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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: rasagiline mesylate

• Registration Number: NCT00203164
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-09
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-08
• Last Update Posted: 2010-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rasagiline mesylate	rasagiline mesylate	rasagiline mesylate 1 mg oral once daily

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

University of Rochester; 🇺🇸 Rochester, New York, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States

Margolin Brain Institute; 🇺🇸 Fresno, California, United States

Rush - Presbyterian St. Luke's Medical Center; 🇺🇸 Chicago, Illinois, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States