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Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management (PROSPER-FM)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Digital ACT
Digital Symptom Tracker
Sponsored by
Swing Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site #37
  • Site #15
  • Site #31
  • Site #38
  • Site #36
  • Site #35
  • Site #13
  • Site #33
  • Site #25
  • Site #21
  • Site #20
  • Site #22
  • Site #39
  • Site #24
  • Site #34
  • Site #32
  • Site #12
  • Site #27
  • Site #14
  • Site #28
  • Site #23
  • Site #16
  • Site #29
  • Site #26
  • Site #30

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Digital Acceptance and Commitment Therapy (ACT) Arm

Digital Symptom Tracker

Arm Description

Outcomes

Primary Outcome Measures

Patient Global Impression of Change (PGIC) response rate

Secondary Outcome Measures

Full Information

First Posted
February 7, 2022
Last Updated
June 13, 2023
Sponsor
Swing Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05243511
Brief Title
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Acronym
PROSPER-FM
Official Title
"PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swing Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Acceptance and Commitment Therapy (ACT) Arm
Arm Type
Active Comparator
Arm Title
Digital Symptom Tracker
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Digital ACT
Intervention Description
Participants in this arm receive Digital ACT as well as standard of care.
Intervention Type
Other
Intervention Name(s)
Digital Symptom Tracker
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC) response rate
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participant is 22 to 75 years of age, inclusive Participant has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM Participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment. Participant is capable of reading and understanding English and has provided written informed consent to participate. Key Exclusion Criteria: Lifetime history of bipolar or other psychotic disorder Severe depression at screening (measured by BDI-II) 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") 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gendreau, MD
Organizational Affiliation
Consulting Chief Medical Officer
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lesley Arnold, MD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site #37
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Site #15
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site #31
City
San Bernardino
State/Province
California
ZIP/Postal Code
92498
Country
United States
Facility Name
Site #38
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Site #36
City
Tujunga
State/Province
California
ZIP/Postal Code
91042
Country
United States
Facility Name
Site #35
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Site #13
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Site #33
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Site #25
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Site #21
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Site #20
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Site #22
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Facility Name
Site #39
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Site #24
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Site #34
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Site #32
City
Scarsdale
State/Province
New York
ZIP/Postal Code
10583
Country
United States
Facility Name
Site #12
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site #27
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Site #14
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site #28
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Site #23
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Site #16
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Site #29
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Facility Name
Site #26
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Site #30
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

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