Trial · NCT05900466
Metformin for Fibromyalgia Symptoms (INFORM Trial)
NCT05900466, Phase 2, Recruiting, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin for Fibromyalgia Symptoms (INFORM Trial). Trials, record NCT05900466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05900466
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin for Fibromyalgia Symptoms (INFORM Trial)
- NCT number
- NCT05900466
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 72 participants, estimated
- Lead sponsor
- University of Utah
- Conditions
- Fibromyalgia Syndrome
- Interventions
- Metformin, Placebo
- First posted
- 2023-06-12
- Last updated
- 2026-03-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS | 12-14 weeks | Safety will be measured by the Fibromyalgia Impact Questionnaire, Revised (FIQ-R score and will measure overall FMS severity. The numeric scale ranges from 0-10 with 0 being "low difficulty" (better outcome) and 10 being "high difficulty" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Pain Intensity | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of pain intensity (PROMIS Pain Intensity SF3a). The scale ranges from 0-10, 0 being "no pain" (better outcome) and 10 being "worst pain imaginable" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Fatigue | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of fatigue (PROMIS Fatigue SF7a). The scale ranges from 1-5, 1 being "not at all" (better outcome) and 5 being "very much" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Sleep Disturbance | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of sleep disturbance (PROMIS Sleep Disturbance SF8b). The scale ranges from 1-5, 1 being "very poor" or "not at all" (worse outcome) and 5 being "very good" or "very much" (better outcome). |
| Secondary | Examine changes in individual FMS symptoms - Depression | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of depression (PROMIS Depression SF8b). The scale ranges from 1-5, 1 being "never" (better outcome) and 5 being "always" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Anxiety | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of anxiety (PROMIS Anxiety SF7a). The scale ranges from 1-5, 1 being "never" (better outcome) and 5 being "always" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Physical Function | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of physical functioning (PROMIS Physical Function SF10a). The scale ranges from 1-5, 1 being "unable to do" (worse outcome) and 5 being "without any difficulty" (better outcome). |
| Secondary | Examine changes in individual FMS symptoms - Perceived Cognitive Function | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of perceived cognitive functioning (title: Multiple Ability Self-Report Questionnaire (MASQ)). The scale ranges from 1-5 with 1 being "never" (better outcome) to 5 being "always" (worse outcome). |
| Secondary | Examine changes in ecological momentary assessment (EMA) symptoms | 12-14 weeks | EMA will allow us to evaluate symptom variations at home environment |
| Secondary | Examine patient's global improvement impression | 12-14 weeks | Global impression of improvement scale will be used to assess clinical global impression (CGI). Global impression of improvement scale is a 7-point scale. Scores range from 1 being the better outcome (i.e. "normal", "improved") and 7 being the worse outcome (i.e. "most severely ill", "very much worse"). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AR082574 | Metformin as a novel, mechanistic treatment of fibromyalgia; a proof of concept RCT | TAYLOR, NORMAN; OKIFUJI, AKIKO | UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2023 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05900466
GET https://conductscience.org/api/trials/v1/NCT05900466/registered