Refractory Epilepsy in ChildrenPhase 3CBD-uN1queNCT07668856
Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials
A Phase 3 study testing Cannabidiol (CBD) oral solution in people with Refractory Epilepsy in Children and Refractory Epilepsy, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
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: Does cannabidiol lower the number of seizure in children with severe epilepsy? Does cannabidiol effect other… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Refractory Epilepsy in Children, Refractory Epilepsy, Epilepsy
- What is being tested?
- Cannabidiol (CBD) oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 throughout the trial.
- Informed consent/ of legal representative/ parents.
- Presence of a consistently available patient caregiver for proxy-reports.
Who cannot join
- 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 aminotransferase ≥ 3 x upper limit.
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
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:
- Does cannabidiol lower the number of seizure in children with severe epilepsy?
- Does cannabidiol effect other outcomes such as behaviour, sleep, communication, activities?
- What medical problems do participants have when taking cannabidiol?
Read more
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:
- Register their seizures in a digital application during 4 to 6 periods. During these periods, CBD oil of placebo will be provided
- Take CBD oil during 2 to 3 periods. One period will last around 7 weeks.
- Also take placebo oil during the other 2 to 3 periods
- Have a blood test every 7 weeks to monitor for safety and possible adverse effects
- Visit the clinic once every 15 weeks for checkups and tests
- Fill in questionnaires about quality of life, functioning, sleep, behaviour, epilepsy severity every 7 weeks.
- Being tested
- Cannabidiol (CBD) oral solution, Placebo
- Keywords
- Refractory epilepsy, rare diseases, Cannabidiol., bedrolite, n-of-1 trial, medicinal cannabis
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD) oral solutionDrug
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.
PlaceboOther
Cannabis extract with less than 0.5% CBD/0.02%THC
| Study group | Role | What they receive |
|---|---|---|
| Active treatment with CBD oil | Active comparator | 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. Receives: Drug: Cannabidiol (CBD) oral solution |
| Placebo | Placebo comparator | Placebo is identical to the IMP apart from the active ingredients (less than 0.5% CBD/0.02%THC ), with identical packaging. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (10)
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.
Measured: 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
Measured: 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
Measured: - 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
Measured: 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)
Measured: - 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
Measured: - 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
Measured: - 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
Measured: - 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
Measured: - 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)
Measured: - 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start6 Feb 2025
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Epilepsy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The CBD-uN1que trial is designed as a series of 50 double-blind randomized placebo-controlled multiple crossover superiority trials. Each n-of-1 trial consists of 1-3 treatment "cycles", each with 2 treatment "periods" in which the participant is randomized to one of the two treatment arms (cannabidiol or placebo in a 1:1 ratio. Before starting the trial, each patient will start with a 4-week baseline period to assess main baseline outcome measures, and a 19-days dose-titration phase to assess an individualized optimal tolerated dosage (titrated to a dosage of 2.5-20mg/kg/day CBD), administered twice daily. Each period consists of a 7-day run-in period to reduce risk of adverse effects, 4-week treatment period (CBD or placebo), a 10-day taper period to reduce withdrawal symptoms and a 7-day washout period with no intervention to reduce carryover effects. If efficacy is shown in the n-of-1 trial , participants can choose to enter an open-label extension phase of 6 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Epilepsie Instellingen Nederland, Epilepsiecentrum Kempenhaeghe, Erasmus Medical Center, Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, F.E. (Floor) Jansen, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668856
- Sponsor's protocol ID
- 2023-507843-12-01
- Other IDs
- 2023
- Acronym
- CBD-uN1que
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-anonymized results of individual n-of-1 trials will be shared if participants have provided consent for that.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- CBD-uN1que / 2023-507843-12-01
- Keywords
- Refractory epilepsy, rare diseases, Cannabidiol., bedrolite, n-of-1 trial, medicinal cannabis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Stichting Epilepsie Instellingen Nederland, Epilepsiecentrum Kempenhaeghe, Erasmus Medical Center, Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does cannabidiol lower the number of seizure in children with severe epilepsy?
- Does cannabidiol effect other outcomes such as behaviour, sleep, communication, activities?
- What medical problems do participants have when taking cannabidiol?
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:
- Register their seizures in a digital application during 4 to 6 periods. During these periods, CBD oil of placebo will be provided
- Take CBD oil during 2 to 3 periods. One period will last around 7 weeks.
- Also take placebo oil during the other 2 to 3 periods
- Have a blood test every 7 weeks to monitor for safety and possible adverse effects
- Visit the clinic once every 15 weeks for checkups and tests
- Fill in questionnaires about quality of life, functioning, sleep, behaviour, epilepsy severity every 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The CBD-uN1que trial is designed as a series of 50 double-blind randomized placebo-controlled multiple crossover superiority trials. Each n-of-1 trial consists of 1-3 treatment "cycles", each with 2 treatment "periods" in which the participant is randomized to one of the two treatment arms (cannabidiol or placebo in a 1:1 ratio. Before starting the trial, each patient will start with a 4-week baseline period to assess main baseline outcome measures, and a 19-days dose-titration phase to assess an individualized optimal tolerated dosage (titrated to a dosage of 2.5-20mg/kg/day CBD), administered twice daily. Each period consists of a 7-day run-in period to reduce risk of adverse effects, 4-week treatment period (CBD or placebo), a 10-day taper period to reduce withdrawal symptoms and a 7-day washout period with no intervention to reduce carryover effects. If efficacy is shown in the n-of-1 trial , participants can choose to enter an open-label extension phase of 6 months.
| Arm | Type | Receives |
|---|---|---|
| Active treatment with CBD oil | Active comparator | Drug: Cannabidiol (CBD) oral solutionAll 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo is identical to the IMP apart from the active ingredients (less than 0.5% CBD/0.02%THC ), with identical packaging. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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 throughout the trial.
- Informed consent/ of legal representative/ parents.
Key exclusion criteria (13 listed)
- 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 aminotransferase ≥ 3 x upper limit.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD) oral solutionBedrolite, 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. | Drug | Active treatment with CBD oil |
| PlaceboCannabis extract with less than 0.5% CBD/0.02%THC | Other | Placebo |
Primary outcome
Seizure frequency
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.
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.
10 secondary outcomes
Seizure free days
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
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
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
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
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
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
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
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
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. De-anonymized results of individual n-of-1 trials will be shared if participants have provided consent for that.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabidiol (CBD) oral solution in people with Refractory Epilepsy in Children and Refractory Epilepsy, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marit van de Wiel, MD (088 755 5555, m.vandewiel@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.