Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221390
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2005-09-19
Brief Title:
Trial of Ropinirole in Motor Recovery After Stroke
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Randomized Placebo-controlled Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ropinirolephysiotherapy will show improved gait velocity over the 12 weeks of study participation as compared to patients randomized to placebophysiotherapy 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 armleg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None