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Anti-diabetic drug
Metformin for Cerebral Palsy
Phase 2
Recruiting
Led By Darcy Fehlings, MD, MSc
Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of hypoglycemia after 2 years of age
Age 5 to 18 years, 11 months at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.25 years
Awards & highlights
Study Summary
This trial studies the safety, adherence, and tolerability of metformin in kids with CP, and looks for possible health benefits for motor and cognitive function.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Metformin may cause stomach upset like diarrhea or nausea, potential for low blood sugar levels (hypoglycemia), vitamin B12 deficiency over long-term use which could lead to anemia or nerve problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
I haven't had low blood sugar episodes since turning 2 years old.
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I am between 5 and 18 years old.
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English is my native language or I've studied in English for at least two years.
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I have been diagnosed with cerebral palsy, affecting my movement and posture.
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I haven't been hospitalized for lung infections caused by inhaling food or liquid in the past year.
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I have never had kidney disease.
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My mobility is moderately to severely limited.
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My kidney and liver are functioning normally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.25 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.25 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The first indicator of feasibility will be assessed
The fourth indicator of feasibility will be assessed
The second indicator of feasibility will be assessed
+2 moreSecondary outcome measures
Change in spasticity as measured by the Modified Tardieu Scale from baseline/pre-intervention (visit 2) to 48 weeks
Gross Motor Function Measure-66
Other outcome measures
Neuropsychological Tests
Changes in the tissue structure cortical-spinal tract and other relevant white matter tracts or grey matter tracts as measured by Diffusion Kurtosis Imaging (DKI).
Children's Auditory Verbal Learning Test-2 [CAVLT-2] or Rey Auditory Verbal Learning Test [RAVLT] (depending on age of participant)
+2 moreSide effects data
From 2015 Phase 4 trial β’ 156 Patients β’ NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: MetforminExperimental Treatment1 Intervention
Metformin oral tablet will be taken by mouth or through a gastrostomy tube, once or twice a day for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved
Find a Location
Who is running the clinical trial?
Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
67 Previous Clinical Trials
14,064 Total Patients Enrolled
24 Trials studying Cerebral Palsy
4,034 Patients Enrolled for Cerebral Palsy
The Hospital for Sick ChildrenOTHER
689 Previous Clinical Trials
6,945,411 Total Patients Enrolled
11 Trials studying Cerebral Palsy
4,695 Patients Enrolled for Cerebral Palsy
Darcy Fehlings, MD, MScPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital
3 Previous Clinical Trials
43 Total Patients Enrolled
3 Trials studying Cerebral Palsy
43 Patients Enrolled for Cerebral Palsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I haven't had low blood sugar episodes since turning 2 years old.I am between 5 and 18 years old.I have taken metformin before.I need sedation to undergo blood tests.I am currently taking or planning to take water pills.I am taking or will take drugs that are cleared by the kidneys.I have been diagnosed with cerebral palsy, affecting my movement and posture.I haven't been hospitalized for lung infections caused by inhaling food or liquid in the past year.I have never had kidney disease.I can express when I feel pain or discomfort.My mobility is moderately to severely limited.I haven't had any major physical therapy for 4 months and won't start new treatments for my CP during the trial.I can take pills whole, crushed, or through a feeding tube.My kidney and liver are functioning normally.I have diabetes (Type I or II).I haven't had leg surgery in the last 6 months.English is my native language or I've studied in English for at least two years.My doses of baclofen or benzodiazepines have been stable for less than 2 months, or I plan to change them.I am not taking any medications that could badly interact with metformin.I am not pregnant, nursing, or planning to become pregnant during the study.My weight is in the bottom 5% for my age.I experience seizures that medication does not control.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
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