Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 8:03 PM
Study NCT ID:
NCT05119712
Status:
WITHDRAWN
Last Update Posted:
2023-08-28
First Post:
2021-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Terbinafine Treatment of Axial Spondyloarthropathy
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
Terbinafine Treatment of Axial Spondyloarthropathy
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to poor recruitment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUN
Brief Summary:
This is a pilot study to determine if further research is warranted to assess if anti-fungal therapy is an effective adjunctive treatment for axial spondyloarthropathy
Detailed Description:
The purpose of this trial is to determine if terbinafine is an effective therapy for ankylosing spondylitis. Benefit will be determined by a reduction of the BASDAI by two or more.
The primary endpoint is the BASDAI at the completion of 16 weeks of terbinafine versus the BASDAI at the start of the trial and at the completion of the placebo. The secondary endpoint with the percent of patients whose BASDAI improves by two or more while on terbinafine (week 16) versus the percent of subjects with a similar improvement after 16 weeks of placebo.
The primary endpoint is the BASDAI at the completion of 16 weeks of terbinafine versus the BASDAI at the start of the trial and at the completion of the placebo. The secondary endpoint with the percent of patients whose BASDAI improves by two or more while on terbinafine (week 16) versus the percent of subjects with a similar improvement after 16 weeks of placebo.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: