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Taking people in NetherlandsPhase 3

Testing cannabidiol added to usual medicines for hard-to-control childhood epilepsy

Tests cannabidiol alongside usual medicines against a placebo in children with hard-to-control epilepsy.

Key facts

Who runs it
Universitair Medisch Centrum Utrecht
Where
Heemstede, Heeze, Maastricht, Rotterdam, and Utrecht, NetherlandsSee the 5 sites
Registry title
Cannabidiol in refractory childhood epilepsy, a personalized high-quality approach
Status
Recruiting
Phase
Phase 3
People taking part
50 people, planned
Started
24 Jan 2025
Expected to end
1 Jun 2027
Type of study
Interventional
Record updated
31 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with epilepsy that is hard to control. It tests add-on cannabidiol (CBD) against placebo.

Age
From 1 year to 18 years old (the registry also lists a maximum age of 17 years).
Sex
All sexes can join.
Disease stage
Confirmed refractory (hard to treat) epilepsy by ILAE criteria, with at least 4 countable seizures (not all on one day) in the 4-week baseline period.
Earlier treatment
Must take at least 1 anti-seizure medicine (ASM). All epilepsy medicines or treatments must have been on a stable dose for one month before screening.

Main reasons for not taking part

  • Known or suspected allergy to cannabinoids or to the ingredients of the study medicine
  • Cannabis or cannabinoid medicine in the last three months, if unwilling to stop for the trial
  • Severe liver problems, with bilirubin level ≥ 2 x upper limit of normal or ALT/AST ≥ 3 x upper limit of normal
  • Structural heart disease or glaucoma
  • Pregnancy, breastfeeding, or planning to become pregnant during the trial or within 3 months after treatment

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Netherlands

  • Epilepsy Instellingen Nederland StichtingHeemstede, NetherlandsTaking people
  • KempenhaegheHeeze, NetherlandsTaking people
  • University Hospital MaastrichtMaastricht, NetherlandsTaking people
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people

About the trial

What the trial wants to find out

To study efficacy of add-on CBD compared to placebo in individuals with refractory epilepsy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Cannabidiol in refractory childhood epilepsy, a personalized high-quality approach
Plain-language title
Testing cannabidiol added to usual medicines for hard-to-control childhood epilepsyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
31 December 2025