Status:
COMPLETED
Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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 ther...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00203177
Start Date
October 1 2001
Last Update
March 9 2010
Active Locations (8)
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1
Margolin Brain Institute
Fresno, California, United States, 93720
2
Emory University
Atlanta, Georgia, United States, 30329
3
Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
4
Creighton University
Omaha, Nebraska, United States, 68131