Using metformin to treat progressive multiple sclerosis

A Double-blind, Placebo Controlled Trial of Metformin Treatment in Progressive Multiple Sclerosis

This study is testing if the diabetes drug metformin can be safe and helpful for people with progressive multiple sclerosis who haven't taken it before.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT05349474 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety of metformin in patients with primary and secondary progressive multiple sclerosis. It is a single-site, randomized, placebo-controlled study involving 44 participants aged 30-65 who are not diabetic and have not previously been treated with metformin. Over a 12-month period, participants will undergo a titration of metformin dosage while being monitored for adverse events and changes in brain MRI and cognitive function. The study aims to gather data on both safety and potential efficacy of metformin in this patient population.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 30-65 with primary or secondary progressive multiple sclerosis who are not currently using metformin.

Not a fit: Patients with recent clinical relapses, new MRI lesions, or those with contraindications to metformin will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with progressive forms of multiple sclerosis.

How similar studies have performed: While there is limited research on metformin for multiple sclerosis, similar studies exploring repurposed medications for neurological conditions have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Patient signed informed consent.
2. Age 30-65
3. Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria
4. Intent to maintain current MS disease modifying treatment through the trial duration

Exclusion Criteria:

1. Clinical relapse in prior 12 months
2. New T2 lesion or gadolinium enhancing lesion in prior 12 months
3. Glucocorticoid use in prior six months outside the context of premedication for disease modifying treatment
4. Changes in disease modifying therapy in prior three months
5. Plans to change current disease modifying therapy
6. Contraindication to MRI, inability to tolerate MRI
7. Use of metformin for any other indication
8. Renal dysfunction (GFR \< 60)
9. Hepatic dysfunction (AST or ALT \> 1.5 x upper limit of normal)
10. B12 deficiency
11. Prior poor reaction to metformin
12. Congestive heart failure
13. Alcohol abuse
14. Metabolic acidosis
15. Females who are pregnant or who plan to become pregnant during the 12 months of enrollment, or who wish to breastfeed during any part of the 12 months of enrollment
16. Concomitant use of drugs with drug-drug interactions with metformin
17. Previous adverse effect with metformin treatment

Where this trial is running

Los Angeles, California

• University of California, Los Angeles — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Kevin R Patel, MD — University of California, Los Angeles
• Study coordinator: Kevin R Patel, MD

Conditions Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis; Multiple sclerosis; Demyelinating disease