Metformin for Cerebral Palsy

Recruiting at 1 trial location

Overseen By Eisha Amjad

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Must not be taking: Diuretics, Cationic drugs, others

Disqualifiers: Diabetes, Uncontrolled seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

3 Participants Needed

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.

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

I have been diagnosed with cerebral palsy, affecting my movement and posture.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase A1

Participants undergo a baseline period with no metformin

16 weeks

Phase B

Participants receive metformin for 16 weeks

16 weeks

7 safety visits

Phase A2

Participants undergo a follow-up period with no metformin

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

• Metformin

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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Glucophage for:

• Type 2 diabetes

Approved in United States as Glucophage for:

• Type 2 diabetes

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+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+