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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)
Information provided by (Responsible Party):
Susan Fox, University Health Network, Toronto Identifier:
First received: March 20, 2006
Last updated: July 26, 2012
Last verified: July 2012
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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:

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.

Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00305331

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

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

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms
Dopamine Agonists
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Protective Agents processed this record on May 23, 2017