Could a common diabetes drug help repair MS damage in kids?
NCT ID NCT04121468
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether metformin, a widely used diabetes drug, is safe and feasible for children and young adults (ages 10-25) with multiple sclerosis. Participants take metformin daily for 3 to 9 months, with the start time randomly assigned. The main goal is to see if the drug can help repair nerve damage in the eye, which may indicate broader benefits for the brain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin (a common diabetes drug)
- What this could lead to
- If it works, this could point toward a way to repair nerve damage in young people with MS, potentially slowing disease progression.
- What could go wrong
- This is a very early, small trial (20 people) focused on safety and feasibility, not effectiveness. Metformin is not proven for MS, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with a history of MS with anterior visual pathway involvement and longer than 6 months after presentation with ON or an acute demyelinating event/relapse * Age 10 year to 25 years and 11 months * Latency delay \> 115 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination) or \> 10 milliseconds difference between eyes, or Retinal Nerve Fiber Layer (RNFL) thickness on OCT of \< 90 µm in at least one eye or an inter-eye difference in the RNFL of 10 µm or more * Retinal Nerve Fiber Layer (RNFL) Thickness on baseline OCT ≥60 µm * If on an MS disease-modifying therapy, no changes in the therapeutic agent or dosing in the 6 months prior to study initiation * No significant renal or liver abnormalities * Expanded Disability Status Scale (EDSS) 0-6.0 (inclusive) * Has either English as his or her native language or English comprehension needed to complete the neuropsychological testing * Meet criteria for adequate organ function requirements as described below: Adequate renal function defined as: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 70 mL/min/1.73 m2 or serum creatinine based on age/gender as follows: Range Serum Creatinine Level (µmol/L): Age 5 to \<12 years (male)=25-50, Age 5 to \<12 years (female)=25-50; Age 12 to \<15 years (male)=37-67, Age 12 to \<15 years (female)=37-67; Age 15 to \<19 years (male)=51-89, Age 15 to \<19 years (female)=40-69; Age ≥19 years (male)=58-110; Age ≥19 years (female)=46-92 Adequate liver function defined as: Total bilirubin \< 1.5 x upper limit of normal (ULN) for age SGOT (AST) or SGPT (ALT) \< 1.5 x upper limit of normal (ULN) for age Exclusion Criteria: * A history of retinal pathology (major ophthalmologic disease / concomitant ophthalmologic disorders) * Unstable and/or insulin-dependent (Type 1) diabetes, metabolic acidosis and/or lactic acidosis * History of unexplained hypoglycemia (\<2.8 mmol/L) * Already on metformin * Concomitant use of any other putative remyelinating therapy as determined by the Principal/Qualified Investigator * Treatment for an acute attack with corticosteroids within 30 days prior to screening / relapse within 30 days prior to screening * Concomitant use of insulin * Concomitant use of any drugs that are listed to have drug-drug interactions with metformin (i.e. calcium channel blockers, diuretics, etc.) as determined by Principal/Qualified Investigator * Lactate levels \> 1.5x upper limit of normal * Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Hospital for Sick Children
RECRUITINGToronto, Ontario, M5G 1X8, Canada
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