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Biguanide
Metformin for Infant Brain Injury
Phase 1
Waitlist Available
Led By Brian T Kalish, MD
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
HIE Patients: > 35 weeks gestation at time of birth
Preterm Infants: Clinical team anticipates hospitalization at SickKids for at least 1 week after study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial will study the safety and feasibility of giving the drug metformin to infants with brain injuries, to see if it can help improve their neural circuit remodeling and recovery.
Who is the study for?
This trial is for infants with brain injuries due to lack of oxygen at birth or premature birth. Eligible preterm infants must be expected to stay in the hospital for a week post-enrollment and born before 32 weeks gestation. HIE patients should be over 35 weeks gestation, under three months old, live within an hour of SickKids Hospital, and have received cooling therapy for HIE.Check my eligibility
What is being tested?
The study is testing the safety and how well metformin can be used in treating infants who suffered from hypoxic ischemic encephalopathy (HIE) or brain injury related to being born too early. It's a phase I trial which means it's the first time they're trying this treatment on babies.See study design
What are the potential side effects?
While specific side effects are not listed here, metformin generally may cause stomach issues like diarrhea or nausea, low blood sugar levels especially in those with risk factors, and potentially vitamin B12 deficiency with long-term use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born after 35 weeks of pregnancy.
Select...
My preterm infant is expected to stay in the hospital for at least a week after joining the study.
Select...
I have been diagnosed with Hypoxic-Ischemic Encephalopathy (HIE).
Select...
My baby was born before 32 weeks of pregnancy.
Select...
My infant underwent cooling therapy for HIE treatment.
Select...
I have been diagnosed with hypoxic-ischemic encephalopathy.
Select...
My infant underwent cooling therapy for brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
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 with hypoglycemia (serum glucose <3.3mmol/L)
Secondary outcome measures
Number of patients who complete all study procedures
Number of patients who complete study
Plasma metformin levels
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Group I: Preterm: 20 mg/kgExperimental Treatment1 Intervention
Group II: Preterm: 15 mg/kgExperimental Treatment1 Intervention
Group III: HIE: 25 mg/kgExperimental Treatment1 Intervention
Group IV: HIE: 20 mg/kgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~1460
Find a Location
Who is running the clinical trial?
University of AlbertaOTHER
889 Previous Clinical Trials
385,019 Total Patients Enrolled
University of WaterlooOTHER
124 Previous Clinical Trials
209,357 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
691 Previous Clinical Trials
6,945,603 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed genetic or chromosomal disorder.I have liver or kidney conditions that could affect how my body processes medication.My baby was born after 35 weeks of pregnancy.My preterm infant is expected to stay in the hospital for at least a week after joining the study.I needed special treatment for low blood sugar as a newborn.I have been diagnosed with Hypoxic-Ischemic Encephalopathy (HIE).Your weight is less than 10% of what is considered normal for your age according to the WHO growth charts when you start taking the study drug.I am older than 3 months.I am currently breastfeeding and taking metformin.My baby was born before 32 weeks of pregnancy.Infants who are less than 3 months old when they agree to participate.My baby was born prematurely and is between 36-44 weeks in corrected age.My infant underwent cooling therapy for HIE treatment.I have been diagnosed with hypoxic-ischemic encephalopathy.My infant underwent cooling therapy for brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Preterm: 15 mg/kg
- Group 2: HIE: 25 mg/kg
- Group 3: HIE: 20 mg/kg
- Group 4: Preterm: 20 mg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is the 25 mg/kg dosage sanctioned by the FDA?
"Based on the limited data surrounding 25 mg/kg, our team has assigned a score of 1 to this potential therapy's safety. This is due to its current status as an early phase trial."
Answered by AI
Are there any openings in this trial's participant pool?
"The clinicaltrial.gov index reflects that this medical study is currently not enrolling participants. Despite the initial posting on January 1st, 2023 and its latest update occurring on November 15th 2022, there are 460 other trials actively recruiting patients at present."
Answered by AI
Who else is applying?
What site did they apply to?
The Hospital for Sick Children
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
Alberta
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