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

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

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2003-01-31

Brief Summary

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

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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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental 1

0.5 mg rasagiline mesylate oral once daily

Group Type EXPERIMENTAL

rasagiline mesylate

Intervention Type DRUG

0.5 mg rasagiline mesylate oral once daily

Experimental 2

1.0 mg rasagiline mesylate oral once daily

Group Type EXPERIMENTAL

1.0 mg rasagiline mesylate

Intervention Type DRUG

1.0 mg rasagiline mesylate oral once daily

Placebo

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

oral placebo once daily

Interventions

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rasagiline mesylate

0.5 mg rasagiline mesylate oral once daily

Intervention Type DRUG

1.0 mg rasagiline mesylate

1.0 mg rasagiline mesylate oral once daily

Intervention Type DRUG

Placebo

oral placebo once daily

Intervention Type OTHER

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.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No