RecruitingPhase 1Phase 2NCT04121468

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


Sponsor

The Hospital for Sick Children

Enrollment

20 participants

Start Date

Feb 24, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 10 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the diabetes drug metformin can help repair damaged nerve fibres in children and young adults with multiple sclerosis (MS) who have experienced vision problems. Metformin is thought to stimulate nerve repair cells in the brain. **You may be eligible if...** - You are between 10 and 25 years old (and 11 months) - You have MS with a history of vision loss (optic neuritis) or a nerve attack at least 6 months ago - Tests show evidence of nerve damage in your eye (based on eye scans and electrical response tests) - If you are already on an MS medication, the dose has been stable for at least 6 months - Your kidneys and liver are functioning normally - Your MS disability score is 6.0 or below **You may NOT be eligible if...** - Your nerve damage on eye testing is too severe (RNFL thickness below 60 µm) - You have significant kidney or liver problems - You are not able to complete the neurological tests (due to language barriers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

Each tablet contains 500mg of metformin hydrochloride

OTHERPlacebo

Each tablet contains no active drug ingredient


Locations(1)

The Hospital for Sick Children

Toronto, Ontario, Canada

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NCT04121468


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