Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05900466 · ClinicalTrials.gov registry record · Phase 2
Metformin for Fibromyalgia Symptoms (INFORM Trial)
A Phase 2 study of Fibromyalgia Syndrome, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05900466: Recruiting Phase 2 study of Fibromyalgia Syndrome, sponsored by University of Utah.
NCT05900466 is a Phase 2 study of Fibromyalgia Syndrome that is actively recruiting participants, run by University of Utah. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05900466, a Phase 2 study of Fibromyalgia Syndrome, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
Study Locations (1)
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
What NCT05900466 shows while recruiting
NCT05900466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Fibromyalgia Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05900466 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05900466 about?
NCT05900466 is a clinical study titled "Metformin for Fibromyalgia Symptoms (INFORM Trial)". 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 gr...
What is the current status of trial NCT05900466?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2023-04-01. Estimated completion is 2026-03-31.
What conditions does trial NCT05900466 study?
This clinical trial studies the following conditions: Fibromyalgia Syndrome.
What interventions are being tested in trial NCT05900466?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT05900466?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05900466 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05900466's enrollment target sits among peer trials
72 925th of 2000 higher than 1,066 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI