Trial of Ropinirole in Motor Recovery After Stroke

Cerebrovascular Accident Clinical Trial

Official title:

Randomized, Placebo-controlled, Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221390
• Other study ID #: HS#2003-3096
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2005
• Last updated: October 28, 2016
• Start date: October 2003
• Est. completion date: May 2007

Study information

• Verified date: October 2016
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hemiparesis
• Paresis
• Stroke

Intervention

Drug:
• Ropinirole (+ physical therapy)

• (vs.) Placebo + physical therapy

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (21)

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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 Feb 1;25(3):265-74. — View Citation

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Dobkin BH. Neurologic Rehabilitation. Philadelphia: FA Davis, 1996

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. — View Citation

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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. — View Citation

Gladstone DJ, Black SE. Enhancing recovery after stroke with noradrenergic pharmacotherapy: a new frontier? Can J Neurol Sci. 2000 May;27(2):97-105. Review. — View Citation

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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.

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. — View Citation

Nieoullon A. Dopamine and the regulation of cognition and attention. Prog Neurobiol. 2002 May;67(1):53-83. Review. — View Citation

Nudo RJ. Recovery after damage to motor cortical areas. Curr Opin Neurobiol. 1999 Dec;9(6):740-7. Review. — View Citation

Nutt JG, Fellman JH. Pharmacokinetics of levodopa. Clin Neuropharmacol. 1984;7(1):35-49. Review. — View Citation

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. — View Citation

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. — View Citation

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.

Scheidtmann K, Fries W, Müller 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Barthel Index		Measured at weeks 1, 9, and 12	Yes
Secondary	Leg motor Fugl-Meyer scale		Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12	Yes
Secondary	Stroke Impact Scale-16		Measured at weeks 1, 4, 7, 9, and 12	Yes
Secondary	Gait endurance		Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12	Yes
Secondary	Hamilton Depression Scale		Measured at baseline and weeks 1, 2, 9, and 12	Yes
Secondary	Safety		12 weeks	Yes