Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
What it found
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
SafetyPercent 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 progressionSymbol Digit Modality Test (SDMT)
1 year
Thinking and memoryBrief Visuospatial Memory Test ( BVMT)
1 year
Thinking and memoryCalifornia Verbal Learning Test (CVLT)
1 year
Conventional MRI outcomes
9 months
MRI lesionsTimed 25-foot walk test (T25FWT)
1 year
Disability progressionWalking and mobility9-hole peg test (9HPT)
1 year
Disability progressionMyelin 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 registryAbout 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
Started
Sept 2025
Main results due
Jan 2027
Finished
Jun 2027
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