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

NCT ID: NCT00624741

Last Updated: 2012-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Interventions

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Pergolide

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.

Intervention Type DRUG

Other Intervention Names

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Permax

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PRG-001

Identifier Type: -

Identifier Source: org_study_id

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