Trial of Ropinirole in Motor Recovery After Stroke

University of California, Irvine52 enrolled

Overview

The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cerebrovascular Accident Hemiparesis

Interventions

Ropinirole (+ physical therapy)DRUG

(vs.) Placebo + physical therapyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California, Irvine Medical Center

Orange, California, United States

Outcomes

Secondary Outcomes

Barthel Index

Time frame: Measured at weeks 1, 9, and 12

Leg motor Fugl-Meyer scale

Time frame: Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12

Stroke Impact Scale-16

Time frame: Measured at weeks 1, 4, 7, 9, and 12

Gait endurance

Time frame: Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12

Hamilton Depression Scale

Time frame: Measured at baseline and weeks 1, 2, 9, and 12

Safety

Time frame: 12 weeks

Data from ClinicalTrials.gov

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