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

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

NCT00203164

Enrollment

254

Registered

2005-09-20

Start date

2002-05-31

Completion date

2006-09-30

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

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.

Interventions

DRUGrasagiline mesylate

rasagiline mesylate 1 mg oral once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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

Design outcomes

Primary

Measure	Time frame	Description
long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy	until commericially available	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

Countries

United States

Outcome results

None listed

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