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A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rasagiline mesylate
tyramine
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

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

Inclusion Criteria: Men and women with idiopathic Parkinson's disease (PD) who have met inclusion criteria for PRESTO, and have completed the 26-week PRESTO study. The subject should be available to participate in the sub-study immediately following the last PRESTO visit (same day). Subjects must continue PRESTO study drug until the morning of the Tyramine Sub-Study. Subjects must provide separate informed consent to participate in the Tyramine Sub-Study. Exclusion Criteria: Subjects must not have a history of intracranial aneurysm or stroke. Subjects should not have uncontrolled hypertension, defined as systolic pressure > 160 mmHg, or diastolic pressure > 90 mmHg.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    An increase in systolic blood pressure of > 30mmHg from the mean baseline value (documented by at least 3 consecutive measurements). Or Bradycardia with a heart rate below 40 beats per minute

    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
    NCT00203125
    Brief Title
    A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.
    Official Title
    Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2000 (undefined)
    Primary Completion Date
    January 2003 (Actual)
    Study Completion Date
    January 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo

    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
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    rasagiline mesylate
    Other Intervention Name(s)
    TVP-1012
    Intervention Description
    0.5 or 1 mg oral, once-daily
    Intervention Type
    Other
    Intervention Name(s)
    tyramine
    Intervention Description
    50 mg once daily
    Primary Outcome Measure Information:
    Title
    An increase in systolic blood pressure of > 30mmHg from the mean baseline value (documented by at least 3 consecutive measurements). Or Bradycardia with a heart rate below 40 beats per minute
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and women with idiopathic Parkinson's disease (PD) who have met inclusion criteria for PRESTO, and have completed the 26-week PRESTO study. The subject should be available to participate in the sub-study immediately following the last PRESTO visit (same day). Subjects must continue PRESTO study drug until the morning of the Tyramine Sub-Study. Subjects must provide separate informed consent to participate in the Tyramine Sub-Study. Exclusion Criteria: Subjects must not have a history of intracranial aneurysm or stroke. Subjects should not have uncontrolled hypertension, defined as systolic pressure > 160 mmHg, or diastolic pressure > 90 mmHg.
    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

    A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.

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