Trial intelligence / Profile preview

Metformin for Fibromyalgia Syndrome

NCT05900466Phase 2

Key facts

Status: Recruiting
Start: Apr 2023
Primary completion: Mar 2027
Countries: 1
Sponsor: University of Utah
Modality: Small Molecules

Drugs: metformin
Conditions: fibromyalgia syndrome (FMS)

Overview

Phase 2, randomised, double-blind trial in fibromyalgia syndrome (FMS) comparing Metformin Treatment with Placebo (2 arms). Primary endpoint: Safety and efficacy of low-dose metformin in improving FMS symptoms. Started Apr 2023; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Metformin Treatment
500 mg metformin ER tablets once daily in the morning with a glass of water for 8 weeks.
Placebo
Matching metformin ER placebo tablets once daily in the morning with a glass of water for 8 weeks.

Who it enrols

Participants must have Fibromyalgia Syndrome. Excludes patients with diabetes, progressive diseases, serious psychopathology, autoimmune disorders, neuropathic pain, or eGFR below 45.

Endpoints

Primary

Safety and efficacy of low-dose metformin in improving FMS symptoms12-14 weeks

Secondary

Changes in individual FMS symptoms - Pain Intensity12-14 weeks
Changes in individual FMS symptoms - Fatigue12-14 weeks
Changes in individual FMS symptoms - Sleep Disturbance12-14 weeks
Changes in individual FMS symptoms - Depression12-14 weeks
Changes in individual FMS symptoms - Anxiety12-14 weeks
Changes in individual FMS symptoms - Physical Function12-14 weeks
Changes in individual FMS symptoms - Perceived Cognitive Function12-14 weeks
Changes in ecological momentary assessment (EMA) symptoms12-14 weeks

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