Metformin for Fibromyalgia

Overseen By Reiko Mitsunaga, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Weight controlling medications

Disqualifiers: Diabetes, Pregnancy, Cardiovascular, Autoimmune, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether low-dose metformin, a common diabetes medication, can reduce fibromyalgia symptoms by targeting inflammation in the nervous system. Participants will receive either metformin or a placebo (a pill with no active ingredients) to compare results. The trial seeks individuals diagnosed with fibromyalgia who can take medication daily. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research shows that metformin is generally safe for use. The FDA has approved it for treating diabetes, indicating a strong safety record. Studies suggest that metformin may reduce pain and other symptoms in conditions like fibromyalgia and long COVID.

Serious side effects are rare when using metformin for these conditions. Some people might experience mild side effects, such as an upset stomach or diarrhea, but these are usually manageable and resolve on their own.

Ongoing research examines whether low-dose metformin can safely alleviate fibromyalgia symptoms by affecting certain processes in the body. So far, evidence suggests it could be a safe option for many people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for fibromyalgia?

Researchers are excited about using metformin for fibromyalgia because it offers a fresh approach to managing this chronic pain condition. Unlike current treatments, which often include pain relievers, antidepressants, and anticonvulsants, metformin is originally a diabetes medication that may target inflammation and metabolic dysfunction believed to play a role in fibromyalgia. This new mechanism of action could provide relief for patients who haven't found success with existing options. Plus, metformin's long-standing safety profile as a diabetes treatment adds to its appeal as a potentially effective and well-tolerated option for fibromyalgia sufferers.

What evidence suggests that metformin might be an effective treatment for fibromyalgia?

Research has shown that metformin, which participants in this trial may receive, might help reduce fibromyalgia symptoms by decreasing inflammation in the brain and nervous system. Studies have found that metformin can protect nerve tissues and help balance brain chemicals that affect pain and mood. In other cases, metformin demonstrated benefits for conditions with similar inflammation. It is also widely used to treat diabetes, so its safety is well-known. These findings suggest that metformin could effectively ease fibromyalgia symptoms. ^{1 4 5 6 7}

Who Is on the Research Team?

Akiko Okifuji, PhD

Principal Investigator

University of Utah

Norman Taylor, MD, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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

To be able to follow the protocol in English

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

Fibromyalgia syndrome (FMS) affects 1-5% of the population and is characterized by neural oversensitization and cognitive dysfunction, making its treatment complex; currently, only three drugs (pregabalin, duloxetine, and milnacipran) are FDA-approved for its management.

Future research into cannabinoids, opioids, and personalized medicine approaches, including genetics and functional imaging, may lead to the development of more effective and tailored treatments for FMS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and Emerging Pharmacotherapy for Fibromyalgia. Tzadok, R., Ablin, JN.[2020]

In a 4-week clinical trial involving women with fibromyalgia, duloxetine showed a statistically significant improvement in pain scores compared to pregabalin, indicating it may be more effective for managing fibromyalgia pain.

However, the duloxetine group experienced a higher dropout rate and more nausea, suggesting that while it may be more effective, it could also have a less favorable safety profile compared to pregabalin.

NCBI (Pubmed)

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. Bidari, A., Moazen-Zadeh, E., Ghavidel-Parsa, B., et al.[2020]

In a study involving 130 fibromyalgia patients, adding palmitoylethanolamide (PEA) and acetyl-L-carnitine (ALC) to ongoing treatment with pregabalin and duloxetine led to significant improvements in pain and overall disease severity over 24 weeks.

This research is the first randomized controlled trial to show that the combination of PEA and ALC can enhance the effectiveness of standard fibromyalgia treatments, as evidenced by reduced scores on key pain and impact measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palmitoylethanolamide and acetyl-L-carnitine act synergistically with duloxetine and pregabalin in fibromyalgia: results of a randomised controlled study. Salaffi, F., Farah, S., Sarzi-Puttini, P., et al.[2023]

A study on fibromyalgia treatments found that 82% of patients were prescribed only one medication, with pregabalin and duloxetine being the most common choices, used by 21% and 20% of patients respectively.

The majority of treatments were from the antidepressant class (46%), followed by antiepileptics (35%) and pain therapies (25%), indicating a diverse approach to managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of fibromyalgia. Dussias, P., Kalali, AH., Staud, RM.[2021]

Pregabalin (Lyrica) is the first approved medication for managing fibromyalgia syndrome (FMS) and has been shown to effectively reduce pain, improve sleep, and enhance quality of life in FMS patients based on five randomized, placebo-controlled trials.

While pregabalin is generally safe and can be combined with other medications, it may cause side effects like somnolence and dizziness, and should be started at a low dose (25-50 mg) to minimize these effects, with careful monitoring for any worsening of depression or suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregabalin for the management of fibromyalgia syndrome. Boomershine, CS.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05900466

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39692938/

Metformin and fibromyalgia pathophysiology: current ...

Metformin has been shown to mitigate neuroinflammation, protect neural tissues, and modulate key neurotransmitters involved in pain and mood ...

3.

allclinicaltrials.com

allclinicaltrials.com/blog/benefits-of-metformin-for-fibromyalgia

Potential Benefits of Metformin for Fibromyalgia

Metformin – which is currently used for treating diabetes – has demonstrated the potential to alleviate many of fibromyalgia's unpleasant symptoms.

4.

trialx.com

trialx.com/clinical-trials/listings/234018/metformin-for-fibromyalgia-symptoms-inform-trial/?&geo_lat=40.6668916&geo_lng=-111.8879909&radius=10&place=Murray&user_country=United%20States

Metformin for Fibromyalgia Symptoms (INFORM Trial)

The investigators hypothesize that FMS patients in the low-dose metformin conditions will show greater improvement in FMS symptoms than those ...

5.

healthrising.org

healthrising.org/blog/2023/01/02/metformin-long-covid-fibromyalgia-chronic-fatigue-buster/

Metformin - A Long COVID, Fibromyalgia and ME/CFS ...

Metformin decreased the risk of coming down with long COVID by about 40%. The size and duration of the trial were unlike virtually anything that's been done in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7538784/

Metformin: A Prospective Alternative for the Treatment of ...

Data strongly suggest that metformin could open a new avenue for the treatment of pathological pain and some of its associated comorbidities. Mechanisms of ...

7.

reporter.nih.gov

reporter.nih.gov/project-details/10809033

fibromyalgia - NIH RePORTER

The goal of this project is to determine the effectiveness and safety of metformin in treating pain, mood and cognitive symptoms of fibromyalgia, and identify ...