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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00256204 |
A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: Rasagiline Mesylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects |
Enrollment: | 1176 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
1mg early start active treatment arm (72 weeks active)
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Drug: Rasagiline Mesylate
tablet, 1 or 2 mg, once daily, 72 weeks
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2: Experimental
1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
|
Drug: Rasagiline Mesylate
tablet, placebo for 36 weeks, then 1 or 2 mg, once daily, for additional 36 weeks
|
3: Experimental
2mg early start active treatment arm (72 weeks active)
|
Drug: Rasagiline Mesylate
tablet, 1 or 2 mg, once daily, 72 weeks
|
4: Experimental
2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
|
Drug: Rasagiline Mesylate
tablet, placebo for 36 weeks, then 1 or 2 mg, once daily, for additional 36 weeks
|
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all the inclusion criteria to be eligible:
Exclusion Criteria:
Any of the following will exclude the subject from the study:
Subjects with any one of the following features that tend to exclude PD as the cause of Parkinsonism: -
Study Director: | Weiss Yoni, MD, MBA | Teva Pharamaceutical Industries |
Responsible Party: | Teva Neuroscience ( Siyu Liu, Vice President, North American Innovative Research and Development and Head of Global Clinical Operations ) |
Study ID Numbers: | TVP-1012/500 (ADAGIO) |
Study First Received: | November 16, 2005 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00256204 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Parkinson's Rasagiline Mesylate |
Rasagiline Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Disease Progression Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Monoamine Oxidase Inhibitors |
Enzyme Inhibitors Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |