A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-18
SponsorElizabeth Donner
About this trial
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 criteria
Qualifiers
Male or female aged 2 through 18 years, inclusive.
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.
Disqualifiers
Previous or current exposure to Epidiolex.
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).
Trial design
Treatments tested in this trial
- Epidiolex 100 mg/mL Oral Solution
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
1The Hospital for Sick ChildrenM5G 1X8, TorontoOntario, Canada
Sponsors and collaborators
Elizabeth Donner
Lead sponsor
The Hospital for Sick Children
Sponsor institution
Jazz Pharmaceuticals
Collaborator
Alberta Children's Hospital
Collaborator
BC Children's Hospital Research Institute
Collaborator
Source ClinicalTrials.gov