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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
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-09-11
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Registry facts
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Interventions
The participant's 'artisanal' CBD and Epidiolex dose should be taken consistently with food or consistently without food throughout the entire study. The participant's dosing with or without food should be consistent with their method of dosing of 'artisanal' CBD prior to screening. Oral administration is recommended. When necessary, Epidiolex can be enterally administered via silicone feeding tubes, such as nasogastric or gastrostomy tubes.
Eligibility
primary outcomes
Time frame: Baseline (visit 2, Day 1) through visit 4 (Day 15), the two-week transition phase.
Participants successfully transitioned from 'artisanal' CBD to Epidiolex if they complete the transition protocol and continue treatment with Epidiolex at visit 2 following the two-week transition phase of the study. The success rate will be determined as the percentage of participants that complete the two-week transition phase.
secondary outcomes
Time frame: Baseline (visit 2, Day 15) to end of treatment (visit 7, Day 85).
Participants accepted transition to Epidiolex if they continued treatment with Epidiolex after the last scheduled visit of the maintenance period (visit 7). The acceptability rate will be determined as the percentage of participants that continue treatment with Epidiolex after the last scheduled visit of the maintenance period (visit 7, Day 85).
Time frame: Baseline (visit 2, Day 1) through the end of treatment (visit 7, Day 85).
The percent change (increase or decrease) from baseline in 28-day seizure frequency during the maintenance period. Seizure frequency will be calculated as the total number of seizures divided by the number of days with seizure data, multiplied by 28.
Time frame: Baseline (visit 2, Day 1) through visit 4 (Day 15), visit 5 (Day 29) and end of treatment (visit 7, Day 85).
The Pediatric Epilepsy Side Effects Questionnaire (PESQ) is a rating scale to assess pediatric participant-reported side effects associated with anti-seizure medication treatment. Each side-effect is rated on a 6-point Likert scale as follows: (1) - "Not present", (2) - "Low severity", (3) - "Low-moderate severity", (4) - "Moderate severity", (5) - "Moderate-high severity", (6) - "High severity". Higher scores indicated worse side-effects.
Time frame: Baseline (visit 2, Day 1) through visit 5 (Day 29) and end of treatment (visit 7, Day 85).
The Clinical Global Impression of Improvement (CGI-I) is a 7-point Likert scale used to rate the overall change in seizure control, behaviour, safety and tolerability after transitioning to Epidiolex relative to baseline. The participant's overall improvement is rated by the clinician and caregiver as: 1- "very much improved", 2- "much improved', 3- "minimally improved", 4- "no change", 5- "minimally worse", 6- "much worse", and 7- "very much worse". Higher scores indicate worse condition.
Time frame: Baseline (visit 2, Day 1) through visit 5 (Day 29) and end of treatment (visit 7, Day 85).
The Clinical Global Impression of Change in Seizure Intensity/Duration (CGI-CSID) is a 7-point Likert scale used to rate the overall change in seizure intensity and/or duration after transitioning to Epidiolex relative to baseline. The participant's overall improvement is rated by the clinician and caregiver as: 1- "very much improved", 2- "much improved', 3- "minimally improved", 4- "no change", 5- "minimally worse", 6- "much worse", and 7- "very much worse". Higher scores indicate worse condition.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
The Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) is a caregiver-reported questionnaire that evaluates quality of life in epileptic children. It contains 55 questions that measure quality of life in 4 areas: cognitive functioning, emotional functioning, social functioning, and physical functioning. Each question is rated on a 5-point Likert scale, with the option to answer "not applicable" as follows: (1) - "All of the time", (2) - "Most of the time", (3) - "Some of the time", (4) - "A little of the time", (5) - "None of the time", (6) - Not applicable. Higher scores indicate higher health-related quality of life.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85)
The Measure Yourself Medical Outcome Profile 2 (MYMOP2) questionnaire is a scale that allows participants or caregivers to identify the problem(s) that are most important to them/the participant, and rate the severity of the problem (s) on a 7-point Likert scale ranging from 0 (as good as it can be) to 6 (as bad as it could be). Higher scores indicate worse problems.
Time frame: Baseline (visit 2, Day 1) through visit 5 (Day 29) and end of treatment (visit 7, Day 85).
The Children's Sleep Habit Questionnaire (CSHQ) is a caregiver-reported questionnaire to measure sleep behaviours in children. The questionnaire has 45 questions about bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. Each question is rated on a 3-point Likert scale as follows: (1) - "Usually (5 or more times in a week)", (2) - "Sometimes (2-4 times in a week)", (3) - Rarely (never or 1 time during a week). A higher score indicates more sleep problems.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
The number of dose increases in anti-seizure medications (ASMs), including Epidiolex, due to worsening seizure burden or other factors.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
The number of dose increases in anti-seizure medications (ASMs), including Epidiolex, due to adverse events or other factors.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
Adverse events of special interest (AESIs) include: somnolence, sedation, appetite changes, gastro-intestinal upset (including diarrhea and vomiting), and transaminase elevations. Frequency of AESIs will be measured by determining the total number of AESIs experienced throughout the treatment period of the study.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
Adverse events of special interest (AESIs) include: somnolence, sedation, appetite changes, gastro-intestinal upset (including diarrhea and vomiting), and transaminase elevations. The severity of AESIs will be assessed as: "Mild - Events require minimal or no treatment and do not interfere with the participant's daily activities", "Moderate - Events result in a low level of inconvenience or concern", or "Severe - Events interrupt a participant's usual daily activity and may require therapy or other treatment". The total number of mild, moderate and severe AESIs experienced throughout the treatment period of the study will be determined.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
Adverse events of special interest (AESIs) include: somnolence, sedation, appetite changes, gastro-intestinal upset (including diarrhea and vomiting), and transaminase elevations. The duration of AESIs will be measured by calculating the length of individual AESIs experienced throughout the treatment period of the study.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
The withdrawal rate will be determined as the percentage of participants who withdraw from the study and discontinue Epidiolex due to adverse events.
Time frame: Baseline (visit 2, Day 1) through end of treatment (visit 7, Day 85).
The percent change (increase or decrease) from baseline in 28-day seizure rescue medication use during the maintenance period. Rescue medication frequency will be calculated as the total number of doses of rescue medication administered divided by the number of days with diary data, multiplied by 28.
Time frame: Baseline (visit 1, Day -28) through end of treatment (visit 7, Day 85).
The Columbia-Suicide Severity Rating Scale (C-SSRS) assess the risk of suicidal ideation and behaviour. The questions are divided into categories related to ideation (thoughts) and behaviour (actions). Higher scores indicate more serious/worse suicidal ideation or behaviors.
other outcomes
Time frame: Baseline (visit 1, Day -28), once at beginning of study.
The switching questionnaire consists of two multiple choice questions, along with an open-ended question designed to understand the caregiver's primary and secondary reasons for transitioning their child from 'artisanal' CBD to Epidiolex.
Publications
No exact PMID-linked public article is currently readable locally.