drugset / Trial / NCT05900466

Metformin for Fibromyalgia Symptoms (INFORM Trial)

NCT05900466 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-04-01
Primary completion
2027-03-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg —

Indications