Recruiting
Phase 2

Metformin

Sponsor:

State University of New York at Buffalo

Code:

NCT06463743

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

metformin

Placebo

Study Details

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

Conditions

Multiple Sclerosis

Study ID

NCT06463743

Start date

Sep 24, 2025

Status verified date

Oct, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: metformin

metformin

placebo comparator: placebo

placebo

Interventions

metformin

metformin

Placebo

Placebo

Primary outcome measure

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 1 year ]
  • Percent change in N-Acetyl Aspartate (NAA) in the cortex over 9 months [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Kara Patrick

7168295037kpatrick@buffalo.edu

Locations

UBMD Neurolgy

Recruiting

Buffalo, New York, United States, 14203

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Nov 21, 2025

Last verified

Oct, 2025

Keywords

  • metformin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2025-11-21.