Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
Completed · Phase 3
Conditions studied: Parkinson's Disease
In brief
Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.
Key facts
- Study ID
- NCT00203177
- Run by
- Teva Branded Pharmaceutical Products R&D, Inc.
- People needed
- 254
- Starts
- 2001-10-01
- 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, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.
Where it is running
- Margolin Brain Institute — Fresno, California, United States
- Emory University — Atlanta, Georgia, 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
- CHUM-Hotel-Dieu — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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