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A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
rasagiline mesylate
Rasagiline mesylate plus Mirapex
Rasagiline mesylate with Levodopa
Rasagiline mesylate with Requip
Sponsored by
Teva Neuroscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

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

Inclusion Criteria:

  1. Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism.

  2. Requiring therapy for PD symptom control

    • Azilect monotherapy.
    • Azilect as adjunct therapy..

Exclusion Criteria:

  1. Patients previously exposed to Azilect
  2. Patients with pheochromocytoma
  3. Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Rasagiline mesylate

    Rasagiline mesylate plus adjunct therapy

    Arm Description

    Rasagiline mesylate with one of three adjunct therapies

    Outcomes

    Primary Outcome Measures

    To identify the earliest scheduled visit of symptomatic effect

    Secondary Outcome Measures

    To characterize the effectiveness of Azilect in a usual community neurological

    Full Information

    First Posted
    November 10, 2006
    Last Updated
    April 8, 2011
    Sponsor
    Teva Neuroscience, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00399477
    Brief Title
    A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease
    Official Title
    Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Teva Neuroscience, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with Parkinson's Disease (PD) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their PD: Group 1 Patients using Azilect and no other therapy. Group 2 Azilect in combination with other medications like Levodopa, Mirapex, or Requip.

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rasagiline mesylate
    Arm Type
    Active Comparator
    Arm Title
    Rasagiline mesylate plus adjunct therapy
    Arm Type
    Experimental
    Arm Description
    Rasagiline mesylate with one of three adjunct therapies
    Intervention Type
    Drug
    Intervention Name(s)
    rasagiline mesylate
    Intervention Description
    Azilect®
    Intervention Type
    Drug
    Intervention Name(s)
    Rasagiline mesylate plus Mirapex
    Intervention Description
    Mirapex, Azilect®
    Intervention Type
    Drug
    Intervention Name(s)
    Rasagiline mesylate with Levodopa
    Intervention Description
    Azilect®, Levodopa
    Intervention Type
    Drug
    Intervention Name(s)
    Rasagiline mesylate with Requip
    Intervention Description
    Azilect®, Requip
    Primary Outcome Measure Information:
    Title
    To identify the earliest scheduled visit of symptomatic effect
    Time Frame
    8 months
    Secondary Outcome Measure Information:
    Title
    To characterize the effectiveness of Azilect in a usual community neurological
    Time Frame
    8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Idiopathic Parkinson's disease. Diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism. Requiring therapy for PD symptom control Azilect monotherapy. Azilect as adjunct therapy.. Exclusion Criteria: Patients previously exposed to Azilect Patients with pheochromocytoma Concomitant MAO inhibitors or medications contraindicated for use with MAO inhibitors are not allowed.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MerriKay Oleen-Burkey, PhD
    Organizational Affiliation
    Teva Neuroscience, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease

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