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Cannabidiol in refractory childhood epilepsy, a personalized high-quality approach
EU CTIS ID: 2023-507843-12-01
What this study is testing
To study efficacy of add-on CBD compared to placebo in individuals with refractory epilepsy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Minimum age of 1 year old and maximum age of 18 years old.
- Confirmed diagnosis of refractory epilepsy according to ILAE criteria.
- At least 4 countable seizures (not all on one day) during the 4-week baseline period while receiving at least 1 ASM.
- All medications or interventions for epilepsy must have been stable dosed for one month prior to screening and the participant is willing to maintain the current ASM regimen throughout the trial.
- Informed consent/assent of legal representative/ parents.
- Presence of a consistently available patient caregiver for proxy-reports.
You likely can't join if
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP).
- History of recreational or medicinal cannabis, or cannabinoid-based medications, within three months prior to screening and the patient is unwilling to abstain for the duration of the study.
- Planned intervention under general anesthesia interfering with the baseline period; or any planned major surgery within the duration of the trial.
- Expected inability to undergo blood sampling due to anxiety or resistance.
- History or current symptoms of significantly impaired liver function, such as bilirubin level ≥ 2 x upper limit of normal; or presence of liver damage as indicated by levels of alanine aminotransferase and/or aspartate aminotransferase ≥ 3 x upper limit of normal.
- Pregnancy, breastfeeding, or intention to become pregnant throughout the trial or within 3 months of completing treatment.
See the full eligibility criteria
- Minimum age of 1 year old and maximum age of 18 years old.
- Confirmed diagnosis of refractory epilepsy according to ILAE criteria.
- At least 4 countable seizures (not all on one day) during the 4-week baseline period while receiving at least 1 ASM.
- All medications or interventions for epilepsy must have been stable dosed for one month prior to screening and the participant is willing to maintain the current ASM regimen throughout the trial.
- Informed consent/assent of legal representative/ parents.
- Presence of a consistently available patient caregiver for proxy-reports.
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP).
- History of recreational or medicinal cannabis, or cannabinoid-based medications, within three months prior to screening and the patient is unwilling to abstain for the duration of the study.
- Planned intervention under general anesthesia interfering with the baseline period; or any planned major surgery within the duration of the trial.
- Expected inability to undergo blood sampling due to anxiety or resistance.
- History or current symptoms of significantly impaired liver function, such as bilirubin level ≥ 2 x upper limit of normal; or presence of liver damage as indicated by levels of alanine aminotransferase and/or aspartate aminotransferase ≥ 3 x upper limit of normal.
- Pregnancy, breastfeeding, or intention to become pregnant throughout the trial or within 3 months of completing treatment.
- Structural heart disease.
- Glaucoma.
- Ongoing evaluation for epilepsy surgery.
- Implementation of vagal nerve stimulation within 3 months prior to screening and unwillingness to delay inclusion until stable settings of vagal nerve stimulation are reached.
- Starting a ketogenic diet within 3 months prior to screening and unwillingness to delay inclusion until a stable ketogenic diet is reached.
- Unstable medical condition(s), other than refractory epilepsy, that are of significant influence on participation in the trial; significance to be determined with the treating physician/pediatric neurologist.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.