Clinical trial NCT05243511: Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Official title: "PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Swing Therapeutics, Inc.
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 275
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient Global Impression of Change (PGIC) response rate
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Covina
country: United States
facility: Site #37
state: California
city: Oceanside
country: United States
facility: Site #15
state: California
city: San Bernardino
country: United States
facility: Site #31
state: California
city: Thousand Oaks
country: United States
facility: Site #38
state: California
city: Tujunga
country: United States
facility: Site #36
state: California
city: Whittier
country: United States
facility: Site #35
state: California
city: Orlando
country: United States
facility: Site #13
state: Florida
city: Saint Petersburg
country: United States
facility: Site #33
state: Florida
city: Atlanta
country: United States
facility: Site #25
state: Georgia
city: Covington
country: United States
facility: Site #21
state: Louisiana
city: New Orleans
country: United States
facility: Site #20
state: Louisiana
city: Prairieville
country: United States
facility: Site #22
state: Louisiana
city: Chestnut Hill
country: United States
facility: Site #39
state: Massachusetts
city: Ocean Springs
country: United States
facility: Site #24
state: Mississippi
city: Brooklyn
country: United States
facility: Site #34
state: New York
city: Scarsdale
country: United States
facility: Site #32
state: New York
city: Williamsville
country: United States
facility: Site #12
state: New York
city: Fargo
country: United States
facility: Site #27
state: North Dakota
city: Cincinnati
country: United States
facility: Site #14
state: Ohio
city: Dayton
country: United States
facility: Site #28
state: Ohio
city: Tulsa
country: United States
facility: Site #23
state: Oklahoma
city: Allentown
country: United States
facility: Site #16
state: Pennsylvania
city: Austin
country: United States
facility: Site #29
state: Texas
city: McKinney
country: United States
facility: Site #26
state: Texas
city: Pflugerville
country: United States
facility: Site #30
state: Texas
Study officials:
affiliation: Consulting Chief Medical Officer
name: Michael Gendreau, MD
role: STUDY_CHAIR
affiliation: Study Principal Investigator
name: Lesley Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References: