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

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
Susan Fox, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00305331
First received: March 20, 2006
Last updated: July 26, 2012
Last verified: July 2012

March 20, 2006
July 26, 2012
March 2006
July 2008   (final data collection date for primary outcome measure)
left foot volume measured by water displacement
Same as current
Complete list of historical versions of study NCT00305331 on ClinicalTrials.gov Archive Site
subjective reporting of leg oedema; UPDRS, CGI and adverse events
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Parkinson's Disease
  • Peripheral Edema
Drug: Domperidone (drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
September 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00305331
MDCDOM2006
Not Provided
Susan Fox, University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Susan H Fox Toronto Western Hospital, UHN
University Health Network, Toronto
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP