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

Teva Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: rasagiline mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00203164

TVP - 1012/135 Open Label

Details and patient eligibility

About

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.

Enrollment

254 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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).