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

NCT00624741 | Unknown

• 1 other identifier: PRG-001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Antiparkinsonian; Compassionate use

Interventions

Pergolide DRUG

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.

Also known as: Permax

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pergolide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Last Updated: June 22, 2012

Record last verified: 2012-06