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Sponsored by: |
Teva Pharmaceutical Industries |
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Information provided by: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00203138 |
Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson’s disease (PD). During this study the patient’s safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: rasagiline mesylate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson’s Disease |
Estimated Enrollment: | 306 |
Multicenter, open-label study of outpatients with early PD. Patients completing the week 52 evaluation of study TVP-1012/232 will be eligible for an open-label extension. All patients will take rasagiline 1 mg per day. Participation is voluntary and a separate informed consent form will be obtained.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator
Exclusion Criteria:
• Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study
United States, Illinois | |
Rush - Presbyterian St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Nebraska | |
Creighton University | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
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 - 1012/233 |
Study First Received: | September 13, 2005 |
Last Updated: | February 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00203138 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Rasagiline Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
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 |