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

N/ANo Longer AvailableNCT00624741

Bausch Health Americas, Inc.

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Parkinson Disease

Interventions

PergolideDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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