Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.

Key facts

Study ID

NCT00203164

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

254

Starts

2002-05-01

Expected to finish

2006-09-01

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…

• Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
• Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0.
• Patients must be willing and able to give informed consent.

You may not qualify if…

• Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133.
• Premature discontinuation from study TVP 1012/133 for any reason.
• 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, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).

Where it is running

• Margolin Brain Institute — Fresno, California, United States
• Rush - Presbyterian St. Luke's Medical Center — Chicago, Illinois, United States
• Creighton University — Omaha, Nebraska, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• University of Rochester — Rochester, New York, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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