Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
- Conditions
- Parkinson's Disease
- Interventions
- Registration Number
- NCT00203177
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental 1 rasagiline mesylate 0.5 mg rasagiline mesylate oral once daily Expermental 2 rasagiline mesylate 1.0 mg 1.0 mg rasagiline mesylate oral once daily
- Primary Outcome Measures
Name Time Method long-term safety and tolerability of rasagiline 6 months To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy.
- Secondary Outcome Measures
Name Time Method long- term clinical effect of rasagiline 6 months To assess the long- term clinical effect of rasagiline on the course of the disease.
Trial Locations
- Locations (8)
Creighton University
🇺🇸Omaha, Nebraska, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Rush - Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CHUM-Hotel-Dieu
🇨🇦Montreal, Quebec, Canada
University of Rochester
🇺🇸Rochester, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States