Clinical Trial

Metformin for Fibromyalgia Symptoms (INFORM Trial)

Recruiting Phase 2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-06-02; most recent amendment 2026-03-26.
Status change: Active, Not Recruiting → Recruiting 2023-10-05
Trial Details
NCT Number NCT05900466
Lead Sponsor University of Utah
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Fibromyalgia Syndrome
Enrollment 72 participants
Start Date 2023-04-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-30