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

Who is this study for? Patients with Multiple Sclerosis
What treatments are being studied? Metformin
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 25
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
E. Ann Yeh, MA, MD, FRCPC, Dip ABPN
ann.yeh@sickkids.ca
416-813-7353
Backup
Brenna Wong
brenna.wong@sickkids.ca
416-813-7654
Time Frame
Start Date: 2020-02-24
Estimated Completion Date: 2027-10
Participants
Target number of participants: 20
Treatments
Other: Group A
Placebo for 3 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.~Metformin for 9 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.
Other: Group B
Placebo for 6 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.~Metformin for 6 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.
Other: Group C
Placebo for 9 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.~Metformin for 3 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.
Authors
Related Therapeutic Areas
Sponsors
Leads: The Hospital for Sick Children
Collaborators: Queen's University, Multiple Sclerosis Society of Canada, Ontario Institute for Regenerative Medicine, Stem Cell Network, Unity Health Toronto

This content was sourced from clinicaltrials.gov