Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: 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, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).