Stroke Trials Registry

Trial of Ropinirole in Motor Recovery After Stroke

Principal Investigator
Steven C Cramer, MD

PI Address
Steven C Cramer, MD University of California, Irvine

Contact Email
scramer@uci.edu

Sponsor

Trial Phase:	Phase II
Study Size Planned:	52
Centers Planned:	1
Max Time from onset:	12 Months
Min Age:	18
Follow-up Duration:	12 Weeks
ISRCTN#	NCT00221390

Status:
This study has been completed.

Purpose:
To assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.

Interventions:

Physical therapy

Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.

Ropinirole
Ropinirole acts as an agonist at the D2 and D3 dopamine receptor subtypes, binding with higher affinity to D3 than to D2 or D4 and It has no affinity for D1 receptors. It has medium in vitro affinity to opioid receptors. Ropinirole is weakly active at the 5-HT2, and α2 receptors and is said to have virtually no affinity to 5-HT1, benzodiazepine, GABA, muscarinic, α1, and β-adrenoreceptors.[4]

Location(s):
California

Year Started: 2003

Year Finished: 2007

Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Inclusion Criteria
Stroke onset 4 weeks-12 months prior; stroke is radiologically confirmed as either (a) ischemic or (b) hemorrhagic; 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; terminal medical diagnosis consistent with survival < 1 year; coexistent major neurological disease; coexistent major psychiatric disease; history of significant alcohol or drug abuse in the prior 3 years; 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.

Patient Involvement:
Patients with chronic stroke will be randomized to either ropinirole+physiotherapy or placebo+physiotherapy. Patients will be assessed for gait endurance at Gait endurance measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12. They will have Barthel Index measured at weeks 1, 9, and 12. Leg motor Fugl-Meyer scale will be 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. Hamilton Depression Scale measured at baseline and weeks 1, 2, 9, and 12. Safety will be evaluated at the end of 12 weeks.

Secondary Outcome:
Barthel Index; Leg motor Fugl-Meyer scale; Stroke Impact Scale-16; Gait endurance; Hamilton Depression Scale; & Safety

Comments:
Scientific Name: Randomized, Placebo-Controlled, Double-Blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke

Source of Information:
ClinicalTrials.gov
Publications: 1. 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. 2. Rathore SS, Hinn AR, Cooper LS, Tyroler HA, Rosamond WD. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke 2002;33:2718-21. 3. Dobkin BH. Neurologic Rehabilitation. Philadelphia: FA Davis, 1996. 4. Nudo RJ. Recovery after damage to motor cortical areas. Curr Opin Neurobiol 1999;9:740-7. 5. Cramer SC, Chopp M. Recovery recapitulates ontogeny. Trends Neurosci 2000;23:265-71. 6. Finklestein S, Campbell A, Baldessarini RJ, Moya KL, Haber SN. Late changes in cerebral monoamine metabolism following focal ventrolateral cerebrocortical lesions in rats. Brain Res 1985;344:205-10. 7. Finklestein S, Campbell A, Stoll AL, Baldessarini RJ, Stinus L, Paskevitch PA, Domesick VB. Changes in cortical and subcortical levels of monoamines and their metabolites following unilateral ventrolateral cortical lesions in the rat. Brain Res 1983;271:279-88. 8. Boyeson MG, Feeney DM. Striatal dopamine after cortical injury. Exp Neurol 1985;89:479-83. 9. Stroemer RP, Kent TA, Hulsebosch CE. Enhanced neocortical neural sprouting, synaptogenesis, and behavioral recovery with D-amphetamine therapy after neocortical infarction in rats. Stroke 1998;29:2381-95. 10. Cramer SC, Nelles G, Benson RR, Kaplan JD, Parker RA, Kwong KK, Kennedy DN, Finklestein SP, Rosen BR. A functional MRI study of subjects recovered from hemiparetic stroke. Stroke 1997;28:2518-27. 11. Feeney DM, Gonzalez A, Law WA. Amphetamine, Halperidol, and experience interact to affect the rate of recovery after motor cortex injury. Science 1982;217:855-857. 12. Gladstone DJ, Black SE. Enhancing recovery after stroke with noradrenergic pharmacotherapy: a new frontier? Can J Neurol Sci 2000;27:97-105. 13. 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. 14. Scheidtmann K, Fries W, Muller F, Koenig E. Effect of levodopa in combination with physiotherapy on functional motor recovery after stroke: a prospective, randomised, double-blind study. Lancet 2001;358:787-790. 15. Sullivan KJ, Knowlton BJ, Dobkin BH. Step training with body weight support: effect of treadmill speed and practice paradigms on poststroke locomotor recovery. Arch Phys Med Rehabil 2002;83:683-91. 16. 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. 17. Potter JM, Evans AL, Duncan G. Gait speed and activities of daily living function in geriatric patients. Arch Phys Med Rehabil 1995;76:997-9. 18. Nieoullon A. Dopamine and the regulation of cognition and attention. Prog Neurobiol 2002;67:53-83. 19. Medico M, De Vivo S, Tomasello C, Grech M, Nicosia A, Castorina M, D'Agata MA, Rampello L, Lempereur L, Drago F. Behavioral and neurochemical effects of dopaminergic drugs in models of brain injury. Eur Neuropsychopharmacol 2002;12:187-94. 20. Bracha HS, Lyden PD, Khansarinia S. Delayed emergence of striatal dopaminergic hyperactivity after anterolateral ischemic cortical lesions in humans; evidence from turning behavior. Biol Psychiatry 1989;25:265-74. 21. Nutt JG, Fellman JH. Pharmacokinetics of levodopa. Clin Neuropharmacol 1984;7:35-49.

Web Links and Publications:

Randomized, placebo-controlled, double-blind study of ropinirole in chronic stroke.
Stroke 2009 Sep;40(9):3034-8

Trial of Ropinirole in Motor Recovery After Stroke
ClinicalTrials.gov

This information last updated on: 10/27/2009

Reviewed on: 10/27/2009.

UID: 967