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Cannabinoid
CBD for Epileptic Encephalopathy (CARE-E Trial)
Phase 1
Waitlist Available
Led By Richard Huntsman, MD
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will see if it is safe to give CBD-rich cannabis extract to children with a certain kind of epilepsy. The dosage will be increased slowly over four months.
Who is the study for?
This trial is for children aged 1-10 with Epileptic Encephalopathy who experience frequent major seizures and haven't responded to two anticonvulsants. They must be able to attend regular appointments. Children can't join if they've recently changed seizure treatments, use certain medications, have serious organ issues, or started a ketogenic diet or vagal nerve stimulator within specific time frames.
What is being tested?
The study tests the safety of CanniMed® 1:20, a cannabidiol-enriched Cannabis Herbal Extract in kids with severe epilepsy that doesn’t respond to usual drugs. Over four months, the dosage will gradually increase to assess tolerance.
What are the potential side effects?
Possible side effects may include drowsiness, changes in appetite, digestive issues, mood alterations (like irritability), and potential interactions with other seizure medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Clobazam and Norclobazam Levels (umol/L)
Clonazepam Level (umol/L)
+2 moreSecondary study objectives
11-nor-9-carboxy-tetrahydrocannabinol (11-nor-9-Carboxy-THC) (ng/mL)
Cannabidiol (CBD) (ng/mL)
Tetrahydrocannabinol (Δ9-THC) (ng/mL)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Medical Cannabis OilExperimental Treatment1 Intervention
CanniMed® 1:20
Find a Location
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
256 Previous Clinical Trials
154,432 Total Patients Enrolled
Richard Huntsman, MDPrincipal InvestigatorDalhousie University
Richard Tang-Wai, MDPrincipal InvestigatorLoma Linda University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You started taking or changed the amount of oral or injected steroids in the past 3 months.You have changed your anticonvulsant medications, ketogenic diet, or settings on Vagal Nerve Stimulator in the past month.You have changed your intravenous immunoglobulin (IVIG) treatment in the last 6 months.You are allergic to any of the ingredients in the study medication.You have a serious heart, kidney, or liver condition, as determined by the doctor at the study site.You must be between 1 and 10 years old.You have been diagnosed with a severe form of epilepsy that affects the brain.You have at least one big seizure per week or four big seizures per month.You have tried two different anticonvulsant medications at the right doses, but they did not work.Women who have had their period need to have a negative pregnancy test when they are screened for the trial.You have taken certain types of antidepressant or antipsychotic medications in the past month.You regularly take strong painkillers, unless it's in an emergency and a doctor is overseeing it.You have started a special diet called the ketogenic diet in the last 6 months. If you are on this diet, you need to have been on it for at least 6 months before joining the study.If you have had a device called a Vagal Nerve Stimulator implanted and activated within the last year, you cannot participate in the study. If you have had the device for over a year, you may still be eligible to participate.You have used cannabis-based therapy within the last 2 months. If you have used it before, you need to stop using it for 2 months before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Medical Cannabis Oil
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.
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