Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

Fibromyalgia Clinical Trial

— PROSPER-FM  

Official title:

"PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243511
• Other study ID #: Swing-005
• Status: Completed
• Phase: Phase 3
• Start date: February 8, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: February 2023
• Source: Swing Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive assigned therapy for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Key Inclusion Criteria:

1. Participant is 22 to 75 years of age, inclusive

2. Participant has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM

3. Participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.

4. Participant is capable of reading and understanding English and has provided written informed consent to participate.

Key Exclusion Criteria:

1. Lifetime history of bipolar or other psychotic disorder

2. Severe depression at screening (measured by BDI-II)

3. The participant is at increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS")

4. Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Digital ACT
Participants in this arm receive Digital ACT as well as standard of care.

Other:
• Digital Symptom Tracker
Participants in this arm complete a digital symptom and function tracker and monitor, are provided access to digital fibromyalgia and health education, and receive standard of care.

Locations

Country	Name	City	State
United States	Site #16	Allentown	Pennsylvania
United States	Site #25	Atlanta	Georgia
United States	Site #29	Austin	Texas
United States	Site #34	Brooklyn	New York
United States	Site #39	Chestnut Hill	Massachusetts
United States	Site #14	Cincinnati	Ohio
United States	Site #37	Covina	California
United States	Site #21	Covington	Louisiana
United States	Site #28	Dayton	Ohio
United States	Site #27	Fargo	North Dakota
United States	Site #26	McKinney	Texas
United States	Site #20	New Orleans	Louisiana
United States	Site #24	Ocean Springs	Mississippi
United States	Site #15	Oceanside	California
United States	Site #13	Orlando	Florida
United States	Site #30	Pflugerville	Texas
United States	Site #22	Prairieville	Louisiana
United States	Site #33	Saint Petersburg	Florida
United States	Site #31	San Bernardino	California
United States	Site #32	Scarsdale	New York
United States	Site #38	Thousand Oaks	California
United States	Site #36	Tujunga	California
United States	Site #23	Tulsa	Oklahoma
United States	Site #35	Whittier	California
United States	Site #12	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Swing Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Change (PGIC) response rate		Week 12