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

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ClinicalTrials.gov Identifier: NCT00305331
Recruitment Status : Terminated (lack of recruitment)
First Posted : March 21, 2006
Last Update Posted : July 30, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Peripheral Edema Drug: Domperidone (drug) Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (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
Study Start Date : March 2006
Primary Completion Date : July 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. left foot volume measured by water displacement

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

Eligibility Criteria

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00305331     History of Changes
Other Study ID Numbers: MDCDOM2006
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by Susan Fox, 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
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Gastrointestinal Agents
Dopamine Antagonists