Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations

Study Overview
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Brief Summary
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Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo

Official Title
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A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: rasagiline mesylate
* Drug: 1.0 mg rasagiline mesylate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without any other known or suspected cause of parkinsonism. Subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours daily in the OFF state. Subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days prior to baseline. Subjects must be receiving at least 3 daily doses of levodopa, not including a bedtime dose. Selegiline must be discontinued for at least 90 days prior to baseline. Subject must be age 30 or older. Subjects must be willing and able to give informed consent. Exclusion Criteria: Subjects with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, chest x-ray, or ECG for Parkinson's disease [e.g., pallidotomy, thalamotomy, and deep brain stimulation (DBS)] within the 12 months preceding the Baseline visit. Subjects who have undergone neurosurgical transplantation are excluded regardless of when the procedure(s) was performed. No programming changes are permitted in subjects who have undergone DBS. Participation in a previous clinical trial of rasagiline. Concomitant therapy with MAO inhibitors, reserpine, methyldopa within the past three months, or treatment with an anti-emetic or neuroleptic medication with central dopamine antagonist activity with the past six months.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>0.5 mg rasagiline mesylate oral once daily | Drug: rasagiline mesylate<br>* 0.5 mg rasagiline mesylate oral once daily<br>|
| Experimental: Experimental 2<br>1.0 mg rasagiline mesylate oral once daily | Drug: 1.0 mg rasagiline mesylate<br>* 1.0 mg rasagiline mesylate oral once daily<br>|
| Placebo Comparator: Placebo<br>Placebo Comparator | Other: Placebo<br>* oral placebo once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the mean total daily OFF time |  | 26 weeks |