Trial of Ropinirole in Motor Recovery After Stroke

NCT00221390 | Completed Phase 2

• 1 other identifier: HS#2003-3096
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebrovascular Accident; Hemiparesis

Keywords

stroke; Chronic stroke with hemiparesis

Outcome Measures

Secondary Outcomes (6)

• Barthel Index

  Measured at weeks 1, 9, and 12

• Leg motor Fugl-Meyer scale

  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

• Gait endurance

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

• Hamilton Depression Scale

  Measured at baseline and weeks 1, 2, 9, and 12

Interventions

Ropinirole (+ physical therapy) DRUG

(vs.) Placebo + physical therapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Contraindication to ropinirole prescription

Sponsors & Collaborators

• University of California, Irvine: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (22)

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  BACKGROUND

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  PMID: 12411667 BACKGROUND

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

  BACKGROUND

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• 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.

  PMID: 9412643 BACKGROUND

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  PMID: 10830340 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11564483 BACKGROUND

• 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.

  PMID: 11994808 BACKGROUND

• 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.

  BACKGROUND

• 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.

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  PMID: 6367973 BACKGROUND

• 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.

  PMID: 19520987 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Interventions

ropinirole; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Steven C Cramer, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: May 1, 2007
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

US (1)