CLINICAL TRIALS PROFILE FOR PARLODEL
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All Clinical Trials for PARLODEL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| 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. |
| NCT00649168 ↗ | Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg | Completed | Mylan Pharmaceuticals | Phase 1 | 2007-04-01 | The objective of this study was to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine mesylate capsules, following the administration of a 10 mg dose, under fed conditions. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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