Metformin for Cerebral Palsy

Recruiting at1 trial location

Overseen by Darcy Fehlings, MD, MSc

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a diabetes medication in children with cerebral palsy to see if it can help them move and think better by improving how their bodies use energy.

Research Team

Darcy Fehlings, MD, MSc

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria

Children aged 5-18 with cerebral palsy who can follow simple instructions, have no history of renal disease or severe lung infections, and haven't had recent orthopedic surgery. They must not be on certain other medications, have uncontrolled seizures, heart failure, diabetes, or a known allergy to metformin.

Inclusion Criteria

I haven't had low blood sugar episodes since turning 2 years old.

I am between 5 and 18 years old.

Informed consent (and assent, where applicable) will be obtained from the participants by study team members authorized to consent for this study

Exclusion Criteria

I have pernicious anemia.

I haven't had brain scans to check for white or gray matter issues.

I have been treated for heart failure in the last 2 years.

Treatment Details

Interventions

• Metformin (Anti-diabetic drug)

Trial Overview The trial is testing the safety and how well children stick to taking metformin. It's also looking at whether metformin can improve movement and thinking skills in kids with cerebral palsy. The study has periods without the drug followed by a period with it.

Participant Groups

Group I: Metformin Experimental Treatment 1 Intervention

Metformin oral tablet will be taken by mouth or through a gastrostomy tube, once or twice a day for 16 weeks.

Metformin is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+

Julia Hanigsberg

Holland Bloorview Kids Rehabilitation Hospital

Chief Executive Officer since 2015

Law degrees from McGill University and Columbia Law School

Dr. Golda Milo-Manson

Holland Bloorview Kids Rehabilitation Hospital

Chief Medical Officer since 2010

MD from University of Toronto

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University