Back to resultsDomperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease, Peripheral Edema
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Domperidone (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Domperidone, Peripheral edema, Pramipexole, Ropinirole
Eligibility Criteria
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
Sites / Locations
- Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St
Outcomes
Primary Outcome Measures
left foot volume measured by water displacement
Secondary Outcome Measures
subjective reporting of leg oedema; UPDRS, CGI and adverse events
Full Information
NCT ID
NCT00305331
First Posted
March 20, 2006
Last Updated
July 26, 2012
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00305331
Brief Title
Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease
Official Title
Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Peripheral Edema
Keywords
Parkinson's disease, Domperidone, Peripheral edema, Pramipexole, Ropinirole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Domperidone (drug)
Primary Outcome Measure Information:
Title
left foot volume measured by water displacement
Secondary Outcome Measure Information:
Title
subjective reporting of leg oedema; UPDRS, CGI and adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan H Fox
Organizational Affiliation
Toronto Western Hospital, UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 2T8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease
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