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Trial of Ropinirole in Motor Recovery After Stroke

Primary Purpose

Cerebrovascular Accident, Hemiparesis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ropinirole (+ physical therapy)

(vs.) Placebo + physical therapy

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke, Chronic stroke with hemiparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

University of California, Irvine Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Barthel Index

Leg motor Fugl-Meyer scale

Stroke Impact Scale-16

Gait endurance

Hamilton Depression Scale

Safety

Full Information

NCT ID

NCT00221390

First Posted

September 19, 2005

Last Updated

October 28, 2016

Sponsor

University of California, Irvine

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00221390

Brief Title

Trial of Ropinirole in Motor Recovery After Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebrovascular Accident, Hemiparesis

Keywords

stroke, Chronic stroke with hemiparesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ropinirole (+ physical therapy)

Intervention Type

Drug

Intervention Name(s)

(vs.) Placebo + physical therapy

Secondary Outcome Measure Information:

Title

Barthel Index

Time Frame

Measured at weeks 1, 9, and 12

Title

Leg motor Fugl-Meyer scale

Time Frame

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

Title

Stroke Impact Scale-16

Time Frame

Measured at weeks 1, 4, 7, 9, and 12

Title

Gait endurance

Time Frame

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

Title

Hamilton Depression Scale

Time Frame

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

Title

Safety

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven C Cramer, MD

Organizational Affiliation

University of California, Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Irvine Medical Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

12. IPD Sharing Statement

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Trial of Ropinirole in Motor Recovery After Stroke

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