About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metformin
- Placebo
Treatment groups
Sponsors and collaborators
The Hospital for Sick Children
Lead sponsor
Queen's University
Collaborator
Ontario Institute for Regenerative Medicine
Collaborator
Unity Health Toronto
Collaborator
Stem Cell Network
Collaborator
Multiple Sclerosis Society of Canada
Collaborator