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
You may not be if
A history of retinal pathology (major ophthalmologic disease / concomitant ophthalmologic disorders)
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
Clareo Health | A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis
