Multiple Sclerosis (MS) Clinical Trial
Official title:
A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children With Multiple Sclerosis
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 25 Years |
Eligibility | 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 - Retinal Nerve Fiber Layer (RNFL) Thickness on baseline OCT =60 µm - Stable immunomodulatory therapy - no switch or planned switch in > 6 months and no change in doses in 30 days prior to screening - 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 (male)=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) - Severe refractive error (± 6 diopters) - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Multiple Sclerosis Society of Canada, Ontario Institute for Regenerative Medicine, Queen's University, Stem Cell Network, Unity Health Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with adverse events (safety and tolerability) | 3 years | ||
Primary | Number of patients who were approached to participate, declined participation and consented to participate (recruitment) | 3 years | ||
Primary | Proportion of patients who completed each visit within the trial (retention) | 3 years | ||
Primary | Proportion of patients who completed each of the outcome measures at the appropriate time points (adherence with outcome measures) | 3 years | ||
Primary | Number of patients enrolled in the study compared to the number of patients who were able to complete study measures (tolerability with outcome measures) | 3 years | ||
Secondary | Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness | 3 years | ||
Secondary | Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness | 3 years | ||
Secondary | Optical Coherence Tomography (OCT) - Optic Nerve Head Volume | 3 years | ||
Secondary | Visual Evoked Potentials (VEP) - p100 | 3 years |
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