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Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations | Clinical Trials | Clareo Health

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

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

NCT00203034•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

Rush - Presbyterian St. Luke's Medical Center

Chicago, Illinois, United States

Columbia - Presbyterian Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

May 1, 2000

Primary Completion Date

January 1, 2003

Completion Date

January 1, 2003

Last Updated

March 9, 2010

Enrollment

472

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

rasagiline mesylate

DRUG

1.0 mg rasagiline mesylate

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

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