Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2003-10-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Interventions
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Ropinirole (+ physical therapy)
(vs.) Placebo + physical therapy
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
University of California, Irvine
OTHER
Responsible Party
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Steven C. Cramer, MD
Professor
Principal Investigators
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Steven C Cramer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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University of California, Irvine Medical Center
Orange, California, United States
Countries
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References
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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 Nov;33(11):2718-21. doi: 10.1161/01.str.0000035286.87503.31.
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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 Jul 25;271(2):279-88. doi: 10.1016/0006-8993(83)90290-1.
Boyeson MG, Feeney DM. Striatal dopamine after cortical injury. Exp Neurol. 1985 Aug;89(2):479-83. doi: 10.1016/0014-4886(85)90107-4.
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 Nov;29(11):2381-93; discussion 2393-5. doi: 10.1161/01.str.29.11.2381.
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 Dec;28(12):2518-27. doi: 10.1161/01.str.28.12.2518.
Feeney DM, Gonzalez A, Law WA. Amphetamine, haloperidol, and experience interact to affect rate of recovery after motor cortex injury. Science. 1982 Aug 27;217(4562):855-7. doi: 10.1126/science.7100929.
Gladstone DJ, Black SE. Enhancing recovery after stroke with noradrenergic pharmacotherapy: a new frontier? Can J Neurol Sci. 2000 May;27(2):97-105.
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.
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 Sep 8;358(9284):787-90. doi: 10.1016/S0140-6736(01)05966-9.
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 May;83(5):683-91. doi: 10.1053/apmr.2002.32488.
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.
Potter JM, Evans AL, Duncan G. Gait speed and activities of daily living function in geriatric patients. Arch Phys Med Rehabil. 1995 Nov;76(11):997-9. doi: 10.1016/s0003-9993(95)81036-6.
Nieoullon A. Dopamine and the regulation of cognition and attention. Prog Neurobiol. 2002 May;67(1):53-83. doi: 10.1016/s0301-0082(02)00011-4.
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 Jun;12(3):187-94. doi: 10.1016/s0924-977x(02)00010-x.
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Cramer SC, Dobkin BH, Noser EA, Rodriguez RW, Enney LA. Randomized, placebo-controlled, double-blind study of ropinirole in chronic stroke. Stroke. 2009 Sep;40(9):3034-8. doi: 10.1161/STROKEAHA.109.552075. Epub 2009 Jun 11.
Other Identifiers
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HS#2003-3096
Identifier Type: -
Identifier Source: org_study_id