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New treatment option for Refractory Epilepsy in Children
Official title Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials
ClinicalTrials.gov ID: NCT07668856
What this study is testing
What is Cannabidiol (CBD) oral solution?
Cannabidiol (CBD) oral solution is an investigational medicine, given as an once-daily, being studied as a potential treatment for refractory epilepsy in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if cannabidiol ("CBD-oil") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
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 in one week) of epileptic origin, during the 4-week baseline period while receiving care as usual.
- All medication doses or other interventions for epilepsy must have been stable for one month prior to screening and the participants/parents and...
- Informed consent/ of legal representative/ parents.
You likely can't join if
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (cannabis extract and...
- History or current signs of significantly impaired liver function, such as bilirubin level ≥ 2 x upper limit of normal, or presence of liver damage...
- Pregnancy, breastfeeding, or intention to become pregnant throughout the trial or within 3 months of completing treatment
- Cardiac disease including: Structural heart disease with hemodynamic significance, heart failure, ischemic heart disease, Brugada syndrome, long-QT...
- Glaucoma
- Ongoing evaluation for epilepsy surgery
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 in one week) of epileptic origin, during the 4-week baseline period while receiving care as usual.
- All medication doses or other interventions for epilepsy must have been stable for one month prior to screening and the participants/parents and treating physicians are willing to maintain the current treatment regimen...
- Informed consent/ 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 (cannabis extract and refined peanut oil, generally safe for patients with peanut allergy)
- History or current signs 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...
- Pregnancy, breastfeeding, or intention to become pregnant throughout the trial or within 3 months of completing treatment
- Cardiac disease including: Structural heart disease with hemodynamic significance, heart failure, ischemic heart disease, Brugada syndrome, long-QT syndrome, cardiac arrythmia
- 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, other than refractory epilepsy, that is of significant influence on participation in the trial; significance to be determined with the treating physician/pediatric neurologist
- History of recreational or medicinal cannabis use, 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
- Use of clobazam dosage of \> 0,5 mg/kg/day in the last month
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Utrecht, Netherlands
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, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.