Parkinson's Disease
Conditions
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.
Interventions
tablet, 1 or 2 mg, daily, 58 weeks
DRUGplacebo
tablet, once daily, 58 weeks
Sponsors
Teva Neuroscience, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed