Trial of Ropinirole in Motor Recovery After Stroke

Study Overview
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Brief Summary
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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
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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 that can be targeted therapeutically, and improve function. The current study evaluates one such potential therapy, the dopamine agonist ropinirole. The current study tests the hypothesis that patients with chronic stroke randomized to ropinirole+physiotherapy will show improved gait velocity over the 12 weeks of study participation as compared to patients randomized to placebo+physiotherapy. A secondary aim is to test the hypothesis that ropinirole will improve three secondary endpoints at 12 weeks after study entry: the proportion of patients with no significant disability (Barthel Index ≥ 95); overall motor status, measured with the arm/leg FM score; and overall physical function, defined as the score on the Stroke Impact Scale-16 (SIS-16). This study will also evaluate the safety of ropinirole in patients recovering from stroke.

Official Title
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Randomized, Placebo-controlled, Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke

Conditions
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Cerebrovascular Accident, Hemiparesis

Intervention / Treatment
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* Drug: Ropinirole (+ physical therapy)
* Drug: (vs.) Placebo + physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ropinirole (+ physical therapy)|nan|
|Drug: (vs.) Placebo + physical therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index |  | Measured at weeks 1, 9, and 12 | 
| Leg motor Fugl-Meyer scale |  | Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12 | 
| Stroke Impact Scale-16 |  | Measured at weeks 1, 4, 7, 9, and 12 | 
| Gait endurance |  | Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12 | 
| Hamilton Depression Scale |  | Measured at baseline and weeks 1, 2, 9, and 12 | 
| Safety |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, Chronic stroke with hemiparesis