Metformin for Fibromyalgia

Recruiting in Palo Alto (17 mi)

Overseen by Akiko Okifuji, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Utah

Must not be taking: Weight controlling medications

Disqualifiers: Diabetes, Pregnancy, Cardiovascular, Autoimmune, others

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this 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 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using weight-controlling medications, you cannot participate in the trial.

How is the drug Metformin unique in treating fibromyalgia?

Metformin is unique in treating fibromyalgia because it is primarily used for managing blood sugar levels in diabetes, unlike the typical fibromyalgia treatments like pregabalin and duloxetine, which are used for pain and depression. This suggests a novel approach by potentially addressing fibromyalgia through metabolic pathways.

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Eligibility Criteria

This trial is for individuals who can follow English instructions, take oral medication, and adhere to a daily regimen. Participants must meet the criteria for Fibromyalgia Syndrome as per the American College of Rheumatology 2016. Those with diabetes, pregnancy or planning to become pregnant, serious organ diseases, autoimmune disorders, neuropathic pain, terminal illness-related pain or using weight control meds cannot join.

Inclusion Criteria

Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia

To be able to follow the protocol in English

I can take pills and will follow a daily metformin plan.

Exclusion Criteria

I have another worsening illness as diagnosed by a doctor.

I have an autoimmune disorder like rheumatoid arthritis.

I have pain from a terminal illness or specific organ damage.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 500 mg metformin ER tablets or placebo once daily for 8 weeks

8 weeks

Weekly visits for monitoring and pill counts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

2 visits (in-person)

Participant Groups

The INFORM Trial is testing if low-dose metformin improves fibromyalgia symptoms by affecting neuroinflammatory pathways. It compares the effects of metformin against a placebo in improving symptoms and altering certain cellular markers related to inflammation and pain signaling.

Group I: 1: Metformin Treatment Active Control 1 Intervention

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

Group II: 2: Placebo Placebo Group 1 Intervention

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

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Glucophage for:

• Type 2 diabetes

🇺🇸 Approved in United States as Glucophage for:

• Type 2 diabetes

🇨🇦 Approved in Canada as Glucophage for:

• Type 2 diabetes

🇯🇵 Approved in Japan as Glucophage for:

• Type 2 diabetes

🇨🇳 Approved in China as Glucophage for:

• Type 2 diabetes

🇨🇭 Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah Lead Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing duloxetine and pregabalin for treatment of pain and depression in women with fibromyalgia: an open-label randomized clinical trial. [2020] Duloxetine and pregabalin are among the most widely used medications in the treatment of patients with fibromyalgia syndrome (FM).

2. Italy pubmed.ncbi.nlm.nih.gov

Palmitoylethanolamide and acetyl-L-carnitine act synergistically with duloxetine and pregabalin in fibromyalgia: results of a randomised controlled study. [2023] Fibromyalgia (FM) is characterised by a form of debilitating pain that is unresponsive to standard analgesics. The aim of this study was to evaluate the efficacy of supplementing ongoing pregabalin (PGB) and duloxetine (DLX) treatment with palmitoylethanolamide (PEA) and acetyl-L-carnitine (ALC) for 24 weeks in FM patients.

3. United States pubmed.ncbi.nlm.nih.gov

Current and Emerging Pharmacotherapy for Fibromyalgia. [2020] Introduction. Fibromyalgia syndrome (FMS) is a pain disorder with an estimated prevalence of 1-5%. It is associated with a variety of somatic and psychological disorders. Its exact pathogenesis is still unclear but is involved with neural oversensitization and decreased conditioned pain modulation (CPM), combined with cognitive dysfunction, memory impairment, and altered information processing. Connectivity between brain areas involved in pain processing, alertness, and cognition is increased in the syndrome, making its pharmacologic therapy complex. Only three drugs, pregabalin, duloxetine, and milnacipran are currently FDA-approved for FM treatment, but many other agents have been tested over the years, with varying efficacy. Areas Covered. The purpose of this review is to summarize current clinical experience with different pharmacologic treatments used for fibromyalgia and introduce future perspectives in developing therapies. Expert Opinion. Future insights into the fields of cannabinoid and opioid research, as well as an integrative approach towards the incorporation of genetics and functional imaging combined with additional fields of research relevant towards the study of complex CNS disorders, are likely to lead to new developments of novel tailor-made treatments for FMS patients.

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of fibromyalgia. [2021] In this article, we investigate the range of treatments prescribed for fibromyalgia. The data suggest that the majority of those treated, 82 percent, receive only one pharmaceutical. An additional 12 percent of patients were prescribed two products and six percent received three products. Pregabalin (Lyrica(R)) monotherapy was the most commonly prescribed regimen (21% of patients) followed by duloxetine (Cymbalta(R)) monotherapy (20%). From a therapeutic class perspective, fibromyalgia patients received antidepressants (46%), antiepileptics (35%), pain therapies (25%), muscle relaxants (8%), and sleep agents (2%). An expert commentary is included.

5. New Zealand pubmed.ncbi.nlm.nih.gov

Pregabalin for the management of fibromyalgia syndrome. [2021] This last article in a three-part series on approved medications for managing fibromyalgia syndrome (FMS) reviews pregabalin (Lyrica(®)). Pregabalin was the first drug approved for FMS management and, as an anticonvulsant, differs from the other approved agents that are antidepressants. Pregabalin inhibits presynaptic excitatory neurotransmitter release by blocking α(2)δ calcium channels. Five randomized, placebo-controlled trials have demonstrated pregabalin reduces pain and improves sleep and health-related quality of life in FMS patients. While indicated dosing is 300-450 mg divided twice daily, initial dosing of 25-50 mg at night is recommended owing to side effects including somnolence, dizziness, and cognitive dysfunction. Since side effects such as weight gain and peripheral edema are dose-related, uptitration in weekly increments based on tolerability and therapeutic response is recommended. Due to its lack of protein binding and negligible hepatic metabolism, pregabalin can be safely combined with other medications and used in patients with renal failure when the dose is appropriate. Pregabalin may worsen sedation when combined with central nervous system depressants. Pregabalin should be discontinued gradually. Pregabalin-treated patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior. Pregabalin in combination with the other approved medications may be synergistic in treating FMS.