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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Study Completion Date

2000-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Rasagiline treatment

Group Type EXPERIMENTAL

Rasagiline Mesylate

Intervention Type DRUG

tablet, 1 or 2 mg, daily, 58 weeks

B

placebo arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablet, once daily, 58 weeks

Interventions

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Rasagiline Mesylate

tablet, 1 or 2 mg, daily, 58 weeks

Intervention Type DRUG

placebo

tablet, once daily, 58 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No