Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05005351
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2021-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Sponsor:
Swing Therapeutics, Inc.
Organization:
Study Overview
Official Title:
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2022-02
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:
SMART-FM
Brief Summary:
This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: