Status:
COMPLETED
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
Lead Sponsor:
Swing Therapeutics, Inc.
Conditions:
Fibromyalgia
Eligibility:
All Genders
22-75 years
Phase:
PHASE3
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. Eligib...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2023
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT05243511
Start Date
February 8 2022
End Date
May 15 2023
Last Update
June 15 2023
Active Locations (25)
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1
Site #37
Covina, California, United States, 91722
2
Site #15
Oceanside, California, United States, 92056
3
Site #31
San Bernardino, California, United States, 92498
4
Site #38
Thousand Oaks, California, United States, 91360