Apply to Trial

Compensation: Varies

Number of Visits: 5

25 Participants Needed

Epidiolex for Epilepsy
(CANN-SWITCH Trial)

Overseen ByLaura MacDougall, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Elizabeth Donner

Must be taking: Artisanal CBD, Anti-seizure medications

Must not be taking: Cannabis, Epidiolex

Disqualifiers: Pregnancy, Hepatic impairment, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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

Do I have to stop taking my current medications for the trial?

You will not have to stop taking your current anti-seizure medications, but you will need to gradually switch from 'artisanal' CBD to Epidiolex. Your other medications should remain stable unless a change is needed for safety reasons.

Is Epidiolex generally safe for humans?

The safety of antiepileptic drugs (AEDs), including newer ones, has been studied, showing that while they can cause side effects like drowsiness and dizziness, newer AEDs may be better tolerated than older ones. Serious side effects are rare but can occur, especially in children, and include skin, blood, and liver issues. Careful monitoring and adjusting doses can help manage these risks.¹ ² ³ ⁴ ⁵

How is the drug Epidiolex unique in treating epilepsy?

Epidiolex is unique because it is derived from cannabidiol (CBD), a component of cannabis, and is specifically approved for treating rare forms of epilepsy like Dravet syndrome and Lennox-Gastaut syndrome. Unlike many traditional antiepileptic drugs, it offers a novel mechanism of action by interacting with the body's endocannabinoid system, which may provide benefits for patients who do not respond well to other treatments.⁶ ⁷ ⁸ ⁹ ¹⁰

Who Is on the Research Team?

Elizabeth Donner, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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

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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

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transition

Participants gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex

2 weeks

2 visits (in-person)

Maintenance

Participants remain on their matched dose of Epidiolex throughout the maintenance period, unless a dose modification is clinically indicated

11 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

Epidiolex

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.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: Epidiolex TreatmentExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elizabeth Donner

Lead Sponsor

Alberta Children's Hospital

Collaborator

Trials

Recruited

44,700+

BC Children's Hospital Research Institute

Collaborator

Trials

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

Published Research Related to This Trial

In a study of 309 epilepsy patients in Poland, 73.8% reported at least one adverse event (AE) while on antiepileptic drugs (AEDs), with cognitive disturbances, psychological issues, and sedation being the most common AEs.

Treatment modifications occurred in 22.3% of patients, primarily due to lack of efficacy (10.7%) and adverse events (5.2%), highlighting the need for careful monitoring of AED effectiveness and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pattern of adverse events of antiepileptic drugs: results of the aESCAPE study in Poland.Chmielewska, B., Lis, K., Rejdak, K., et al.[2022]

The long-term efficacy and safety of four third-generation antiepileptic drugs (AEDs) - lacosamide, perampanel, eslicarbazepine acetate, and brivaracetam - were confirmed in extension studies, showing patient retention rates of 75-80% at one year and 36-68% at two years.

These newer AEDs offer improved tolerability and safety profiles compared to older medications, with no major safety risks identified and specific adverse effects like hyponatremia noted, making them valuable options for treating refractory focal onset seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.Kwok, CS., Johnson, EL., Krauss, GL.[2021]

Common treatment-emergent adverse events (TEAEs) in pediatric epilepsy patients include somnolence, sedation, and behavioral changes, which are frequently associated with various antiepileptic drugs (AEDs).

Among the AEDs studied, Lamotrigine, Gabapentin, Oxcarbazepine, and Levetiracetam are noted for their good tolerability, with withdrawal rates of 2% or less, while Tiagabine and Everolimus have higher discontinuation rates due to intolerable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability profile of new antiepileptic drug treatment in children with epilepsy.Moavero, R., Pisani, LR., Pisani, F., et al.[2019]