Status:
RECRUITING
A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Queen's University
Ontario Institute for Regenerative Medicine
Conditions:
Multiple Sclerosis (MS)
Eligibility:
All Genders
10-25 years
Phase:
PHASE1
PHASE2
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- If on an MS disease-modifying therapy, no changes in the therapeutic agent or dosing in the 6 months prior to study initiation
- No significant renal or liver abnormalities
- Expanded Disability Status Scale (EDSS) 0-6.0 (inclusive)
- Has either English as his or her native language or English comprehension needed to complete the neuropsychological testing
- Meet criteria for adequate organ function requirements as described below:
- Adequate renal function defined as:
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 70 mL/min/1.73 m2 or serum creatinine based on age/gender as follows:
- Range Serum Creatinine Level (µmol/L): Age 5 to \<12 years (male)=25-50, Age 5 to \<12 years (female)=25-50; Age 12 to \<15 years (male)=37-67, Age 12 to \<15 years (female)=37-67; Age 15 to \<19 years (male)=51-89, Age 15 to \<19 years (female)=40-69; Age ≥19 years (male)=58-110; Age ≥19 years (female)=46-92
- Adequate liver function defined as:
- Total bilirubin \< 1.5 x upper limit of normal (ULN) for age SGOT (AST) or SGPT (ALT) \< 1.5 x upper limit of normal (ULN) for age
Exclusion
- 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
- Concomitant use of any other putative remyelinating therapy as determined by the Principal/Qualified Investigator
- Treatment for an acute attack with corticosteroids within 30 days prior to screening / relapse within 30 days prior to screening
- Concomitant use of insulin
- Concomitant use of any drugs that are listed to have drug-drug interactions with metformin (i.e. calcium channel blockers, diuretics, etc.) as determined by Principal/Qualified Investigator
- Lactate levels \> 1.5x upper limit of normal
- Pregnancy
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04121468
Start Date
February 24 2020
End Date
October 1 2027
Last Update
September 23 2025
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8