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Biguanide
Metformin for Multiple Sclerosis
Phase 1 & 2
Waitlist Available
Led By E. Ann Yeh, MA, MD, FRCPC, Dip ABPN
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will test whether metformin can be taken at different points during a 12-month period to see if it is effective.
Eligible Conditions
- Multiple Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients enrolled in the study compared to the number of patients who were able to complete study measures (tolerability with outcome measures)
Number of patients who were approached to participate, declined participation and consented to participate (recruitment)
Number of patients with adverse events (safety and tolerability)
+2 moreSecondary outcome measures
Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness
Optical Coherence Tomography (OCT) - Optic Nerve Head Volume
Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment2 Interventions
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.
Group II: Group BExperimental Treatment2 Interventions
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.
Group III: Group AExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,763 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
211 Patients Enrolled for Multiple Sclerosis
Ontario Institute for Regenerative MedicineUNKNOWN
1 Previous Clinical Trials
29 Total Patients Enrolled
Unity Health TorontoOTHER
537 Previous Clinical Trials
447,509 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
909 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are already taking metformin.Your lactate levels are higher than they should be.The thickness of a specific part of your eye, called the Retinal Nerve Fiber Layer, must be at least 60 micrometers on a special eye scan taken before the trial starts.You are currently taking insulin.You have very severe eyesight problems (more than 6 diopters).You have unstable or insulin-dependent (Type 1) diabetes, metabolic acidosis, or lactic acidosis.You have had unexplained low blood sugar in the past.You are using another treatment for repairing myelin as decided by the main doctor in charge of the study.You are taking other medications that may interact with metformin, as decided by the study's lead doctor.You have a history of multiple sclerosis (MS) that has affected your vision and it has been more than 6 months since you had a related episode.You have had serious eye problems in the past.You have received corticosteroids for an acute attack or had a relapse within 30 days before the screening.Your kidneys and liver are working normally.You have a delay in the electrical signals from your eyes to your brain, which shows a possible problem with the protective covering of nerve cells.You have a disability status scale score between 0 and 6.
Research Study Groups:
This trial has the following groups:- Group 1: Group C
- Group 2: Group A
- Group 3: Group B
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other studies been conducted regarding this therapeutic intervention?
"Currently, there are 170 clinical trials related to this intervention in action and 43 of them have advanced to Phase 3. Though many tests for this treatment begin in Pittsburgh, PA, they span across 1903 medical sites globally."
Answered by AI
Is there an opportunity to partake in this medical experiment?
"The requirements to be accepted into this trial are a diagnosis of multiple sclerosis and an age range between 10-25. A maximum of 30 patients will be chosen for the clinical research."
Answered by AI
In what clinical scenarios is this therapy commonly employed?
"This particular treatment is known to be an efficacious remedy for exercise-induced stress, type 1 diabetes mellitus, and diabetic ketoacidosis."
Answered by AI
Is the age limit for enrolment in this trial over 45?
"Patients applying to this medical trial must range in age from 10 to 25. There are 64 trials specifically targeting minors and 524 for people over the retirement age of 65."
Answered by AI
How many participants are participating in the present clinical trial?
"Assertively, clinicaltrials.gov has information that attests to the fact this medical study is in search of participants. It was made available on February 24th 2020 and its most recent update occurred March 15th 2021; it requires 30 patients distributed across 2 different sites."
Answered by AI
Are there still slots available for participation in this clinical trial?
"Indeed, the trial is presently open for enrollment as per reports found on clinicaltrials.gov. This research began enrolling participants back in February 2020 and was recently refreshed on March 15th 2022."
Answered by AI
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