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

Completed · Phase 3 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID

NCT00203034

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

472

Starts

2000-05-01

Expected to finish

2003-01-01

Last updated by the study team

2010-03-09

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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