Status:
TERMINATED
Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease
Lead Sponsor:
University Health Network, Toronto
Conditions:
Parkinson's Disease
Peripheral Edema
Eligibility:
All Genders
30-90 years
Phase:
PHASE2
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...
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 fin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00305331
Start Date
March 1 2006
End Date
September 1 2008
Last Update
July 30 2012
Active Locations (1)
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1
Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St
Toronto, Ontario, Canada, M5V 2T8