Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa

Phase 3CompletedNCT00203060

Teva Neuroscience, Inc.404 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

404

Conditions

Parkinson's Disease

Interventions

Rasagiline MesylateDRUG

tablet, 1 or 2 mg, daily, 58 weeks

placeboDRUG

tablet, once daily, 58 weeks

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 58 weeks

Data from ClinicalTrials.gov

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