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 groupSponsors 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