Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa
- Registration Number
- NCT00203060
- Lead Sponsor
- Teva Neuroscience, Inc.
- Brief Summary
Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
Inclusion Criteria
Men and women with Parkinson's disease (PD) whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without other known or suspected cause of parkinsonism.
Subjects must be age 35 years or older.
Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.
Exclusion Criteria
Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B placebo placebo arm A Rasagiline Mesylate Rasagiline treatment
- Primary Outcome Measures
Name Time Method The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks. 58 weeks
- Secondary Outcome Measures
Name Time Method