Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT06463743
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • metformin — DRUG
    metformin
  • Placebo — DRUG
    Placebo

Study Details

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

Key Dates

Start date
Sep 24, 2025
Status verified
Oct 2025
Primary completion
Jan 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: metformin
    metformin
  • Placebo Comparator: placebo
    placebo

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UBMD NeurolgyBuffaloNew York14203-

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