A Phase 3 interventional study of Cannabidiol (CBD) oral solution and Placebo in Refractory Epilepsy in Children, Refractory Epilepsy and Epilepsy, sponsored by UMC Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by UMC Utrecht · Phase 3, Interventional, and Treatment
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. The main questions it aims to answer are:
Researchers will compare cannabidiol to a placebo (a look-alike oil that contains no cannabidiol) to see if drug cannabidiol works to treat severe epilepsy. All participants will receive both the cannabidiol and the placebo during different periods. At the end of the trial, we will evaluate for each patient seperately, whether seizures were less or more frequent during cannabidiol periods or placebo periods, to see what works best for every patient seperately.
Participants will:
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will undergo one to three treatment cycles. In each cycle, each participant will receive both the active comparator as the placebo comparator. The investigational medicinal product (IMP): Bedrolite, which is a full spectrum extract of Cannabis sativa L. "Rensina", with a CBD:THC ratio of approximately 26:1. Cannabidiol will be titrated up to a dosage of 2.5-20mg/kg/day, which is in line with previous clinical trials. There is scarce evidence in literature on optimal dosing of this specific CBD:THC preparation, therefore, directly after the baseline period, a titration phase is used to determine the maximum tolerated dose. The maximum daily dose is set at 1000mg CBD per day. Therefore, for patients weighing over 50 kg, a calculation weight of 50 kg will be used.
Drug: Cannabidiol (CBD) oral solution
Placebo is identical to the IMP apart from the active ingredients (less than 0.5% CBD/0.02%THC ), with identical packaging.
Other: Placebo
Bedrolite, which is a full spectrum cannabis extract with 10%CBD/0.4%THC. Cannabidiol will be titrated up to a dosage of 2.5-20mg/kg/day, dosed twice daily.
Cannabis extract with less than 0.5% CBD/0.02%THC
Seizure frequency
The primary outcome measure is the change from baseline in daily seizure frequency during active treatment periods and placebo periods, at the individual level and the aggregated group level. This will be collected by the participants' caregivers using an electronic diary (app) developed specifically for epilepsy research, to register seizure frequency and -type, and the need for emergency medication, for up to 7 days in hindsight.
Time frame: Daily, from start of baseline after enrollment to the end of the last treatment cycle (each cycle - consisting of two periods with run in, taper and washout phases - is 15 weeks). Adittionally, untill up to 6 months during open label extension phase.
Seizure free days
At the individual level, key secondary outcomes include the change from baseline in number of seizure free days in the CBD periods, compared to the placebo periods.
Time frame: Registered daily using a seizure diary. Analysis endpoints specifically after completion of cycle 2 and (if applicable) cycle 3 and after 6 months of open label extension (if applicable), or else at withdrawal. Each cycle (two periods) lasts 15 weeks.
Response rates
At the aggregated group level, key secondary outcome measures include: * The number of patients in which CBD is considered effective, which corresponds to the achieved 30% minimum clinically important difference (MCID) * The number of patients with a responder rate of \>50%, \>75% or 100% Mean change from baseline in seizure free days in the CBD periods compared to the placebo
Time frame: Seizures will be registered daily using a seizure diary. Analysis endpoints after cycle 2 and (if applicable) cycle 3 and after 6 months of open label extension (if applicable), or else at withdrawal. Each cycle (two periods) lasts 15 weeks.
Patient-centered outcome measures: QOLCE-55
By including an extensive set of patient-centered outcome measures, we aim to capture clinically relevant differences in life domains that significantly impact the patient's wellbeing but are challenging to measure in a generic manner using an online data capturing system (Castor Database). The Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) is a validatedquestionnaire for use by parents of children with epilepsy. It consists of 55 items covering cognitive, emotional, social and physical wellbeing, resulting in a total score and a sub score per domain. It has been used in a number of previous trials testing both CBD as well as other ASM in children with epilepsy. Score range: 0-100 (domain and total scores are typically transformed to a 0-100 scale) Higher score: Better quality of life
Time frame: - Once durine the 4-week baseline - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Patient-centered outcome measures: GASE scale
The Global Assessment of Severity of Epilepsy (GASE) scale. The Global Assessment of Severity of Epilepsy (GASE) scale was chosen as a measure of epilepsy severity. It has been validated for use in pediatric patients, has proven correlation with clinical aspects of epilepsy such as seizure intensity, and has been shown to be responsive to changes. We therefore expect this scale to add valuable information to the effect of CBD on epilepsy characteristics. Score range: 1-7 Higher score: More severe epilepsy
Time frame: Once durine the 4-week baseline - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Patient-centered outcome measures: GCI scale
The Clinical Global Impressions (CGI) scale. The Clinical Global Impressions (CGI) scale is a well-established, brief assessment of the patient's global functioning prior to and after initiating a study medication, applicable to patients with central nervous system disorders. As such, it is universally regarded as a useful scale for measuring the efficacy of ASM for assessing the patient's general condition. Previous randomized clinical trials have shown improvement on the CGI scale after treatment with CBD, and we therefore expect it to be both a responsive tool as well as useful for comparison of results to previous research. CGI-Severity score range: 1-7 Higher score: Greater illness severity CGI-Improvement score range: 1-7 Higher score: Worse change (less improvement / greater worsening)
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Patient-centered outcome measures: ABC
The Aberrant Behaviour Checklist (ABC). The Aberrant Behavior Checklist (ABC) will be used to measure the effect of CBD on behavioral challenges associated with epilepsy. It is a proxy-rated scale for assessing various domains of problematic behavior, and has been validated for the pediatric population, including children with a developmental delay. It has also previously been used as an outcome measure in studies with CBD and clobazam Score range: 0-174 (58 items scored 0-3) Higher score: More severe behavioral problems
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 2 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Patient-centered outcome measures: VABS-III
The Vineland Adaptive Behavior Scale (VABS-III), We will include the Vineland Adaptive Behavior Scale (VABS-III) - Parent/Caregiver Form as a measurement of adaptive functioning. It has good psychometric properties in the pediatric population with development delay and has been extensively used for research concerning pediatric epilepsy, including the previous randomized clinical trials with CBD. Score range: Standard scores typically 20-160 (domain and composite scores; mean = 100, SD = 15) Higher score: Better adaptive functioning
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 2 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Patient-centered outcome measures: SDSC
The Sleep Disturbance Scale for Children (SDSC).The Sleep Disturbance Scale for Children (SDSC) is a caregiver-completed rating tools validated for the pediatric population. It has been previously used in assessing the impact of epilepsy on sleep in children with epilepsy Score range: 26-130 Higher score: Greater sleep disturbance / worse sleep quality
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Patient-centered outcome measures: GAS
Goal Attainment Scaling (GAS). Lastly, Goal Attainment Scaling (GAS) will be performed to enable the clinician and patient to measure effectiveness of CBD on personalized treatment goals. GAS has been developed to specify individual goals along with a standardized outcome scale, thereby enabling the calculation of personalized results in a standardized manner. It has been shown to be a reliable and responsive measurement instrument, particularly suitable for measuring treatment effect in small and heterogenous patient populations. Score range: Individual goal scores typically range from -2 to +2 per goal (often transformed into a standardized T-score with mean = 50, SD = 10, range approximately 0-100 in aggregated analyses) Higher score: Greater achievement of individualized treatment goals
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Patient-centered outcome measures: SSQ
The Seizure Severity Questionnaire (SSQ).The Seizure Severity Questionnaire will be used to determine seizure severity including questions on pre- inter- and post-ictal symptoms Score range: 1-7 for each question Higher score: Greater seizure severity (more severe pre-ictal, ictal, and post-ictal symptom burden)
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Productivity Cost Questionnaire iPCQ
Change in caregivers' productivity loss will be measured by the Institute for Medical Consumption Questionnaire (iMTA) Productivity Cost Questionnaire (iPCQ), measuring lost productivity at paid work due to absenteeism and lost productivity at paid work due to presenteeism. The iPCQ will be collected for the main caregivers. Score range: No fixed total score (results expressed as number of hours of productivity loss and/or converted to monetary costs) Higher score: Greater productivity loss / higher indirect costs (worse outcome)
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Medical Consumption Questionnaire iMCQ
Change in healthcare resources used will be measured by the iMTA Medical Consumption Questionnaire (iMCQ). The iMCQ is an often-used tool in the Netherlands and a version adapted to epilepsy in children will be used.The iMCQ will be used to measure all direct medical costs (healthcare and medication), and direct non-medical costs (for example, travelling costs). Healthcare resource use will be multiplied with Dutch unit costs to determine healthcare costs. Unit costs will be used as described in the Dutch Costing guideline or tariffs stablished by Dutch Care Authorities, or the participating centers if both are missing. Score range: No fixed total score (results expressed as counts of healthcare resource use per recall period, optionally converted to costs) Higher score: Higher healthcare utilization / greater healthcare burden (worse outcome)
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Quality of life: EQ-5D-Y questionnaire
Change in health-related quality of life will be measured by the EuroQol Five-Dimensional Questionnaire Youth (EQ-5D-Y). The Dutch tariffs will be used to result in a utility score. Utility values at the end of a treatment or placebo period will be used to estimate mean utility values in the two groups. Descriptive system score range: 5 dimensions (mobility, looking after myself, doing usual activities, having pain or discomfort, feeling worried/sad), each scored 1-5. 1 = no problems, 5 = extreme problems EQ Visual Analogue Scale (EQ-VAS): 0-100 Higher score: Better perceived health Higher scores (descriptive system): Worse health state (more problems)
Time frame: - Once durine the 4-week baseline. - Once every period (up to maximum of 6 periods), one period lasts 7 weeks. - At the and of the open label extension phase after 6 months (if applicable).
Plan to share: Yes — De-anonymized results of individual n-of-1 trials will be shared if participants have provided consent for that.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: Protocol will be published before last inclusion of last patient. Informed consent, analytical code and individual data will be shared within one year of last visit of last participant.
Access criteria: Access will be granted to researchers affiliated with recognized academic or clinical institutions who submit a methodologically sound research proposal. Proposals will be reviewed by the researches involved in our CBD consortium. Approved applicants will be granted access through a secure remote data access environment or controlled data repository.
Data sharing details ↗ · www.umcutrecht.nl
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Nov 2027, 33 months after the start.
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Studies of the drug tested here: Cannabidiol