Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305331
Status:
TERMINATED
Last Update Posted:
2012-07-30
First Post:
2006-03-20
Brief Title:
Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinsons Disease
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinsons Disease
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The dopamine agonists pramipexole Mirapex and ropinirole Requip are drugs that are used to treat symptoms of Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None