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.
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
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
Parallel
Metformin
DrugEach tablet contains 500mg of metformin hydrochloride
Placebo
Other interventionEach tablet contains no active drug ingredient
Number of patients with adverse events (safety and tolerability)
Number of patients who were approached to participate, declined participation and consented to participate (recruitment)
Proportion of patients who completed each visit within the trial (retention)
Proportion of patients who completed each of the outcome measures at the appropriate time points (adherence with outcome measures)
Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness
Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness
Optical Coherence Tomography (OCT) - Optic Nerve Head Volume
Visual Evoked Potentials (VEP) - p100
Click on the lead sponsor to view all of their trials.
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
