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| Name | Class |
|---|---|
| Queen's University | OTHER |
| Ontario Institute for Regenerative Medicine | OTHER |
| Unity Health Toronto | OTHER |
| Stem Cell Network |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | 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. |
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| Group B | Other | 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. |
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| Group C | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Each tablet contains 500mg of metformin hydrochloride |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events (safety and tolerability) | 3 years | |
| Number of patients who were approached to participate, declined participation and consented to participate (recruitment) | 3 years | |
| Proportion of patients who completed each visit within the trial (retention) | 3 years | |
| Proportion of patients who completed each of the outcome measures at the appropriate time points (adherence with outcome measures) | 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) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness | 3 years | |
| Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness | 3 years | |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| E. Ann Yeh, MA, MD, FRCPC, Dip ABPN | Contact | 416-813-7353 | ann.yeh@sickkids.ca | |
| Brenna Wong | Contact | 416-813-7654 | 415744 | brenna.wong@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| E. Ann Yeh, MA, MD, FRCPC, Dip ABPN | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| OTHER |
| Multiple Sclerosis Society of Canada | OTHER |
Multiple baseline
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| Placebo | Other | Each tablet contains no active drug ingredient |
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| Optical Coherence Tomography (OCT) - Optic Nerve Head Volume |
| 3 years |
| Visual Evoked Potentials (VEP) - p100 | 3 years |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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