back to overview]Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)
NCT00991276 (31) [back to overview]Wake After Sleep Onset (WASO)
NCT00991276 (31) [back to overview]Minutes of Stage N1, N2, N3 and R Sleep
NCT00991276 (31) [back to overview]Restless Legs Syndrome-Next Day Impact (RLS-NDI)
NCT00991276 (31) [back to overview]Latency to Persistent Sleep (LPS)
NCT00991276 (31) [back to overview]Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)
NCT00991276 (31) [back to overview]Periodic Limb Movement Index (PLMI)
NCT00991276 (31) [back to overview]Hourly and Quarterly Assessment of Sleep Efficiency (SE)
NCT00991276 (31) [back to overview]Periodic Limb Movement in Sleep Index (PLMSI)
NCT00991276 (31) [back to overview]Periodic Limb Movement Arousal Index (PLMAI)
NCT00991276 (31) [back to overview]International Restless Legs Syndrome Study Group Rating Scale (IRLS)
NCT00991276 (31) [back to overview]Arousal Index (NASOI)
NCT00991276 (31) [back to overview]Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale
NCT00991276 (31) [back to overview]Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)
NCT00991276 (31) [back to overview]Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)
NCT00991276 (31) [back to overview]Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)
NCT00991276 (31) [back to overview]Hourly and Quarterly Assessment of Number of Arousals (NASO)
NCT00991276 (31) [back to overview]Wake Time During Sleep (WTDS)
NCT00991276 (31) [back to overview]Wake Time After Sleep (WTAS)
NCT00991276 (31) [back to overview]Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)
NCT00991276 (31) [back to overview]Total Sleep Time (TST)
NCT00991276 (31) [back to overview]Subjective Total Sleep Time (sTST)
NCT00991276 (31) [back to overview]Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale
NCT00991276 (31) [back to overview]Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale
NCT00991276 (31) [back to overview]Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale
NCT00991276 (31) [back to overview]Subjective Sleep Questionnaire (SSQ): Latency Subscale
NCT00991276 (31) [back to overview]Sleep Efficiency (SE)
NCT01066897 (2) [back to overview]% Change in Hamilton Depression Rating Scale From Baseline to week8
NCT01066897 (2) [back to overview]Number of Participants Who Discontinued Study Due to Side-effects of the Medication
NCT01074450 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01074450 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01074450 (3) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT01074463 (3) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT01074463 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01074463 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01097421 (7) [back to overview]Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment
NCT01097421 (7) [back to overview]Adverse Events (AE) Considered Related to Observed Medication
NCT01097421 (7) [back to overview]Clinical Global Impressions (CGI)
NCT01097421 (7) [back to overview]Level of Adherence
NCT01097421 (7) [back to overview]Patient Preference
NCT01097421 (7) [back to overview]Patients Global Impressions (PGI)
NCT01097421 (7) [back to overview]Pramipexole (PPX) Dose
NCT01191944 (20) [back to overview]Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Percentage Off-time During Waking Hours at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks
NCT01191944 (20) [back to overview]Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Duration of On-time Without Dyskinesia at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Duration of Off-time During Waking Hours at Week 18
NCT01191944 (20) [back to overview]Responder in UPDRS Parts II+III Score at Week 18
NCT01191944 (20) [back to overview]Responder in Percentage Off-time During Waking Hours at Week 18
NCT01191944 (20) [back to overview]Patient Global Impressions of Improvement (PGI-I) Responder at Week 18
NCT01191944 (20) [back to overview]Levodopa (L-Dopa) Introduction During the Study
NCT01191944 (20) [back to overview]Clinical Global Impression of Improvement (CGI-I) Responder at Week 18
NCT01191944 (20) [back to overview]Levodopa (L-Dopa) Dose Change During the Study
NCT01191944 (20) [back to overview]Change From Baseline in UPDRS III Score Separately at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in UPDRS II Score Separately at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18
NCT01191944 (20) [back to overview]Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
NCT01214109 (20) [back to overview]Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)
NCT01214109 (20) [back to overview]Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)
NCT01214109 (20) [back to overview]Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)
NCT01214109 (20) [back to overview]Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)
NCT01281189 (6) [back to overview]Death up to 18 Months
NCT01281189 (6) [back to overview]Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component)
NCT01281189 (6) [back to overview]Composite Assessment of Function and Survival (CAFS) at 12 Months
NCT01281189 (6) [back to overview]Death or Respiratory Insufficiency (DRI) up to Month 18
NCT01281189 (6) [back to overview]Death up to 12 Months (CAFs Individual Component)
NCT01281189 (6) [back to overview]≤50% Predicted Upright Slow Vital Capacity (SVC) or Died up to 18 Months
NCT01361009 (4) [back to overview]Incidence of AE/SAE
NCT01361009 (4) [back to overview]The Dosage Related Information of Pramipexole at the End of Study
NCT01361009 (4) [back to overview]The Dosage Related Information of Pramipexole at Baseline
NCT01361009 (4) [back to overview]Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)
NCT01388478 (1) [back to overview]Number of Patients With Adverse Events
NCT01470859 (5) [back to overview]Longitudinal Change of Brain Network Activity
NCT01470859 (5) [back to overview]Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).
NCT01470859 (5) [back to overview]Parkinson's Disease Questionnaire (PDQ39)
NCT01470859 (5) [back to overview]Hoehn&Yahr (H&Y) Staging
NCT01470859 (5) [back to overview]Unified Parkinson's Disease Rating Score (UPDRS II, III)
NCT01525641 (6) [back to overview]Percentage of Adverse Drug Reactions
NCT01525641 (6) [back to overview]Clinical Global Impression of Effect
NCT01525641 (6) [back to overview]Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
NCT01525641 (6) [back to overview]Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
NCT01525641 (6) [back to overview]Change From Baseline in the Modified Hoehn & Yahr to Last Observation
NCT01525641 (6) [back to overview]Change From Baseline in Total Score of the UPDRS Part III to Last Observation
NCT01622088 (11) [back to overview]Number of Participants With Potentially Clinically Significant ECG Results
NCT01622088 (11) [back to overview]Number of Participants With Potentially Clinically Significant Vital Sign Results
NCT01622088 (11) [back to overview]Number of Participants With Potentially Clinically Significant Hematology Results
NCT01622088 (11) [back to overview]Slope of Sniff Nasal Inspiratory Pressure (SNIP) From Baseline to End of Study
NCT01622088 (11) [back to overview]Number of Subjects Who Discontinued the Study Treatment Due to an Adverse Event
NCT01622088 (11) [back to overview]Slope of ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to End of Study
NCT01622088 (11) [back to overview]Number of Participants With Potentially Clinically Significant Blood Chemistry Results
NCT01622088 (11) [back to overview]Death up to 6 Months
NCT01622088 (11) [back to overview]Number of Subjects Who Experienced a Serious Adverse Event
NCT01622088 (11) [back to overview]Number of Subjects Who Reported an Adverse Event
NCT01622088 (11) [back to overview]Percentage of Participants With Death or Death Equivalent up to 6 Months
NCT01968460 (5) [back to overview]PDQ39
NCT01968460 (5) [back to overview]CGI-S
NCT01968460 (5) [back to overview]Total UPDRS I, II, III Scores
NCT01968460 (5) [back to overview]UPDRS Motor (Part III)
NCT01968460 (5) [back to overview]UPDRS ADL (Part II)
NCT02033369 (7) [back to overview]Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale
NCT02033369 (7) [back to overview]Change in Hamilton Rating Scale for Depression
NCT02033369 (7) [back to overview]Change in Clinical Global Improvement - Severity Scale
NCT02033369 (7) [back to overview]Change in Mood and Anxiety Symptom Questionnaire, Short Form
NCT02033369 (7) [back to overview]Change in Snaith Hamilton Pleasure Scale
NCT02033369 (7) [back to overview]Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale
NCT02033369 (7) [back to overview]Change in the Apathy Evaluation Rating Scale
NCT02217332 (8) [back to overview]Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment
NCT02217332 (8) [back to overview]Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight
NCT02217332 (8) [back to overview]Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations
NCT02217332 (8) [back to overview]Ratio to Baseline in Peripheral Blood Eosinophil Counts After 3 Months of Treatment
NCT02217332 (8) [back to overview]Change From Baseline in TPS After 3 Months of Treatment
NCT02217332 (8) [back to overview]Change From Baseline in Total Polyp Score (TPS) After 6 Months of Treatment
NCT02217332 (8) [back to overview]Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters
NCT02217332 (8) [back to overview]Ratio to Baseline in Polyp Tissue Eosinophil Count After 6 Months of Treatment
NCT02231918 (19) [back to overview]AUCτ,ss
NCT02231918 (19) [back to overview]λz,ss
NCT02231918 (19) [back to overview]Number of Patients With Drug Related Adverse Events
NCT02231918 (19) [back to overview]Ae 0-12,ss
NCT02231918 (19) [back to overview]Cavg
NCT02231918 (19) [back to overview]CL/F,ss
NCT02231918 (19) [back to overview]CLR,ss
NCT02231918 (19) [back to overview]Cmax,ss
NCT02231918 (19) [back to overview]Cmin,ss
NCT02231918 (19) [back to overview]Cpre,N
NCT02231918 (19) [back to overview]fe 0-12,ss
NCT02231918 (19) [back to overview]MRTpo,ss
NCT02231918 (19) [back to overview]PTF
NCT02231918 (19) [back to overview]t1/2,ss
NCT02231918 (19) [back to overview]Tmax,ss
NCT02231918 (19) [back to overview]Tmin,ss
NCT02231918 (19) [back to overview]Vital Signs (Pulse Rate)
NCT02231918 (19) [back to overview]Vital Signs (Systolic and Diastolic Blood Pressure)
NCT02231918 (19) [back to overview]Vz/F,ss
NCT02397837 (10) [back to overview]The Probabilistic Stimulus Selection Task
NCT02397837 (10) [back to overview]The Probabilistic Stimulus Selection Task
NCT02397837 (10) [back to overview]Young Mania Rating Scale (YMRS)
NCT02397837 (10) [back to overview]Hamilton Rating Scale for Depression (HRSD)
NCT02397837 (10) [back to overview]Brief Psychiatric Rating Scale (BPRS)
NCT02397837 (10) [back to overview]MATRICS Consensus Cognitive Battery
NCT02397837 (10) [back to overview]MATRICS Consensus Cognitive Battery
NCT02397837 (10) [back to overview]MATRICS Consensus Cognitive Battery
NCT02397837 (10) [back to overview]Number of Participants With Suicidal Acknowledgements
NCT02397837 (10) [back to overview]The Probabilistic Stimulus Selection Task
NCT03329508 (5) [back to overview]Change From Baseline to Week 12 in Total UPDRS III Motor
NCT03329508 (5) [back to overview]Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39
NCT03329508 (5) [back to overview]Change From Baseline to Week 12 in Total UPDRS II ADL
NCT03329508 (5) [back to overview]Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).
NCT03329508 (5) [back to overview]Change in Epworth Sleepiness Scale (ESS) Score.
NCT03521635 (10) [back to overview]Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)
NCT03521635 (10) [back to overview]Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline)
NCT03521635 (10) [back to overview]The Parkinson's Disease Questionnaire (PDQ)-8 Score (Change From Baseline)
NCT03521635 (10) [back to overview]Responder Rate for Patient Global Impression of Improvement (PGI-I)
NCT03521635 (10) [back to overview]Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18
NCT03521635 (10) [back to overview]Responder Rate for Early Morning Off (EMO) Score
NCT03521635 (10) [back to overview]Responder Rate for Clinical Global Impression of Improvement (CGI-I)
NCT03521635 (10) [back to overview]Epworth Sleepiness Scale (ESS) Score (Change From Baseline)
NCT03521635 (10) [back to overview]Early Morning Off (EMO) Score (Change From Baseline)
NCT03521635 (10) [back to overview]Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score
NCT04046939 (13) [back to overview]Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12
NCT04046939 (13) [back to overview]Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12
NCT04046939 (13) [back to overview]Change in Post-bronchodilator FEV1 From Baseline to Week 12
NCT04046939 (13) [back to overview]Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12
NCT04046939 (13) [back to overview]Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12
NCT04046939 (13) [back to overview]Change in Blood Absolute Eosinophil Count From Baseline to Week 12
NCT04046939 (13) [back to overview]Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12
NCT04046939 (13) [back to overview]Change in Blood Absolute Blood Basophil Count From Baseline to Week 12
NCT04046939 (13) [back to overview]Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
NCT04046939 (13) [back to overview]Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12
NCT04046939 (13) [back to overview]Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
NCT04046939 (13) [back to overview]Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
NCT04046939 (13) [back to overview]Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12

Montgomery Asberg Depression Rating Scale (MADRS)

The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression. (NCT00086307)
Timeframe: Weekly

InterventionScore on a scale (Least Squares Mean)
Pramipexole22.629
Escitalopram26.102
Escitalopram and Pramipexole29.455

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Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. (NCT00144300)
Timeframe: 1 year

InterventionScore on a scale (Mean)
Pramipexole7.0
Ropinirole8.4

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Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. (NCT00144300)
Timeframe: 2 years

InterventionScore on a scale (Mean)
Pramipexole8.4
Ropinirole9.3

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Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. (NCT00144300)
Timeframe: Baseline

InterventionScore on a scale (Mean)
Pramipexole8.0
Ropinirole9.5

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Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year

Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. (NCT00144300)
Timeframe: Baseline, 1 year

InterventionScore on a scale (Mean)
Pramipexole-3.0
Ropinirole-2.6

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Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years

Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. (NCT00144300)
Timeframe: Baseline, 2 year

InterventionScore on a scale (Mean)
Pramipexole-1.0
Ropinirole-1.5

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Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year

Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. (NCT00144300)
Timeframe: 1 year

InterventionScore on a scale (Mean)
Pramipexole17.7
Ropinirole19.8

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Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years

Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. (NCT00144300)
Timeframe: 2 years

InterventionScore on a scale (Mean)
Pramipexole19.7
Ropinirole20.9

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Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline

This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). (NCT00144300)
Timeframe: Baseline

InterventionScore on a scale (Mean)
Pramipexole28.8
Ropinirole31.9

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Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs

Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported. (NCT00144300)
Timeframe: Screen (Baseline) and final visit (24 months)

,
Interventionparticipants (Number)
Haematocrit - DecreaseHaemoglobin - DecreaseEosinophils - IncreasePhosphate - DecreaseCalcium - IncreaseGlucose - Decrease
Pramipexole184014
Ropinirole250200

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Expert Panel Overall Assessment Following 1 Year on Drug

Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments (NCT00144300)
Timeframe: up to 1 years

,
InterventionParticipants (Number)
Have retinal deteriorationHave no retinal deterioration
Pramipexole2887
Ropinirole2198

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Expert Panel Overall Assessment Following 2 Years on Drug

Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments (NCT00144300)
Timeframe: up to 2 years

,
InterventionParticipants (Number)
Have retinal deteriorationHave no retinal deterioration
Pramipexole3481
Ropinirole3386

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Hoehn and Yahr Scale at 1 Year

This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) (NCT00144300)
Timeframe: Up to 1 year

,
InterventionParticipants (Number)
Stage 0Stage 1Stage 1.5Stage 2Stage 2.5Stage 3Stage 4Stage 5
Pramipexole1339708000
Ropinirole12216728600

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Hoehn and Yahr Scale at 2 Years

This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) (NCT00144300)
Timeframe: Up to 2 years

,
InterventionParticipants (Number)
Stage 0Stage 1Stage 1.5Stage 2Stage 2.5Stage 3Stage 4Stage 5
Pramipexole12767410300
Ropinirole023127310700

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Hoehn and Yahr Scale at Baseline

This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden) (NCT00144300)
Timeframe: Baseline

,
InterventionParticipants (Number)
Stage 0Stage 1Stage 1.5Stage 2Stage 2.5Stage 3Stage 4Stage 5
Pramipexole02811718300
Ropinirole02319715700

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Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. (NCT00144300)
Timeframe: Baseline, 1 year

InterventionScore on a scale (Mean)
Pramipexole-1.1
Ropinirole-1.1

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Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years

Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52. (NCT00144300)
Timeframe: Baseline, 2 year

InterventionScore on a scale (Mean)
Pramipexole0.4
Ropinirole-0.2

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Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline

Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. (NCT00144300)
Timeframe: Baseline

InterventionScore on a scale (Mean)
Pramipexole20.7
Ropinirole22.4

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Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year

This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). (NCT00144300)
Timeframe: Baseline, 1 year

InterventionScore on a scale (Mean)
Pramipexole-4.1
Ropinirole-3.7

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Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years

This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). (NCT00144300)
Timeframe: Baseline, 2 year

InterventionScore on a scale (Mean)
Pramipexole-0.7
Ropinirole-1.7

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Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year

This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). (NCT00144300)
Timeframe: 1 year

InterventionScore on a scale (Mean)
Pramipexole24.7
Ropinirole28.2

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Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years

This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction). (NCT00144300)
Timeframe: 2 years

InterventionScore on a scale (Mean)
Pramipexole28.1
Ropinirole30.2

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Adverse Effects Experienced

Number of adverse effect experienced by participants in the different conversion ratio groups. (NCT00275275)
Timeframe: Week 4

Interventionnumber of events (Number)
Preferred Requip PR29
Preferred Mirapex43

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Number of Dose Adjustments

Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced. (NCT00275275)
Timeframe: Week 4

Interventionnumber of adjustments (Mean)
Preferred Requip PR0.6
Preferred Mirapex1.3

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Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs

(NCT00297778)
Timeframe: Baseline and Week 12

,
Interventionparticipants (Number)
HypotensionOrthostatic hypotension
Placebo11
Pramipexole10

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Clinical Global Impressions of Global Improvement (CGI-I) at Week 12

The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse) (NCT00297778)
Timeframe: Week 12

Interventionunits on a scale (Median)
Placebo3
Pramipexole3

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Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12

BDI clinical response was defined as a reduction of ≥50% from baseline (NCT00297778)
Timeframe: Week 12

Interventionparticipants (Number)
Placebo27
Pramipexole38

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Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12

The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain). (NCT00297778)
Timeframe: Baseline and Week 12

Interventionmm (Least Squares Mean)
Placebo-3
Pramipexole-3.5

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Change From Baseline in the UPDRS Part IV Total Score at Week 12

The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms. (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.2
Pramipexole-0.3

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Change From Baseline in the UPDRS Part III Total Score at Week 12

The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-2.2
Pramipexole-4.4

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Change From Baseline in the UPDRS Part II+III Total Score at Week 12

The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-3.4
Pramipexole-6.8

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Change From Baseline in the UPDRS Part II Total Score at Week 12

Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.2
Pramipexole-2.4

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Change From Baseline in the UPDRS Part I Total Score at Week 12

The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms. (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Median)
Placebo-1.0
Pramipexole-1.0

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Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12

This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Median)
Placebo0
Pramipexole0.07

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Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12

The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Median)
Placebo-1
Pramipexole-1

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Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12

The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Median)
Placebo0
Pramipexole0

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Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) (NCT00297778)
Timeframe: Baseline and Week 12

InterventionScore on scale (Least Squares Mean)
Placebo-4
Pramipexole-5.9

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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12

The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Median)
Placebo-2.4
Pramipexole-3.3

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Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12

The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms) (NCT00297778)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.7
Pramipexole-2.5

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Percentage Change From Baseline in the Striatum Uptake at Month 15

The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT). (NCT00321854)
Timeframe: Baseline and Month 15

InterventionPercentage change (Least Squares Mean)
Early Pramipexole-15.1
Delayed Pramipexole-14.6

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Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. (NCT00321854)
Timeframe: Month 9

,
InterventionParticipants (Number)
No risk of gamblingRisk of gambling
Delayed Pramipexole1340
Early Pramipexole1460

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Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. (NCT00321854)
Timeframe: Month 6

,
InterventionParticipants (Number)
No risk of gamblingRisk of gambling
Delayed Pramipexole1340
Early Pramipexole1460

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Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. (NCT00321854)
Timeframe: Month 15

,
InterventionParticipants (Number)
No risk of gamblingRisk of gambling
Delayed Pramipexole1320
Early Pramipexole1450

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Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. (NCT00321854)
Timeframe: Month 12

,
InterventionParticipants (Number)
No risk of gamblingRisk of gambling
Delayed Pramipexole1280
Early Pramipexole1430

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Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. (NCT00321854)
Timeframe: Month 1

,
InterventionParticipants (Number)
No risk of gamblingRisk of gambling
Delayed Pramipexole1330
Early Pramipexole1460

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. (NCT00321854)
Timeframe: Month 9

,
InterventionParticipants (Number)
No compulsive sexual behaviourCompulsive sexual behaviour
Delayed Pramipexole1340
Early Pramipexole1460

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Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 3

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-2.8
Delayed Pramipexole0.0

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. (NCT00321854)
Timeframe: Month 6

,
InterventionParticipants (Number)
No compulsive sexual behaviourCompulsive sexual behaviour
Delayed Pramipexole1340
Early Pramipexole1460

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. (NCT00321854)
Timeframe: Month 15

,
InterventionParticipants (Number)
No compulsive sexual behaviourCompulsive sexual behaviour
Delayed Pramipexole1311
Early Pramipexole1450

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. (NCT00321854)
Timeframe: Month 12

,
InterventionParticipants (Number)
No compulsive sexual behaviourCompulsive sexual behaviour
Delayed Pramipexole1262
Early Pramipexole1430

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. (NCT00321854)
Timeframe: Month 1

,
InterventionParticipants (Number)
No compulsive sexual behaviourCompulsive sexual behaviour
Delayed Pramipexole1330
Early Pramipexole1460

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. (NCT00321854)
Timeframe: Month 9

,
InterventionParticipants (Number)
No compulsive buyingCompulsive buying
Delayed Pramipexole1340
Early Pramipexole1433

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. (NCT00321854)
Timeframe: Month 6

,
InterventionParticipants (Number)
No compulsive buyingCompulsive buying
Delayed Pramipexole1340
Early Pramipexole1442

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. (NCT00321854)
Timeframe: Month 15

,
InterventionParticipants (Number)
No compulsive buyingCompulsive buying
Delayed Pramipexole1320
Early Pramipexole1432

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. (NCT00321854)
Timeframe: Month 12

,
InterventionParticipants (Number)
No compulsive buyingCompulsive buying
Delayed Pramipexole1280
Early Pramipexole1412

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Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. (NCT00321854)
Timeframe: Month 1

,
InterventionParticipants (Number)
No compulsive buyingCompulsive buying
Delayed Pramipexole1330
Early Pramipexole1451

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Clinically Significant Abnormalities in Vital Signs

(NCT00321854)
Timeframe: Baseline and Month 15

,
Interventionpercentage of participants (Number)
Sinus bradycardiaHypotension
Delayed Pramipexole0.40.5
Early Pramipexole00

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Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates

(NCT00321854)
Timeframe: Baseline and Month 15

,
Interventionpercentage of participants (Number)
Glucose - decreaseGlucose - increaseCholesterol - increaseBlood Urea Nitrogen - increaseCreatinine - increaseTriglyceride - increaseUric acid - increase
Delayed Pramipexole2.202.90.51.000.5
Early Pramipexole03.61.40.90.51.40.5

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Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes

(NCT00321854)
Timeframe: Baseline and Month 15

,
Interventionpercentage of participants (Number)
Haematocrit - decreaseHaemoglobin - decreaseMCV - increaseSodium - decreaseCalcium - increaseChloride - decreasePhosphate - decreasePhosphate - increase
Delayed Pramipexole1.00.900.50.5000
Early Pramipexole1.42.30.51.400.91.00.5

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Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes

(NCT00321854)
Timeframe: Baseline and Month 15

,
Interventionpercentage of participants (Number)
GGT - increaseAmylase - increase
Delayed Pramipexole00
Early Pramipexole0.51.4

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Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15

The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening). (NCT00321854)
Timeframe: Baseline and Month 15

,
InterventionParticipants (Number)
ImprovedEssentially unchangedWorsened
Delayed Pramipexole31914
Early Pramipexole42005

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Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15

The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2. (NCT00321854)
Timeframe: Month 15

InterventionParticipants (Number)
Early Pramipexole18
Delayed Pramipexole21

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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9

The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Median)
Early Pramipexole-0.5
Delayed Pramipexole1.4

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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15

The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Median)
Early Pramipexole-0.4
Delayed Pramipexole0.3

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Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.5
Delayed Pramipexole4.3

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Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.3
Delayed Pramipexole0.7

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Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 6

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-1.8
Delayed Pramipexole2.6

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Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 3

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-2.9
Delayed Pramipexole-0.1

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Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.6
Delayed Pramipexole0.5

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Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.3
Delayed Pramipexole4.2

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Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 6

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-1.5
Delayed Pramipexole2.5

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Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.8
Delayed Pramipexole0.6

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Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.6
Delayed Pramipexole2.7

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Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 6

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-1.6
Delayed Pramipexole1.3

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Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 3

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-2.1
Delayed Pramipexole-0.3

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Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.2
Delayed Pramipexole-0.1

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Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.4
Delayed Pramipexole1.5

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Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 6

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.1
Delayed Pramipexole1.2

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Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 3

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.7
Delayed Pramipexole0.3

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Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.6
Delayed Pramipexole0.6

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Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.2
Delayed Pramipexole0.1

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Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 3

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.2
Delayed Pramipexole-0.1

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Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 6

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.3
Delayed Pramipexole0.1

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Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-1
Delayed Pramipexole-0.5

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Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) (NCT00321854)
Timeframe: Baseline and Month 3

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-1
Delayed Pramipexole-0.3

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Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) (NCT00321854)
Timeframe: Baseline and Month 6

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-1.2
Delayed Pramipexole0.2

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Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-1.1
Delayed Pramipexole0.3

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Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.3
Delayed Pramipexole0

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Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.5
Delayed Pramipexole0.4

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Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.1
Delayed Pramipexole0.3

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Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole0.6
Delayed Pramipexole0.7

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Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15

The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Median)
Early Pramipexole0
Delayed Pramipexole0

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Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9

The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Median)
Early Pramipexole0
Delayed Pramipexole0

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Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15

The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Median)
Early Pramipexole0
Delayed Pramipexole0

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Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9

The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state) (NCT00321854)
Timeframe: Baseline and Month 9

InterventionUnits on a scale (Median)
Early Pramipexole0
Delayed Pramipexole-0.5

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Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) (NCT00321854)
Timeframe: Baseline and Month 15

InterventionUnits on a scale (Least Squares Mean)
Early Pramipexole-0.2
Delayed Pramipexole-0.1

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Clinical Global Impression Global Improvement (CGI-I) Responder

CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders. (NCT00390689)
Timeframe: baseline to week 6

InterventionPercentage of patients (Number)
Pramipexole 0.25mg Group77.1
Pramipexole 0.5mg Group75.5
Pramipexole 0.75mg Group69.8

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Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period

Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week (NCT00390689)
Timeframe: baseline to week 52

InterventionPercentage of patients (Number)
Pramipexole 0.125mg Group0.0
Pramipexole 0.25mg Group0.0
Pramipexole 0.5mg Group0.0
Pramipexole 0.75mg Group0.0

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Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.

(NCT00390689)
Timeframe: baseline to 6 weeks

,,
Interventionparticipants (Number)
Blood pressure increasedCardiovascular disorder
Pramipexole 0.25mg Group00
Pramipexole 0.5mg Group10
Pramipexole 0.75mg Group01

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Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period

ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep) (NCT00390689)
Timeframe: Week 52 - change from baseline

InterventionPoints on a scale (Mean)
Pramipexole 0.125mg Group-9.5
Pramipexole 0.25mg Group-3.8
Pramipexole 0.5mg Group-4.4
Pramipexole 0.75mg Group-2.6

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Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks

PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep). (NCT00390689)
Timeframe: Week 6 - change from baseline

InterventionPoints on a scale (Least Squares Mean)
Pramipexole 0.25mg Group-3.2
Pramipexole 0.5mg Group-3.2
Pramipexole 0.75mg Group-2.5

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Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period

PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep). (NCT00390689)
Timeframe: Week 52 - change from baseline

InterventionPoints on a scale (Mean)
Pramipexole 0.125mg Group-4.0
Pramipexole 0.25mg Group-3.3
Pramipexole 0.5mg Group-3.3
Pramipexole 0.75mg Group-2.4

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Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period

CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders. (NCT00390689)
Timeframe: baseline to week 52

InterventionPercentage of patients (Number)
Pramipexole 0.125mg Group100.0
Pramipexole 0.25mg Group95.0
Pramipexole 0.5mg Group98.0
Pramipexole 0.75mg Group84.0

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IRLS Responder

The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications) (NCT00390689)
Timeframe: baseline to week 6

InterventionPercentage of patients (Number)
Pramipexole 0.25mg Group60.4
Pramipexole 0.5mg Group58.5
Pramipexole 0.75mg Group49.1

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Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks

ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep) (NCT00390689)
Timeframe: Week 6 - change from baseline

InterventionPoints on a scale (Least Squares Mean)
Pramipexole 0.25mg Group-2.6
Pramipexole 0.5mg Group-3.0
Pramipexole 0.75mg Group-2.3

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IRLS Responder for Open-label Period

The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications) (NCT00390689)
Timeframe: baseline to week 52

InterventionPercentage of patients (Number)
Pramipexole 0.125mg Group100.0
Pramipexole 0.25mg Group90.0
Pramipexole 0.50mg Group92.0
Pramipexole 0.75mg Group68.0

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Patient Global Impression (PGI) Responder

PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders. (NCT00390689)
Timeframe: baseline to week 6

InterventionPercentage of patients (Number)
Pramipexole 0.25mg Group72.9
Pramipexole 0.5mg Group79.2
Pramipexole 0.75mg Group67.9

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Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period

PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders. (NCT00390689)
Timeframe: baseline to week 52

InterventionPercentage of patients (Number)
Pramipexole 0.125mg Group100.0
Pramipexole 0.25mg Group97.5
Pramipexole 0.5mg Group94.0
Pramipexole 0.75mg Group80.0

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Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks

The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole. (NCT00390689)
Timeframe: Week 6 - change from baseline

InterventionPoints on a scale (Least Squares Mean)
Pramipexole 0.25mg Group-12.3
Pramipexole 0.5mg Group-12.5
Pramipexole 0.75mg Group-11.8

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Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period

The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). (NCT00390689)
Timeframe: Week 52 - change from baseline

InterventionPoints on a scale (Mean)
Pramipexole 0.125mg Group-18.5
Pramipexole 0.25mg Group-17.3
Pramipexole 0.5mg Group-18.3
Pramipexole 0.75mg Group-14.8

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Modified Hoehn and Yahr Stage

Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided) (NCT00402233)
Timeframe: From baseline to week 12

,,,
Interventionunits on a scale (Mean)
Modified Hoehn and Yahr Stage at baselineModified Hoehn and Yahr Stage at week 12
Mirapex (Pramipexole 0.5 mg Bid)1.721.69
Mirapex (Pramipexole 0.5 mg Tid)1.741.68
Mirapex (Pramipexole 0.75 mg Bid)1.731.62
Placebo1.811.74

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Epworth Sleepiness Scale

Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing) (NCT00402233)
Timeframe: From baseline to week 12

,,,
Interventionunits on a scale (Mean)
Epworth Sleepiness Scale at baselineEpworth Sleepiness Scale at week 12
Mirapex (Pramipexole 0.5 mg Bid)5.786.44
Mirapex (Pramipexole 0.5 mg Tid)5.86.58
Mirapex (Pramipexole 0.75 mg Bid)6.347.52
Placebo5.295.09

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Beck Depression Inventory II

Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe) (NCT00402233)
Timeframe: From baseline to week 12

,,,
Interventionunits on a scale (Mean)
Beck Depression Inventory II at baselineBeck Depression Inventory II at week 12
Mirapex (Pramipexole 0.5 mg Bid)6.965.97
Mirapex (Pramipexole 0.5 mg Tid)6.665.70
Mirapex (Pramipexole 0.75 mg Bid)7.46.54
Placebo6.055.92

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Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination) (NCT00402233)
Timeframe: From baseline to week 12

,,,
Interventionunits on a scale (Mean)
UPDRS at baselineUPDRS at week 12
Mirapex (Pramipexole 0.5 mg Bid)27.2122.96
Mirapex (Pramipexole 0.5 mg Tid)27.6622.92
Mirapex (Pramipexole 0.75 mg Bid)27.7722.65
Placebo28.9728.19

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Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks

ranging from 0 (worst case) to 100 (best case) (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER5.8
Pramipexole IR7.6
Placebo4.3

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Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks

Ranging from 0 (best case) to 156 (worst case) (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-9.1
Pramipexole IR-13.1
Placebo-6.2

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Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks

ranging from 0 (worst case) to 150 (best case) (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER8.1
Pramipexole IR8.9
Placebo4.9

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Response in Patient Global Impression (PGI-I)

PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better) (NCT00466167)
Timeframe: after 18 weeks of treatment

,,
InterventionParticipants (Number)
ResponderNon-Responder
Placebo47127
Pramipexole ER60101
Pramipexole IR7696

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Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)

(NCT00466167)
Timeframe: baseline and week 18

,,
Interventionparticipants (Number)
Haematocrit - decreaseHaemoglobin - decreaseRed blood cell ct - decreaseEosinophils - IncreaseNeut.,poly. (segs),absol. - decreaseSodium - decreaseGGT - increaseGlucose - decreaseGlucose - increaseTriglyceride - increaseWeight - decreaseBlood pressure - increaseBlood pressure - decrease
Placebo1311001115101
Pramipexole ER2213001102010
Pramipexole IR3502120023320

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Clinical Global Impression - Global Improvement (CGI-I) Responder

CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved) (NCT00466167)
Timeframe: after 18 weeks of treatment

,,
InterventionParticipants (Number)
ResponderNon-Responder
Placebo56115
Pramipexole ER7882
Pramipexole IR8881

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Change From Baseline in UPDRS IV Score After 18 Weeks

UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-0.8
Pramipexole IR-0.9
Placebo-0.6

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Change From Baseline in UPDRS III Score After 18 Weeks

UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-8.3
Pramipexole IR-9.2
Placebo-4.3

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Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period

UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities. (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-2.7
Pramipexole IR-3.6
Placebo-1.9

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Change From Baseline in UPDRS I Score After 18 Weeks

UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Median)
Pramipexole ER0
Pramipexole IR0
Placebo0

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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18

UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00466167)
Timeframe: baseline and week 18

InterventionPercentage of change from baseline (Least Squares Mean)
Pramipexole ER-11.0
Pramipexole IR-12.8
Placebo-6.1

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Change From Baseline in Percentage On-time Without Dyskinesia at Week 18

Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00466167)
Timeframe: baseline and week 18

InterventionPercentage of on-time without dyskinesia (Least Squares Mean)
Pramipexole ER11.9
Pramipexole IR12.6
Placebo8.9

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Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18

Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00466167)
Timeframe: baseline and week 18

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole ER-0.8
Pramipexole IR-0.8
Placebo-1.0

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Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18

Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00466167)
Timeframe: baseline and week 18

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole ER1.9
Pramipexole IR3.9
Placebo1.0

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Change From Baseline in Percentage Off-time at Week 18

Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). (NCT00466167)
Timeframe: baseline and week 18

InterventionPercentage of off-time (Least Squares Mean)
Pramipexole ER-13.3
Pramipexole IR-15.9
Placebo-8.8

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Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks

ranging from 0 (best case) to 63 (worst case) (NCT00466167)
Timeframe: baseline and 18 weeks

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-3.2
Pramipexole IR-4.0
Placebo-2.8

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Change From Baseline in SF-36 Dimension Vitality After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better vitality (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole6.3
Placebo3.1

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Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating less bodily pain (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole12
Placebo9

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Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks

The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm) (NCT00472199)
Timeframe: Baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole-26
Placebo-15

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Diagnosis of Classified Augmentation According to Independent Expert Panel

Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment. (NCT00472199)
Timeframe: after at least 4 weeks of treatment

Interventionparticipants (Number)
Pramipexole18
Placebo14

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Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation

"Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation).~Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline." (NCT00472199)
Timeframe: after at least 1 week of treatment discontinuation

Interventionparticipants (Number)
Pramipexole14
Placebo2

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Baseline, Week 26 Mean Standing Diastolic Blood Pressure

(NCT00472199)
Timeframe: Baseline, Week 26

,
Interventionmm Hg (Mean)
BaselineWeek 26
Placebo81.780.8
Pramipexole82.780.5

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Baseline, Week 26 Mean Standing Pulse Rate

(NCT00472199)
Timeframe: Baseline, Week 26

,
Interventionbpm (Mean)
BaselineWeek 26
Placebo74.075.0
Pramipexole74.674.1

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Baseline, Week 26 Mean Standing Systolic Blood Pressure

(NCT00472199)
Timeframe: Baseline, Week 26

,
Interventionmm Hg (Mean)
BaselineWeek 26
Placebo130.6130.1
Pramipexole132.6132.4

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Baseline, Week 26 Mean Supine Diastolic Blood Pressure

(NCT00472199)
Timeframe: Baseline, Week 26

,
Interventionmm Hg (Mean)
BaselineWeek 26
Placebo79.679.5
Pramipexole79.278.3

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Baseline, Week 26 Mean Supine Systolic Blood Pressure

(NCT00472199)
Timeframe: Baseline, Week 26

,
Interventionmm Hg (Mean)
BaselineWeek 26
Placebo132.7132.2
Pramipexole133.4132.3

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Clinical Global Impression - Global Improvement (CGI-I) Responder Rate

CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved) (NCT00472199)
Timeframe: after 26 weeks of treatment

,
Interventionparticipants (Number)
CGI-I responder (at least much improved)CGI-I non-responder
Placebo8079
Pramipexole11151

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International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate

IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms) (NCT00472199)
Timeframe: after 26 weeks of treatment

,
Interventionparticipants (Number)
IRLS responderIRLS non-responder
Placebo6891
Pramipexole9567

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Patient Global Impression (PGI) Responder Rate

PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better) (NCT00472199)
Timeframe: after 26 weeks of treatment

,
Interventionparticipants (Number)
PGI responder (much better or very much better)PGI non-responder
Placebo7089
Pramipexole10161

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Baseline, Week 26 Mean Supine Pulse Rate

(NCT00472199)
Timeframe: Baseline, Week 26

,
Interventionbpm (Mean)
BaselineWeek 26
Placebo68.768.3
Pramipexole68.569.1

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"Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score Satisfaction With Sleep After 26 Weeks"

"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week" (NCT00472199)
Timeframe: baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole-2.5
Placebo-2

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"Change From Baseline in RLS-6 Score Severity During the Day When at Rest After 26 Weeks"

"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week" (NCT00472199)
Timeframe: Baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole-3
Placebo-1

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"Change From Baseline in RLS-6 Score Severity During the Night After 26 Weeks"

"The question was rated on an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week" (NCT00472199)
Timeframe: baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole-3
Placebo-2

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"Change From Baseline in RLS-6 Score Severity Falling Asleep After 26 Weeks"

"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week" (NCT00472199)
Timeframe: Baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole-3
Placebo-1

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"Change From Baseline in RLS-6 Score Tired or Sleepy During the Day After 26 Weeks"

"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week" (NCT00472199)
Timeframe: Baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole-1
Placebo-1

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"Change From Baseline RLS-6 Score Severity During the Day Engaged in Activities After 26 Weeks"

"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week" (NCT00472199)
Timeframe: Baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole0
Placebo0

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Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks

IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms) (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Least Squares Mean)
Pramipexole-13.7
Placebo-11.1

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Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks

Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe) (NCT00472199)
Timeframe: Baseline and 26 weeks of treatment

Interventionscores on a scale (Median)
Pramipexole-1
Placebo-1

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Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks

RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life (NCT00472199)
Timeframe: Baseline and 26 weeks of treatment

InterventionScores on a scale (Median)
Pramipexole15
Placebo12.5

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Change From Baseline in SF-36 Dimension General Health After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better health status (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole0
Placebo0

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Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better health (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole1.7
Placebo1.9

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Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better mental health (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole5
Placebo5

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Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better health (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole2.1
Placebo2

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Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better physical functioning (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole0
Placebo0

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Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole0
Placebo0

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Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole6.3
Placebo6.3

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Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks

Score ranging from 0 to 100 with higher scores indicating better social functioning (NCT00472199)
Timeframe: Baseline and 26 weeks

InterventionScores on a scale (Median)
Pramipexole0
Placebo0

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Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale

Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. Responders are the patients with 'much better' and 'very much better' on the score. (NCT00479401)
Timeframe: after 18 weeks of treatment compared to baseline

InterventionPercentage of Participants (Number)
Pramipexole Extended Release (PPX ER)35.6
Pramipexole Immediate Release (PPX IR)23.8
Placebo12

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UPDRS Part I Change From Baseline

UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement (NCT00479401)
Timeframe: baseline and after 33 weeks treatment

Interventionunits on a scale (Median)
Pramipexole Extended Release (PPX ER)0.0
Pramipexole Immediate Release (PPX IR)0.0
Placebo0.0

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UPDRS II+III Responder Rate (at Least 20% Improvement)

Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse. (NCT00479401)
Timeframe: after 33 weeks treatment

Interventionpercentage of responders (Number)
Pramipexole Extended Release (PPX ER)68.5
Pramipexole Immediate Release (PPX IR)65.7
Placebo48.5

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Change From Baseline in European Quality of Life Visual Analog Scale

European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status. (NCT00479401)
Timeframe: after 33 weeks treatment

Interventionunits on a scale (Mean)
Pramipexole Extended Release (PPX ER)4.0
Pramipexole Immediate Release (PPX IR)6.6
Placebo3.2

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Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score

"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include:~mobility (e.g. fear of falling when walking): 10 items~activities of daily living (e.g. difficulty cutting food): 6 items~emotional well-being (e.g. feelings of isolation): 6 items~stigma (e.g. social embarrassment): 4 items~social support: 3 items~cognition: 4 items~communication: 3 items~bodily discomfort: 3 items.~A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement." (NCT00479401)
Timeframe: after 33 weeks treatment

Interventionunits on a scale (Mean)
Pramipexole Extended Release (PPX ER)-4.1
Pramipexole Immediate Release (PPX IR)-6.5
Placebo-2.1

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Beck's Depression Inventory Version I A

The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression). (NCT00479401)
Timeframe: after 33 weeks treatment

Interventionunits on a scale (Mean)
Pramipexole Extended Release (PPX ER)-2.0
Pramipexole Immediate Release (PPX IR)-2.7
Placebo-2.1

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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score

Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement. (NCT00479401)
Timeframe: baseline and after 33 weeks treatment

Interventionunits on a scale (Least Squares Mean)
Pramipexole Extended Release (PPX ER)-8.6
Pramipexole Immediate Release (PPX IR)-8.8
Placebo-3.8

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Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)

mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4). (NCT00479401)
Timeframe: from trial start on to any time before final assessment of the patient, up to 33 weeks

Interventionpatients (Number)
Pramipexole Extended Release (PPX ER)4
Pramipexole Immediate Release (PPX IR)3
Placebo1

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Possible Clinically Significant Abnormal Laboratory Parameters

The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values. (NCT00479401)
Timeframe: baseline and after 33 weeks of treatment

,,
Interventionparticipants (Number)
Haematocrit - decreaseHaemoglobin - decreaseRed blood cell ct. - decreaseWhite blood cell ct. - decreaseNeut., poly (segs) - decreaseEosinophils - increaseNeut., poly (segs), absol. - decreaseSodium - decreasePotassium - increaseChloride - decreaseAlkaline phosphatase - increaseGGT - increaseGlucose - decreaseGlucose - increaseCholesterol, total - increaseCreatinine - increaseTriglyceride - increaseUric acid - increase
Placebo110003000000001152
Pramipexole Extended Release (PPX ER)4111126153203310093
Pramipexole Immediate Release (PPX IR)360003051011010031

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Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events

(NCT00479401)
Timeframe: baseline and after 33 weeks of treatment

,,
Interventionparticipants (Number)
HypertensionOrthostatic hypotensionHypotensionWeight increasedWeight decreasedBlood pressure diastolic increased
Placebo511000
Pramipexole Extended Release (PPX ER)670020
Pramipexole Immediate Release (PPX IR)716731

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UPDRS Part III Total Score

UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement (NCT00479401)
Timeframe: after 33 weeks treatment

Interventionunits on a scale (Mean)
Pramipexole Extended Release (PPX ER)-6.4
Pramipexole Immediate Release (PPX IR)-6.4
Placebo-2.8

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Parkinson's Disease Sleep Scale (PDSS)

PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150) (NCT00479401)
Timeframe: after 33 weeks treatment

Interventionunits on a scale (Mean)
Pramipexole Extended Release (PPX ER)2.3
Pramipexole Immediate Release (PPX IR)5.6
Placebo5.6

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Patients Who Started to Use L-Dopa Rescue Medication

L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population (NCT00479401)
Timeframe: from trial start on to any time before final assessment of the patient, up to 33 weeks

Interventionpatients (Number)
Pramipexole Extended Release (PPX ER)15
Pramipexole Immediate Release (PPX IR)9
Placebo22

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Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale

Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale (NCT00479401)
Timeframe: after 18 weeks of treatment compared to baseline

InterventionPercentage of Participants (Number)
Pramipexole Extended Release (PPX ER)37
Pramipexole Immediate Release (PPX IR)48
Placebo18

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UPDRS Part II Total Score

UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement (NCT00479401)
Timeframe: after 33 weeks treatment

Interventionunits on a scale (Mean)
Pramipexole Extended Release (PPX ER)-2.2
Pramipexole Immediate Release (PPX IR)-2.4
Placebo-0.9

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Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)

Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment) (NCT00558025)
Timeframe: Baseline and week 9

InterventionScore on Scale (Mean)
Pramipexole Extended Release (ER)-0.3
Pramipexole Immediate Release (IR)-0.1

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Pramipexole Dose Adaptation, FAS (LOCF)

Patients with increase in daily Pramipexole dose on FAS (NCT00558025)
Timeframe: Week 9

,
Interventionparticipants (Number)
Daily dose increasedDaily dose not increased
Pramipexole Extended Release (ER)1786
Pramipexole Immediate Release (IR)745

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Final Pramipexole Dose (mg) After 9 Weeks, Treated Set

The mean final daily Pramipexole dose is displayed (NCT00558025)
Timeframe: Week 9

Interventionmg (Mean)
Pramipexole Extended Release (ER)2.75
Pramipexole Immediate Release (IR)2.83

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Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)

Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse' (NCT00558025)
Timeframe: Week 9

,
Interventionparticipants (Number)
CGI-I responderCGI-I non-responder
Pramipexole Extended Release (ER)9013
Pramipexole Immediate Release (IR)4111

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Patient Global Impression - Improvement (PGI-I), FAS (LOCF)

Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse' (NCT00558025)
Timeframe: Week 9

,
Interventionparticipants (Number)
PGI-I responder (unchanged to very much better)PGI-I non-responder
Pramipexole Extended Release (ER)8419
Pramipexole Immediate Release (IR)3715

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Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)

A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment) (NCT00558025)
Timeframe: from baseline to week 9

,
InterventionPercentage of participants (Number)
Successfully switchedNot successfully switched
Pramipexole Extended Release (ER)84.515.5
Pramipexole Immediate Release (IR)94.25.8

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Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)

A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment). (NCT00558025)
Timeframe: from baseline to week 4

,
InterventionPercentage of participants (Number)
Successfully switchedNot successfully switched
Pramipexole Extended Release (ER)81.618.4
Pramipexole Immediate Release (IR)92.37.7

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Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)

Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment) (NCT00558025)
Timeframe: Baseline and week 9

InterventionScore on Scale (Least Squares Mean)
Pramipexole Extended Release (ER)-1.2
Pramipexole Immediate Release (IR)-0.3

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Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)

Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment) (NCT00558025)
Timeframe: Baseline and week 9

InterventionScore on scale (Least Squares Mean)
Pramipexole Extended Release (ER)-1.6
Pramipexole Immediate Release (IR)-0.5

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Patient Global Impression at Week 1

Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). (NCT00558467)
Timeframe: baseline and Week 1

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo416
Pramipexole735

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Patient Global Impression at Week 2

Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). (NCT00558467)
Timeframe: baseline and Week 2

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo614
Pramipexole933

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Patient Global Impression at Week 3

Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). (NCT00558467)
Timeframe: baseline and Week 3

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo515
Pramipexole735

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Patient Global Impression at Week 4

Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). (NCT00558467)
Timeframe: baseline and Week 4

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo416
Pramipexole735

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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 (NCT00558467)
Timeframe: baseline 1 week

Interventionscore on a scale (Mean)
Placebo-3.7
Pramipexole-4.1

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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale

"Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.~Analysis was adjusted for baseline total tic score and age as linear covariates." (NCT00558467)
Timeframe: baseline 6 weeks

Interventionscore on a scale (Least Squares Mean)
Placebo-7.17
Pramipexole-7.16

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) (NCT00558467)
Timeframe: baseline and 6 weeks

Interventionscore on a scale (Least Squares Mean)
Placebo-15.43
Pramipexole-15.58

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) (NCT00558467)
Timeframe: baseline 4 weeks

Interventionscore on a scale (Mean)
Placebo-15.5
Pramipexole-13.9

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) (NCT00558467)
Timeframe: baseline and 3 weeks

Interventionscore on a scale (Mean)
Placebo-14.1
Pramipexole-12.2

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) (NCT00558467)
Timeframe: baseline and 2 weeks

Interventionscore on a scale (Mean)
Placebo-9.5
Pramipexole-10.6

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) (NCT00558467)
Timeframe: baseline 1 week

Interventionscore on a scale (Mean)
Placebo-6.2
Pramipexole-8.8

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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 (NCT00558467)
Timeframe: baseline and 2 weeks

Interventionscore on a scale (Mean)
Placebo-5.3
Pramipexole-5

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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 (NCT00558467)
Timeframe: baseline and 3 weeks

Interventionscore on a scale (Mean)
Placebo-6.2
Pramipexole-5.4

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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50 (NCT00558467)
Timeframe: baseline and 4 weeks

Interventionscore on a scale (Mean)
Placebo-6
Pramipexole-6.4

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Clinical Global Impressions - Improvement at 1 Week

Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. (NCT00558467)
Timeframe: baseline and Week 1

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo020
Pramipexole537

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Clinical Global Impressions - Improvement at Week 2

Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. (NCT00558467)
Timeframe: baseline and Week 2

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo119
Pramipexole636

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Clinical Global Impressions - Improvement at Week 3

Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. (NCT00558467)
Timeframe: baseline and Week 3

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo218
Pramipexole537

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Clinical Global Impressions - Severity of Illness at Week 6

Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. (NCT00558467)
Timeframe: baseline and Week 6

,
InterventionNumber of Patients (Number)
ImprovedUnchangedWorsened
Placebo4160
Pramipexole10320

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Patient Global Impression at Week 6

Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). (NCT00558467)
Timeframe: baseline and Week 6

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo614
Pramipexole1230

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Clinical Global Impressions - Improvement at Week 4

Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. (NCT00558467)
Timeframe: baseline and Week 4

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo713
Pramipexole636

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Clinical Global Impressions - Improvement at Week 6

Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. (NCT00558467)
Timeframe: baseline and Week 6

,
InterventionNumber of Patients (Number)
ResponderNot Responder
Placebo713
Pramipexole1131

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Clinical Global Impressions - Severity of Illness at Week 1

Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. (NCT00558467)
Timeframe: baseline and Week 1

,
InterventionNumber of Patients (Number)
ImprovedUnchangedWorsened
Placebo0200
Pramipexole4380

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Clinical Global Impressions - Severity of Illness at Week 2

Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. (NCT00558467)
Timeframe: baseline and Week 2

,
InterventionNumber of Patients (Number)
ImprovedUnchangedWorsened
Placebo1190
Pramipexole4371

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Clinical Global Impressions - Severity of Illness at Week 3

Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. (NCT00558467)
Timeframe: baseline and Week 3

,
InterventionNumber of Patients (Number)
ImprovedUnchangedWorsened
Placebo3170
Pramipexole4371

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Clinical Global Impressions - Severity of Illness at Week 4

Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater. (NCT00558467)
Timeframe: baseline and Week 4

,
InterventionNumber of Patients (Number)
ImprovedUnchangedWorsened
Placebo4160
Pramipexole4380

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Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.

(NCT00558467)
Timeframe: baseline and Week 6

,
Interventionparticipants (Number)
Phosphate - increaseBilirubin, total - increaseTachycardiaOrthostatic hypotension
Placebo2001
Pramipexole5114

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Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)

Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse) (NCT00560508)
Timeframe: Week 12 to Week 16

,
Interventionpercentage of participants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worse
From PPX ER to PPX ER0.08.048.034.010.0
From PPX IR to PPX ER1.95.735.850.95.7

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UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)

Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

Interventionpercentage of participants (Number)
Pramipexole ER: Open-Label Phase92.0

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UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)

Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

Interventionpercentage of participants (Number)
Pramipexole Extended Release Group (PPX ER)78.6
Pramipexole Immediate Release Group (PPX IR)82.1

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Trough Plasma Concentration at Steady State

Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg. (NCT00560508)
Timeframe: at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment

Interventionng/ml (Geometric Mean)
Pramipexole Extended Release Group (PPX ER)5.46
Pramipexole Immediate Release Group (PPX IR)5.09

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Responder Rate For Clinical Global Impression of Improvement (CGI-I)

CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved) (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

Interventionpercentage of participants (Number)
Pramipexole Extended Release Group (PPX ER)48.2
Pramipexole Immediate Release Group (PPX IR)50.0

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Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)

Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionPercentage of on-time (Mean)
Pramipexole ER: Open-Label Phase11.8

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Change From Baseline in Percentage On-time Without Dyskinesia

Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)6.4
Pramipexole Immediate Release Group (PPX IR)7.0

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Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)

Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionPercentage of on-time (Mean)
Pramipexole ER: Open-Label Phase-0.2

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Change From Baseline in Percentage On-time With Troublesome Dyskinesia

Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-0.1
Pramipexole Immediate Release Group (PPX IR)0.5

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Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)

Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionPercentage of on-time (Mean)
Pramipexole ER: Open-Label Phase-0.1

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Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia

Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-0.4
Pramipexole Immediate Release Group (PPX IR)0.1

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Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)

Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionPercentage of off-time (Mean)
Pramipexole ER: Open-Label Phase-11.6

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Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)

UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline. (NCT00560508)
Timeframe: Week 12 to Week 16

InterventionUPDRS scores on a scale (Least Squares Mean)
From PPX ER to PPX ER-2.2
From PPX IR to PPX ER-0.2

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Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)

The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit. (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

Interventionmg per day (Mean)
Pramipexole ER: Open-Label Phase10.3

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Change From Baseline in L-dopa Daily Dose

The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit. (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

Interventionmg per day (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-5.3
Pramipexole Immediate Release Group (PPX IR)-1.8

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Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment

Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration (NCT00560508)
Timeframe: from Visit 1 to Visit 8 after pramipexole ER

Interventionng/mL (Mean)
Pramipexole Extended Release Group (PPX ER)1.0375

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Change From Baseline in UPDRS Part I Score

UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionUPDRS scores on a scale (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)0.1
Pramipexole Immediate Release Group (PPX IR)-0.2

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Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)

UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionUPDRS scores on a scale (Mean)
Pramipexole ER: Open-Label Phase-0.3

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Change From Baseline in UPDRS Part II Score

UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities. (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionUPDRS scores on a scale (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-3.3
Pramipexole Immediate Release Group (PPX IR)-3.4

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Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)

UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities. (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionUPDRS scores on a scale (Mean)
Pramipexole ER: Open-Label Phase-3.4

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Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)

Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionPercentage of on-time (Mean)
Pramipexole ER: Open-Label Phase11.9

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Change From Baseline in UPDRS Part III Score

UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionUPDRS scores on a scale (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-10.2
Pramipexole Immediate Release Group (PPX IR)-9.9

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Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)

UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionUPDRS scores on a scale (Least Squares Mean)
Pramipexole ER: Open-Label Phase-11.9

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Change From Baseline in UPDRS Part IV Score

UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionUPDRS scores on a scale (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-0.2
Pramipexole Immediate Release Group (PPX IR)-0.4

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Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)

UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy (NCT00560508)
Timeframe: baseline and after 64 weeks treatment

InterventionUPDRS scores on a scale (Mean)
Pramipexole ER: Open-Label Phase-0.6

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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score

UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionUPDRS scores on a scale (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-13.6
Pramipexole Immediate Release Group (PPX IR)-13.3

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Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)

Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase) (NCT00560508)
Timeframe: Week 12 to Week 16

Interventionpercentage of participants (Number)
From PPX ER to PPX ER78.4
From PPX IR to PPX ER83.0

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Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)

UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00560508)
Timeframe: Baseline and after 64 weeks treatment

InterventionUPDRS scores on a scale (Mean)
Pramipexole ER: Open-Label Phase-15.2

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Percentage of Participants Who Experienced Adverse Events

An adverse event is defined as any untoward medical occurrence (NCT00560508)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Pramipexole Extended Release Group (PPX ER)83.93
Pramipexole Immediate Release Group (PPX IR)83.93

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Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia

Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)6.0
Pramipexole Immediate Release Group (PPX IR)7.1

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Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)

Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse). (NCT00560508)
Timeframe: Week 12 to Week 16

,
Interventionpercentage of participants (Number)
Very much betterMuch betterA little betterNo changeA little worse
From PPX ER to PPX ER2.014.036.036.012.0
From PPX IR to PPX ER3.811.335.839.69.4

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Responder Rate For Patient Global Impression of Improvement (PGI-I)

PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better) (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

Interventionpercentage of participants (Number)
Pramipexole Extended Release Group (PPX ER)33.9
Pramipexole Immediate Release Group (PPX IR)33.9

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Change From Baseline in Percentage Off-time

Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). (NCT00560508)
Timeframe: baseline and after 12 weeks treatment

InterventionPercentage of off-time (Least Squares Mean)
Pramipexole Extended Release Group (PPX ER)-5.8
Pramipexole Immediate Release Group (PPX IR)-7.8

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Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionmm Hg (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)77.477.4
PPX ER (Previous PPX ER)77.378.3
PPX ER (Previous PPX IR)77.677.2

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Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionbeats per minute (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)73.675.8
PPX ER (Previous PPX ER)72.674.2
PPX ER (Previous PPX IR)73.274.4

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Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionmm Hg (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)121.6124.2
PPX ER (Previous PPX ER)124.5123.8
PPX ER (Previous PPX IR)125.7124.4

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Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionkg (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)73.073.9
PPX ER (Previous PPX ER)72.172.7
PPX ER (Previous PPX IR)70.872.0

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Number of Participants With Response in CGI-I

"Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders" (NCT00577460)
Timeframe: 32 weeks

InterventionPatients (Number)
PPX ER (Previous Placebo)50
PPX ER (Previous PPX ER)106
PPX ER (Previous PPX IR)114
Total PPX ER270

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Number of Participants With Response in Percentage Off Time During Waking Hours

Response means >=20% improvement relative to OL baseline in the % off-time during waking hours (NCT00577460)
Timeframe: 80 weeks

InterventionPatients (Number)
PPX ER (Previous Placebo)35
PPX ER (Previous PPX ER)40
PPX ER (Previous PPX IR)28
Total PPX ER103

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Number of Participants With Response in PGI-I

"Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders" (NCT00577460)
Timeframe: 32 weeks

InterventionPatients (Number)
PPX ER (Previous Placebo)45
PPX ER (Previous PPX ER)102
PPX ER (Previous PPX IR)113
Total PPX ER260

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Number of Participants With Response in PGI-I for Early Morning Off Symptoms

"Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders" (NCT00577460)
Timeframe: 32 weeks

InterventionPatients (Number)
PPX ER (Previous Placebo)45
PPX ER (Previous PPX ER)103
PPX ER (Previous PPX IR)112
Total PPX ER260

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Number of Participants With Serious Adverse Events

(NCT00577460)
Timeframe: 80 weeks

InterventionPatients (Number)
PPX ER (Previous Placebo)14
PPX ER (Previous PPX ER)11
PPX ER (Previous PPX IR)14
Total PPX ER39

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Number of Participants With UPDRS II+III Response

A response means an improvement of >=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00577460)
Timeframe: Week 80

InterventionPatients (Number)
PPX ER (Previous Placebo)35
PPX ER (Previous PPX ER)30
PPX ER (Previous PPX IR)31

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Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time

A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). (NCT00577460)
Timeframe: One week

InterventionPatients (Number)
PPX ER (Previous PPX ER)57
PPX ER (Previous PPX IR)70

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Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80

PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD (NCT00577460)
Timeframe: OL baseline and week 80

InterventionUnit on a scale (Least Squares Mean)
PPX ER (Previous Placebo)-0.3
PPX ER (Previous PPX ER)3.8
PPX ER (Previous PPX IR)3.5

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Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III

Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00577460)
Timeframe: One week

InterventionPatients (Number)
PPX ER (Previous PPX ER)88
PPX ER (Previous PPX IR)106

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Percentage Off Time During Waking Hours Total Score: Change From Baseline

"Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).~A negative change implies improvement" (NCT00577460)
Timeframe: Baseline and week 80

Interventionpercentage during waking hours (Least Squares Mean)
PPX ER (Previous Placebo)-1.5
PPX ER (Previous PPX ER)-0.3
PPX ER (Previous PPX IR)1.7

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Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement (NCT00577460)
Timeframe: Baseline and week 80

Interventionpercentage during waking hours (Least Squares Mean)
PPX ER (Previous Placebo)3.8
PPX ER (Previous PPX ER)-2.7
PPX ER (Previous PPX IR)0.2

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Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement (NCT00577460)
Timeframe: Baseline and week 80

Interventionpercentage during waking hours (Least Squares Mean)
PPX ER (Previous Placebo)-0.4
PPX ER (Previous PPX ER)-0.3
PPX ER (Previous PPX IR)-0.7

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Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement. (NCT00577460)
Timeframe: Baseline and week 80

Interventionpercentage during waking hours (Least Squares Mean)
PPX ER (Previous Placebo)-1.6
PPX ER (Previous PPX ER)2.9
PPX ER (Previous PPX IR)-2.0

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Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement (NCT00577460)
Timeframe: Baseline and week 80

Interventionpercentage during waking hours (Least Squares Mean)
PPX ER (Previous Placebo)1.8
PPX ER (Previous PPX ER)0.7
PPX ER (Previous PPX IR)-0.9

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UPDRS I Total Score and Change From OL Baseline at Week 80

UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood (NCT00577460)
Timeframe: OL baseline and week 80

Interventionunits on a scale (Least Squares Mean)
PPX ER (Previous Placebo)0.1
PPX ER (Previous PPX ER)0.5
PPX ER (Previous PPX IR)0.5

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UPDRS II Total Score and Change From OL Baseline at Week 80

UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities (NCT00577460)
Timeframe: OL baseline and week 80

Interventionunits on a scale (Least Squares Mean)
PPX ER (Previous Placebo)-0.4
PPX ER (Previous PPX ER)0.4
PPX ER (Previous PPX IR)1.0

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UPDRS II+III Change From Open Label (OL) Baseline

UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00577460)
Timeframe: OL Baseline and week 80

InterventionScores on a scale (Least Squares Mean)
PPX ER (Previous Placebo)-3.6
PPX ER (Previous PPX ER)1.1
PPX ER (Previous PPX IR)2.5

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UPDRS III Total Score and Change From OL Baseline at Week 80

UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms (NCT00577460)
Timeframe: OL baseline and week 80

Interventionunits on a scale (Least Squares Mean)
PPX ER (Previous Placebo)-3.1
PPX ER (Previous PPX ER)0.7
PPX ER (Previous PPX IR)1.3

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UPDRS IV Total Score and Change From OL Baseline at Week 80

UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy (NCT00577460)
Timeframe: OL baseline and week 80

InterventionUnit on a scale (Least Squares Mean)
PPX ER (Previous Placebo)0.0
PPX ER (Previous PPX ER)-0.0
PPX ER (Previous PPX IR)0.2

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Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionkg (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)61.963.6
PPX ER (Previous PPX ER)61.761.7
PPX ER (Previous PPX IR)63.863.6

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Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set

ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing) (NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionunits on a scale (Mean)
OL BaselineChange from baseline at end of OL
PPX ER (Previous Placebo)7.20.5
PPX ER (Previous PPX ER)8.11.2
PPX ER (Previous PPX IR)8.11.2

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Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set

The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral. (NCT00577460)
Timeframe: Baseline, 80 weeks

,,
Interventionparticipants (Number)
Abnormal behavior - pathological gamblingAbnormal behavior - compulsive buyingAbnormal behavior - compulsive sexual behavior
PPX ER (Previous Placebo)022
PPX ER (Previous PPX ER)002
PPX ER (Previous PPX IR)020

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Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline

(NCT00577460)
Timeframe: OL baseline and week 80

,,,
InterventionPatients (Number)
ReducedUnchangedIncreased
PPX ER (Previous Placebo)564029
PPX ER (Previous PPX ER)334339
PPX ER (Previous PPX IR)265347
Total PPX ER115136115

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Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80

(NCT00577460)
Timeframe: OL baseline and week 80

,,,
InterventionPatients (Number)
DecreaseIncreaseNo change
PPX ER (Previous Placebo)24893
PPX ER (Previous PPX ER)121884
PPX ER (Previous PPX IR)122793
Total PPX ER4853270

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Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation. (NCT00577460)
Timeframe: 80 weeks

,,
InterventionPercentage of participants (Number)
Percentage of Patients with Adverse EventsPercentage of Patients with Adverse Drug ReactionsPercentage of Patients with Serious Adverse Events
Placebo85.352.710.9
PPX ER83.748.88.9
PPX IR79.945.310.1

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Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionmm Hg (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)77.877.6
PPX ER (Previous PPX ER)77.378.1
PPX ER (Previous PPX IR)77.676.4

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Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionbeats per minute (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)78.379.3
PPX ER (Previous PPX ER)78.077.7
PPX ER (Previous PPX IR)77.778.8

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Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

(NCT00577460)
Timeframe: OL Baseline and Week 80

,,
Interventionmm Hg (Mean)
OL BaselineEnd of OL
PPX ER (Previous Placebo)120.2121.9
PPX ER (Previous PPX ER)121.1121.6
PPX ER (Previous PPX IR)120.9120.5

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Change From Baseline to Week 8 in Hopkins Verbal Learning Test

The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionwords (Mean)
BaselineWeek 8Change from Baseline to Week 8
Active Pramipexole8.008.09.09
Placebo Pramipexole8.138.42.29

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Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)

The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionnumber of correct numbers recalled (Mean)
BaselineWeek 8Change from Baseline to Week 8
Active Pramipexole8.438.48.05
Placebo Pramipexole8.548.13-.41

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Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency

The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionwords (Mean)
BaselineWeek 8Change from Baseline to Week 8
Active Pramipexole38.3339.621.29
Placebo Pramipexole33.6333.50-.13

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Change From Baseline to Week 8 in d2 Test of Attention

"The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the d's with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed." (NCT00597896)
Timeframe: Change from Baseline to Week 8

Interventionunits on a scale (Mean)
Active Pramipexole.90
Placebo Pramipexole1.54

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Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint

"The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 (Insight) which is rated on a 5-point Likert scale. These items yield two subscale scores-one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74." (NCT00597896)
Timeframe: Change from Baseline to Week 8

Interventionunits on a scale (Mean)
Active Pramipexole.5
Placebo Pramipexole-.9

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Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint

The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64. (NCT00597896)
Timeframe: Change from Baseline to Week 8

Interventionunits on a scale (Mean)
Active Pramipexole-.9
Placebo Pramipexole-1.5

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Change From Baseline to Week 8 in Stroop Color-Word Test

The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with 'Xs' printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionwords (Mean)
Word-BaselineWord-Week 8Word- Change from Baseline to Week 8Color- BaselineColor-Week 8Color- Change from Baseline to Week 8Color-Word- BaselineColor-Word-Week 8Color-Word-Change from Baseline to Week 8
Active Pramipexole99.95103.103.1468.1072.244.1441.5743.952.38
Placebo Pramipexole95.4294.33-1.0866.5466.29-.2539.2940.08.79

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Change From Baseline to Week 8 in Trail Making Test Part A

"The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe executive functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8." (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionseconds (Mean)
BaselineWeek 8Change from Baseline to Week 8
Active Pramipexole32.8828.57-4.31
Placebo Pramipexole35.3732.79-2.58

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Change From Baseline to Week 8 in Trail Making Test Part B

"The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe executive functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8." (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionseconds (Mean)
BaselineWeek 8Change from Baseline to Week 8
Active Pramipexole76.9075.55-1.35
Placebo Pramipexole106.1493.39-12.74

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Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)

The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionnumber of correct numbers recalled (Mean)
BaselineWeek 8Change from Baseline to Week 8
Active Pramipexole6.486.86.38
Placebo Pramipexole6.466.67.21

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Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test

Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8. (NCT00597896)
Timeframe: Change from Baseline to Week 8

,
Interventionunits on a scale (Mean)
BaselineWeek 8Change from Baseline to Week 8
Active Pramipexole8.529.05.52
Placebo Pramipexole8.088.75.67

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Patient Rating of Convenience of Treatment Dosing

Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing (NCT00601523)
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

,
Interventionparticipants (Number)
Once Daily much more convenientOnce Daily more convenient3 Times Daily much more convenient3 Times Daily more convenientNo difference in preferenceMissing
Patients From 248.5241967926777
Patients From 248.636591901455

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UPDRS I Total Score: Change From OL Baseline

UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood (NCT00601523)
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

InterventionUnits of scale (Mean)
Patients From 248.5240.3
Patients From 248.6360.1

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UPDRS II Total Score: Change From OL Baseline

UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living. (NCT00601523)
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

InterventionUnits of scale (Mean)
Patients From 248.5241.0
Patients From 248.6360.6

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Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline

UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00601523)
Timeframe: Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

InterventionUnits of scale (Mean)
Patients From 248.5242.2
Patients From 248.6361.5

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Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation (NCT00601523)
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

,
InterventionPercentage of participants (Number)
Percentage of Patients with Adverse EventsPercentage of Patients with Adverse Drug ReactionsPercentage of Patients with Serious Adverse Events
Patients From 248.52484.545.714.4
Patients From 248.63676.223.114.7

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Number of Patients Introducing L-Dopa Medication in OL Trial

Number of patients requiring Levodopa supplementation during the study (NCT00601523)
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

,
InterventionPatients (Number)
NoYes
Patients From 248.52432047
Patients From 248.63611721

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Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline

PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD. (NCT00601523)
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

InterventionUnits of scale (Mean)
Patients From 248.5242.0
Patients From 248.6362.2

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UPDRS III Total Score: Change From OL Baseline

UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms (NCT00601523)
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

InterventionUnits of scale (Mean)
Patients From 248.5241.1
Patients From 248.6360.9

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L-Dopa Dose: Change From OL Baseline

Change from open-label baseline in Levodopa dose (NCT00601523)
Timeframe: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

,
InterventionPatients (Number)
DecreaseIncreaseNo change
Patients From 248.5244919
Patients From 248.63602341

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Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients

Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment (NCT00601523)
Timeframe: Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)

,
InterventionPatients (Number)
DecreaseIncreaseNo change
Patients From 248.52410182156
Patients From 248.63694473

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Response in Patient Global Impression of Improvement (PGI-I)

"Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders" (NCT00601523)
Timeframe: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)

InterventionPatients (Number)
Patients From 248.524265
Patients From 248.636111

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Response in Clinical Global Impression of Improvement (CGI-I)

"Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders" (NCT00601523)
Timeframe: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)

InterventionPatients (Number)
Patients From 248.524284
Patients From 248.636108

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Patient Preference Regarding Treatment Dosing

Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing (NCT00601523)
Timeframe: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

,
Interventionparticipants (Number)
Prefer Once Daily dosingPrefer 3 Times Daily dosingNo PreferenceMissing
Patients From 248.5242759776
Patients From 248.636781455

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Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)

A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms (NCT00601523)
Timeframe: OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)

InterventionPatients (Number)
Patients From 248.52473
Patients From 248.63627

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Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements

Number of Participants with Potentially Clinically Significant Vital Sign Measurements by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group. (NCT00647296)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Systolic Blood Pressure Increase of > 20 mmHg from baseline and >= 180mmHgSystolic Blood Pressure Decrease of < -20 mmHg from baseline and <= 90 mmHgDiastolic Blood Pressure Increase of > 15 mmHg from baseline and >= 105 mmHgDiastolic Blood Pressure Decrease of < -15 mmHg from baseline and <= 50 mmHgPulse Increase of > 15 bpm from baseline and >= 120Pulse Decrease of < -15 bpm from baseline and <= 50Body Weight Increase of > 7% lbs from baselineBody Weight Decrease of < -7% lbs from baseline
Placebo00201100

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Part 2 Double-Blind Treatment: Slope of the ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to Week 28 by Treatment Group

The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis ALSFRS-R score. Units for slope are change per month n units on the ALSFRS-R scale. (NCT00647296)
Timeframe: 28 weeks

Interventionslope (Least Squares Mean)
Dexpramipexole (50 mg/Day)-1.284
Dexpramipexole (300 mg/Day)-1.021

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Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Hematology

Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT00647296)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
White Blood Cell Count (x10^3/uL) < 2000/uLNeutrophils (x10^3/uL) < 1000/uLEosinophils (x10^3/uL) > 5000/uLHemoglobin (g/dL) < 8 g/dLPlatelets (x10^3/uL) < 50,000/uL
Placebo00000

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Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results

Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT00647296)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Creatine Kinase (U/L) >= 10xULNTotal Bilirubin (mg/dL) > 1.5xULNALT (SGPT) (U/L) > 3xULNAST (SGOT) (U/L) > 3xULNAlkaline Phosphatase (U/L) > 1.5xULNBUN (mg/dL) > 5xULNCreatinine (mg/dL) > 3xULNSodium (mEq/L) low < 123 mEq/LSodium (mEq/L) high > 157 mEq/LPotassium (mEq/L) Low < 2.5 mEq/LPotassium (mEq/L) High > 6.5 mEq/LGlucose (mg/dL) Low < 40 mg/dLGlucose (mg/dL) High > 250 mg/dLCalcium (mg/dL) Low < 7 mg/dLCalcium (mg/dL) High > 12.5 mg/dL
Placebo000000000000000

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Part 2 Double-Blind Treatment: Slope of Percent Predicted Upright Vital Capacity From Baseline by Treatment Group

Slope of Upright Vital Capacity (percent predicted) through Week 28. A negative change indicates clinical worsening. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis percent predicted upright vital capacity. Units for slope are change per month in percent predicted upright vital capacity. (NCT00647296)
Timeframe: Baseline of randomized phase of Part 2 to week 28 of randomized phase of Part 2

Interventionslope (Least Squares Mean)
Dexpramipexole (50 mg/Day)-2.452
Dexpramipexole (300 mg/Day)-3.067

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Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group

Number of Participants with Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter. (NCT00647296)
Timeframe: up to 76 weeks

,
InterventionParticipants (Count of Participants)
Rhythm Sinus Tachycardia > 120 bpmRhythm Sinus Bradycardia < 40 bpmRhythm Sinus Block/Sinus ArrestRhythm Junctional RhythmRhythm Atrial FlutterRhythm Atrial FibrillationRhythm SupraventricularRhythm Tachycardia > 100 bpmRhythm Torsades de PointesRhythm Other Ventricular RhythmConduction 1st Degree A-V BlockConduction 2nd Degree A-V BlockConduction 3rd Degree A-V BlockConduction Left Bundle Branch BlockConduction Right Bundle Branch BlockConduction Pre-excitation (PR < 120 msec)Conduction Prolonged QTcBConduction Prolonged QTcFMyocardial Ischemia/Infarction Myocardial IschemiaMyocardial Ischemia/Infarction Possible Myocardial IschemiaMyocardial Ischemia/Infarction Old Myocardial InfarctionMyocardial Ischemia/Infarction Acute or Subacute Myocardial InfarctionMyocardial Ischemia/Infarction Possible Myocardial InfarctionU Wave Abnormal U wave present
300 mg/Day000101000020002031002020
50 mg/Day200000000020001061013040

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Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group

Number of Participants with Potentially Clinically Significant Vital Sign Measurements by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter. (NCT00647296)
Timeframe: up to 76 weeks

,
InterventionParticipants (Count of Participants)
Systolic Blood Pressure Increase of > 20 mmHg from baseline and >= 180mmHgSystolic Blood Pressure Decrease of < -20 mmHg from baseline and <= 90 mmHgDiastolic Blood Pressure Increase of > 15 mmHg from baseline and >= 105 mmHgDiastolic Blood Pressure Decrease of < -15 mmHg from baseline and <= 50 mmHgPulse Increase of > 15 bpm from baseline and >= 120Pulse Decrease of < -15 bpm from baseline and <= 50Body Weight Increase of > 7% lbs from baselineBody Weight Decrease of < -7% lbs from baseline
300 mg/Day011120116
50 mg/Day002310114

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Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group

Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter. (NCT00647296)
Timeframe: up to 76 weeks

,
InterventionParticipants (Count of Participants)
White Blood Cell Count (x10^3/uL) < 2000/uLNeutrophils (x10^3/uL) < 1000/uLEosinophils (x10^3/uL) > 5000/uLHemoglobin (g/dL) < 8 g/dLPlatelets (x10^3/uL) < 50,000/uL
300 mg/Day00010
50 mg/Day00000

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Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group

Number of Participants with Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group. (NCT00647296)
Timeframe: 12 weeks

,,,
InterventionParticipants (Count of Participants)
Rhythm Sinus Tachycardia > 120 bpmRhythm Sinus Bradycardia < 40 bpmRhythm Sinus Block/Sinus ArrestRhythm Junctional RhythmRhythm Atrial FlutterRhythm Atrial FibrillationRhythm SupraventricularRhythm Tachycardia > 100 bpmRhythm Torsades de PointesRhythm Other Ventricular RhythmConduction 1st Degree A-V BlockConduction 2nd Degree A-V BlockConduction 3rd Degree A-V BlockConduction Left Bundle Branch BlockConduction Right Bundle Branch BlockConduction Pre-excitation (PR < 120 msec)Conduction Prolonged QTcBConduction Prolonged QTcFMyocardial Ischemia/Infarction Myocardial IschemiaMyocardial Ischemia/Infarction Possible Myocardial IschemiaMyocardial Ischemia/Infarction Old Myocardial InfarctionMyocardial Ischemia/Infarction Acute or Subacute Myocardial InfarctionMyocardial Ischemia/Infarction Possible Myocardial InfarctionU Wave Abnormal U wave present
150 mg/Day000000000000001010000030
300 mg/Day000001000000000031010000
50 mg/Day000000000010000030101020
Placebo000000000000000030001030

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Part 1: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group

Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT00647296)
Timeframe: 12 weeks

,,,
InterventionParticipants (Count of Participants)
White Blood Cell Count (x10^3/uL) < 2000/uLNeutrophils (x10^3/uL) < 1000/uLEosinophils (x10^3/uL) > 5000/uLHemoglobin (g/dL) < 8 g/dLPlatelets (x10^3/uL) < 50,000/uL
150 mg/Day00000
300 mg/Day00000
50 mg/Day00000
Placebo00000

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Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group

Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT00647296)
Timeframe: 12 weeks

,,,
InterventionParticipants (Count of Participants)
Creatine Kinase (U/L) >= 10xULNTotal Bilirubin (mg/dL) > 1.5xULNALT (SGPT) (U/L) > 3xULNAST (SGOT) (U/L) > 3xULNAlkaline Phosphatase (U/L) > 1.5xULNBUN (mg/dL) > 5xULNCreatinine (mg/dL) > 3xULNSodium (mEq/L) low < 123 mEq/LSodium (mEq/L) high > 157 mEq/LPotassium (mEq/L) Low < 2.5 mEq/LPotassium (mEq/L) High > 6.5 mEq/LGlucose (mg/dL) Low < 40 mg/dLGlucose (mg/dL) High > 250 mg/dLCalcium (mg/dL) Low < 7 mg/dLCalcium (mg/dL) High > 12.5 mg/dL
150 mg/Day000000000000000
300 mg/Day102110000000000
50 mg/Day000000000000000
Placebo000000000000100

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Part 2 Placebo Washout: Absolute Change in Upright Vital Capacity (Percent Predicted) From Baseline to End of Placebo Washout (Week 4)

Absolute change in Upright Vital Capacity From Baseline to Week 4. Units are percent of predicted Upright Vital Capacity. A negative change indicates clinical worsening. (NCT00647296)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Placebo-3.1

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Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group

Number of Participants with Potentially Clinically Significant Vital Sign Measurements by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group. (NCT00647296)
Timeframe: 12 weeks

,,,
InterventionParticipants (Count of Participants)
Systolic Blood Pressure Increase of > 20 mmHg from baseline and >= 180mmHgSystolic Blood Pressure Decrease of < -20 mmHg from baseline and <= 90 mmHgDiastolic Blood Pressure Increase of > 15 mmHg from baseline and >= 105 mmHgDiastolic Blood Pressure Decrease of < -15 mmHg from baseline and <= 50 mmHgPulse Increase of > 15 bpm from baseline and >= 120Pulse Decrease of < -15 bpm from baseline and <= 50Body Weight Increase of > 7% lbs from baselineBody Weight Decrease of < -7% lbs from baseline
150 mg/Day00000000
300 mg/Day00000101
50 mg/Day20111002
Placebo02010003

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Part 2 Placebo Washout: Absolute Change in ALSFRS-R Total Score

"The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function.~Units are points on the ALSFRS-R score as an absolute change from the baseline of the placebo washout to week 4 of the placebo washout." (NCT00647296)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Placebo-1.2

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Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group

Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter. (NCT00647296)
Timeframe: up to 76 weeks

,
InterventionParticipants (Count of Participants)
Creatine Kinase (U/L) >= 10xULNTotal Bilirubin (mg/dL) > 1.5xULNALT (SGPT) (U/L) > 3xULNAST (SGOT) (U/L) > 3xULNAlkaline Phosphatase (U/L) > 1.5xULNBUN (mg/dL) > 5xULNCreatinine (mg/dL) > 3xULNSodium (mEq/L) low < 123 mEq/LSodium (mEq/L) high > 157 mEq/LPotassium (mEq/L) Low < 2.5 mEq/LPotassium (mEq/L) High > 6.5 mEq/LGlucose (mg/dL) Low < 40 mg/dLGlucose (mg/dL) High > 250 mg/dLCalcium (mg/dL) Low < 7 mg/dLCalcium (mg/dL) High > 12.5 mg/dL
300 mg/Day002010000100110
50 mg/Day001110001000100

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Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings

Number of Participants with Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group. (NCT00647296)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Rhythm Sinus Tachycardia > 120 bpmRhythm Sinus Bradycardia < 40 bpmRhythm Sinus Block/Sinus ArrestRhythm Junctional RhythmRhythm Atrial FlutterRhythm Atrial FibrillationRhythm SupraventricularRhythm Tachycardia > 100 bpmRhythm Torsades de PointesRhythm Other Ventricular RhythmConduction 1st Degree A-V BlockConduction 2nd Degree A-V BlockConduction 3rd Degree A-V BlockConduction Left Bundle Branch BlockConduction Right Bundle Branch BlockConduction Pre-excitation (PR < 120 msec)Conduction Prolonged QTcBConduction Prolonged QTcFMyocardial Ischemia/Infarction Myocardial IschemiaMyocardial Ischemia/Infarction Possible Myocardial IschemiaMyocardial Ischemia/Infarction Old Myocardial InfarctionMyocardial Ischemia/Infarction Acute or Subacute Myocardial InfarctionMyocardial Ischemia/Infarction Possible Myocardial InfarctionU Wave Abnormal U wave present
Placebo000000000020002043024040

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Part 1: Slope of Upright Vital Capacity From Baseline to Week 12 by Treatment Group

Slope of change in Upright Vital Capacity (percent predicted upright vital capacity) from Baseline to Week 12. A negative change/slope indicates clinical worsening. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis as percent predicted upright vital capacity. Units for slope are change per month in percent predicted upright vital capacity. (NCT00647296)
Timeframe: 12 weeks

Interventionslope (Least Squares Mean)
Placebo-4.398
Dexpramipexole (50 mg/Day)-4.003
Dexpramipexole (150 mg/Day)-2.389
Dexpramipexole (300 mg/Day)-3.947

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Part 1: Slope of ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to Week 12 by Treatment Group

The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis ALSFRS-R score. Units for slope are change per month in units on the ALSFRS-R scale. (NCT00647296)
Timeframe: 12 weeks

Interventionslope (Least Squares Mean)
Placebo-1.278
Dexpramipexole (50 mg/Day)-1.885
Dexpramipexole (150 mg/Day)-1.165
Dexpramipexole (300 mg/Day)-0.878

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Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore

"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale." (NCT00651183)
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)

InterventionPoints on a scale (Median)
Early PD3
Advanced PD4

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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)

"Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement.~Total UPDRS part I score ranges from 0 = best score to 16 = worst score" (NCT00651183)
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)

InterventionPoints on a scale (Median)
Early PD2
Advanced PD2

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Change From Baseline in UPDRS Part III (Motor Examination)

14 components rating scale with 27 items scored by 0 (none) - 4 (severe) (NCT00651183)
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)

InterventionPoints on a scale (Median)
Early PD9
Advanced PD10

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Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore

"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale." (NCT00651183)
Timeframe: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)

InterventionPoints on a scale (Median)
Early PD2
Advanced PD4

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The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.

"RLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS during the rest at day." (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Mean)
Pramipexole-2.9
Placebo-2.36

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The Proportion of Patient Global Impression(PGI) Responders

"PGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of much better or very much better." (NCT00654498)
Timeframe: 6 weeks of treatment

InterventionProportion of participants (Number)
Pramipexole0.686
Placebo0.435

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The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10

The ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep. (NCT00654498)
Timeframe: week 6 of treatment

InterventionProportion of Patients (Number)
Pramipexole0.108
Placebo0.054

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"The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved"

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved. (NCT00654498)
Timeframe: 6 weeks of treatment

InterventionProportion of Patients (Number)
Pramipexole0.819
Placebo0.543

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The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.

RLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Mean)
Pramipexole-4.9
Placebo-3.53

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The Change From Baseline in Visual Analogue Scales (VAS)

"VAS is for assessment of RLS-associated pain. The patient was asked How severe was your RLS associated pain in legs or arms during the past week?. No pain:0; very worst pain:10" (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Mean)
Pramipexole2.6
Placebo3.9

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The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).

The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms). (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Least Squares Mean)
Pramipexole-15.87
Placebo-11.35

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The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale

"RLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the intensity of tiredness and sleepiness at day." (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Mean)
Pramipexole-2.96
Placebo-2.25

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The Proportion of IRLS Responders

responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population. (NCT00654498)
Timeframe: 6 weeks of treatment

InterventionProportion of Patients (Number)
Pramipexole0.738
Placebo0.489

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The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale

"RLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS during the activity at day." (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Mean)
Pramipexole-0.93
Placebo-0.61

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The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.

"RLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS during the night." (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Mean)
Pramipexole-4.68
Placebo-3.32

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the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales

RLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep. (NCT00654498)
Timeframe: Baseline and 6 weeks of treatment

InterventionScore on a scale (Mean)
Pramipexole-4.52
Placebo-3.04

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 24 (end of treatment visit)

InterventionScore on a scale (Mean)
Pramipexole-22.0

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 24

InterventionScore on a scale (Mean)
Pramipexole-22.0

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 3

InterventionScore on a scale (Mean)
Pramipexole-18.4

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 4

InterventionScore on a scale (Mean)
Pramipexole-20.9

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 8

InterventionScore on a scale (Mean)
Pramipexole-22.4

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and Week 1

InterventionScore on a scale (Mean)
Pramipexole-7.2

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and Week 12

InterventionScore on a scale (Mean)
Pramipexole-12.3

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and Week 16

InterventionScore on a scale (Mean)
Pramipexole-12.4

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and Week 2

InterventionScore on a scale (Mean)
Pramipexole-8.3

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and Week 20

InterventionScore on a scale (Mean)
Pramipexole-11.7

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and week 24

InterventionScore on a scale (Mean)
Pramipexole-9.8
Pramipexole-9.3

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and Week 3

InterventionScore on a scale (Mean)
Pramipexole-8.6

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and week 4

InterventionScore on a scale (Mean)
Pramipexole-9.3

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Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale

Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. (NCT00681863)
Timeframe: baseline and Week 8

InterventionScore on a scale (Mean)
Pramipexole-10.7

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Patients With Adverse Events Leading to Discontinuation of Trial Drug

Number of patients with Adverse Events leading to discontinuation of trial drug (NCT00681863)
Timeframe: 24 Weeks

Interventionparticipants (Number)
Pramipexole1

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Clinical Global Impressions - Improvement

Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00681863)
Timeframe: week 24

Interventionparticipants (Number)
Responder (Much improved or Very much improved)Not Responder
Pramipexole2223

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Clinical Global Impressions - Severity of Illness, Categorized

"Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients).~Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement." (NCT00681863)
Timeframe: week 24

Interventionparticipants (Number)
Improved (change score <= -2)Unchanged (change score of -1, 0, or +1)Worsened (change score >= +2)
Pramipexole11310

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Patient Global Impression - Improvement

Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2). (NCT00681863)
Timeframe: week 24

Interventionparticipants (Number)
Responder (Much better or Very much better)Not Responder
Pramipexole1728

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Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters

Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis) (NCT00681863)
Timeframe: Baseline and 24 weeks

Interventionparticipants (Number)
Haemoglobin - decreaseEosinophils - increasePhosphate - increaseAlkaline phosphatase - increase
Pramipexole2321

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Clinical Global Impressions - Severity of Illness

Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement. (NCT00681863)
Timeframe: week 24

Interventionscore on a scale (Mean)
Pramipexole-1.1

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 1

InterventionScore on a scale (Mean)
Pramipexole-14.5

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 12

InterventionScore on a scale (Mean)
Pramipexole-27.7

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 16

InterventionScore on a scale (Mean)
Pramipexole-28.3

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 2

InterventionScore on a scale (Mean)
Pramipexole-17.4

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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale

Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). (NCT00681863)
Timeframe: baseline and Week 20

InterventionScore on a scale (Mean)
Pramipexole-26.7

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Change in Total Scores of IRLS (International Restless Legs Rating Scale)

"The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.~The change from baseline was calculated as baseline minus the week 12 value." (NCT00721279)
Timeframe: Baseline and final visit (week12)

Interventionscores on a scale (Median)
De-novo Patients17
Pre-treated Patients16

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Change in Global Clinical Impression - Improvement (CGI-I) Scale

The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse (NCT00721279)
Timeframe: baseline and final visit (week 12)

,
Interventionpercentage of participants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worsemissing
De-novo Patients47.045.53.01.80.00.20.02.5
Pre-treated Patients44.642.28.42.40.00.00.02.4

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Correlation of the Change in IRLS at End of Titration and at Final Visit

Correlation of the change in IRLS at end of titration and at final visit (NCT00721279)
Timeframe: Up to 12 weeks

Interventionpercentage of patients (Number)
End of titration - Deterioration (n=517)End of titration - No change (n=517)End of titration - Improvement (n=517)Final Visit - DeteriorationFinal Visit - No changeFinal Visit - Improvement
Overall0.019.780.30.25.494.5

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Frequency Analysis for Baseline Pattern of RLS Symptoms

Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe. (NCT00721279)
Timeframe: Baseline

,
Interventionpercentage of participants (Number)
MildModerateSevereVery Severe
De-novo Patients0.719.362.018.0
Pre-treated Patients2.418.155.424.1

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Frequency of Adverse Events

Frequency of patients with any adverse event, causally related adverse events and serious adverse events (NCT00721279)
Timeframe: Up to 16 weeks

Interventionparticipants (Number)
Any adverse eventCausally related adverse eventserious adverse events
Overall2572

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Change From Baseline in RLS-NDI at Week 12

The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact. (NCT00806026)
Timeframe: Baseline, Week 12

InterventionUnits on a Scale (Least Squares Mean)
Pregabalin 300 mg-8.10
Pramipexole 0.25 mg-4.30
Pramipexole 0.5 mg-14.50
Placebo-6.60

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Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Baseline

Interventionminutes (Mean)
Pregabalin 300 mg90.60
Pramipexole 0.25 mg100.20
Pramipexole 0.5 mg83.90
Placebo79.50

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Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep. (NCT00806026)
Timeframe: Week 12

InterventionUnits on a scale (Mean)
Pregabalin 300 mg66.50
Pramipexole 0.25 mg57.40
Pramipexole 0.5 mg60.20
Placebo57.70

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Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Week 12

Interventionminutes (Mean)
Pregabalin 300 mg41.60
Pramipexole 0.25 mg43.10
Pramipexole 0.5 mg35.90
Placebo47.70

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Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep. (NCT00806026)
Timeframe: Week 12

Interventionhours (Mean)
Pregabalin 300 mg7.00
Pramipexole 0.25 mg6.70
Pramipexole 0.5 mg6.80
Placebo6.70

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Severity of Augmentation Symptoms at Week 12

ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation. (NCT00806026)
Timeframe: Week 12

InterventionUnits on a Scale (Mean)
Pregabalin 300 mg0.90
Pramipexole 0.25 mg1.60
Pramipexole 0.5 mg1.30
Placebo1.40

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RLS-Next Day Impact (RLS-NDI)

The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact. (NCT00806026)
Timeframe: Baseline

InterventionUnits on a Scale (Mean)
Pregabalin 300 mg49.30
Pramipexole 0.25 mg51.90
Pramipexole 0.5 mg58.40
Placebo50.00

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Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12

RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. (NCT00806026)
Timeframe: Week 12

InterventionUnits on Scale (Mean)
Pregabalin 300 mg77.75
Pramipexole 0.25 mg73.33
Pramipexole 0.5 mg75.48
Placebo73.23

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Restless Legs Syndrome (RLS) Symptom Severity

International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life. (NCT00806026)
Timeframe: Baseline

InterventionUnits on a Scale (Mean)
Pregabalin 300 mg22.30
Pramipexole 0.25 mg22.40
Pramipexole 0.5 mg22.10
Placebo22.40

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Percentage of Participants With Augmentation

Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation. (NCT00806026)
Timeframe: Baseline up to Week 52

InterventionPercentage of participants (Number)
Pregabalin 300 mg1.70
Pramipexole 0.25 mg6.60
Pramipexole 0.5 mg9.00

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Medical Outcomes Study-Short Form 36 (SF-36) at Week 12

"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from 0=much worse now to 4=much better now. Higher subscale and summary score reflect better health status." (NCT00806026)
Timeframe: Week 12

,,,
InterventionUnits on a Scale (Mean)
Physical functioningRole physicalBodily painGeneral healthVitalitySocial functioningRole emotionalMental healthSummary physical scoreSummary mental scoreSummary of health status
Placebo83.0081.5065.5072.8059.3086.8087.0078.7075.7078.003.10
Pramipexole 0.25 mg81.9079.6065.2069.8059.0084.5083.9074.6074.2075.503.10
Pramipexole 0.5 mg82.4079.1069.0070.5059.8084.0084.6076.1075.3076.103.20
Pregabalin 300 mg83.7081.2073.3073.6062.4087.2085.1077.4078.0078.003.10

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Percentage of Participants Responding to Treatment at Week 12

"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of very much improved or much improved." (NCT00806026)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Pregabalin 300 mg71.40
Pramipexole 0.25 mg51.20
Pramipexole 0.5 mg62.70
Placebo46.80

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Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12

MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes. (NCT00806026)
Timeframe: Week 12

InterventionParticipants (Number)
Pregabalin 300 mg84
Pramipexole 0.25 mg64
Pramipexole 0.5 mg77
Placebo68

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Limb Pain-Visual Analog Scale (Limb Pain-VAS)

100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. (NCT00806026)
Timeframe: Baseline

Interventionmm (Mean)
Pregabalin 300 mg4.20
Pramipexole 0.25 mg4.30
Pramipexole 0.5 mg4.00
Placebo4.10

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Clinical Global Impressions-Severity (CGI-S) at Week 12

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. (NCT00806026)
Timeframe: Week 12

InterventionUnits on a Scale (Mean)
Pregabalin 300 mg2.90
Pramipexole 0.25 mg3.50
Pramipexole 0.5 mg3.10
Placebo3.70

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Change From Baseline in the RLS Symptom Severity at Week 12

IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life. (NCT00806026)
Timeframe: Baseline, Week 12

InterventionUnits on a Scale (Least Squares Mean)
Pregabalin 300 mg-11.80
Pramipexole 0.25 mg-7.90
Pramipexole 0.5 mg-10.50
Placebo-7.30

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Change From Baseline in SSQ: Subjective WASO at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Baseline, Week 12

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg-49.86
Pramipexole 0.25 mg-33.69
Pramipexole 0.5 mg-37.18
Placebo-32.61

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Change From Baseline in Limb Pain-VAS at Week 12

100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean. (NCT00806026)
Timeframe: Baseline, Week 12

Interventionmm (Least Squares Mean)
Pregabalin 300 mg-3.20
Pramipexole 0.25 mg-2.64
Pramipexole 0.5 mg-2.75
Placebo-2.20

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Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12

SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep. (NCT00806026)
Timeframe: Week 12

Interventionawakenings (Mean)
Pregabalin 300 mg1.10
Pramipexole 0.25 mg1.70
Pramipexole 0.5 mg1.50
Placebo1.80

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Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12

WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. (NCT00806026)
Timeframe: Week 12

,,,
InterventionPercentage of impairment (Mean)
Overall work (n= 10, 7, 11, 10)Activity (n= 18, 22, 25, 20)Work time missed (n= 10, 7, 11, 10)
Placebo14.6023.001.50
Pramipexole 0.25 mg5.7020.900.00
Pramipexole 0.5 mg9.1022.800.00
Pregabalin 300 mg6.0012.200.00

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Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12

MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes. (NCT00806026)
Timeframe: Week 12

,,,
InterventionUnits on a Scale (Mean)
Sleep disturbance (n = 175, 169, 178, 171)Snoring (n = 172, 169, 178, 170)Awakening short of breath (n = 175, 169, 178, 171)Sleep adequacy (n = 128, 120, 133, 125 )Somnolence (n = 175, 169, 178, 171)Sleep quantity (n = 175, 169, 178, 171)Sleep problem index I (n = 175, 169, 178, 171)Sleep problem index II (n = 175, 169, 178, 171)
Placebo38.6024.609.6050.0026.006.5035.0036.30
Pramipexole 0.25 mg39.3025.8012.3054.8027.606.5035.3036.60
Pramipexole 0.5 mg34.4025.8013.8055.2025.506.6033.4034.10
Pregabalin 300 mg30.5029.0010.5061.3023.906.8029.4030.70

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Change in Upright Vital Capacity From Baseline to Week 12

Change in Percent Predicted Upright Vital Capacity from Baseline to Week 12. A negative change indicates clinical worsening. (NCT00931944)
Timeframe: 12 weeks

Interventionpercentage of predicted vital capacity (Mean)
KNS-760704 300 mg/Day-7.7

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Change in Upright Vital Capacity From Baseline to Week 24

Change in Percent Predicted Upright Vital Capacity from Baseline to Week 24. A negative change indicates clinical worsening. (NCT00931944)
Timeframe: 24 weeks

Interventionpercentage of predicted vital capacity (Mean)
KNS-760704 300 mg/Day-12.5

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Change in Upright Vital Capacity From Baseline to Week 48

Change in Percent Predicted Upright Vital Capacity from Baseline to Week 48. A negative change indicates clinical worsening. (NCT00931944)
Timeframe: 48 weeks

Interventionpercentage of predicted vital capacity (Mean)
KNS-760704 300 mg/Day-15.8

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Number of Subjects With Feeding Tube Placed During the Study.

Number of participants who had a feeding tube placed during the study. (NCT00931944)
Timeframe: 144 weeks

Interventionparticipants (Number)
KNS-760704 300 mg/Day24

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Number of Participants With Potentially Clinically ECG Abnormalities

Number of participants with potentially clinically significant ECG abnormalities for the safety population are presented. Percentages are based on the number of patients in the safety population who had at least one non-missing, post-baseline value. (NCT00931944)
Timeframe: 180 weeks

InterventionParticipants (Count of Participants)
Axis - LEFT AXIS DEVIATIONAxis - RIGHT AXIS DEVIATIONConduction - LEFT ANTERIOR HEMIBLOCKConduction - RSR' SUGGESTS RIGHT VENTRICULAR CONDUCTION DELAYConduction - SHORT P-R INTERVALMorphology - LEFT ATRIAL ENLARGEMENTMorphology - LEFT VENTRICULAR HYPERTROPHY BY VOLTAGE CRITERIA ONLYMorphology - LEFT VENTRICULAR HYPERTROPHY WITH REPOLARIZATION ABNORMALITIESMorphology - POSSIBLE RIGHT VENTRICULAR HYPERTROPHYMorphology - RIGHT VENTRICULAR HYPERTROPHYMyocardial Ischemia/Infarction - ANTEROSEPTAL MYOCARDIAL INFARCTION - AGE UNDETERMINEDMyocardial Ischemia/Infarction - CANNOT RULE OUT POSSIBLE MYOCARDIAL INFARCTION (INFERIOR)Myocardial Isch/Infar. CANNOT RULE OUT POSSIBLE MYOCARDIAL INFARCTION MAY BE IMPROPER LEAD POSITIONSMyocardial Ischemia/Infarction - INFERIOR MYOCARDIAL INFARCTION - AGE UNDETERMINEDMyocardial Ischemia/Infarction - OLD INFERIOR MYOCARDIAL INFARCTIONOther - POOR PRECORDIAL R WAVE PROGRESSION. POSSIBLE IMPROPER PLACEMENT OF V LEADS.Other - POOR R WAVE PROGRESSION, PRECORDIAL LEADSQT Interval - QTCB BORDERLINE PROLONGEDRhythm - ATRIAL FLUTTER WITH 3:1 VENTRICULAR RESPONSERhythm - FREQUENT VENTRICULAR PREMATURE BEATSRhythm - RARE VENTRICULAR PREMATURE BEATSRhythm - SINUS BRADYCARDIARhythm - SINUS TACHYCARDIARhythm - UNUSUAL P AXIS, POSSIBLE ECTOPIC ATRIAL RHYTHMRhythm - VENTRICULAR PREMATURE BEATSST-T Wave - COUNTERCLOCKWISE ROTATIONST-T Wave - EARLY REPOLARIZATIONST-T Wave - NON-SPECIFIC ST ABNORMALITYST-T Wave - NON-SPECIFIC ST AND T WAVE ABNORMALITYST-T Wave - NON-SPECIFIC T WAVE ABNORMALITY
KNS-760704 300 mg/Day51233221111111113911122511112114

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Number of Participants With Potentially Clinically Significant Hematology Results

Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT00931944)
Timeframe: 180 weeks

InterventionParticipants (Count of Participants)
WBC (<3.0 x 10^9/L)WBC (>=16.0 x 10^9/L)Neutrophils (<1.5 x 10^9/L)Neutrophils (>13.5 x 10^9/L)
KNS-760704 300 mg/Day5234

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Number of Participants With Potentially Clinically Significant Liver Enzyme Abnormalities

Number of participants with potentially clinically significant liver enzyme abnormalities for the safety population are presented. Percentages are based on the number of patients with at least one non-missing, post-baseline value for each parameter. (NCT00931944)
Timeframe: 180 weeks

InterventionParticipants (Count of Participants)
Alkaline phosphatase >2.5 times ULN (upper limit of the 'normal' reference range)ALT >3 times ULNAST >3 times ULNTotal Bilirubin >1.5 times ULNCreatinine >1.5 times ULNALT or AST >3 times ULN and total bilirubin >2 times ULN (Hy's Law)
KNS-760704 300 mg/Day152300

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Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Number of participants with potentially clinically significant vital sign abnormalities for the safety population are presented. Percentages are based on the number of patients with at least one non-missing, post-baseline value for each parameter. (NCT00931944)
Timeframe: 180 weeks

InterventionParticipants (Count of Participants)
Temperature - >38 degree C. post-baseline and an increase from baseline of at least 1 degree CelsiusPulse Rate - >120 bpm post-baseline or an increase from baseline of >20 bpmPulse Rate - >120 bpm post-baseline and an increase from baseline of >20 bpmPulse Rate - <50 bpm post-baseline or a decrease from baseline of >20 bpmPulse Rate - <50 bpm post-baseline and a decrease from baseline of >20 bpmSystolic Blood Pressure - >180 mmHg post-baseline or an increase from baseline of >40 mmHgSystolic Blood Pressure - >180 mmHg post-baseline and an increase from baseline of >40 mmHgSystolic Blood Pressure - <90 mmHg post-baseline or a decrease from baseline of >30 mmHgSystolic Blood Pressure - <90 mmHg post-baseline and a decrease from baseline of >30 mmHgDiastolic Blood Pressure - >105 mmHg post-baseline or an increase from baseline of >30 mmHgDiastolic Blood Pressure - >105 mmHg post-baseline and an increase from baseline of >30 mmHgDiastolic Blood Pressure - <50 mmHg post-baseline or a decrease from baseline of >20 mmHgDiastolic Blood Pressure - <50 mmHg post-baseline and a decrease from baseline of >20 mmHgWeight - Increase from baseline of >7%Weight - Decrease from baseline of >7%
KNS-760704 300 mg/Day4261903111140130432

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Change in ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) Total Score From Baseline to Week 24

The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48. Therefore, the score ranges from 0 to 48 with higher scores representing better function. (NCT00931944)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
KNS-760704 300 mg/Day-4.29

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Change in McGill Single-Item Scale (SIS) From Baseline to Week 12

The McGill SIS consists of a single question designed to assess the improvement of or the rate of deterioration of the subject's quality-of-life. Subjects rated their quality of life over the prior 2 days on a scale of 0 (very bad) to 10 (excellent). Decreases from Baseline indicate deterioration of a subject's quality of life. (NCT00931944)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
KNS-760704 300 mg/Day-0.1

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Change in McGill Single-Item Scale (SIS) From Baseline to Week 24

The McGill SIS consists of a single question designed to assess the improvement of or the rate of deterioration of the subject's quality-of-life. Subjects rated their quality of life over the prior 2 days on a scale of 0 (very bad) to 10 (excellent). Decreases from Baseline indicate deterioration of a subject's quality of life. (NCT00931944)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
KNS-760704 300 mg/Day-0.5

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Change in McGill Single-Item Scale (SIS) From Baseline to Week 48

The McGill SIS consists of a single question designed to assess the improvement of or the rate of deterioration of the subject's quality-of-life. Subjects rated their quality of life over the prior 2 days on a scale of 0 (very bad) to 10 (excellent). Decreases from Baseline indicate deterioration of a subject's quality of life. (NCT00931944)
Timeframe: 48 weeks

Interventionunits on a scale (Mean)
KNS-760704 300 mg/Day-0.8

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Change in ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) Total Score From Baseline to Week 12

The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48. Therefore, the score ranges from 0 to 48 with higher scores representing better function. (NCT00931944)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
KNS-760704 300 mg/Day-2.48

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Change in ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) Total Score From Baseline to Week 48

The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48. Therefore, the score ranges from 0 to 48 with higher scores representing better function. (NCT00931944)
Timeframe: 48 weeks

Interventionunits on a scale (Mean)
KNS-760704 300 mg/Day-7.49

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Medical Outcomes Study - Sleep Scale (MOS-SS)

MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity[range 0-24 hours], optimal sleep[range 0-1: 0= <7 or >8 hours;1=7/8 hours]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionunits on a scale (Least Squares Mean)
Awaken Short of Breath/with Headache (n= 68,71,69)Adequacy (n= 68,71,69)Somnolence (n= 68,71,69)Sleep Quantity (n= 68,71,69)6-Item Sleep Problems Index (n= 68,71,69)9-Item Sleep Problems Index (n= 68,71,69)Optimal Sleep (n= 68,71,69)Sleep Disturbance (n= 68,71,69)Snoring (n= 67,71,68)
Placebo10.8840.7923.715.9740.5942.890.2948.6517.96
Pramipexole 0.5 mg13.1043.9021.326.5037.2437.880.3540.1915.97
Pregabalin 300 mg11.5954.9621.286.4330.6932.750.4334.0815.27

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Latency to Stage R Sleep (LREM)

LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg95.22
Pramipexole 0.5 mg130.99
Placebo84.52

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Number of Arousals (NASO)

NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionarousals (Least Squares Mean)
Pregabalin 300 mg17.84
Pramipexole 0.5 mg24.19
Placebo20.29

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Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)

NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM [Stage N2] 30-second (30-sec) epoch, Stage 3 Non-REM [Stage N3] 30-sec epoch, or stage rapid eye movement [stage R] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionawakenings (Least Squares Mean)
Pregabalin 300 mg18.43
Pramipexole 0.5 mg26.30
Placebo21.10

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Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)

NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionawakenings (Least Squares Mean)
Pregabalin 300 mg7.68
Pramipexole 0.5 mg12.39
Placebo10.55

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Wake After Sleep Onset (WASO)

WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep [WTDS] epochs + Wake Time After Sleep [WTAS] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg51.50
Pramipexole 0.5 mg78.42
Placebo78.60

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Minutes of Stage N1, N2, N3 and R Sleep

Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionminutes (Least Squares Mean)
Stage N1 SleepStage N2 SleepStage N3 Sleep/SWSStage R Sleep
Placebo43.72204.3545.9575.37
Pramipexole 0.5 mg48.38241.5234.7851.80
Pregabalin 300 mg38.06227.0566.8870.40

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Restless Legs Syndrome-Next Day Impact (RLS-NDI)

RLS-NDI:participant-rated instrument to assess daytime performance and participant's previous night's sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET

Interventionunits on a scale (Least Squares Mean)
Pregabalin 300 mg41.43
Pramipexole 0.5 mg46.33
Placebo46.78

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Latency to Persistent Sleep (LPS)

"LPS, as determined by PSG, was number of epochs from the beginning of the recording (lights-out) to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model." (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg31.13
Pramipexole 0.5 mg31.52
Placebo38.86

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Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)

RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionunits on a scale (Least Squares Mean)
Pregabalin 300 mg73.30
Pramipexole 0.5 mg70.05
Placebo68.03

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Periodic Limb Movement Index (PLMI)

PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionmovement/hour (Least Squares Mean)
Pregabalin 300 mg25.45
Pramipexole 0.5 mg14.11
Placebo39.95

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Hourly and Quarterly Assessment of Sleep Efficiency (SE)

SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionpercentage of time asleep (Least Squares Mean)
Hour 1Hour 2Hour 3Hour 4Hour 5Hour 6Hour 7Hour 8Quarter 1Quarter 2Quarter 3Quarter 4
Placebo57.8077.3181.8682.6182.9282.4979.8669.7567.6282.3082.7574.84
Pramipexole 0.5 mg66.8883.4384.8679.8481.8581.6480.9069.5175.1582.3781.7475.16
Pregabalin 300 mg62.3186.1390.2289.4190.0090.3384.7078.0774.2189.8490.0981.37

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Periodic Limb Movement in Sleep Index (PLMSI)

PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionmovement/hour (Least Squares Mean)
Pregabalin 300 mg22.42
Pramipexole 0.5 mg8.00
Placebo36.95

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Periodic Limb Movement Arousal Index (PLMAI)

PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionmovement/hour (Least Squares Mean)
Pregabalin 300 mg3.93
Pramipexole 0.5 mg2.66
Placebo7.61

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International Restless Legs Syndrome Study Group Rating Scale (IRLS)

IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionunits on a scale (Least Squares Mean)
Pregabalin 300 mg12.28
Pramipexole 0.5 mg15.35
Placebo18.38

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Arousal Index (NASOI)

Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionarousals/hour (Least Squares Mean)
Pregabalin 300 mg2.75
Pramipexole 0.5 mg4.18
Placebo3.44

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Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale

CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected. (NCT00991276)
Timeframe: Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionpercentage of participants (Number)
Pregabalin 300 mg61.2
Pramipexole 0.5 mg50.0
Placebo33.3

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Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)

PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionmovement/hour (Least Squares Mean)
Hour 1Hour 2Hour 3Hour 4Hour 5Hour 6Hour 7Hour 8Quarter 1Quarter 2Quarter 3Quarter 4
Placebo54.6752.9348.7646.5836.1732.4727.0420.97107.5695.3168.6648.01
Pramipexole 0.5 mg21.5712.4914.0514.5011.9310.5711.1116.5534.0228.5522.4927.64
Pregabalin 300 mg31.4526.3840.9330.3525.7021.0214.2213.3757.8271.2946.7727.60

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Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)

NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionawakenings (Least Squares Mean)
Hour 1 (n= 66, 67, 66)Hour 2 (n= 67, 70, 66)Hour 3 (n= 67, 70, 67)Hour 4 (n= 67, 70, 68)Hour 5 (n= 67, 70, 68)Hour 6 (n= 67, 71, 68)Hour 7 (n= 67, 71, 68)Hour 8 (n= 67, 71, 68)Quarter 1 (n= 67, 70, 66)Quarter 2 (n= 67, 70, 68)Quarter 3 (n= 67, 71, 68)Quarter 4 (n= 67, 71, 68)
Placebo0.731.371.411.481.481.441.571.282.062.852.922.86
Pramipexole 0.5 mg0.611.721.711.841.761.571.941.562.273.563.303.44
Pregabalin 300 mg0.421.040.991.011.061.021.241.001.431.992.102.25

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Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)

NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionawakenings (Least Squares Mean)
Hour 1 (n= 66, 67, 66)Hour 2 (n= 67, 70, 66)Hour 3 (n= 67, 70, 67)Hour 4 (n= 67, 70, 68)Hour 5 (n= 67, 70, 68)Hour 6 (n= 67, 71, 68)Hour 7 (n= 67, 71, 68)Hour 8 (n= 67, 71, 68)Quarter 1 (n= 67, 70, 66)Quarter 2 (n= 67, 70, 68)Quarter 3 (n= 67, 71, 68)Quarter 4 (n= 67, 71, 68)
Placebo1.102.472.662.712.873.163.323.113.495.326.046.44
Pramipexole 0.5 mg1.393.323.423.833.763.684.043.464.617.277.377.36
Pregabalin 300 mg0.702.062.092.442.472.913.072.762.714.535.395.87

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Hourly and Quarterly Assessment of Number of Arousals (NASO)

NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionarousals (Least Squares Mean)
Hour 1 (n= 66, 67, 66)Hour 2 (n= 67, 70, 66)Hour 3 (n= 67, 70, 67)Hour 4 (n= 67, 70, 68)Hour 5 (n= 67, 70, 68)Hour 6 (n= 67, 71, 68)Hour 7 (n= 67, 71, 68)Hour 8 (n= 67, 71, 68)Quarter 1 (n= 67, 70, 66)Quarter 2 (n= 67, 70, 68)Quarter 3 (n= 67, 71, 68)Quarter 4 (n= 67, 71, 68)
Placebo1.792.682.802.762.892.702.662.464.265.555.615.13
Pramipexole 0.5 mg2.063.233.233.413.203.303.282.985.096.676.446.24
Pregabalin 300 mg1.482.362.312.942.332.392.152.073.755.254.754.23

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Wake Time During Sleep (WTDS)

WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg45.77
Pramipexole 0.5 mg70.51
Placebo69.75

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Wake Time After Sleep (WTAS)

WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg5.58
Pramipexole 0.5 mg7.86
Placebo8.88

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Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)

WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

,,
Interventionminutes (Least Squares Mean)
Hour 1 (n= 66, 67, 66)Hour 2 (n= 67, 70, 66)Hour 3 (n= 67, 70, 67)Hour 4 (n= 67, 70, 68)Hour 5 (n= 67, 70, 68)Hour 6 (n= 67, 71, 68)Hour 7 (n= 67, 71, 68)Hour 8 (n= 67, 71, 68)Quarter 1 (n= 67, 70, 66)Quarter 2 (n= 67, 70, 68)Quarter 3 (n= 67, 71, 68)Quarter 4 (n= 67, 71, 68)
Placebo3.357.398.909.5210.0410.5212.0918.1510.3518.1820.5530.21
Pramipexole 0.5 mg2.267.078.2311.5410.3910.5411.4418.278.9919.7720.7729.55
Pregabalin 300 mg1.625.044.896.215.935.789.1813.166.4211.0811.8122.37

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Total Sleep Time (TST)

TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg402.38
Pramipexole 0.5 mg376.52
Placebo369.66

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Subjective Total Sleep Time (sTST)

sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg400.97
Pramipexole 0.5 mg374.19
Placebo370.16

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Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale

SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg53.78
Pramipexole 0.5 mg82.23
Placebo79.09

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Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale

SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET

Interventionunits on a scale (Least Squares Mean)
Pregabalin 300 mg6.74
Pramipexole 0.5 mg5.69
Placebo5.70

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Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale

SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET

Interventionawakenings (Least Squares Mean)
Pregabalin 300 mg1.69
Pramipexole 0.5 mg2.64
Placebo2.51

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Subjective Sleep Questionnaire (SSQ): Latency Subscale

SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep [in minutes]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET

Interventionminutes (Least Squares Mean)
Pregabalin 300 mg42.49
Pramipexole 0.5 mg40.59
Placebo50.07

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Sleep Efficiency (SE)

SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

InterventionPercentage of time asleep (Least Squares Mean)
Pregabalin 300 mg83.81
Pramipexole 0.5 mg78.58
Placebo77.02

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% Change in Hamilton Depression Rating Scale From Baseline to week8

"Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores equals more depression. For the change score, where higher equals greater improvement in depressive symptoms.~Healthy controls were not utilized in this analysis, as no week 8 ratings for health controls were obtained." (NCT01066897)
Timeframe: Baseline and weeks 8

Interventionpercentage reduction in depression score (Mean)
Pramipexole.46

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Number of Participants Who Discontinued Study Due to Side-effects of the Medication

(NCT01066897)
Timeframe: throughout the 8 weeks

InterventionParticipants (Count of Participants)
Pramipexole2
Healthy Controls Who Did Not Take Medication0

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

Bioequivalence based on AUC0-inf. (NCT01074450)
Timeframe: Blood samples collected over a 48 hour period.

Interventionng*h/mL (Mean)
Test (Pramipexole Dihydrochloride)7.09
Reference (Mirapex®)6.82

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t. (NCT01074450)
Timeframe: Blood samples collected over a 48 hour period.

Interventionng*h/mL (Mean)
Test (Pramipexole Dihydrochloride)6.52
Reference (Mirapex®)6.26

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax. (NCT01074450)
Timeframe: Blood samples collected over a 48 hour period.

Interventionng/mL (Mean)
Test (Pramipexole Dihydrochloride)0.54
Reference (Mirapex®)0.55

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax. (NCT01074463)
Timeframe: Blood samples collected over a 48 hour period.

Interventionng/mL (Mean)
Test (Pramipexole Dihydrochloride)0.61
Reference (Mirapex®)0.54

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t. (NCT01074463)
Timeframe: Blood samples collected over a 48 hour period.

Interventionng*h/mL (Mean)
Test (Pramipexole Dihydrochloride)5.86
Reference (Mirapex®)5.68

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

Bioequivalence based on AUC0-inf. (NCT01074463)
Timeframe: Blood samples collected over a 48 hour period.

Interventionng*h/mL (Mean)
Test (Pramipexole Dihydrochloride)6.27
Reference (Mirapex®)6.17

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Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment

Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method. (NCT01097421)
Timeframe: 8-12 weeks

InterventionPercent (Number)
Pramipexole Extended Release75.2

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Clinical Global Impressions (CGI)

Clinical Global Impression (CGI) scale at final visit (NCT01097421)
Timeframe: 8-12 weeks

InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Pramipexole Extended Release0381061492670

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Level of Adherence

Points on Morisky scale (NCT01097421)
Timeframe: 8-12 weeks

InterventionParticipants (Number)
Low AdherenceModerate AdherenceHigh Adherence
Pramipexole Extended Release477245

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Patient Preference

Patients were asked about their preference regarding frequency of intake (once daily or three times daily) (NCT01097421)
Timeframe: 8-12 weeks

InterventionParticipants (Number)
Once daily intakeThree times daily intakeNo difference
Pramipexole Extended Release2841824

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Patients Global Impressions (PGI)

Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation. (NCT01097421)
Timeframe: 8-12 weeks

InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Pramipexole Extended Release345911383991

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Pramipexole (PPX) Dose

mean Pramipexole (PPX) dose (NCT01097421)
Timeframe: pre-treatment and after 8-12 weeks

Interventionmg/24 hr (Mean)
pre-treatment immediate release doseextended release dose at final observation
Pramipexole Extended Release1.071.05

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Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18

Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole ER-0.142
Pramipexole IR0.226

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Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18

Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole ER-0.235
Pramipexole IR3.275

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Change From Baseline in Percentage Off-time During Waking Hours at Week 18

Percentage off-time during waking hours based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionPercentage off-time (Least Squares Mean)
Pramipexole ER-6.962
Pramipexole IR-7.443

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Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks

ESS is a patient-report scale with 8 items rating how likely one is to fall asleep during passive and inconsequential situations such as watching television, more active situations such as sitting and talking to someone, or consequential situations such as sitting in a car, while stopped for a few minutes in traffic. The likelihood of dozing off is rated from 0 points (no chance) to 3 points (high chance). The overall rating scale is scored from 0 (no daytime sleep) to 24 (worst daytime sleep). (NCT01191944)
Timeframe: Baseline and week 18

InterventionUnits on a scale (Mean)
Pramipexole ER0.1
Pramipexole IR-0.0

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Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18

Duration of on-time without Dyskinesia or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

Interventionhours (Least Squares Mean)
Pramipexole ER0.982
Pramipexole IR1.013

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Change From Baseline in Duration of On-time Without Dyskinesia at Week 18

Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

Interventionhours (Least Squares Mean)
Pramipexole ER1.026
Pramipexole IR0.496

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Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18

Duration of on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the duration represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

Interventionhours (Least Squares Mean)
Pramipexole ER-0.000
Pramipexole IR0.031

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Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18

Duration on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

Interventionhours (Least Squares Mean)
Pramipexole ER-0.044
Pramipexole IR0.518

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Change From Baseline in Duration of Off-time During Waking Hours at Week 18

Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

Interventionhours (Least Squares Mean)
Pramipexole ER-1.044
Pramipexole IR-1.098

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Responder in UPDRS Parts II+III Score at Week 18

Responders were defined as patients with at least a 20 percent improvement of UPDRS II+III score relative to baseline. UPDRS II+III ranges 0-160 scores from best to worst and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). (NCT01191944)
Timeframe: Baseline and week 18

,
InterventionParticipants (Number)
ResponderNon-Responder
Pramipexole ER16464
Pramipexole IR15482

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Responder in Percentage Off-time During Waking Hours at Week 18

Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline. (NCT01191944)
Timeframe: Baseline and week 18

,
InterventionParticipants (Number)
ResponderNon-Responder
Pramipexole ER5852
Pramipexole IR5947

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Patient Global Impressions of Improvement (PGI-I) Responder at Week 18

The PGI-I scale is a patient-rated instrument which was used to measure the improvement of a patients PD symptoms throughout the study. Ranging from 1 point=very much better to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much better) when comparing the past week to the assessment at baseline. (NCT01191944)
Timeframe: 18 weeks

,
InterventionParticipants (Number)
ResponderNon-Responder
Pramipexole ER119109
Pramipexole IR127109

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Levodopa (L-Dopa) Introduction During the Study

Number of patients without concomitant L-Dopa treatment at baseline which required L-Dopa supplementation during the study. (NCT01191944)
Timeframe: 18 weeks

,
InterventionParticipants (Number)
with L-Dopa introductionwithout L-Dopa introduction
Pramipexole ER124
Pramipexole IR040

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Clinical Global Impression of Improvement (CGI-I) Responder at Week 18

CGI-I was used to assess the overall status of Parkinsons disease (PD) after interviewing the patient about the various aspects of the PD and after evaluating adverse events and concomitant treatments. Ranging from 1 point=very much improved to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much improved) when comparing the past week to the assessment at baseline. (NCT01191944)
Timeframe: 18 weeks

,
InterventionParticipants (Number)
ResponderNon-Responder
Pramipexole ER12599
Pramipexole IR13895

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Levodopa (L-Dopa) Dose Change During the Study

Although the number of patients who began the study with concomitant L-dopa supplementation and required a change in dosage was not analysed for this study, the change from baseline in L-dopa dose is presented. (NCT01191944)
Timeframe: 18 weeks

Interventionmg (Mean)
Pramipexole ER-5.17
Pramipexole IR-11.22

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Change From Baseline in UPDRS III Score Separately at Week 18

UPDRS Part III (motor examination) ranges from 0 to 108. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-10.068
Pramipexole IR-9.440

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Change From Baseline in UPDRS II Score Separately at Week 18

UPDRS Part II (activities of daily living) ranges from 0 to 52. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-3.750
Pramipexole IR-3.596

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Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18

UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionUnits on a scale (Least Squares Mean)
Pramipexole ER-13.807
Pramipexole IR-13.047

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Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18

Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole ER6.855
Pramipexole IR7.476

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Change From Baseline in Percentage On-time Without Dyskinesia at Week 18

Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. (NCT01191944)
Timeframe: Baseline and week 18

InterventionPercentage of on-time (Least Squares Mean)
Pramipexole ER7.028
Pramipexole IR4.265

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Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)

Cavg = Average concentration of the analyte in plasma at steady state (NCT01214109)
Timeframe: 27 days

Interventionng/mL (Geometric Mean)
0.375 mg q.d.ER0.277
0.125 mg t.i.d. IR0.310
1.5 mg q.d. ER1.04
0.5 mg t.i.d. IR1.14

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Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)

Cmax = maximum observed concentration of the analyte in plasma at steady state (NCT01214109)
Timeframe: 27 days

Interventionng/mL (Geometric Mean)
0.375 mg q.d.ER0.416
0.125 mg t.i.d. IR0.469
1.5 mg q.d. ER1.10
0.5 mg t.i.d. IR1.20

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Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)

Cmax,ss = maximum observed concentration of the analyte in plasma at steady state (NCT01214109)
Timeframe: 27 days

Interventionng/mL (Geometric Mean)
0.375 mg q.d.ER0.436
0.125 mg t.i.d. IR0.463
1.5 mg q.d. ER1.56
0.5 mg t.i.d. IR1.61

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Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)

Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state (NCT01214109)
Timeframe: 27 days

Interventionng/mL (Geometric Mean)
0.375 mg q.d.ERNA
0.125 mg t.i.d. IRNA
1.5 mg q.d. ERNA
0.5 mg t.i.d. IR0.478

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Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)

Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state (NCT01214109)
Timeframe: 27 days

Interventionng/mL (Geometric Mean)
0.375 mg q.d.ERNA
0.125 mg t.i.d. IRNA
1.5 mg q.d. ER0.403
0.5 mg t.i.d. IR0.609

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Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)

PTF = Peak-to-trough fluctuation is measured as a percent (NCT01214109)
Timeframe: 27 days

Interventionpercent (Geometric Mean)
0.375 mg q.d.ER112
0.125 mg t.i.d. IR86.6
1.5 mg q.d. ER101
0.5 mg t.i.d. IR78.2

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Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)

PTF = Peak-to-trough fluctuation is measured as a percent (NCT01214109)
Timeframe: 27 days

Interventionpercent (Geometric Mean)
0.375 mg q.d.ER109
0.125 mg t.i.d. IR86.2
1.5 mg q.d. ER103
0.5 mg t.i.d. IR82.5

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Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)

tmax = time of maximum observed plasma concentration (NCT01214109)
Timeframe: 27 days

Interventionhours (Median)
0.375 mg q.d.ER4.00
0.125 mg t.i.d. IR1.00
1.5 mg q.d. ER4.00
0.5 mg t.i.d. IR1.00

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Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)

tmax = time of maximum observed plasma concentration (NCT01214109)
Timeframe: 27 days

Interventionhours (Median)
0.375 mg q.d.ER4.00
0.125 mg t.i.d. IR1.00
1.5 mg q.d. ER4.00
0.5 mg t.i.d. IR1.00

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The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)

CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration (NCT01214109)
Timeframe: 27 days

InterventionmL/min (Geometric Mean)
0.375 mg q.d.ER942
0.125 mg t.i.d. IR839
1.5 mg q.d. ER1008
0.5 mg t.i.d. IR911

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The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)

CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration (NCT01214109)
Timeframe: 27 days

InterventionmL/min (Geometric Mean)
0.375 mg q.d.ER1007
0.125 mg t.i.d. IR833
1.5 mg q.d. ER1310
0.5 mg t.i.d. IR1228

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Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)

t1/2,ss - Apparent plasma terminal elimination half-life at steady state (NCT01214109)
Timeframe: 27 days

Interventionh (Geometric Mean)
0.375 mg q.d.ER13.4
0.125 mg t.i.d. IR7.68
1.5 mg q.d. ER14.5
0.5 mg t.i.d. IR7.92

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Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)

t1/2,ss - Apparent plasma terminal elimination half-life at steady state (NCT01214109)
Timeframe: 27 days

Interventionh (Geometric Mean)
0.375 mg q.d.ER13.3
0.125 mg t.i.d. IR7.69
1.5 mg q.d. ER14.4
0.5 mg t.i.d. IR8.43

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Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)

Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration (NCT01214109)
Timeframe: 27 days

InterventionL (Geometric Mean)
0.375 mg q.d.ER1167
0.125 mg t.i.d. IR545
1.5 mg q.d. ER1671
0.5 mg t.i.d. IR897

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Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)

Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration (NCT01214109)
Timeframe: 27 days

InterventionL (Geometric Mean)
0.375 mg q.d.ER1092
0.125 mg t.i.d. IR547
1.5 mg q.d. ER1211
0.5 mg t.i.d. IR625

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Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)

Cavg = Average concentration of the analyte in plasma at steady state (NCT01214109)
Timeframe: 27 days

Interventionng/mL (Geometric Mean)
0.375 mg q.d.ER0.259
0.125 mg t.i.d. IR0.312
1.5 mg q.d. ER0.796
0.5 mg t.i.d. IR0.848

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Death up to 18 Months

Estimated time to death up to 18 months. This includes deaths reported greater than 30 days following discontinuation from the study (the time period for reporting all-cause mortality), regardless of subject disposition, up to 18 months from first dose. (NCT01281189)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Placebo23.1
Dexpramipexole20.5

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Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component)

The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function. (NCT01281189)
Timeframe: 12 months

Interventionunits on a scale (Least Squares Mean)
Placebo-13.415
Dexpramipexole-13.339

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Composite Assessment of Function and Survival (CAFS) at 12 Months

The Composite Assessment of Function and Survival (CAFS) is a between-group comparison of a single ranked clinical outcome based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than less worsening or an improvement in ALSFRS-R). The ranked scores range from 001 to 941 (the number of subjects in the Efficacy Population) with larger rank score numbers associated with a better outcome. The ranks were analyzed using an ANCOVA model, which includes treatment as a fixed effect and adjusts for baseline ALSFRS-R score, duration of symptoms, site of onset, and use of riluzole. The least square mean rank score is presented for each treatment group. (NCT01281189)
Timeframe: 12 months

Interventionunits on a scale (Least Squares Mean)
Placebo438.84
Dexpramipexole441.76

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Death or Respiratory Insufficiency (DRI) up to Month 18

Time to Death or Respiratory Insufficiency (DRI) is defined as receipt of a tracheostomy or the use of non-invasive ventilation (NIV) for ≥22 hours per day for at least 10 consecutive days. If NIV is used to meet the criteria for respiratory insufficiency, no measured slow vital capacity (SVC) at any subsequent assessment may be >50%. Time to DRI is calculated from the date of the first dose to the first date of one of the following events: death, tracheostomy, or the 10th day of consecutive NIV with no measured SVC >50% at any subsequent assessment. (NCT01281189)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Placebo27.2
Dexpramipexole22.3

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Death up to 12 Months (CAFs Individual Component)

The longest duration of follow-up for this time to the death analysis was 12 months. In the study, subjects were followed for 12-18 months. (NCT01281189)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Placebo17.2
Dexpramipexole16.0

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≤50% Predicted Upright Slow Vital Capacity (SVC) or Died up to 18 Months

The date of reaching ≤50% of predicted upright slow vital capacity (SVC) is defined as the date of the first visit at which a predicted upright SVC is ≤50% and continues to remain ≤50% at the subsequent visit except for the last available observation. The time to reach ≤50% of predicted upright SVC is defined as the duration between the date of reaching ≤50% of predicted upright SVC and the date of the first dose of study medication. If the subject is alive and does not reach ≤50% of predicted upright SVC, the time to reach ≤50% of predicted upright SVC will be censored and equal to the number of days from the first dose of study medication until the visit date when the subject's last available SVC assessment is performed. The earliest time (Reaching ≤50% Predicted Upright SVC or death) is used in analysis. (NCT01281189)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Placebo41.9
Dexpramipexole36.5

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Incidence of AE/SAE

The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study. (NCT01361009)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Pramipexole Goup5.16

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Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)

Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor). (NCT01361009)
Timeframe: Baseline (Visit 1) and 12 weeks (Visit 3)

Interventionunit on a scale (Mean)
Visit 1Visit 3
Pramipexole Goup3.532.48

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Number of Patients With Adverse Events

Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events. (NCT01388478)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
R(+)Pramipexole18

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Longitudinal Change of Brain Network Activity

"The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).~The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1." (NCT01470859)
Timeframe: twice, baseline and 1 year after baseline

,
InterventionZ-score in PDRP (Mean)
Change from baseline (V5-V1)Z score at baseline (V1)Z score at 1 year (V5)
Levodopa0.412.212.29
Pramipexole0.613.614.09

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Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).

"Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved.~The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)" (NCT01470859)
Timeframe: twice, at 10 weeks(V2) and 1 year(V5)

,
Interventionparticipants (Number)
Patients with improvement at V2Patients with improvement at V5
Levodopa62
Pramipexole44

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Parkinson's Disease Questionnaire (PDQ39)

"The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).~PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe." (NCT01470859)
Timeframe: twice baseline and 1 year

,
Interventionunits on a scale (Mean)
PDQ39 at baseline (V1)PDQ39 at 1 year (V5)
Levodopa19.3820.36
Pramipexole20.3621.07

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Hoehn&Yahr (H&Y) Staging

"The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe.~The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5)." (NCT01470859)
Timeframe: twice baseline and 1 year

,
Interventionunits on a scale (Mean)
H&Y at baseline(V1)H&Y at 1 year(V5)
Levodopa1.351.65
Pramipexole1.431.82

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Unified Parkinson's Disease Rating Score (UPDRS II, III)

baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately. (NCT01470859)
Timeframe: three times: baseline, 10 weeks, 1 year

,
Interventionunits on a scale (Mean)
UPDRS II at baseline (V1)UPDRS II (V2)UPDRS II at 1 year (V5)UPDRS III at baseline (V1)UPDRS III (V2)UPDRS III at 1 year (V5)
Levodopa7.35.87.418.712.719.5
Pramipexole7.14.98.423.120.124.3

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Percentage of Adverse Drug Reactions

Percentage of subjects with adverse drug reactions (NCT01525641)
Timeframe: From baseline up to week 52

Interventionpercentage of participants (Number)
Subjects With Parkinson's Disease (PD)24.78

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Clinical Global Impression of Effect

Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect. (NCT01525641)
Timeframe: Week 52

Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo effect
Subjects With Parkinson's Disease (PD)1422320567

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Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA

"Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off." (NCT01525641)
Timeframe: Week 52

Interventionparticipants (Number)
YesNoUnknown
Subjects With Parkinson's Disease (PD)432622

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Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA

Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication. (NCT01525641)
Timeframe: Week 52

Interventionparticipants (Number)
YesNo
Subjects With Parkinson's Disease (PD)144163

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Change From Baseline in the Modified Hoehn & Yahr to Last Observation

Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement. (NCT01525641)
Timeframe: Baseline and week 52

InterventionUnits on a scale (Mean)
Subjects With Parkinson's Disease (PD)-0.12

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Change From Baseline in Total Score of the UPDRS Part III to Last Observation

"Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score.~UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status.~The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.~The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia." (NCT01525641)
Timeframe: Baseline and week 52

Interventionunits on a scale (Mean)
Subjects With Parkinson's Disease (PD)-3.73

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Number of Participants With Potentially Clinically Significant ECG Results

Number of Participants with Potentially Clinically Significant ECG Results. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT01622088)
Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

InterventionParticipants (Count of Participants)
QTcF > 450 msQTcF > 480 msQTcF > 500 msQTcF Change from Baseline > 30 msQTcF Change from Baseline > 60 msQT > 450 msQT > 480 msQT > 500 msQT Change from Baseline > 30 msQT Change from Baseline > 60 msQTcB > 480 msQTcB > 450 msQTcB > 500 msQTcB Change from Baseline > 30 msQTcB Change from Baseline > 60 msPR > 220 ms and Percent Increase from Baseline >25%QRS > 110 ms and Percent Increase from Baseline >25%
Dexpramipexole 150 mg BID20034300059292069601

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Number of Participants With Potentially Clinically Significant Vital Sign Results

Number of Participants with Potentially Clinically Significant Vital Sign Abnormalities. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT01622088)
Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

InterventionParticipants (Count of Participants)
Systolic BP >180 mmHgSystolic BP Increase from Baseline >40 mmHgSystolic BP <90 mmHgSystolic BP Decrease from Baseline >30 mmHgDiastolic BP >105 mmHgDiastolic BP increase from Baseline >30 mmHgDiastolic BP <50 mmHgDiastolic BP Decrease from Baseline >20 mmHgPulse >120 bpmPulse Increase from Baseline >30 bpmPulse <50 bpmPulse Decrease from Baseline >20 bpmTemperature >38.5 C and Increase from Baseline>=1°CWeight >=7% Increase from BaselineWeight >=7% Decrease from Baseline
Dexpramipexole 150 mg BID2641020522131623011937

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Number of Participants With Potentially Clinically Significant Hematology Results

Number of Participants with Potentially Clinically Significant Hematology Results. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT01622088)
Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

InterventionParticipants (Count of Participants)
White Blood Cell Count < 3.0 x10^9 cells/LWhite Blood Cell Count >= 16 x10^9 cells/LTotal Absolute Neutrophil Count < 1.5 x10^9 cells/LTotal Absolute Neutrophil Count >= 13.5 x10^9 cells/LLymphocyte < 0.8 x10^9 cells/LLymphocyte > 12 x10^9 cells/LMonocytes > 2.5 x10^9 cells/LEosinophils > 1.6 x10^9 cells/LBasophils > 1.6 x10^9 cells/LHemoglobin - Females <= 95 g/LHemoglobin - Females >= 175 g/LHemoglobin - Males <= 115 g/LHemoglobin - Males >= 190 g/LHematocrit - Females <= 32%Hematocrit - Females >= 54%Hematocrit - Males <= 37%Hematocrit - Males >= 60%Red Blood Cell Count <= 3.5 x10^12 cells/LRed Blood Cell Count >= 6.4 x10^12 cells/LPlatelet Count <= 75 x10^9 cells/LPlatelet Count >= 700 x10^9 cells/L
Dexpramipexole 150 mg BID186146650000101318047115303

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Slope of Sniff Nasal Inspiratory Pressure (SNIP) From Baseline to End of Study

SNIP is a test of inspiratory force (sternocleidomastoid and diaphragm) measured via a nasal cannula and is used to assess respiratory muscle weakness and to monitor changes in respiratory muscle strength over time. During the SNIP maneuver, the patient is asked to perform a strong, sharp, maximal sniff, whereby nasal pressure is measured via nasal cannula. The maximum recorded value after several attempts, with rest in between attempts, was use in the analysis. (NCT01622088)
Timeframe: Up to maximum 226 days: approximately 32.2 weeks

InterventionChange per month in SNIP (in cm H20) (Least Squares Mean)
Dexpramipexole 150 mg BID-0.1895

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Number of Subjects Who Discontinued the Study Treatment Due to an Adverse Event

The number of subjects enrolled who discontinued the study treatment due to an adverse event during the study (NCT01622088)
Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

InterventionParticipants (Count of Participants)
Dexpramipexole 150 mg BID30

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Slope of ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to End of Study

The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score between 0 to 48, with higher scores representing better function. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis ALSFRS-R score. Units for slope are change per month in units on the ALSFRS-R scale. (NCT01622088)
Timeframe: Up to maximum 226 days: approximately 32.2 weeks

InterventionChange per month in ALSFRS-R (Least Squares Mean)
Dexpramipexole 150 mg BID-0.7355

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Number of Participants With Potentially Clinically Significant Blood Chemistry Results

Number of Participants with Potentially Clinically Significant Blood Chemistry Results. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT01622088)
Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

InterventionParticipants (Count of Participants)
Sodium <= 126 mmol/LSodium >= 156 mmol/LPotassium <= 3 mmol/LPotassium >= 6 mmol/LChloride <= 90 mmol/LChloride >= 118 mmol/LBicarbonate <= 16 mmol/LBicarbonate >= 35 mmol/LCalcium <= 2 mmol/LCalcium >= 3 mmol/LMagnesium <= 0.5 mmol/LMagnesium >= 1.2 mmol/LPhosphorus <= 0.6 mmol/LPhosphorus >= 1.7 mmol/LAspartate Aminotransferase - SGOT >= 3 x ULN U/LAlanine Aminotransferase - SGPT >= 3 x ULN U/LAlkaline Phosphatase >= 1.5 x ULN U/LCreatinine - Females >= 176.8 umol/LCreatinine - Males >= 176.8 umol/LBlood Urea Nitrogen >= 10.7 mmol/LTotal Bilirubin >= 1.5 x ULN umol/LTotal Protein <= 45 g/LTotal Protein >= 100 g/LAlbumin <= 25 g/LUric Acid - Females >= 506 umol/LUric Acid - Males >= 625 umol/LGlucose <= 2.2 mmol/LGlucose >= 9.7 mmol/L
Dexpramipexole 150 mg BID5014907670000941241023810314043

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Death up to 6 Months

Kaplan-Meier estimate of percentage of subjects who died up to 6 months (NCT01622088)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
Dexpramipexole 150 mg BID13.95

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Number of Subjects Who Experienced a Serious Adverse Event

The number of subjects enrolled who reported a serious adverse event during the study (NCT01622088)
Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

InterventionParticipants (Count of Participants)
Dexpramipexole 150 mg BID152

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Number of Subjects Who Reported an Adverse Event

The number of subjects who reported an adverse event during the study (NCT01622088)
Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

InterventionParticipants (Count of Participants)
Dexpramipexole 150 mg BID454

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Percentage of Participants With Death or Death Equivalent up to 6 Months

Kaplan-Meier estimate of percentage of subjects who died or had a death equivalent event (tracheostomy or permanent assisted ventilation [PAV], defined as use of noninvasive ventilation [NIV] for ≥22 hours per day for ≥10 days) up to 6 months (NCT01622088)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Dexpramipexole 150 mg BID16.35

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PDQ39

Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem. (NCT01968460)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
P2B001 Treatment A-3.01
P2B001 Treatment B-2.19
Placebo0.26

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CGI-S

Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more. (NCT01968460)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
P2B001 Treatment A13
P2B001 Treatment B9
Placebo3

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Total UPDRS I, II, III Scores

"Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176.~High score mean worse outcome." (NCT01968460)
Timeframe: Week 12

Interventionunits on a scale (Least Squares Mean)
P2B001 Treatment A-5.97
P2B001 Treatment B-5.15
Placebo-1.31

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UPDRS Motor (Part III)

Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome) (NCT01968460)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
P2B001 Treatment A-4.43
P2B001 Treatment B-3.95
Placebo-1.62

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UPDRS ADL (Part II)

Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome) (NCT01968460)
Timeframe: Week 12

Interventionunits on a scale (Least Squares Mean)
P2B001 Treatment A-1.49
P2B001 Treatment B-1.06
Placebo0.36

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Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale

"A validated self-rated scale shown to assess consummatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108." (NCT02033369)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Pramipexole35.6

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Change in Hamilton Rating Scale for Depression

Hamilton Rating Scale for Depression (HRSD), 17-item version. This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 6, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression) (NCT02033369)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Pramipexole8.4

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Change in Clinical Global Improvement - Severity Scale

Seven-point Likert scale rating clinical severity of mental illness from 1 (least severe) to 7 ( most severe). Physician-rated scale. One item. (NCT02033369)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Pramipexole2.59

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Change in Mood and Anxiety Symptom Questionnaire, Short Form

Change in Mood and Anxiety Symptom Questionnaire, Short Form. A 62-item scale assessing anxiety and depression. Items were measured on a scale of 1-5, higher number indicating higher levels of symptoms.The lowest possible score was 62, and the highest 310. (NCT02033369)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Pramipexole123.1

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Change in Snaith Hamilton Pleasure Scale

"Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as strongly disagree (1), disagree (2), agree (3), or strongly agree (4). The lowest possible score was 14, the highest possible score was 56." (NCT02033369)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Pramipexole26

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Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale

"A validated self-rated scale shown to assess anticipatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108." (NCT02033369)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Pramipexole43.2

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Change in the Apathy Evaluation Rating Scale

A validated self-rated 18 item scale assessing apathy. Items were rated from 1 (not at all true) to 4 (very true). Higher scores indicate lower apathy, lower scores indicate higher apathy. Lowest possible score is 18, highest possible score is 72. (NCT02033369)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Pramipexole31.7

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Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment

Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 6 is presented as ratio to baseline. (NCT02217332)
Timeframe: Baseline and Month 6

Interventionratio to baseline (Geometric Mean)
Dexpramipexole0.06

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Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight

Summary of subjects from the safety population who experienced potentially clinically significant values or changes in vital signs or weight (NCT02217332)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Systolic Blood Pressure: >180 mmHgSystolic Blood Pressure: increase from pre-dosing of more than 40 mmHgSystolic Blood Pressure: <90 mmHgSystolic Blood Pressure: decrease from pre-dosing of more than 30 mmHgDiastolic Blood Pressure: >105 mmHgDiastolic Blood Pressure: increase from pre-dosing of more than 30 mmHgDiastolic Blood Pressure: <50 mmHgDiastolic Blood Pressure: decrease from pre-dosing of more than 20 mmHgHeart Rate: >120 beats per minuteHeart Rate: increase from pre-dosing of more than 20 beats per minuteHeart Rate: <50 beats per minuteHeart Rate: decrease from pre-dosing of more than 20 beats per minuteTemperature: >38ºC and an increase from pre-dosing of at least 1ºCBody Weight: >7% increase from baseline valueBody Weight: <=7% decrease from baseline value
Dexpramipexole000000000100000

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Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations

Summary of subjects from the safety population who experienced potentially clinically significant values in hand serum chemistry results (NCT02217332)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
LOW: Albumin <= 25 g/LHIGH: Alanine aminotransferase (ALT) >= 1.5 x ULNHIGH: Aspartate aminotransferase (AST) >= 1.5 x ULNHIGH: Total bilirubin >= 1.5 x ULNHIGH: Glucose>= 9.7 mmol/LLOW: Glucose <= 2.2 mmol/LHIGH: Eosinophils > 1.6 x 10(9)/LHIGH: Hematocrit - Females >=54%LOW: Hematocrit - Females <= 32%HIGH: Hemoglobin - Females >=175g/LLOW: Hemoglobin - Females <= 95g/LHIGH: Lymphocytes > 12 x 10(9)/LLOW: Lymphocytes < 0.8 x 10(9)/LLOW: Neutrophils < 1.5 x 10(9)/L
Dexpramipexole01001110202020

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Ratio to Baseline in Peripheral Blood Eosinophil Counts After 3 Months of Treatment

Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 3 is presented as ratio to baseline. (NCT02217332)
Timeframe: Baseline and Month 3

Interventionratio (Geometric Mean)
Dexpramipexole0.05

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Change From Baseline in TPS After 3 Months of Treatment

The change in Nasal Polyp Score (NPS) score after 3 months of treatment is presented. A blinded Central Endoscopy Rater determined the NPS for each nare on a scale of 0 to 4, and the bilateral NPS scores were added to generate the Total Polyp Score (TPS) on a scale of 0 to 8. A lower TPS corresponds to a lower polyp burden. (NCT02217332)
Timeframe: Baseline and Month 3

Interventionunits on a scale (Mean)
Dexpramipexole0.0

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Change From Baseline in Total Polyp Score (TPS) After 6 Months of Treatment

The change in Nasal Polyp Score (NPS) score after 6 months of treatment is presented. A blinded Central Endoscopy Rater determined the NPS for each nare on a scale of 0 to 4, and the bilateral NPS scores were added to generate the Total Polyp Score (TPS) on a scale of 0 to 8. A lower TPS corresponds to a lower polyp burden. (NCT02217332)
Timeframe: Baseline and Month 6

Interventionunits on a scale (Mean)
Dexpramipexole0.07

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Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters

Summary of subjects from the safety population who experienced potentially significant values in electrocardiogram parameters (NCT02217332)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
QTcF: >450 msecQTcF: >480 msecQTcF: > 450 msec and ≤ 450 msec at baselineQTcF: > 480 msec and ≤ 480 msec at baselineQTcF: > 450 msec and change from baseline > 30 msecQTcF: > 480 msec and change from baseline > 30 msecQTcF change from baseline: >30 msecQTcF change from baseline: >60 msecRhythm abnormalities: Sinus rhythmRhythm abnormalities: Sinus bradycardiaRhythm abnormalities: Premature atrial complexes, conducted or non-conducted sinus rhythmST-T abnormalities: Nonspecific T wave abnormalityST-T abnormalities: Early repolarizationST-T abnormalities: Early repolarization, considered normal variantST-T abnormalities: Nonspecific ST deviationST-T abnormalities: Nonspecific ST deviation, prolonged QTcF intervalST-T abnormalities: Nonspecific T wave abnormality, prolonged QTcF intervalST-T abnormalities: Prolonged QTcF intervalConduction abnormality: First degree AV blockConduction abnormality: Complete right bundle branch blockConduction abnormality: Complete right bundle branch block first degree AV block
Dexpramipexole2010001017313111111211

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Ratio to Baseline in Polyp Tissue Eosinophil Count After 6 Months of Treatment

Change in polyp tissue eosinophil count measured as eosinophils/hpf (high powered field) from baseline to month 6 is presented as ratio to baseline. (NCT02217332)
Timeframe: Baseline and Month 6

Interventionratio to baseline (Geometric Mean)
Dexpramipexole0.03

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AUCτ,ss

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ). (NCT02231918)
Timeframe: 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.

,,
Interventionng*h/mL (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6, 1)
PPX (MIRAPEX®, 0.125 mg)5.123.28
PPX (MIRAPEX®, 0.25 mg)11.07.42
PPX (MIRAPEX®, 0.5 mg)NANA

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λz,ss

Terminal rate constant in plasma at steady state (λz,ss ). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Intervention1/h (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6, 1)
PPX (MIRAPEX®, 0.125 mg)0.1320.113
PPX (MIRAPEX®, 0.25 mg)0.1070.0938
PPX (MIRAPEX®, 0.5 mg)NANA

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Ae 0-12,ss

Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h). (NCT02231918)
Timeframe: 12 hours after last study drug administration on day 1

,,
Interventionng (Geometric Mean)
6 to <12 years (N=4, 6, 0)12 to <18 years (N=3, 6, 0)
PPX (MIRAPEX®, 0.125 mg)5060055200
PPX (MIRAPEX®, 0.25 mg)12300082300
PPX (MIRAPEX®, 0.5 mg)NANA

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Cavg

Average concentration of the analyte in plasma at steady state (Cavg). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionng/mL (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6, 1)
PPX (MIRAPEX®, 0.125 mg)0.2130.137
PPX (MIRAPEX®, 0.25 mg)0.4580.309
PPX (MIRAPEX®, 0.5 mg)NANA

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CL/F,ss

Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
InterventionmL/min (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6, 1)
PPX (MIRAPEX®, 0.125 mg)284444
PPX (MIRAPEX®, 0.25 mg)265393
PPX (MIRAPEX®, 0.5 mg)NANA

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CLR,ss

Renal clearance of the analyte at steady state (CLR(0-12),ss ). (NCT02231918)
Timeframe: 12h after last study drug administration on day 1

,,
InterventionmL/min (Geometric Mean)
6 to <12 years (N=4, 2, 0)12 to <18 years (N=2, 5, 0)
PPX (MIRAPEX®, 0.125 mg)201NA
PPX (MIRAPEX®, 0.25 mg)NA253
PPX (MIRAPEX®, 0.5 mg)NANA

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Cmax,ss

Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionng/mL (Geometric Mean)
6 to <12 years (N=5, 9, 0)12 to <18 years(N=4, 6, 2))
PPX (MIRAPEX®, 0.125 mg)0.6330.396
PPX (MIRAPEX®, 0.25 mg)1.130.677
PPX (MIRAPEX®, 0.5 mg)NANA

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Cmin,ss

Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionng/mL (Geometric Mean)
6 to <12 years (N=5, 9, 0)12 to <18 years(N=4, 6, 2)
PPX (MIRAPEX®, 0.125 mg)0.08720.0972
PPX (MIRAPEX®, 0.25 mg)0.1360.122
PPX (MIRAPEX®, 0.5 mg)NANA

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Cpre,N

Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionng/mL (Geometric Mean)
6 to <12 years (N=4, 8, 0)12 to <18 years (N=1, 5, 1)
PPX (MIRAPEX®, 0.125 mg)0.074NA
PPX (MIRAPEX®, 0.25 mg)0.1470.112
PPX (MIRAPEX®, 0.5 mg)NANA

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fe 0-12,ss

Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ). (NCT02231918)
Timeframe: 12 hours after last study drug administration on day 1.

,,
Intervention% of PPX excreted (Geometric Mean)
6 to <12 years (N=4, 2, 0)12 to <18 years (N=2, 5, 0)
PPX (MIRAPEX®, 0.125 mg)58.0NA
PPX (MIRAPEX®, 0.25 mg)NA42.0
PPX (MIRAPEX®, 0.5 mg)NANA

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MRTpo,ss

Mean residence time of the analyte in the body at steady state (MRTpo,ss). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionh (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6, 1)
PPX (MIRAPEX®, 0.125 mg)8.199.47
PPX (MIRAPEX®, 0.25 mg)10.111.6
PPX (MIRAPEX®, 0.5 mg)NANA

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PTF

Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state. (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Intervention% of PTF (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6, 1)
PPX (MIRAPEX®, 0.125 mg)250216
PPX (MIRAPEX®, 0.25 mg)209168
PPX (MIRAPEX®, 0.5 mg)NANA

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t1/2,ss

Terminal half-life of the analyte in plasma at steady state (t1/2,ss ). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionhours (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6, 1)
PPX (MIRAPEX®, 0.125 mg)5.266.13
PPX (MIRAPEX®, 0.25 mg)6.507.39
PPX (MIRAPEX®, 0.5 mg)NANA

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Tmax,ss

Time from dosing to maximum concentration at steady state (Tmax,ss). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionhours (Median)
6 to <12 years (N=5, 9, 0)12 to <18 years (N=4, 6, 2)
PPX (MIRAPEX®, 0.125 mg)2.002.00
PPX (MIRAPEX®, 0.25 mg)2.001.96
PPX (MIRAPEX®, 0.5 mg)NANA

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Tmin,ss

Time from dosing to minimum concentration at steady state (Tmin,ss ). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
Interventionhours (Median)
6 to <12 years (N=5, 9, 0)12 to <18 years (N=4, 6, 2)
PPX (MIRAPEX®, 0.125 mg)12.06.25
PPX (MIRAPEX®, 0.25 mg)24.023.9
PPX (MIRAPEX®, 0.5 mg)NANA

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Vital Signs (Pulse Rate)

Vital signs (Pulse rate (both supine and after standing for 1 minute)). (NCT02231918)
Timeframe: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h

,,
Interventionbpm (Mean)
Pulse rate-supine(N=9,15,2): -0:15hPulse rate-supine(N=9,15,2): 0:30hPulse rate-supine(N=9,15,2): 1:00hPulse rate-supine(N=9,15,2): 2:00hPulse rate-supine(N=9,15,1): 3:00hPulse rate-supine(N=9,15,1): 5:00hPulse rate-supine(N=9,14,1): 7:00hPulse rate-supine(N=9,14,1): 12:00hPulse rate-supine(N=9,14,1): 24:00hPulse rate- standing(N=9,15,2):-0:15hPulse rate- standing(N=9,15,2): 0:30hPulse rate- standing(N=9,15,2): 1:00hPulse rate- standing (N=9,15,2): 2:00hPulse rate- standing (N=9,15,1): 3:00hPulse rate- standing (N=9,14,1): 5:00hPulse rate- standing (N=9,13,1): 7:00hPulse rate- standing (N=9,14,1): 12:00hPulse rate- standing (N=9,14,1): 24:00h
PPX (MIRAPEX®, 0.125 mg)82.476.782.785.489.382.788.177.877.990.884.794.892.899.099.310097.890.0
PPX (MIRAPEX®, 0.25 mg)73.378.075.277.979.975.972.068.677.679.481.585.489.392.787.182.181.285.8
PPX (MIRAPEX®, 0.5 mg)75.592.087.094.572.077.078.069.077.099.010312312110976.072.086.086.0

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Vital Signs (Systolic and Diastolic Blood Pressure)

Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)). (NCT02231918)
Timeframe: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.

,,
InterventionmmHg (Mean)
Systolic blood pressure-supine(N= 9,15,2): -0:15hSystolic blood pressure-supine(N= 9,15,2): 0:30hSystolic blood pressure-supine(N= 9,15,2): 1:00hSystolic blood pressure-supine(N= 9,15,2): 2:00hSystolic blood pressure-supine(N= 9,15,1): 3:00hSystolic blood pressure-supine(N= 9,15,1): 5:00hSystolic blood pressure-supine(N= 9,14,1): 7:00hSystolic blood pressure-supine(N= 9,14,1): 12:00hSystolic blood pressure-supine(N= 9,14,1): 24:00hDiastolic blood pressure-supine(N= 9,15,2): -0:15Diastolic blood pressure-supine(N= 9,15,2): 0:30Diastolic blood pressure-supine(N= 9,15,2): 1:00Diastolic blood pressure-supine(N= 9,15,2): 2:00Diastolic blood pressure-supine(N= 9,15,1): 3:00Diastolic blood pressure-supine(N= 9,15,1): 5:00Diastolic blood pressure-supine(N= 9,14,1): 7:00Diastolic blood pressure-supine(N= 9,14,1): 12:00Diastolic blood pressure-supine(N= 9,14,1): 24:00Systolic blood pressure-standing(N= 9,15,2):-0:15hSystolic blood pressure-standing(N= 9,15,2): 0:30hSystolic blood pressure-standing(N= 9,15,2): 1:00hSystolic blood pressure-standing(N= 9,15,2): 2:00hSystolic blood pressure-standing(N= 9,15,1): 3:00hSystolic blood pressure-standing(N= 9,14,1): 5:00hSystolic blood pressure-standing(N= 9,13,1): 7:00hSystolic blood pressure-standing(N=9,14,1): 12:00hSystolic blood pressure-standing(N=9,14,1): 24:00hDiastolicblood pressure-standing(N=9,15,2): -0:15hDiastolic blood pressure-standing(N=9,15,2): 0:30hDiastolic blood pressure-standing(N=9,15,2): 1:00hDiastolic blood pressure-standing(N=9,15,2): 2:00hDiastolic blood pressure-standing(N=9,15,1): 3:00hDiastolic blood pressure-standing(N=9,14,1): 5:00hDiastolic blood pressure-standing(N=9,13,1):7:00hDiastolic blood pressure-standing(N=9,14,1):12:00hDiastolicblood pressure-standing(N=9,14,1):24:00h
PPX (MIRAPEX®, 0.125 mg)109.33112.89113.00111.00106.89105.11108.44107.56109.2266.6768.6769.3366.0066.7864.2267.5670.0066.56109.89113.56110.11110.33110.11110.22109.11108.22113.8968.1170.1169.2271.1172.6774.0072.0074.3373.11
PPX (MIRAPEX®, 0.25 mg)109.20110.33108.07111.93110.53108.80109.86106.93112.2165.7365.8065.7365.8065.4063.8762.4361.0065.71113.93113.67110.07112.27113.07111.93103.85107.14115.5071.2069.2072.0073.1371.4770.5766.6970.0773.57
PPX (MIRAPEX®, 0.5 mg)117.00116.00105.50113.00113.00104.00108.00109.00120.0076.0073.0064.0075.0075.0070.0067.0066.0078.00122.00115.50125.50115.00108.00115.0065.00100.00102.0086.0080.0091.0086.5079.0098.0048.0062.0084.00

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Vz/F,ss

Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ). (NCT02231918)
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

,,
InterventionL (Geometric Mean)
6 to <12 years (N=5, 8, 0)12 to <18 years (N=4, 6,1)
PPX (MIRAPEX®, 0.125 mg)129236
PPX (MIRAPEX®, 0.25 mg)149251
PPX (MIRAPEX®, 0.5 mg)NANA

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The Probabilistic Stimulus Selection Task

"The probabilistic selection task assesses the tendency to learn from positive versus negative outcomes. In the probabilistic stimulus selection task, participants are trained to choose one of two paired stimuli; three sets of paired stimuli are shown in total (AB, CD, and EF) and are presented randomly during the training period. To minimize verbal encoding, stimuli are Japanese Hiragana characters. Probabilistic feedback regarding the correct choice is provided. We report the mean percentage of accuracy on choosing the correct paired stimuli among the two treatment groups." (NCT02397837)
Timeframe: Week 12

Interventionpercentage of accuracy (Mean)
Pramipexole59.54
Placebo50.99

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The Probabilistic Stimulus Selection Task

"The probabilistic selection task assesses the tendency to learn from positive versus negative outcomes. In the probabilistic stimulus selection task, participants are trained to choose one of two paired stimuli; three sets of paired stimuli are shown in total (AB, CD, and EF) and are presented randomly during the training period. To minimize verbal encoding, stimuli are Japanese Hiragana characters. Probabilistic feedback regarding the correct choice is provided. We report the mean percentage of accuracy on choosing the correct paired stimuli among the two treatment groups." (NCT02397837)
Timeframe: Week 6

Interventionpercentage of accuracy (Mean)
Pramipexole56.91
Placebo56.94

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Young Mania Rating Scale (YMRS)

Mean change of symptoms of mania throughout the study. YMRS contains 7 items rated from 0 (symptom absent) to 4 (severe symptom) and 4 items scored 0 (symptom absent) to 8 (severe symptom), with total range from 0 to 60, where higher score indicates manic symptoms. (NCT02397837)
Timeframe: Baseline and week 12

Interventionscore on a scale (Mean)
Pramipexole-0.92
Placebo-0.57

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Hamilton Rating Scale for Depression (HRSD)

Mean change of symptoms of depression throughout the study. HRSD consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where higher score indicates more depressive symptoms. (NCT02397837)
Timeframe: Baseline and week 12

Interventionscore on a scale (Mean)
Pramipexole-0.24
Placebo-.22

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Brief Psychiatric Rating Scale (BPRS)

Mean change for positive symptoms throughout the study. BPRS consists of 18 items, each defined by a series of symptoms. Each item is rated on a 7-point scale, ranging from 1 (not observed) to 7 (very severe), with a total score range from 18-126, where higher scores indicate psychiatric symptoms. (NCT02397837)
Timeframe: Baseline and week 12

Interventionscore on a scale (Mean)
Pramipexole-0.63
Placebo-0.61

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MATRICS Consensus Cognitive Battery

MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance. (NCT02397837)
Timeframe: Baseline

InterventionT-score (Mean)
Pramipexole35.45
Placebo38.07

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MATRICS Consensus Cognitive Battery

MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance. (NCT02397837)
Timeframe: Week 12

InterventionT-score (Mean)
Pramipexole36.46
Placebo41.50

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MATRICS Consensus Cognitive Battery

MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance. (NCT02397837)
Timeframe: Week 6

InterventionT-score (Mean)
Pramipexole35.57
Placebo39.81

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Number of Participants With Suicidal Acknowledgements

Number of individual participants who acknowledged at least one item on the Columbia Suicide Severity Rating Scale (C-SSRS) over the 12-week study period. Examples of items on the scale are suicidal ideation (having thoughts, planning) and suicidal behavior (preparing, attempting). (NCT02397837)
Timeframe: up to Week 12

InterventionParticipants (Count of Participants)
Pramipexole0
Placebo5

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The Probabilistic Stimulus Selection Task

"The probabilistic selection task assesses the tendency to learn from positive versus negative outcomes. In the probabilistic stimulus selection task, participants are trained to choose one of two paired stimuli; three sets of paired stimuli are shown in total (AB, CD, and EF) and are presented randomly during the training period. To minimize verbal encoding, stimuli are Japanese Hiragana characters. Probabilistic feedback regarding the correct choice is provided. We report the mean percentage of accuracy on choosing the correct paired stimuli among the two treatment groups." (NCT02397837)
Timeframe: Baseline

Interventionpercentage of accuracy (Mean)
Pramipexole56.94
Placebo67.56

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Change From Baseline to Week 12 in Total UPDRS III Motor

"Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of Motor UPDRS score (UPDRS Part III ).~UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)" (NCT03329508)
Timeframe: baseline to week 12

Interventionscore on a scale (Least Squares Mean)
P2B001-5.82
Rasagiline Capsule-4.07
Pramipexole Capsule-4.30
Pramipexole Extended Release-6.36

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Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39

"The efficacy of P2B 0.6/0.75 mg as compared to Pramipexole ER tablet titrated to optimal dose.~ADL PDQ39- Activity of daily life part in Parkinson's Disease Questionaries' 39 Score 0-100 when 100 is the worse outcome" (NCT03329508)
Timeframe: Baseline to week 12

Interventionscore on a scale (Least Squares Mean)
P2B001-5.30
Rasagiline Capsule-2.04
Pramipexole Capsule-3.40
Pramipexole Extended Release-3.12

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Change From Baseline to Week 12 in Total UPDRS II ADL

Differences between of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS score (UPDRS part II) Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome) (NCT03329508)
Timeframe: Baseline to week 12

Interventionscore on a scale (Least Squares Mean)
P2B001-2.14
Rasagiline Capsule-0.62
Pramipexole Capsule-0.97
Pramipexole Extended Release-2.02

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Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).

"Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160).~UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160.~High score mean worse outcome." (NCT03329508)
Timeframe: baseline to week 12

Interventionscore on a scale (Least Squares Mean)
P2B001-7.98
Rasagiline Capsule-4.69
Pramipexole Capsule-5.32
Pramipexole Extended Release-8.35

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Change in Epworth Sleepiness Scale (ESS) Score.

"Differences between P2B 0.6/0.75 mg as compared to pramipexole ER tablets in the change of Epworth Sleepiness Scale (ESS) score.~Scale is 0-24 , when 24 is worse outcome" (NCT03329508)
Timeframe: baseline to week 12

Interventionscore on a scale (Least Squares Mean)
P2B001-0.33
Rasagiline Capsule-0.81
Pramipexole Capsule0.39
Pramipexole Extended Release2.33

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Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)

SCOPA-Sleep score is composed of three parts: a night-time scale (5 item scale with 4 Response Options (0-not at all to 3-very much) addressing night time disturbances. Total night-time scale score runs from 0 to 15, with a higher score indicating more severe problems, a single-item about perceived quality of nocturnal sleep (7-point scale ranging from slept very well to slept very badly.), and a daytime sleepiness scale (6 items with 4 Response options, from 0 (never) to 3 (often), and a maximum total score of 18.). (NCT03521635)
Timeframe: Baseline and Week 18

,
InterventionScore on a scale (Mean)
Night-time sleep scoreOverall night sleep scoreDaytime sleepiness score
Pramipexole Immediate Release-3.2-1.6-0.9
Pramipexole Sustained Release-3.8-1.9-1.4

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Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline)

"The Nocturnal Hypokinesia Questionnaire (NHQ) is designed to assess hypokinesia symptoms in night in Parkinson's disease (PD) patients, composed of two sections. Section 1 is assessed by PD patients with 10 one-point items evaluating turning over in bed, getting out of bed, parkinsonian motor symptoms, and others. Section 2 is assessed by spouses or caregivers who are with the patients during the night with 10 one-point items evaluating the same aspects as Section 1. The score for each section is by summing up points from the items in the respective section. Score of each of the two Sections is from 0 to 10, with a higher score indicating worse symptoms. The score was reported by section: Section 1 by patients, Section 2 by caregivers." (NCT03521635)
Timeframe: Baseline and Week 18

,
InterventionScore on a scale (Mean)
By patients (Section 1)By caregivers (Section 2)
Pramipexole Immediate Release-1.7-0.6
Pramipexole Sustained Release-1.9-1.4

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The Parkinson's Disease Questionnaire (PDQ)-8 Score (Change From Baseline)

The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms. The total score summed up the items together and transformed onto a score from 0 (never have problems/issues) to 100 (always have problems or cannot do at all). (NCT03521635)
Timeframe: Baseline and Week 18

InterventionScore on a scale (Mean)
Pramipexole Sustained Release-4.1
Pramipexole Immediate Release-3.5

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Responder Rate for Patient Global Impression of Improvement (PGI-I)

The responder of PGI-I is the patient rated of any improvement (1 = Very much better, 2 = Much better, or 3 = A little better). The PGI-I scale is a patient-rated instrument (from 1: very much better, to 7: very much worse) which was used to measure the improvement of the patient's Parkinson disease symptoms throughout the study. (NCT03521635)
Timeframe: At Week 18

InterventionPercentage of participants (Number)
Pramipexole Sustained Release95.6
Pramipexole Immediate Release86.0

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Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18

Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often) based on their experience during the past week. PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). The PDSS-2 total score less < 18 were compared between groups. (NCT03521635)
Timeframe: At Week 18

InterventionPercentage of participants (Number)
Pramipexole Sustained Release73.3
Pramipexole Immediate Release72.1

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Responder Rate for Early Morning Off (EMO) Score

"The responder of EMO is the patient with an improvement of at least 1 comparing to his/her baseline condition. The EMO is measured by the question of do you feel like your bodily movements are poor when you wake up? Patients answered this question according to the frequency during the previous one week by scoring from 0 (never) to 4 (very often or 6 to 7 days a week)." (NCT03521635)
Timeframe: At Week 18

InterventionPercentage of participants (Number)
Pramipexole Sustained Release86.7
Pramipexole Immediate Release76.7

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Responder Rate for Clinical Global Impression of Improvement (CGI-I)

The responder of CGI-I is the patient rated of any improvement (1 = Very much better, 2 = Much better, or 3 = A little better). The CGI-I was rated (from 1: very much improved, to 7: very much worse) by the same evaluator to assess the overall status of Parkinson's disease. (NCT03521635)
Timeframe: At Week 18

InterventionPercentage of participants (Number)
Pramipexole Sustained Release95.6
Pramipexole Immediate Release86.0

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Epworth Sleepiness Scale (ESS) Score (Change From Baseline)

The ESS is a patient-rated scale about how likely one is to fall asleep during situations of passive and inconsequential to active. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness. (NCT03521635)
Timeframe: Baseline and Week 18

InterventionScore on a scale (Mean)
Pramipexole Sustained Release-2.4
Pramipexole Immediate Release-2.6

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Early Morning Off (EMO) Score (Change From Baseline)

"The EMO is measured by the question of do you feel like your bodily movements are poor when you wake up? Patients answered this question according to the frequency during the previous one week by scoring from 0 (never) to 4 (very often or 6 to 7 days a week)." (NCT03521635)
Timeframe: Baseline and Week 18

InterventionScore on a scale (Mean)
Pramipexole Sustained Release-1.8
Pramipexole Immediate Release-1.5

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Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score

Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often). Patients were asked to rate the severity of each question based on their experience during the past week (7 days) from 0 (Never) to 4 (Very often, that meant 6 to 7 days a week). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). (NCT03521635)
Timeframe: Baseline and Week 18

InterventionScore on a scale (Mean)
Pramipexole Sustained Release-13.7
Pramipexole Immediate Release-14.4

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Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma. The 32 questions in the AQLQ are divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment. (NCT04046939)
Timeframe: Baseline, 12 Weeks

Interventionscores on a scale (Least Squares Mean)
Placebo BID0.376
37.5 mg BID Dexpramipexole0.531
75 mg BID Dexpramipexole0.312
150 mg BID Dexpramipexole0.584

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Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12

FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. (NCT04046939)
Timeframe: Baseline, 12 Weeks

Interventionliters (Least Squares Mean)
Placebo BID0.0700
37.5 mg BID Dexpramipexole0.208
75 mg BID Dexpramipexole0.0557
150 mg BID Dexpramipexole0.247
Combined 150 mg BID and 75 mg BID Arms0.151

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Change in Post-bronchodilator FEV1 From Baseline to Week 12

Post-bronchodilator FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation, after treatment with inhaled albuterol. (NCT04046939)
Timeframe: Baseline, 12 Weeks

Interventionliters (Least Squares Mean)
Placebo BID-0.00546
37.5 mg BID Dexpramipexole0.0932
75 mg BID Dexpramipexole-0.000717
150 mg BID Dexpramipexole0.176

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Change in Nasal Eosinophil Peroxidase (Presented as Ratio to Protein) From Baseline to Week 12

The EPX:protein ratio was used to normalize the EPX for the quantity of sample, yielding the values in ng EPX per mg protein. The ratio of nasal Eosinophil Peroxidase to Protein is a biomarker for airway eosinophils. A lower ratio to Baseline represents a lowering in airway eosinophilia, which is a marker of successful drug therapy. (NCT04046939)
Timeframe: Baseline, Week 12

Interventionratio to baseline (Median)
Placebo BID0.833
37.5 mg BID Dexpramipexole0.645
75 mg BID Dexpramipexole0.174
150 mg BID Dexpramipexole0.110

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Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 12

FeNO is non-invasive biomarker of airway inflammation in asthma participants. (NCT04046939)
Timeframe: Baseline, Week 12

Interventionparts per billion (Least Squares Mean)
Placebo BID3.38
37.5 mg BID Dexpramipexole-6.79
75 mg BID Dexpramipexole-3.14
150 mg BID Dexpramipexole-4.86

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Change in Blood Absolute Eosinophil Count From Baseline to Week 12

The primary endpoint of this study was the change in AEC from Baseline to Week 12 on a ratio scale. The analysis used a mixed effects model repeated-measures (MMRM) with terms for log10 transformed baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and log10 transformed baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the log10 transformed post-baseline value minus the log10 transformed baseline value. The estimates of Geometric LS Means and their ratios were obtained by back transforming the corresponding estimates of LS means and their differences to the original scale. (NCT04046939)
Timeframe: Baseline, 12 Weeks

Interventionratio to baseline (Geometric Least Squares Mean)
Placebo BID0.8980
37.5 mg BID Dexpramipexole0.4031
75 mg BID Dexpramipexole0.3056
150 mg BID Dexpramipexole0.2051

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Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12

ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). The original protocol planned to analyze the ACQ-7 score. As a result of FEV1 testing restrictions imposed on the study during the COVID-19 pandemic, the analysis was prospectively modified to the ACQ-6 score prior to database lock. The ACQ-6 is a validated questionnaire and is identical to the ACQ-7, with the exception of FEV1 data that is also utilized in the ACQ-7 questionnaire total score calculation. (NCT04046939)
Timeframe: Baseline, 12 Weeks

Interventionscores on a scale (Least Squares Mean)
Placebo BID-0.391
37.5 mg BID Dexpramipexole-0.419
75 mg BID Dexpramipexole-0.437
150 mg BID Dexpramipexole-0.655

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Change in Blood Absolute Blood Basophil Count From Baseline to Week 12

The analysis used a mixed effects model repeated-measures MMRM with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value. Basophils were enumerated as part of the WBC automated differential performed by the Central Laboratory. (NCT04046939)
Timeframe: Baseline, Week 12

Interventioncells (10*9/L) (Least Squares Mean)
Placebo BID-0.00439
37.5 mg BID Dexpramipexole-0.00655
75 mg BID Dexpramipexole-0.0250
150 mg BID Dexpramipexole-0.0277

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Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12

Number of Participants with Potentially Clinically Significant Vital Signs Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT04046939)
Timeframe: Immediately post-baseline up to Week 12

,,,
InterventionParticipants (Count of Participants)
Systolic blood pressure: >180 mmHgSystolic blood pressure: Increase >40 mmHgSystolic blood pressure: <90 mmHgSystolic blood pressure: Decrease >30 mmHgDiastolic blood pressure: >105 mmHgDiastolic blood pressure: Increase >30 mmHgDiastolic blood pressure: <50 mmHgDiastolic blood pressure: Decrease >20 mmHgPulse: >120 bpmPulse: Increase >30 bpmPulse: <50 bpmPulse: Decrease >20 bpmTemperature: >38.5°C and an increase ≥1°CBody weight: Increase ≥7% from BaselineBody weight: Decrease ≥7% from Baseline
150 mg BID Dexpramipexole000000000001011
37.5 mg BID Dexpramipexole000001000010000
75 mg BID Dexpramipexole000000000001010
Placebo BID000000000000000

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Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12

Number of Participants with Potentially Clinically Significant Urinalysis Results (glycosuria, ketonuria, or proteinuria) by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline urinalysis value in each treatment group. Patients are only counted once per criterion per laboratory test. The number of participants with potential clinical important urinalysis findings at any post-baseline visit were reported. (NCT04046939)
Timeframe: Immediately post-baseline up to Week 12

,,,
InterventionParticipants (Count of Participants)
glycosuria (glucose in urine ++++)ketonuria (ketones in urine ≥ ++++)proteinuria (protein in urine ≥ ++)
150 mg BID Dexpramipexole000
37.5 mg BID Dexpramipexole200
75 mg BID Dexpramipexole100
Placebo BID101

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Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12

Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT04046939)
Timeframe: Immediately post-baseline up to Week 12

,,,
InterventionParticipants (Count of Participants)
Eosinophils >1.6 x 10^9/LBasophils >1.6 x 10^9/LErythrocytes ≤3.5 x 10^12/LErythrocytes ≥6.4 x 10^12/LHematocrit ≤32% - FemalesHematocrit ≥54% - FemalesHematocrit ≤37% - MalesHematocrit ≥60% - MalesHemoglobin ≤9.5 g/dL - FemalesHemoglobin ≥17.5 g/dL - FemalesHemoglobin ≤11.5 g/dL - MalesHemoglobin ≥19.0 g/dL - MalesLeukocytes <3.0 x 10^9/LLeukocytes ≥16 x 10^9/LLymphocytes <0.8 x 10^9/LLymphocytes >12 x 10^9/LMonocytes >2.5 x 10^9/LNeutrophils <1.5 x 10^9/LNeutrophils ≥13.5 x 10^9/LPlatelets ≤75 x 10^9/LPlatelets ≥700 x 10^9/L
150 mg BID Dexpramipexole002010100010111001000
37.5 mg BID Dexpramipexole001020001000010001000
75 mg BID Dexpramipexole000000100000000001000
Placebo BID000000200020000001000

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Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12

Number of Participants with Potentially Clinically Significant ECG Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT04046939)
Timeframe: Immediately post-baseline up to Week 12

,,,
InterventionParticipants (Count of Participants)
Heart Rate >120 bpmHeart Rate Increase from Baseline >30 bpmQT Interval: >450 msQT Interval: >480 msQT Interval: >500 msQT Interval: Increase from Baseline >30 msQT Interval: Increase from Baseline >60 msQTcF Interval: >450 msQTcF Interval: >480 msQTcF Interval: >500 msQTcF Interval: Increase from Baseline >30 msQTcF Interval: Increase from Baseline >60 msChange from Baseline in PR >25% and PR value >220 msChange from Baseline in QRS >25% and QRS value >110 ms
150 mg BID Dexpramipexole01000000000000
37.5 mg BID Dexpramipexole00000300000000
75 mg BID Dexpramipexole00000200000000
Placebo BID00000700001000

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Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12

Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test. (NCT04046939)
Timeframe: Immediately post-baseline up to Week 12

,,,
InterventionParticipants (Count of Participants)
ALT ≥ 3 x ULNAlbumin ≤ 2.5 g/dLAlkaline Phosphatase ≥ 1.5 x ULNAST ≥ 3 x ULNBicarbonate ≤ 16 mEq/LBicarbonate ≥ 35 mEq/LBilirubin > 2 X ULN and (ALT or AST ≥ 3 X ULN)Bilirubin ≥ 1.5 x ULNCalcium ≤ 8 mg/dLCalcium ≥ 12 mg/dLChloride ≤ 90 mEq/LChloride ≥ 118 mEq/LCreatinine ≥ 2 mg/dL - FemalesCreatinine ≥ 2 mg/dL - MalesGlucose ≤ 39.6 mg/dLGlucose ≥ 175 mg/dLMagnesium ≤ 1.2 mg/dLMagnesium ≥ 2.9 mg/dLPhosphate ≤ 1.86 mg/dLPhosphate ≥ 5.27 mg/dLPotassium ≤ 3 mEq/LPotassium ≥ 6 mEq/LProtein [Serum] ≤ 4.5 g/dLProtein [Serum] ≥ 10 g/dLSodium ≤ 126 mEq/LSodium ≥ 156 mEq/LUrate ≥ 8.5 mg/dL - FemalesUrate ≥ 10.5 mg/dL - MalesUrea Nitrogen ≥ 30 mg/dL
150 mg BID Dexpramipexole00100000300000011000000000100
37.5 mg BID Dexpramipexole00000000200000021000000000000
75 mg BID Dexpramipexole10101000000000010000000000000
Placebo BID00000000000000020000000000000

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