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Trial of Ropinirole in Motor Recovery After Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221390
First Posted: September 22, 2005
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
  Purpose
The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.

Condition Intervention Phase
Cerebrovascular Accident Hemiparesis Drug: Ropinirole (+ physical therapy) Drug: (vs.) Placebo + physical therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-controlled, Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke

Resource links provided by NLM:


Further study details as provided by Steven C. Cramer, MD, University of California, Irvine:

Secondary Outcome Measures:
  • Barthel Index [ Time Frame: Measured at weeks 1, 9, and 12 ]
  • Leg motor Fugl-Meyer scale [ Time Frame: Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12 ]
  • Stroke Impact Scale-16 [ Time Frame: Measured at weeks 1, 4, 7, 9, and 12 ]
  • Gait endurance [ Time Frame: Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12 ]
  • Hamilton Depression Scale [ Time Frame: Measured at baseline and weeks 1, 2, 9, and 12 ]
  • Safety [ Time Frame: 12 weeks ]

Estimated Enrollment: 52
Study Start Date: October 2003
Study Completion Date: May 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221390


Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
GlaxoSmithKline
Investigators
Principal Investigator: Steven C Cramer, MD University of California, Irvine
  More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven C. Cramer, MD, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00221390     History of Changes
Other Study ID Numbers: HS#2003-3096
First Submitted: September 19, 2005
First Posted: September 22, 2005
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Steven C. Cramer, MD, University of California, Irvine:
stroke
Chronic stroke with hemiparesis

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs