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
396 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
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.
CONDITIONS
Official 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 MS involving the anterior visual pathway, more than 6 months after optic neuritis or an acute demyelinating event
- Age between 10 years and 25 years 11 months
- Baseline delayed visual evoked potentials or retinal nerve fiber layer thickness showing evidence of demyelination
- Retinal nerve fiber layer thickness of 60 micrometers or more at baseline
- Stable MS disease-modifying therapy with no changes in the past 6 months
- No significant kidney or liver problems
- Expanded Disability Status Scale score between 0 and 6.0 inclusive
- English native language or comprehension adequate for neuropsychological testing
- Adequate kidney and liver function as defined by specific creatinine, bilirubin, and liver enzyme levels
You will not qualify if you...
- History of major retinal disease or other significant eye disorders
- Unstable or insulin-dependent diabetes, metabolic or lactic acidosis
- History of unexplained low blood sugar (hypoglycemia <2.8 mmol/L)
- Current or prior use of metformin
- Use of other remyelinating therapies
- Corticosteroid treatment for acute attack or relapse within 30 days
- Use of insulin or drugs interacting with metformin
- Elevated lactate levels above 1.5 times normal
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
B
Brenna Wong
CONTACT
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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