Cannabidiol in refractory childhood epilepsy, a personalized high-quality approach
Key facts
- Where
- Heemstede, Heeze, Maastricht, Rotterdam és Utrecht, HollandiaSee the 5 sites
- Phase
- 3. fázis
Where in Hollandia
- Epilepsy Instellingen Nederland StichtingHeemstede, HollandiaTaking people
- KempenhaegheHeeze, HollandiaTaking people
- University Hospital MaastrichtMaastricht, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Medisch Centrum Utrecht
- Trial code
- EU 2023-507843-12-01
- Record updated
- 2025. december 31.
- Original description
To study efficacy of add-on CBD compared to placebo in individuals with refractory epilepsy.Read full original descriptionShow less
To study efficacy of add-on CBD compared to placebo in individuals with refractory epilepsy.
Inclusion: 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.
Exclusion: 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; 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; Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP); Structural heart disease; Ongoing evaluation for epilepsy surgery; 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; 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; Expected inability to undergo blood sampling due to anxiety or resistance; Pregnancy, breastfeeding, or intention to become pregnant throughout the trial or within 3 months of completing treatment; Glaucoma.