Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-04 @ 3:35 AM
Study NCT ID:
NCT05184192
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
Status:
COMPLETED
Status Verified Date:
2025-02
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:
GRACE
Brief Summary:
This study will investigate the efficacy of oral gabapentin in olfactory improvement following Covid-19- associated olfactory dysfunction. This is a randomized, double-blinded, placebo-controlled trial.
Detailed Description:
The drug will be given over a maximum 14 weeks with up to four weeks titrating up, eight weeks maintaining highest tolerable dose, and up to two weeks tapering down. Change in olfactory function from baseline to completion of 8-week fixed-dose period will be compared between the two study groups. Follow-up assessments will be conducted for both groups 4 weeks after completion of taper down.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: