A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex (NCT06924827) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Canada25 participantsStarted 2026-06-01
Plain-language 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
Who can participate
Age range2 Years – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Recreational use of cannabis.
✕. Use of artisanal CBD as a seizure rescue medication.
What they're measuring
1
The success rate of transition of children from 'artisanal' CBD to Epidiolex.
Timeframe: Baseline (visit 2, Day 1) through visit 4 (Day 15), the two-week transition phase.