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A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex | Clinical Trials | Clareo Health

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

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

NCT06924827•Elizabeth Donner

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

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:
•1. Onset of seizures within the first year of life.
•2. Initial seizures present as fever-induced or fever-triggered seizures, hemi-clonic, generalized tonic-clonic, prolonged seizures (more than 15 minutes).
•3. Emergence of other seizure types after 1 year of age.
•4. 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).
+12 more criteria

Exclusion Criteria

•Previous or current exposure to Epidiolex.
•Supplemental use of cannabinoid-containing products, including but not limited to:
•1. Recreational use of cannabis.
•2. Use of artisanal CBD as a seizure rescue medication.
•3. 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:
•1. ALT or AST \> 5x upper limit of normal (ULN).
•2. ALT or AST \> 3x ULN and total bilirubin \>2x ULN (or international normalized ratio \>1.5).
+5 more criteria

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Key Dates

Start Date

June 1, 2026

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2029

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)

Interventions

Epidiolex 100 mg/mL Oral Solution

DRUG

Contacts

Laura MacDougall, PhD

CONTACT

416-813-7996 laura.macdougall@sickkids.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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