Trial of Ropinirole in Motor Recovery After Stroke

October 28, 2016 updated by: Steven C. Cramer, MD, University of California, Irvine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

What is the study measuring?

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 12 weeks
12 weeks
Barthel Index
Time Frame: Measured at weeks 1, 9, and 12
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
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
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
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
Measured at baseline and weeks 1, 2, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

February 1, 2007

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS#2003-3096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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