Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rasagiline mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: • Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator Exclusion Criteria: • Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study
Sites / Locations
Outcomes
Primary Outcome Measures
Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)
Secondary Outcome Measures
Full Information
NCT ID
NCT00203138
First Posted
September 13, 2005
Last Updated
April 8, 2011
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00203138
Brief Title
Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
Official Title
A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
5. Study Description
Brief Summary
Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD). During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rasagiline mesylate
Primary Outcome Measure Information:
Title
Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator
Exclusion Criteria:
• Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phyllis Salzman, Ph.D.
Organizational Affiliation
Teva Neuroscience, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
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