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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00203164 |
This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson’s disease (PD) patients who have been treated with levodopa.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: rasagiline mesylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Safety Study |
Official Title: | A Bi-National, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson’s Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy |
Estimated Enrollment: | 254 |
Study Start Date: | May 2002 |
In the double-blinded phase, patients assigned to receive placebo in study TVP 1012/133 will be randomly assigned in a 1:1 ratio to receive (blinded) rasagiline 0.5 mg or 1 mg. Patients previously treated with rasagiline 0.5 mg and rasagiline 1 mg will continue on their original treatment assignment. Patients continuing beyond six (6) months will receive open-labeled rasagiline 1 mg/day.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Margolin Brain Institute | |
Fresno, California, United States, 93720 | |
United States, Illinois | |
Rush - Presbyterian St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Nebraska | |
Creighton University | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
United States, Pennsylvania | |
Pennsylvania Hospital | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Director: | Phyllis Salzman, Ph.D. | Teva Pharmaceutical Industries |
Study ID Numbers: | TVP - 1012/135 Open Label |
Study First Received: | September 13, 2005 |
Last Updated: | February 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00203164 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Rasagiline Levodopa Ganglion Cysts Movement Disorders Parkinson Disease Carbidopa |
Basal Ganglia Diseases Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Neuroprotective Agents |
Rasagiline Molecular Mechanisms of Pharmacological Action Basal Ganglia Diseases Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Enzyme Inhibitors Brain Diseases Neurodegenerative Diseases |
Neuroprotective Agents Protective Agents Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Monoamine Oxidase Inhibitors Parkinsonian Disorders Central Nervous System Agents |