Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
NCT ID: NCT06463743
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-09-24
2027-06-01
Brief Summary
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* 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
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Detailed Description
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The main aim of this study is to determine the safety of metformin as monotherapy or as an add-on therapy to the disease modifying treatment in aging people with multiple sclerosis (pwMS). While the tolerability of metformin has been studies in the general population, data specific to the MS population is not currently available. Moreover, understanding the gastrointestinal tolerability of metformin when added on MS disease modifying treatment is needed. Secondly, the study aims at understating the potential neuroprotective properties of metformin as measured through magnetic resonance spectroscopy and change in N-acetyl-aspartate (NAA) levels over a 9-month study period. This pilot study will provide valuable insights into the efficacy and safety of add-on or monotherapy metformin therapy as a potential therapeutic approach to address the complex pathophysiology of MS and offer new avenues for promoting neuroprotection along with potential support for neural repair and remyelination in individuals with this debilitating condition. Previous pre-clinical studies have shown that metformin can promote neuroprotection by reducing oxidative stress and inflammation and is able to enhance the reparative mechanisms within the central nervous system (CNS). Currently there are no neuroprotective interventions available for pwMS that directly target the neurodegenerative component of MS, with particular emphasis for the aging MS population. The investigators hypothesize that older pwMS that are treated with metformin will have a significantly lower decline in N-acetylaspartate levels when compared to pwMS not treated with metformin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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metformin
metformin
metformin
metformin
placebo
placebo
Placebo
Placebo
Interventions
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metformin
metformin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
2. inability to participate in the study during the study period
3. diabetes or uncontrolled cardiovascular disease
4. unable to consent
55 Years
75 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
State University of New York at Buffalo
OTHER
Responsible Party
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Bianca Weinstock-Guttman
Professor of Neurology
Locations
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UBMD Neurolgy
Buffalo, New York, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY00007603
Identifier Type: -
Identifier Source: org_study_id
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