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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203164
• Other study ID #: TVP - 1012/135 Open Label
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 8, 2010
• Start date: May 2002
• Est. completion date: September 2006

Study information

• Verified date: March 2010
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: September 2006
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• rasagiline mesylate
rasagiline mesylate 1 mg oral once daily

Locations

Country	Name	City	State
United States	Rush - Presbyterian St. Luke's Medical Center	Chicago	Illinois
United States	Margolin Brain Institute	Fresno	California
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Creighton University	Omaha	Nebraska
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy	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	until commericially available	No