Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: metformin, Placebo.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 55 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS): Randomized, Placebo-controlled Pilot Study.
Overview
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
Detailed description
Specific aims and rationale:
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.
Interventions
- Drug metformin
metformin - Drug Placebo
Placebo
Primary outcome measures
- 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]
Secondary outcome measures (8)
- Disability progression as measured with Expanded Disability Status Scale (EDSS) [Time frame: 1 year]
- Symbol Digit Modality Test (SDMT) [Time frame: 1 year]
- Brief Visuospatial Memory Test ( BVMT) [Time frame: 1 year]
- California Verbal Learning Test (CVLT) [Time frame: 1 year]
- Conventional MRI outcomes [Time frame: 9 months]
- Timed 25-foot walk test (T25FWT) [Time frame: 1 year]
- 9-hole peg test (9HPT) [Time frame: 1 year]
- Myelin water fraction (MWF) [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- inability to undergo MRI scans
- inability to participate in the study during the study period
- diabetes or uncontrolled cardiovascular disease
- unable to consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UBMD Neurolgy — Buffalo
Identifiers
NCT: NCT06463743 · STUDY00007603 · UL1TR001412