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Compassionate Use Study of Pergolide in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Pergolide
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Parkinson Disease focused on measuring Parkinson's disease, Antiparkinsonian, Compassionate use

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Diagnosed with Parkinson's disease and treated successfully with pergolide in the recent past
  • Attempt to taper off pergolide was unsuccessful and patient was unable to change to other forms of therapy for Parkinson's disease
  • No evidence of cardiovalvular disease by echocardiogram conducted within 60 days prior

Exclusion Criteria:

  • History or current diagnosis of cardiac valvulopathy
  • Inability to undergo echocardiograms every 6 months while receiving pergolide
  • Hypersensitivity to pergolide or other ergot derivatives

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 15, 2008
    Last Updated
    June 20, 2012
    Sponsor
    Bausch Health Americas, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00624741
    Brief Title
    Compassionate Use Study of Pergolide in Patients With Parkinson's Disease
    Official Title
    Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch Health Americas, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This compassionate use study is designed to monitor safety in patients who have been doing well on pergolide therapy, wish to continue treatment, and have not been able to tolerate alternative treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson's disease, Antiparkinsonian, Compassionate use

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pergolide
    Other Intervention Name(s)
    Permax
    Intervention Description
    Pergolide tablets should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with Parkinson's disease and treated successfully with pergolide in the recent past Attempt to taper off pergolide was unsuccessful and patient was unable to change to other forms of therapy for Parkinson's disease No evidence of cardiovalvular disease by echocardiogram conducted within 60 days prior Exclusion Criteria: History or current diagnosis of cardiac valvulopathy Inability to undergo echocardiograms every 6 months while receiving pergolide Hypersensitivity to pergolide or other ergot derivatives

    12. IPD Sharing Statement

    Learn more about this trial

    Compassionate Use Study of Pergolide in Patients With Parkinson's Disease

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