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Last Updated: May 27, 2022

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.
NCT00650520 ↗ Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets Completed Mylan Pharmaceuticals Phase 1 2007-05-01 The objective of this study is to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed conditions.
NCT01821001 ↗ Vaginal Bromocriptine for Treatment of Adenomyosis Completed Mayo Clinic Phase 1 2013-03-01 Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as a therapy based on animal models of the disease and our prior clinical research to observe any objective improvement in the extent of the disease using Magnetic Resonance Imaging (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.
NCT02428933 ↗ Dopaminergic Effects on Brown Adipose Tissue Completed Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) N/A 2013-10-01 In this study the investigators will investigate the effect of dopamine (bromocriptine) on Brown Adipose Tissue in lean, young, healthy males. The investigators will also examine energy expenditure, body temperature and insulin sensitivity as measurements of Brown Adipose Tissue activity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Parlodel

Condition Name

Condition Name for Parlodel
Intervention Trials
Healthy 2
Insulin Sensitivity 1
Intracerebral Hemorrhage 1
Ischemic Stroke 1
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Condition MeSH

Condition MeSH for Parlodel
Intervention Trials
Anorexia 1
Hypersensitivity 1
Fever 1
Subarachnoid Hemorrhage 1
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Clinical Trial Locations for Parlodel

Trials by Country

Trials by Country for Parlodel
Location Trials
United States 22
Canada 4
South Africa 3
Netherlands 2
Slovakia 1
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Trials by US State

Trials by US State for Parlodel
Location Trials
California 4
Pennsylvania 2
Arizona 1
Connecticut 1
Florida 1
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Clinical Trial Progress for Parlodel

Clinical Trial Phase

Clinical Trial Phase for Parlodel
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Parlodel
Clinical Trial Phase Trials
Completed 8
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Parlodel

Sponsor Name

Sponsor Name for Parlodel
Sponsor Trials
University of California, San Francisco 3
University of California, Berkeley 2
Mylan Pharmaceuticals 2
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Sponsor Type

Sponsor Type for Parlodel
Sponsor Trials
Other 10
Industry 4
NIH 1
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