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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00624741
First received: February 15, 2008
Last updated: June 20, 2012
Last verified: June 2012
  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

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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Intervention Details:
    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.
    Other Name: Permax
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00624741     History of Changes
Other Study ID Numbers: PRG-001
Study First Received: February 15, 2008
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Parkinson's disease
Antiparkinsonian
Compassionate use

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Pergolide
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014