Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-01 @ 5:57 PM
Study NCT ID:
NCT01674868
Status:
WITHDRAWN
Last Update Posted:
2015-06-16
First Post:
2012-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
Sponsor:
Spaulding Rehabilitation Hospital
Organization:
Study Overview
Official Title:
Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to find patients meeting inclusion/exclusion criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLAN
Brief Summary:
This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: