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Recruiting Phase 2 NCT06463743

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

Trial Parameters

Condition Multiple Sclerosis
Sponsor State University of New York at Buffalo
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 55 Years
Max Age 75 Years
Start Date 2025-09-24
Completion 2027-01-01
Interventions
metforminPlacebo

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 1. age between 55 and 75 years old 2. having a diagnosis of MS based on the latest McDonald criteria 3. 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 4. EDSS score \<7.0 Exclusion Criteria: 1. inability to undergo MRI scans 2. inability to participate in the study during the study period 3. diabetes or uncontrolled cardiovascular disease 4. unable to consent

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