Domperidone as a Treatment for Dopamine Agonist-Induced Peripheral Edema in Patients With Parkinson's Disease - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00305331

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 II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Edema Parkinson's Disease

Drug Information available for: Pramipexol Pramipexole dihydrochloride Ropinirole Ropinirole hydrochloride Dopamine Dopamine hydrochloride Domperidone Domperidone maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-Induced Peripheral Edema in Patients With Parkinson's Disease

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
Estimated Study Completion Date:	December 2009

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

Contacts

Contact: Susan H Fox, MRCP, PhD

416 603 6422

sfox@uhnresearch.ca

Locations

Canada, Ontario
Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St	Recruiting
Toronto, Ontario, Canada, M5V 2T8
Principal Investigator: Susan H Fox, MRCP, PhD

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Susan H Fox

Toronto Western Hospital, UHN

More Information

Study ID Numbers:	MDCDOM2006
Study First Received:	March 20, 2006
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00305331
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Parkinson's disease
Domperidone
Peripheral edema
Pramipexole
Ropinirole

Study placed in the following topic categories:

Ropinirole
Ganglion Cysts
Basal Ganglia Diseases
Edema
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Pramipexol
Signs and Symptoms
Dopamine
Domperidone
Parkinson Disease
Movement Disorders
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Antagonists

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009