RecruitingPhase 2NCT06463743

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

Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS): Randomized, Placebo-controlled Pilot Study.


Sponsor

State University of New York at Buffalo

Enrollment

30 participants

Start Date

Sep 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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

Exclusion Criteria4

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

Interventions

DRUGmetformin

metformin

DRUGPlacebo

Placebo


Locations(1)

UBMD Neurolgy

Buffalo, New York, United States

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NCT06463743


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