FibromyalgiaPhase 3PROSPER-FMNCT05243511

Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

A Phase 3 study testing Digital ACT and Digital Symptom Tracker in people with Fibromyalgia, run by Swing Therapeutics, Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 75 years
Conditions the study is for: Fibromyalgia
What is being tested?: Digital ACT and Digital Symptom Tracker
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 275 participants
Where: 25 sitesUnited States
Study dates: 8 Feb 2022to 15 May 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Site #16
Allentown, Pennsylvania, 18104
Site #25
Atlanta, Georgia, 30329
Site #29
Austin, Texas, 78726
Site #34
Brooklyn, New York, 11235
Site #39
Chestnut Hill, Massachusetts, 02467
Site #14
Cincinnati, Ohio, 45219
Site #37
Covina, California, 91722
Site #21
Covington, Louisiana, 70433
Site #28
Dayton, Ohio, 45419
Site #27
Fargo, North Dakota, 58104
Site #26
McKinney, Texas, 75070
Site #20
New Orleans, Louisiana, 70124
Site #24
Ocean Springs, Mississippi, 39564
Site #15
Oceanside, California, 92056
Site #13
Orlando, Florida, 32801
Site #30
Pflugerville, Texas, 78660
Site #22
Prairieville, Louisiana, 70769
Site #31
San Bernardino, California, 92498
Site #32
Scarsdale, New York, 10583
Site #33
St. Petersburg, Florida, 33709
Site #38
Thousand Oaks, California, 91360
Site #36
Tujunga, California, 91042
Site #23
Tulsa, Oklahoma, 74133
Site #35
Whittier, California, 90602
Site #12
Williamsville, New York, 14221

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About this study

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

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.

Conditions: Fibromyalgia
Being tested: Digital ACT, Digital Symptom Tracker
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Digital ACTDevice
Participants in this arm receive Digital ACT as well as standard of care.
Digital Symptom TrackerOther
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.

Study groups in NCT05243511
Study group	Role	What they receive
Digital Acceptance and Commitment Therapy (ACT) Arm	Active comparator	Not described Receives: Device: Digital ACT
Digital Symptom Tracker	Active comparator	Not described Receives: Other: Digital Symptom Tracker

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Global Impression of Change (PGIC) response rate
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202215 May 2023

First posted17 Feb 2022
Study start8 Feb 2022
Primary completion15 May 2023
Study completion15 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05243511
Sponsor's protocol ID: Swing-005
Acronym: PROSPER-FM
Status last verified: Feb 2023
First submitted: 7 Feb 2022
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Gendreau RM, McCracken LM, Williams DA, Luciano JV, Dai Y, Vega N, Ghalib Z, Guthrie K, Kraus AC, Rosenbluth MJ, Vaughn B, Zomnir JM, Reddy D, Chadwick AL, Clauw DJ, Arnold LM. Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial. Lancet. 2024 Jul 27;404(10450):364-374. doi: 10.1016/S0140-6736(24)00909-7. Epub 2024 Jul 8.
PubMed 38991582

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "PROSPER-FM": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management
ClinicalTrials.gov ID: NCT05243511
Acronym / sponsor ID: PROSPER-FM / Swing-005
Conditions: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: Swing Therapeutics, Inc.University, hospital or other
Study start: 8 Feb 2022 (actual)
Primary completion: 15 May 2023 (actual)
Study completion: 15 May 2023 (actual)
First posted: 17 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Digital Acceptance and Commitment Therapy (ACT) Arm	Active comparator	Device: Digital ACT
Digital Symptom Tracker	Active comparator	Other: Digital Symptom Tracker

Who may qualify

Ages: 22 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digital ACTParticipants in this arm receive Digital ACT as well as standard of care.	Device	Digital Acceptance and Commitment Therapy (ACT) Arm
Digital Symptom TrackerParticipants 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.	Other	Digital Symptom Tracker

Primary outcome

Patient Global Impression of Change (PGIC) response rate
Time frame: Week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Derived from this study: PubMed 38991582Gendreau RM, McCracken LM, Williams DA, Luciano JV, Dai Y, Vega N, Ghalib Z, Guthrie K, Kraus AC, Rosenbluth MJ, Vaughn B, Zomnir JM, Reddy D, Chadwick AL, Clauw DJ, Arnold LM. Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial. Lancet. 2024 Jul 27;404(10450):364-374. doi: 10.1016/S0140-6736(24)00909-7. Epub 2024 Jul 8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Gendreau, MD study chair

Consulting Chief Medical Officer

Lesley Arnold, MD principal investigator

Study Principal Investigator

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Digital ACT and Digital Symptom Tracker in people with Fibromyalgia, run by Swing Therapeutics, Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Global Impression of Change (PGIC) response rate (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243511, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.