ClinicalTrials.gov record NCT06924827

A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Clinical Study of the Transition of Children From 'Artisanal' Cannabidiol to Epidiolex

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Age2 years old to 18 years old
SexAll
LocationCanada
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This treatment study tests a planned switch from non‑pharmaceutical 'artisanal' cannabidiol (CBD) to Epidiolex in children with Dravet Syndrome or Lennox‑Gastaut Syndrome. Participants follow a two‑week transition that gradually replaces artisanal CBD with Epidiolex, then enter a maintenance period with clinic visits and assessments. Caregivers keep seizure diaries while researchers track seizures, side effects, and questionnaire measures.

What it is studying. The study is trying to learn how well a gradual switch from artisanal CBD to the pharmaceutical product Epidiolex works in children with Dravet or Lennox‑Gastaut syndromes. It asks whether matching the Epidiolex dose to the prior artisanal CBD dose is appropriate and what side effects or medical problems occur during and after the switch.

What the researchers hope to learn. Scientific goals: measure the success rate of transition to Epidiolex; assess acceptability (how many continue Epidiolex); track change in seizure frequency; record side effects and adverse events of special interest (somnolence, sedation, appetite change, GI upset, liver enzyme elevations); evaluate questionnaire outcomes (PESQ, CGI‑I, CGI‑CSID, QOLCE‑55, MYMOP2, CSHQ); monitor changes in other anti‑seizure medication dosing, rescue medication use, withdrawal due to adverse events, and suicidal ideation/behavior (C‑SSRS).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The goal of this clinical trial is to learn the best way to switch children with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) taking 'artisanal' (non pharmaceutical-grade) cannabidiol (CBD) to Epidiolex for treatment of seizures. The main questions it aims to answer are:

  • How well does a gradual switch from 'artisanal' CBD to Epidiolex work?
  • Does the same dose of Epidiolex as 'artisanal' CBD work best?
  • What side-effects or medical problems do participants have when switching from 'artisanal' CBD to Epidiolex?

Researchers will examine how successful switching from 'artisanal' CBD to Epidiolex is. Participants will:

  • Gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex
  • Visit the clinic five times over 20 weeks for checkups and tests
  • Keep a diary of their seizures, symptoms and the number of times they use a rescue seizure medication

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Epidiolex 100 mg/mL Oral Solution

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Male or female aged 2 through 18 years, inclusive.
  • Clinical diagnosis of Dravet or Lennox Gastaut Syndrome:
  • Clinical diagnosis of Dravet Syndrome supported by:
  • Onset of seizures within the first year of life.
  • Initial seizures present as fever-induced or fever-triggered seizures, hemi-clonic, generalized tonic-clonic, prolonged seizures (more than 15 minutes).
  • Emergence of other seizure types after 1 year of age.
  • Normal development within the first year of age, then emergence of neurodevelopmental difficulties or delay.
  • Clinical diagnosis of Lennox Gastaut Syndrome supported by:
  • a. History of an EEG with slow/disorganized background and slow (<2.5 Hz or less) spike and wave activity or generalized paroxysmal fast activity (GPFA).
  • b. History of more than 1 type of generalized seizures, including drop seizures (tonic, atonic or tonic-clonic).
  • Participant must be willing and able to give written informed consent for participation. If the participant is not qualified or unable to provide written consent based on age, development, intellectual capacity or other factors, the parent or legally authorized representative must provide written informed consent on their behalf.
  • Must be on a stable dose of a licensed artisanal cannabidiol (CBD) product as maintenance therapy for seizure control for a minimum of 3 months prior to screening (visit 1).
  • 'Artisanal' CBD dose must be between 5 mg/kg/day and 20mg/kg/day.
  • 'Artisanal' CBD preparation must be a high CBD to THC formulation defined as a minimum CBD:THC ratio of 20:1.
  • Must be taking a minimum of 1 other anti-seizure medication (ASM) in addition to an 'artisanal' form of CBD.
  • Must be on a stable dose of ASMs for a minimum of 28 days prior to screening (visit 1) and remain on a stable dose throughout the entire study unless medically necessary change(s) are required for safety events.
  • Participants with a vagal nerve stimulator (VNS) must have the following conditions met:
  • The VNS has been in place for a minimum of 3 months prior to screening (visit 1).
  • The settings have remained constant for 28 days prior to screening (visit 1) and are expected to remain constant throughout the entire study.
  • The battery is expected to last for the duration of the study.
  • Participants on the ketogenic diet must be on a stable regime for a minimum of 28 days prior to screening (visit 1) and expected to remain stable throughout the entire study.
  • Participant and/or caregiver must be willing to maintain a seizure diary throughout the duration of the study.

Exclusion criteria

  • Previous or current exposure to Epidiolex.
  • Supplemental use of cannabinoid-containing products, including but not limited to:
  • Recreational use of cannabis.
  • Use of artisanal CBD as a seizure rescue medication.
  • Use of more than one formulation of 'artisanal' CBD (e.g. THC supplementation).
  • Pregnant or breastfeeding.
  • Any clinically significant, unstable medical condition other than epilepsy that, in the opinion of the investigator, could place the participant at increased risk or interfere with the results of the study.
  • Hepatic impairment at screening (visit 1) defined as either of the following conditions:
  • ALT or AST > 5x upper limit of normal (ULN).
  • ALT or AST > 3x ULN and total bilirubin >2x ULN (or international normalized ratio >1.5).
  • Known sensitivity to any ingredient in Epidiolex, including sesame and sesame oil.
  • Unwillingness to refrain from alcohol consumption throughout the duration of the study.
  • Unwillingness of females of childbearing potential to use a highly effective form of birth control. Acceptable methods include: hormonal contraceptives, intra-uterine devices, bilateral tube occlusion, vasectomized partner and sexual abstinence.
  • Currently enrolled in another clinical trial.
  • Have suicidal plan/intent, active suicidal thoughts, or a suicide attempt in the past 6 month prior to screening.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be switched from their licensed 'artisanal' cannabidiol (CBD) to Epidiolex over a two-week transition (week 1: 75% artisanal CBD / 25% Epidiolex; week 2: 50%/50%), then remain on 100% Epidiolex at a matched dose (daily Epidiolex dose must not exceed 20 mg/kg/day). Dosing should be taken consistently with or without food as before and is usually by mouth; Epidiolex can be given via feeding tubes when needed. Participants will attend five clinic visits over 20 weeks for checkups and tests; the study team may change the Epidiolex dose if clinically indicated for safety, tolerability, or efficacy. Caregivers will keep a seizure diary (seizures, symptoms, rescue medication use) and participants/caregivers and clinicians will complete questionnaires and ratings about side effects, seizure control, sleep, quality of life, and suicidal ideation (e.g., PESQ, CGI‑I, QOLCE‑55, CSHQ, MYMOP2, C‑SSRS).

How the study is structured. Single‑group, non‑masked treatment study: all participants are switched to Epidiolex. The protocol uses a two‑week transition (week 1: 75% artisanal CBD + 25% Epidiolex; week 2: 50%/50%), then participants continue on 100% Epidiolex at the matched dose (not to exceed 20 mg/kg/day). Epidiolex is given as an oral solution (or via feeding tube when needed), and participants attend scheduled clinic visits and assessments through the maintenance period as listed in the registry.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Canada. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Dravet syndrome

This trial is also listed on this site under CDKL5 deficiency disorder.

Clinical trials22 trials listed for Dravet syndromeEvery trial the registry lists for Dravet syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Dravet syndrome researchLatest monthly update: September 2026. Includes: CBD in practice. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Study completion
June 2029 (estimated)
Target enrollment
25 participants (estimated)
Last updated on registry
Sep 11, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Elizabeth Donner
Collaborators
  • Jazz Pharmaceuticals

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8 · Canada

Terms used on this page · explanations by MedicalUpdates.ai

written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
legally authorized representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
stable dose
A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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