Domperidone as a Treatment for Dopamine Agonist-Induced Peripheral Edema in Patients With Parkinson's Disease
Information source: University Health Network, Toronto
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease; Peripheral Edema
Intervention: Domperidone (drug) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s):
Susan H Fox, Principal Investigator, Affiliation: Toronto Western Hospital, UHN
Overall contact:
Susan H Fox, MRCP, PhD, Phone: 416 603 6422, Email: sfox@uhnresearch.ca
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.
Clinical Details
Official title: Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-Induced Peripheral Edema in Patients With Parkinson's Disease
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: left foot volume measured by water displacement
Secondary outcome: subjective reporting of leg oedema; UPDRS, CGI and adverse events
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
Minimum age: 30 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Susan H Fox, MRCP, PhD, Phone: 416 603 6422, Email: sfox@uhnresearch.ca
Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St, Toronto, Ontario M5V 2T8, Canada; Recruiting
Susan H Fox, MRCP, PhD, Principal Investigator
Additional Information
Starting date: March 2006
Ending date: December 2009
Last updated: September 19, 2007
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