Epidiolex for Epilepsy

(CANN-SWITCH Trial)

Overseen By Laura MacDougall, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Elizabeth Donner

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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

Research Team

Elizabeth Donner, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for children with Lennox-Gastaut Syndrome or Dravet Syndrome who are currently using 'artisanal' CBD to treat seizures. They will be transitioning to Epidiolex, a pharmaceutical-grade CBD. The study requires clinic visits and diary keeping over 20 weeks.

Inclusion Criteria

I am currently taking another seizure medication besides artisanal CBD.

Participants on the ketogenic diet must be on a stable regime for a minimum of 28 days prior to screening (visit 1) and expected to remain stable throughout the entire study

Participant and/or caregiver must be willing to maintain a seizure diary throughout the duration of the study

Exclusion Criteria

Pregnant or breastfeeding

Have suicidal plan/intent, active suicidal thoughts, or a suicide attempt in the past 6 month prior to screening

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

Treatment Details

Interventions

• Epidiolex (Cannabis-derived Therapy)

Trial Overview The study tests the effectiveness of switching from 'artisanal' CBD to Epidiolex in managing seizures. It evaluates how well a gradual transition works, if the same dose is effective, and monitors any side effects during the process.

Participant Groups

Group I: Epidiolex Treatment Experimental Treatment 1 Intervention

The participant's dose of Epidiolex will be matched to their dose of 'artisanal' cannabidiol (CBD). Epidiolex will be titrated over two weeks with a concomitant taper of the participant's 'artisanal' CBD. CBD doses during transition week 1 will consist of 75% 'artisanal' and 25% Epidiolex, followed by 50% 'artisanal' and 50% Epidiolex for transition week 2. Participants will commence a CBD dose comprised of 100% Epidiolex once reaching the maintenance period of the study. Participants will remain on their matched dose of Epidiolex throughout the maintenance period, unless a dose modification is clinically indicated for efficacy, safety or tolerability. The daily dose of Epidiolex should not exceed the maximum approved dose of 20 mg/kg/day.

Who Is Running the Clinical Trial?

Elizabeth Donner

Lead Sponsor

Alberta Children's Hospital

Collaborator

Trials

58

Recruited

44,700+

BC Children's Hospital Research Institute

Collaborator

Trials

14

Recruited

2,800+

Jazz Pharmaceuticals

Industry Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland