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Recruiting NCT04121468

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

Phase I / Phase II Interventional Multiple Sclerosis (MS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS). Basic parameters: 10 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Metformin
    Each tablet contains 500mg of metformin hydrochloride
  • Other Placebo
    Each tablet contains no active drug ingredient

Primary outcome measures

  • Number of patients with adverse events (safety and tolerability) [Time frame: 3 years]
  • Number of patients who were approached to participate, declined participation and consented to participate (recruitment) [Time frame: 3 years]
  • Proportion of patients who completed each visit within the trial (retention) [Time frame: 3 years]
  • Proportion of patients who completed each of the outcome measures at the appropriate time points (adherence with outcome measures) [Time frame: 3 years]
  • Number of patients enrolled in the study compared to the number of patients who were able to complete study measures (tolerability with outcome measures) [Time frame: 3 years]
Secondary outcome measures (4)
  • Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness [Time frame: 3 years]
  • Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness [Time frame: 3 years]
  • Optical Coherence Tomography (OCT) - Optic Nerve Head Volume [Time frame: 3 years]
  • Visual Evoked Potentials (VEP) - p100 [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT04121468 · 1000059119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗