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New treatment option for Multiple Sclerosis (MS)
Official title A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis
ClinicalTrials.gov ID: NCT04121468
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for multiple sclerosis (ms).
Also referred to as Glucophage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 25
You may be able to join if
- Patients with a history of MS with anterior visual pathway involvement and longer than 6 months after presentation with ON or an acute demyelinating...
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.