Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The goal of the study is to learn about treating older people with multiple sclerosis (MS) with metformin. Metformin may be used as a single therapy or as an add-on therapy. The investigators want to learn: * The safety and tolerability of metformin extended release (1500 mg/day) as a single therapy or as an add-on therapy in older people with MS compared to placebo * How well metformin protects the nervous system against injury compared with placebo measured by brain MRI over a 9 month treatment period * The effect of metformin to protect brain tissue from age and MS related injury when compared to the placebo group over a 9 month treatment period

Key facts

Study ID

NCT06463743

Run by

State University of New York at Buffalo

People needed

30

Starts

2025-09-24

Expected to finish

2027-06-01

Last updated by the study team

2025-11-21

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age between 55 and 75 years old
• having a diagnosis of MS based on the latest McDonald criteria
• non-active disease course (no relapses and no MRI activity) in the last 2 years as determined by the MS provider and based on the 2020 revised clinical course criteria
• EDSS score <7.0

You may not qualify if…

• inability to undergo MRI scans
• inability to participate in the study during the study period
• diabetes or uncontrolled cardiovascular disease
• unable to consent

Where it is running

• UBMD Neurolgy — Buffalo, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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