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

NCT06924827 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-17

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Epidiolex 100 mg/mL Oral Solution

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.

Sponsors & Collaborators

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • Alberta Children's Hospital

    collaborator OTHER

  • BC Children's Hospital Research Institute

    collaborator OTHER

  • Elizabeth Donner

    lead OTHER

Principal Investigators

  • Elizabeth Donner, MD · The Hospital for Sick Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2029-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924827 on ClinicalTrials.gov