Status:
COMPLETED
Trial of Ropinirole in Motor Recovery After Stroke
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Cerebrovascular Accident
Hemiparesis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.
Detailed Description
Stroke is a leading cause of disability. Current treatments target injury and must be delivered within hours. A body of literature suggests that there are processes ongoing days-months after stroke th...
Eligibility Criteria
Inclusion
- Stroke onset 4 weeks-12 months prior
- Stroke is radiologically confirmed as either (a) ischemic or (b) hemorrhagic
- Minimum age 18
- No significant pre-stroke disability
- No other stroke in previous 3 months
- Absence of major depression
- Fugl-Meyer (FM) motor score of 23-83 out of 100
- Functional Independence Measure (FIM) ambulation-subscore of 3 or more, and 50 foot walk takes longer than 15 seconds
Exclusion
- Significant daytime somnolence or any substantial decrease in alertness, language reception, or attention
- Pregnant or lactating
- Advanced liver, kidney, cardiac, or pulmonary disease
- Orthostatic hypotension
- Current use of ciprofloxacin, a centrally acting dopamine agonist, or a centrally active dopamine antagonist
- A terminal medical diagnosis consistent with survival \< 1 year
- Coexistent major neurological disease
- Coexistent major psychiatric disease
- A history of significant alcohol or drug abuse in the prior 3 years
- A coexistent disease characterized by an abnormality of CNS dopaminergic tone
- Current enrollment in another investigational study related to stroke or stroke recovery
- Contraindication to ropinirole prescription
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00221390
Start Date
October 1 2003
End Date
May 1 2007
Last Update
November 1 2016
Active Locations (1)
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1
University of California, Irvine Medical Center
Orange, California, United States, 92868