"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Phase: PHASE2
Conditions: Fibromyalgia
Sponsor: Swing Therapeutics, Inc.

 
 
 
“SMART-FM”: Smart-Phone Based Digital Therapeutic for 
Management of Fibromyalgia 
 
 
Investigational 
Device: 
Digital ACT 
Protocol Date: 
January 10, 2021 
Protocol Number: 
 
NCT Number:   
Swing-004 
 
NCT05005351 
 
Sponsor: 
Swing Therapeutics 
San Francisco, CA  
 
 
 
 
 
 
 

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STUDY SYNOPSIS 
 
Study Number: 
Swing-004 
Protocol Title: 
Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia 
Study Name: 
SMART-FM 
Study Sponsor: 
Swing Therapeutics 
Study Device: 
Digital ACT 
Study Phase: 
II 
Indications for 
Use: 
Management of Fibromyalgia 
Study 
Objectives: 
The objectives of this study are to: 
1. Assess the effect size between two digital therapies in the treatment of 
fibromyalgia over 12 weeks;  
2. Assess the feasibility of conducting a largely virtual clinical study in a 
fibromyalgia population.  
Study 
Description:  
This is a blinded hypothesis, multicenter, randomized, active-controlled, non-
significant risk study.   
The study has a two-arm parallel group design: 
● 
Digital Acceptance and Commitment Therapy (ACT) Arm (Group 
A): Study subjects receive standard of care + Digital ACT  
 
● 
Digital Symptom Tracker Arm (Group S): Study subjects receive 
standard of care + a daily symptom and function tracker as well as access 
to digital fibromyalgia education.   
Qualified subjects have a diagnosis of fibromyalgia (FM) as defined by the 2016 
ACR classification criteria and no other significant pain disorders that could 
compromise the ability to assess changes in their FM symptoms.  Qualified 
subjects may remain on a stable dose and regimen of concomitant therapy for FM. 
Study 
Procedures: 
The study will consist of the following visit/data collection timepoints 
 
Type of Visit 
Timing of Visit 
Location of Visit 
Visit C1:  
Screening 
Day -14 to 1 
Clinic Visit 
Baseline Data 
Collection Period 
At least 6 days and no 
more than 14 days 
Remote 
Visit C2:  
Baseline 
Day 1 
Videoconference or 
Clinic Visit 
Check-in  
C3, C4, C5 
Weeks 2, 4 and 8 
Telephonic or 
Videoconference  
Visit C6 or C-ET 
Final Appointment or 
Early Termination 
Week 12 or ET 
Videoconference or 
Clinic Visit 

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After the minimum 6-day baseline period, subjects will be randomized to: 
 
1. Digital ACT Arm (Group A): Study subjects receive standard of care + 
Digital ACT 
 
2. Digital Symptom Tracker Arm (Group S): Study subjects receive 
standard of care + a daily symptom and function tracker as well as access 
to digital fibromyalgia education. 
Number of Sites 
and Subjects: 
The study will be recruited from up to 10 North American sites. 
Key Study Entry 
Criteria: 
Key Inclusion criteria: 
1. 
Subject is 22 to 75 years of age, inclusive 
2. 
Subject has a diagnosis of primary FM as defined by the 2016 American 
College of Rheumatology Preliminary Diagnostic Criteria for FM 
3. 
Subject with ongoing treatments should be on stable therapy for 30 days 
prior to screening appointment. 
4. 
Subject is capable of reading and understanding English and has provided 
written informed consent to participate. 
 
Key Exclusion criteria  
1. 
Lifetime history of bipolar disorder as assessed by the MINI. 
2. 
Current, untreated, major depressive episode and/or anxiety disorders as 
assessed by the MINI. 
3. 
Subject has a BDI-II total score > 25 at either the Screening appointment 
or Baseline appointment.    
4. 
The subject is at increased risk of suicide on the basis of the investigator’s 
judgment, a response > 1 to BDI item #9, or the results of the Columbia-
Suicide Severity Rating Scale (“C-SSRS”) conducted at Screening 
or Baseline (i.e., any suicidal behavior during the preceding year or C-
SSRS Type 3, 4, or 5 suicidal ideation during the preceding year).   
5. 
Subject has any other disease or medical condition that, in the opinion of 
the Investigator or Sponsor, could endanger the subject, interfere with the 
evaluation of the study device's efficacy or safety, or compromise the 
subject's ability to comply with/complete the study. 
 
Randomization criteria  
Assessed at the Baseline Virtual appointment:  
Only those subjects meeting all the following randomization criteria at the 
Baseline appointment are eligible for randomization: 
1. 
The subject continues to meet all inclusion and exclusion criteria 
2. 
The subject is familiar and compliant with the digital therapeutic 
application (has completed four daily training sessions within the app) 
3. 
The subject is sufficiently symptomatic as assessed by weekly pain 
scores: 

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a. A mean pain intensity score ≥4 and ≤9 on the 11-point NRS 
scale for the week immediately preceding Baseline 
Appointment(two readings);   
b. No score >9 on either reading preceding Baseline 
Appointment. 
4. 
The subject has successfully completed the FIQ-R at least 2 times during 
the screening phase.   
a. A mean FIQ-R total score ≥35 and ≤80 on the 100-point 
FIQ-R scale for the week immediately preceding Baseline 
Appointment (two readings). 
Efficacy and 
Safety 
Assessments/ 
Endpoints: 
Efficacy assessments: 
● Primary efficacy endpoint  
o The primary efficacy endpoint is the difference between the Group A 
and Group S in the mean change from baseline (CFB) at Week 12 on 
the weekly Revised Fibromyalgia Impact Questionnaire (FIQ-R) total 
score  
● Key Secondary efficacy assessment: 
o Rate of Patient’s Global Impression of Change (PGIC) Responders 
at Week 12 - Any Improvement 
Safety assessments: 
Safety assessments will include: 
● Adverse events/ Unanticipated Adverse Device Effects 
● Assessment of psychological status:   
o Beck Depression Inventory (BDI-II) 
o Columbia-Suicide Severity Rating Scale (C-SSRS)