Actively Recruiting
A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis
Led by The Hospital for Sick Children · Updated on 2025-09-23
20
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
The Hospital for Sick Children
Lead Sponsor
Q
Queen's University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of metformin in children and young adults aged 10 to 25 years with multiple sclerosis (MS) who have involvement of the anterior visual pathway. This randomized, phase 1 and 2 double-blind trial aims to study how metformin affects endogenous neural progenitor cells in this group. The study is designed to assess safety, tolerability, recruitment, retention, and adherence over a 12-month period. Participants will be randomly assigned to one of three groups that start metformin treatment at different times during the 12 months: at 3 months, 6 months, or 9 months. Each participant will take metformin daily for at least 3 months and up to 9 months. The dosing starts at 500 mg per square meter per day, increasing to 1000 mg per square meter per day as tolerated, with a maximum of 2000 mg daily. Placebo tablets are given during periods before starting metformin depending on the group assignment. Throughout the study, participants will have regular visits to monitor safety and treatment effects, including eye imaging tests like Optical Coherence Tomography (OCT) and Visual Evoked Potentials (VEP) to assess the optic nerve and retinal nerve fiber layer. Researchers will track adverse events, participation rates, and completion of study measures. The study aims to complete data collection within three years, ensuring careful monitoring of participants' health and adherence to the protocol.
CONDITIONS
Brief Title
A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a history of multiple sclerosis affecting the anterior visual pathway and at least 6 months after an optic neuritis or acute demyelinating event
- Age between 10 years and 25 years 11 months
- Electrophysiological evidence of demyelination with latency delay over 115 milliseconds on baseline visual evoked potentials or over 10 milliseconds difference between eyes
- Retinal nerve fiber layer (RNFL) thickness on baseline optical coherence tomography of 60 micrometers or more
- No changes in disease-modifying therapy or dosing in the 6 months before study start if on such therapy
- No significant kidney or liver abnormalities as defined by specific lab values
- Expanded Disability Status Scale score between 0 and 6.0 inclusive
- Fluent in English or able to complete neuropsychological testing in English
- Adequate renal and liver function as defined by creatinine clearance, serum creatinine, bilirubin, and liver enzymes
You will not qualify if you...
- History of major retinal or other significant eye diseases
- Unstable or insulin-dependent diabetes, metabolic or lactic acidosis
- History of unexplained low blood sugar
- Already taking metformin
- Use of other remyelinating therapies as determined by the investigator
- Recent corticosteroid treatment or relapse within 30 days before screening
- Use of insulin
- Use of drugs known to interact with metformin as determined by the investigator
- Elevated lactate levels above 1.5 times the upper limit of normal
- Pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 to 9 months
Participants take metformin or placebo tablets in divided doses, starting at a low dose and increasing if no side effects occur. The treatment duration varies by group, lasting between 3 to 9 months.
Trial Site Locations
Total: 1 location
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
Research Team
E
E. Ann Yeh, MA, MD, FRCPC, Dip ABPN
B
Brenna Wong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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