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Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
Susan Fox, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00305331
First received: March 20, 2006
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

The dopamine agonists, pramipexole (Mirapex) and ropinirole (Requip), are drugs that are used to treat symptoms of Parkinson's disease. However, these drugs can induce bothersome leg swelling or edema in about 20 percent of patients. The cause of this edema is unknown but may be secondary to stimulation of peripheral dopamine receptors in the kidney or blood vessels. We hypothesise that a peripherally acting dopamine receptor antagonist, will reduce edema in PD patients. This study will assess the effect of the peripheral acting dopamine D2 receptor antagonist, domperidone as a potential treatment for dopamine agonist-induced leg swelling.


Condition Intervention Phase
Parkinson's Disease
Peripheral Edema
 Drug: Domperidone (drug)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • left foot volume measured by water displacement

Secondary Outcome Measures:
  • subjective reporting of leg oedema; UPDRS, CGI and adverse events

Estimated Enrollment: 25
Study Start Date: March 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The study is a phase II, randomised double-blind, placebo-controlled, cross-over trial. There are four periods: recruitment and randomisation; treatment period one (4 weeks); washout (1 week); and finally treatment period two (4 weeks). Patients will be randomly assigned domperidone 20 mg tid in treatment period one followed by placebo tid in treatment period two, or placebo tid in treatment period one followed by domperidone 20 mg tid in treatment period two.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic PD
  • On a stable medication regimen for at least one month with leg edema occurring after the start of pramipexole or ropinirole and the absence of other possible reasons for discontinuation of pramipexole or ropinirole treatment (e.g. other adverse effects).

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Women of child bearing age not using a reliable method of contraception
  • Coronary disease, abnormal QT interval on electrocardiogram (EKG)
  • Diabetes mellitus
  • Hepatic disease
  • Alcohol abuse
  • Renal disease
  • Edema of one leg only
  • Presence of other conditions possibly causing leg edema
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305331

Locations
Canada, Ontario
Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St
Toronto, Ontario, Canada, M5V 2T8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Susan H Fox Toronto Western Hospital, UHN
  More Information

No publications provided

Responsible Party: Susan Fox, PI, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00305331     History of Changes
Other Study ID Numbers: MDCDOM2006
Study First Received: March 20, 2006
Last Updated: July 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Parkinson's disease
Domperidone
Peripheral edema
Pramipexole
Ropinirole

Additional relevant MeSH terms:
Edema
Parkinson Disease
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Domperidone
Dopamine
Dopamine Agonists
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013