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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00624741
• Other study ID #: PRG-001
• Status: No longer available
• Phase: N/A
• First received: February 15, 2008
• Last updated: June 20, 2012

Study information

• Verified date: June 2012
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.