Status:
COMPLETED
Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
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.
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, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00203164
Start Date
May 1 2002
End Date
September 1 2006
Last Update
March 9 2010
Active Locations (6)
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1
Margolin Brain Institute
Fresno, California, United States, 93720
2
Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
3
Creighton University
Omaha, Nebraska, United States, 68131
4
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040