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

A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00203177

Enrollment

254

Registered

2005-09-20

Start date

2001-10-31

Completion date

Unknown

Last updated

2010-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief 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.

Interventions

DRUGrasagiline mesylate

0.5 rasagiline mesylate

DRUGrasagiline mesylate 1.0 mg

1.0 mg rasagiline mesylate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
long-term safety and tolerability of rasagiline	6 months	To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy.

Secondary

Measure	Time frame	Description
long- term clinical effect of rasagiline	6 months	To assess the long- term clinical effect of rasagiline on the course of the disease.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026