Trial of Ropinirole in Motor Recovery After Stroke
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ClinicalTrials.gov Identifier: NCT00221390
Recruitment Status :
First Posted : September 22, 2005
Last Update Posted : November 1, 2016
University of California, Irvine
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Significant daytime somnolence or any substantial decrease in alertness, language reception, or attention
Pregnant or lactating
Advanced liver, kidney, cardiac, or pulmonary disease
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
Gresham GE, Duncan PW, Stason WB, Adams HP, Adelman AM, Alexander DN, Bishop DS, Diller L, Donaldson NE, Granger CV, Holland AL, Kelly-Hayes M, McDowell FH, Myers L, Phipps MA, Roth EJ, Siebens HC, Tarvin GA, Trombly CA. Post-Stroke Rehabilitation. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service, Agency for Health Care Policy and Research, 1995.
Goldstein LB. Potential impact of drugs on poststroke motor recovery. In: L. B. Goldstein, ed. Restorative Neurology. Advances in pharmacotherapy for recovery after stroke. Armonk, NY: Futura Publishing Co., 1998:241-256.
Richards C, Malouin F, Dumas F, Tardif D. Gait velocity as an outcome measure of locomotor recovery after stroke. In: C. R and O. C, eds. Gait Analysis: Theory and Application. St. Louis: Mosby, 1995:355-364.