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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR APOKYN


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All Clinical Trials for APOKYN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00489255 ↗ Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment Completed INC Research Limited Phase 4 2007-05-01 The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
NCT00489255 ↗ Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment Completed Ipsen Phase 4 2007-05-01 The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
NCT00605683 ↗ MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist Completed Newron Phase 3 2007-11-01 Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
NCT00605683 ↗ MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist Completed Newron Pharmaceuticals SPA Phase 3 2007-11-01 Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
NCT01770145 ↗ Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) Completed Cape Cod Clinical Research Inc. Phase 4 2012-12-01 This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
NCT01770145 ↗ Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) Completed ClinData Services, Inc. Phase 4 2012-12-01 This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
NCT01770145 ↗ Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) Completed US WorldMeds LLC Phase 4 2012-12-01 This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for APOKYN

Condition Name

Condition Name for APOKYN
Intervention Trials
Parkinson's Disease 3
Motor Symptoms 2
Delayed Levadopa Onset 1
Delayed Levodopa Onset 1
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Condition MeSH

Condition MeSH for APOKYN
Intervention Trials
Parkinson Disease 5
Nausea 1
Vomiting 1
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Clinical Trial Locations for APOKYN

Trials by Country

Trials by Country for APOKYN
Location Trials
United States 50
South Africa 3
Canada 2
Croatia 1
Slovakia 1
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Trials by US State

Trials by US State for APOKYN
Location Trials
Florida 5
California 4
Texas 4
Ohio 4
Arizona 3
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Clinical Trial Progress for APOKYN

Clinical Trial Phase

Clinical Trial Phase for APOKYN
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for APOKYN
Clinical Trial Phase Trials
Completed 4
Terminated 1
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Clinical Trial Sponsors for APOKYN

Sponsor Name

Sponsor Name for APOKYN
Sponsor Trials
US WorldMeds LLC 2
INC Research Limited 1
Ipsen 1
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Sponsor Type

Sponsor Type for APOKYN
Sponsor Trials
Industry 9
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