Metformin for Multiple Sclerosis

Overseen By Kara Patrick

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: State University of New York at Buffalo

Disqualifiers: Diabetes, Uncontrolled cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 9 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the safety and effectiveness of metformin, a medication commonly used to treat type 2 diabetes, for older people with multiple sclerosis (MS). Researchers seek to determine if metformin can protect the brain from damage caused by MS and aging, compared to a placebo. They will monitor changes in the brain using MRI scans over nine months. The trial seeks participants aged 55 to 75 who have MS but have not experienced any recent disease activity or relapses. As a Phase 2 trial, this research focuses on measuring metformin's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. Metformin can be used as an add-on therapy, so you might be able to continue your current treatment.

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

Research shows that metformin, a drug approved for treating Type 2 diabetes, is generally safe for people. Some studies are now exploring its safety and effectiveness for multiple sclerosis (MS). Researchers believe metformin may reduce inflammation and act as an antioxidant, potentially benefiting people with MS.

In some studies, metformin has been combined with other MS treatments to assess its efficacy without causing additional problems. So far, results suggest it is well-tolerated, with most participants not experiencing serious side effects. However, since researchers are testing metformin for a new use in older people with MS, they continue to monitor for any issues. ^{1 2 3 4 5}

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

Unlike the standard treatments for multiple sclerosis, such as interferons and monoclonal antibodies, Metformin is a diabetes medication that researchers are repurposing for its potential neuroprotective effects. This treatment is unique because it targets cellular energy metabolism and may promote the repair of damaged nerve cells by activating the AMP-activated protein kinase (AMPK) pathway. Researchers are excited about Metformin because it offers a novel approach by potentially slowing disease progression and enhancing neural repair, which is different from the traditional immune-modulating therapies.

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

Research shows that metformin, which participants in this trial may receive, might protect brain cells in people with multiple sclerosis (MS). Some studies have shown that metformin reduces inflammation and improves outcomes related to nerve damage. For example, it lowered levels of harmful immune cells and decreased nerve damage in research models. Additionally, metformin has been linked to repairing myelin, the protective coating around nerves that MS often damages. These findings suggest metformin could benefit people with MS by potentially slowing nerve damage and promoting healing. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 55-75 with multiple sclerosis (MS) who haven't had active disease symptoms or MRI changes in the last two years. Participants must have an EDSS score below 7, indicating they retain some mobility.

Inclusion Criteria

I am between 55 and 75 years old.

I have been diagnosed with MS according to the latest standards.

My MS has been stable with no relapses or MRI changes for 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metformin or placebo for 9 months to assess safety, tolerability, and neuroprotective effects

9 months

Visits at baseline, 3, 6, 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview The study tests metformin, a medication typically used for diabetes, as either a standalone treatment or an addition to current therapy for MS. It compares metformin's effectiveness and safety against a placebo over nine months using brain MRIs.

How Is the Trial Designed?

Group I: metformin Experimental Treatment 1 Intervention

metformin

Group II: placebo Placebo Group 1 Intervention

placebo

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38070031/

The impact of metformin use on the outcomes of relapse ... We aimed to investigate the efficacy and safety of metformin as an adjuvant therapy to interferon beta 1a (IFNβ-1a) in relapsing-remitting multiple sclerosis ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06463743

Study Details | NCT06463743 | Metformin as an add-on or ... The investigators hypothesize that older pwMS that are treated with metformin will have a significantly lower decline in N-acetylaspartate levels when compared ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006899323004195

Metformin treatment reduces inflammation, dysmyelination ... We found that acute metformin treatment improved functional outcomes, concomitant with reduced microglia numbers and decreased dysmyelination.

4. cam.ac.uk cam.ac.uk/research/news/common-diabetes-drug-and-antihistamine-could-together-repair-multiple-sclerosis-damage-trial-finds

Diabetes drug and antihistamine could together repair ... Diabetes drug and antihistamine could together repair multiple sclerosis damage, trial finds. Dr Nick Cunniffe running a 'visual evoked ...

5. mssociety.org.uk mssociety.org.uk/research/explore-our-research/emerging-research-and-treatments/explore-treatments-in-trials/metformin

Metformin Lab results​​ In 2019, researchers at the MS Society Cambridge Centre for Myelin Repair showed that metformin could promote myelin repair in rats. Cells called ' ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7503488/

Metformin as a Potential Agent in the Treatment of Multiple ... Metformin has properties which are greatly desirable for MS therapy, including antioxidant, anti-inflammatory or antiplatelet functions.

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1362629/full

A metformin add-on clinical study in multiple sclerosis to ... Our study aims to provide evidence for the efficacy of metformin specifically in PMS patients, by focusing on both clinical and cost-related outcome measures.