A Phase 4 interventional study of Epidiolex 100 mg/mL Oral Solution in Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), sponsored by Elizabeth Donner. Not yet recruiting at 1 site in Canada. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Elizabeth Donner · Phase 4, Interventional, and Treatment
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:
Researchers will examine how successful switching from 'artisanal' CBD to Epidiolex is.
Participants will:
92 studies on the registry are indexed under Epilepsies, Myoclonic; 21 are open to participants now.
This study's planned enrollment of 25 is below the median of 31 across 56 interventional studies indexed under Epilepsies, Myoclonic.
Browse Epilepsies, Myoclonic studies →This is the only study on the registry with Elizabeth Donner as lead sponsor.
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.
Clinical diagnosis of Dravet Syndrome supported by:
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).
Participants with a vagal nerve stimulator (VNS) must have the following conditions met:
Exclusion Criteria:
Supplemental use of cannabinoid-containing products, including but not limited to:
Hepatic impairment at screening (visit 1) defined as either of the following conditions:
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participant's dose of Epidiolex will be matched to their dose of 'artisanal' cannabidiol (CBD). Epidiolex will be titrated over two weeks with a concomitant taper of the participant's 'artisanal' CBD. CBD doses during transition week 1 will consist of 75% 'artisanal' and 25% Epidiolex, followed by 50% 'artisanal' and 50% Epidiolex for transition week 2. Participants will commence a CBD dose comprised of 100% Epidiolex once reaching the maintenance period of the study. Participants will remain on their matched dose of Epidiolex throughout the maintenance period, unless a dose modification is clinically indicated for efficacy, safety or tolerability. The daily dose of Epidiolex should not exceed the maximum approved dose of 20 mg/kg/day.
Drug: Epidiolex 100 mg/mL Oral Solution
Drug page: Cannabidiol
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.
The success rate of transition of children from 'artisanal' CBD to Epidiolex.
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.
Time frame: Baseline (visit 2, Day 1) through visit 4 (Day 15), the two-week transition phase.
The acceptability rate of Epidiolex in children previously treated with 'artisanal' CBD.
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 15) to end of treatment (visit 7, Day 85).
The change in seizure frequency following transition of children from 'artisanal' CBD to Epidiolex.
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 the end of treatment (visit 7, Day 85).
Change in reported Pediatric Epilepsy Side-Effects Questionnaire (PESQ) score.
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 4 (Day 15), visit 5 (Day 29) and end of treatment (visit 7, Day 85).
Change Clinical Global Impression of Improvement (CGI-I) score.
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).
Change in Clinical Global Impression of Seizure Intensity/Duration (CGI-CSID) score.
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 visit 5 (Day 29) and end of treatment (visit 7, Day 85).
Change in Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) score.
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).
Change in Measure Yourself Medical Outcome Profile 2 (MYMOP2) score.
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 end of treatment (visit 7, Day 85)
Change in Children's Sleep Habit Questionnaire (CSHQ) score.
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 visit 5 (Day 29) and end of treatment (visit 7, Day 85).
Number of dose increases in anti-seizure medications (ASMs) after starting Epidiolex.
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).
Number of dose decreases in anti-seizure medications (ASMs) after starting Epidiolex.
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).
Frequency of adverse events of special interest (AESIs) after starting Epidiolex.
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).
Severity of adverse events of special interest (AESIs) after starting Epidiolex.
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).
Duration of adverse events of special interest (AESIs) after starting Epidiolex.
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).
Withdrawal rate due to adverse events after starting Epidiolex.
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 change in frequency of seizure rescue medication use following transition from 'artisanal' CBD to Epidiolex.
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 2, Day 1) through end of treatment (visit 7, Day 85).
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) score.
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.
Time frame: Baseline (visit 1, Day -28) through end of treatment (visit 7, Day 85).
Motivation for switching from 'artisanal' CBD to Epidiolex.
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.
Time frame: Baseline (visit 1, Day -28), once at beginning of study.
Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.
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Studies of the drug tested here: Cannabidiol