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

Expanded access is currently available for this treatment.

Verified by Valeant Pharmaceuticals North America, February 2008

Sponsored by:	Valeant Pharmaceuticals North America
Information provided by:	Valeant Pharmaceuticals North America
ClinicalTrials.gov Identifier:	NCT00624741

Purpose

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.

Condition	Intervention
Parkinson Disease	Drug: Pergolide

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa Pergolide Pergolide mesylate

U.S. FDA Resources

Study Type:	Expanded Access
Official Title:	Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease

Further study details as provided by Valeant Pharmaceuticals North America:

Intervention Details:

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

Genders Eligible for Study:

Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624741

Contacts

Contact: Greg Brunson, Pharm.D.

949.461.6971

greg.brunson@valeant.com

Sponsors and Collaborators

Valeant Pharmaceuticals North America

More Information

Responsible Party:	Valeant Pharmaceuticals North America ( Greg Brunson )
Study ID Numbers:	PRG-001
Study First Received:	February 15, 2008
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00624741
Health Authority:	United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals North America:

Parkinson's disease
Antiparkinsonian
Compassionate use

Study placed in the following topic categories:

Levodopa
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Carbidopa

Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Pergolide

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases

Dopamine Agents
Dopamine Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009