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

NCT00305331 | Terminated Phase 2

• 1 other identifier: MDCDOM2006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Parkinson's Disease; Peripheral Edema

Keywords

Parkinson's disease; Domperidone; Peripheral edema; Pramipexole; Ropinirole

Outcome Measures

Primary Outcomes (1)

• left foot volume measured by water displacement

Secondary Outcomes (1)

• subjective reporting of leg oedema; UPDRS, CGI and adverse events

Interventions

Domperidone (drug) DRUG

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

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

Toronto, Ontario, M5V 2T8, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Domperidone; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Susan H Fox

  Toronto Western Hospital, UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 20, 2006
• First Posted: March 21, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

CA (1)