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

Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00624741
Enrollment
Unknown
Registered
2008-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson's disease, Antiparkinsonian, Compassionate use

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.

Interventions

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.

Sponsors

Bausch Health Americas, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026