Cerebrovascular Accident, Hemiparesis
Conditions
Keywords
stroke, Chronic stroke with hemiparesis
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 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.
Interventions
DRUGRopinirole (+ physical therapy)
DRUG(vs.) Placebo + physical therapy
Sponsors
GlaxoSmithKline
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Stroke onset 4 weeks-12 months prior 2. Stroke is radiologically confirmed as either (a) ischemic or (b) hemorrhagic 3. Minimum age 18 4. No significant pre-stroke disability 5. No other stroke in previous 3 months 6. Absence of major depression 7. Fugl-Meyer (FM) motor score of 23-83 out of 100 8. Functional Independence Measure (FIM) ambulation-subscore of 3 or more, and 50 foot walk takes longer than 15 seconds
Exclusion criteria
1. Significant daytime somnolence or any substantial decrease in alertness, language reception, or attention 2. Pregnant or lactating 3. Advanced liver, kidney, cardiac, or pulmonary disease 4. Orthostatic hypotension 5. Current use of ciprofloxacin, a centrally acting dopamine agonist, or a centrally active dopamine antagonist 6. A terminal medical diagnosis consistent with survival \< 1 year 7. Coexistent major neurological disease 8. Coexistent major psychiatric disease 9. A history of significant alcohol or drug abuse in the prior 3 years 10. A coexistent disease characterized by an abnormality of CNS dopaminergic tone 11. Current enrollment in another investigational study related to stroke or stroke recovery 12. Contraindication to ropinirole prescription
Design outcomes
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed