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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
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 13, 2005
    Last Updated
    April 8, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    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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