Clinical trial NCT00221390: Trial of Ropinirole in Motor Recovery After Stroke
Official title: Randomized, Placebo-controlled, Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebrovascular Accident
Hemiparesis
Keywords: stroke
Chronic stroke with hemiparesis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
measure: Barthel Index
timeFrame: Measured at weeks 1, 9, and 12
measure: Leg motor Fugl-Meyer scale
timeFrame: Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12
measure: Stroke Impact Scale-16
timeFrame: Measured at weeks 1, 4, 7, 9, and 12
measure: Gait endurance
timeFrame: Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12
measure: Hamilton Depression Scale
timeFrame: Measured at baseline and weeks 1, 2, 9, and 12
measure: Safety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Steven C Cramer, MD
role: PRINCIPAL_INVESTIGATOR
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