Metformin for Fibromyalgia Symptoms (INFORM Trial)

NCT05900466 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 00160543R21AR082574
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the project is to evaluate the safety and efficacy of low dose metformin for improving symptoms associated with fibromyalgia syndrome (FMS) via modulating neuroinflammatory pathways. The investigators hypothesize that FMS patients in the low-dose metformin conditions will show greater improvement in FMS symptoms than those who are in the placebo group. Further, the investigators hypothesize that metformin will increase phosphorylated AMPK in peripheral immune cells of FMS patients and will decrease the transcription of mTORC1, NLRP3 inflammasome, and nociceptive cytokines interleukin 1beta and interleukin 18.

Conditions

Fibromyalgia Syndrome

Keywords

FMS

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS

  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).

  12-14 weeks

Secondary Outcomes (10)

• Examine changes in individual FMS symptoms - Pain Intensity

  12-14 weeks

• Examine changes in individual FMS symptoms - Fatigue

  12-14 weeks

• Examine changes in individual FMS symptoms - Sleep Disturbance

  12-14 weeks

• Examine changes in individual FMS symptoms - Depression

  12-14 weeks

• Examine changes in individual FMS symptoms - Anxiety

  12-14 weeks

Study Arms (2)

1: Metformin Treatment

ACTIVE COMPARATOR

500 mg metformin ER tablets once daily in the morning with a glass of water for 8 weeks.

Drug: Metformin

2: Placebo

PLACEBO COMPARATOR

Matching metformin ER placebo tablets once daily in the morning with a glass of water for 8 weeks.

Drug: Placebo

Interventions

Metformin DRUG

500 mg Metformin ER tablets once daily in the morning for 8 weeks

Also known as: Glucophage XR (metformin hydrochloride), Glucophage (metformin hydrochloride)

1: Metformin Treatment

Placebo DRUG

Matching tablets once daily in the morning for 8 weeks

2: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be able to follow the protocol in English
• Fibromyalgia Syndrome: Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia
• Ability to take oral medication and be willing to adhere to the metformin regimen (once daily)

You may not qualify if:

• Co-occurring progressive disease (self-report, physician-diagnosed)
• Diabetes
• Pregnancy or planning to be pregnant in the next year (all premenopausal participants will be tested)
• Having known cardiovascular, liver, kidney or pulmonary diseases (self-report, physician-diagnosed)
• Having known serious psychopathology (Clinician diagnoses of psychosis, organic mental disorder, or dissociative disorder, self-reported active suicidal intent, self-reported history of inpatient admission to a psychiatric ward in the past year, evidence or self-report of self-injurious behaviors in the past year, reported current or recent history (2years) of non-IV substance abuse, any history of recreational IV drug use)
• Having autoimmune disorder (e.g., rheumatoid arthritis) (self-report, physician-diagnosed)
• Having neuropathic pain (self-report, physician-diagnosed)
• Having pain associated with a terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer) (self-report, physician-diagnosed)
• Concurrent use of weight controlling medications (eg, Xenical)
• Requiring an interpreter to communicate
• Abnormal levels of creatinine, vitamin B12, or hepatic function panel
• eGFR of below 45mL/min/1.73m2

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Akiko Okifuji, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Norman Taylor, MD, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reiko Mitsunaga, RN

CONTACT

801-585-7695; reiko.mitsunaga@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a proof of concept pilot study, a single site, randomized, double-blinded, phase 2 clinical trial with 2 parallel dosing arms comparing the effects of placebo, and 500mg of once a day metformin on improving hyperalgesia and other symptoms in 72 patients with FMS.

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 12, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)