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

Parkinson's Disease Clinical Trial

Official title:

Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00305331
• Other study ID #: MDCDOM2006
• Status: Terminated
• Phase: Phase 2
• First received: March 20, 2006
• Last updated: July 26, 2012
• Start date: March 2006
• Est. completion date: September 2008

Study information

• Verified date: July 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Parkinson Disease
• Parkinson's Disease
• Peripheral Edema

Intervention

Drug:
• Domperidone (drug)

Locations

Country	Name	City	State
Canada	Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left foot volume measured by water displacement
Secondary	subjective reporting of leg oedema; UPDRS, CGI and adverse events