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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age10-25
SponsorThe Hospital for Sick Children

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

20 Participants
are divided into 3 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