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

NCT04121468

RecruitingPhase 1, Phase 2

Sponsor: The Hospital for Sick Children

Conditions: Multiple Sclerosis (MS)

Interventions: Metformin, Placebo

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 10 Years to 25 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Toronto, Ontario, Canada