RecruitingPhase 2MS (type not specified)NCT06463743

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Metformin

Placebo or sham

  • Placebo

What it measured

Main measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

    1 year

    Safety
  • Percent change in N-Acetyl Aspartate (NAA) in the cortex over 9 months

    9 months

    MRI lesions

Other measures (8)

  • Disability progression as measured with Expanded Disability Status Scale (EDSS)

    1 year

    Disability progression
  • Symbol Digit Modality Test (SDMT)

    1 year

    Thinking and memory
  • Brief Visuospatial Memory Test ( BVMT)

    1 year

    Thinking and memory
  • California Verbal Learning Test (CVLT)

    1 year

  • Conventional MRI outcomes

    9 months

    MRI lesions
  • Timed 25-foot walk test (T25FWT)

    1 year

    Disability progressionWalking and mobility
  • 9-hole peg test (9HPT)

    1 year

    Disability progression
  • Myelin water fraction (MWF)

    9 months

    MRI lesionsMyelin repair

Who could take part

MS (type not specified) · 55 to 75

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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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

Papers

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    History

      1. Started

        Sept 2025

      2. Main results due

        Jan 2027

      3. Finished

        Jun 2027

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