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

NCT06463743 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY00007603UL1TR001412
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

metformin

Outcome Measures

Primary Outcomes (2)

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

  The adverse events (AE) will be collected using standardized Adverse Events Form. The severity of the AE will be determined using 5-level grading system where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Additional information regarding the relation to the study medication (related/non related), treatment required (none/drug/non-drug) and the outcome of the AE will be recorded

  1 year

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

  The MRI scans will be acquired at baseline and 9-month follow-up using magnetic resonance spectroscopy (MRS).

  9 months

Secondary Outcomes (8)

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

  1 year

• Symbol Digit Modality Test (SDMT)

  1 year

• Brief Visuospatial Memory Test ( BVMT)

  1 year

• California Verbal Learning Test (CVLT)

  1 year

• Conventional MRI outcomes

  9 months

Other Outcomes (1)

• Exploratory/tertiary MRI metrics

  9 months

Study Arms (2)

metformin

EXPERIMENTAL

metformin

Drug: metformin

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

metformin DRUG

metformin

metformin

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• inability to undergo MRI scans
• inability to participate in the study during the study period
• diabetes or uncontrolled cardiovascular disease
• unable to consent

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UBMD Neurolgy

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Kara Patrick

CONTACT

7168295037; kpatrick@buffalo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 18, 2024
• Study Start: September 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)