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

Teva Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: rasagiline mesylate 1.0 mg

Drug: rasagiline mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00203177

TVP - 1012/135 Double Blind

Details and patient eligibility

About

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.

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, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.