NCT00305331

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Parkinson's Disease
• Peripheral Edema

Interventions

Type	Name	Description
DRUG	Domperidone (drug)

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2006-03-21
• Last updated: 2012-07-30

Locations

1 site across 1 country: Canada