Trial of Ropinirole in Motor Recovery After Stroke

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Collaborator: GlaxoSmithKline
• Treatments: Ropinirole

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