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CBD for Epileptic Encephalopathy (CARE-E Trial)
CARE-E Trial 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.
CARE-E Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CARE-E Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Medical Cannabis Oil
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many sites are currently hosting this clinical trial?
"As of now, 4 sites are involved in this medical trial: the University of Manitoba (Winnipeg), the University of British Columbia (Vancouver), Universite de Montreal (Montreal), and other locations."
Who do you consider to be ideal participants for this medical research?
"For admittance to this trial, applicants must suffer from epileptic encephalopathy and be younger than 10 years old. The team is searching for a total of 20 participants."
What kind of associated risks does CanniMed® 1:20 pose to individuals?
"Due to a lack of evidence supporting safety and efficacy, CanniMed® 1:20 was assigned an initial score of 1 on our team's risk scale."
Have any other research initiatives utilized CanniMed® 1:20?
"CanniMed® 1:20 first had its efficacy and safety evaluated in 2015 at the Hasassah - Hebrew University Ein Kerem Medical Center. Since then, 63 studies have concluded with a further 27 currently ongoing; notably in Winnipeg, Manitoba."
What is the total size of the cohort for this research endeavor?
"The recruitment period for this trial has concluded as of April 24th 2023. However, there are still 376 trials related to epileptic encephalopathy and 27 studies associated with CanniMed® 1:20 that are presently seeking participants."
Does this medical experiment accommodate individuals aged 55 and above?
"The age requirement for this trial indicates that participants must be between 1 and 10 years old. There are 167 trials available to those under the age of 18, while 242 exist for patients over 65."
Is the recruitment process for this experiment still open?
"Currently, this trial is not actively recruiting. It was first posted on April 26th 2017 and underwent its latest revision on April 24th 2023. If you are seeking other studies that may be of interest to you, there are 376 trials enrolling patients with epileptic encephalopathy and 27 medical trials for CanniMed® 1:20 admitting new individuals."
Is this an unprecedented or one-of-a-kind trial?
"Currently, there are 27 trials that utilize CanniMed® 1:20 in 37 cities across four nations. This pharmaceutical product was first tested in 2015 with a 200-person study sponsored by Jazz Pharma; the Phase 2 and 3 stages of drug approval were completed successfully. Since then, 63 additional clinical tests have been concluded."
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