Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Carbidopa; Levodopa; Rasagiline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.