Tests metformin timing in young people with multiple sclerosis

Trial details

Who runs it

The Hospital for Sick Children

Trial code

NCT04121468

Record updated

23 September 2025

Original description

A randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.Read full original descriptionShow less

A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis

A randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.

Inclusion: 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: A history of retinal pathology (major ophthalmologic disease / concomitant ophthalmologic disorders); 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; Unstable and/or insulin-dependent (Type 1) diabetes, metabolic acidosis and/or lactic acidosis; History of unexplained hypoglycemia (<2.8 mmol/L); 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; Already on metformin; Lactate levels > 1.5x upper limit of normal; Pregnancy.

ClinicalTrials.gov NCT04121468