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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease Peripheral Edema

Keywords

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Parkinson's disease Domperidone Peripheral edema Pramipexole Ropinirole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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Domperidone (drug)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Susan Fox

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan H Fox

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hospital, UHN

Locations

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Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MDCDOM2006

Identifier Type: -

Identifier Source: org_study_id