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

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: NCT00203177
• Other study ID #: TVP - 1012/135 Double Blind
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 8, 2010
• Start date: October 2001

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. primary completion date: December 2006
• 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, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• rasagiline mesylate
0.5 rasagiline mesylate
• rasagiline mesylate 1.0 mg
1.0 mg rasagiline mesylate

Locations

Country	Name	City	State
Canada	CHUM-Hotel-Dieu	Montreal	Quebec
United States	Emory University	Atlanta	Georgia
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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term safety and tolerability of rasagiline	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.	6 months	No
Secondary	long- term clinical effect of rasagiline	To assess the long- term clinical effect of rasagiline on the course of the disease.	6 months	No