Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
Phase 3
Completed
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00203138
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout) 2.5 years
- Secondary Outcome Measures
Name Time Method