Not yet recruitingPHASE4INTERVENTIONAL

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

This study aims to find the best and safest way to help children with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) switch from their 'artisanal' (unregulated) CBD medicines to a properly approved CBD medicine called Epidiolex. Researchers want to see if switching gradually works well, if the same amount of Epidiolex is needed, and what side effects might happen during this change. During the study, children will slowly increase their Epidiolex dose while reducing their artisanal CBD. They will visit a clinic five times over 20 weeks for check-ups and tests, and keep a diary of how they're feeling and how their seizures are managed. This helps doctors understand the best way to make this important change for these children.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Elizabeth Donner

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Jun 2029

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

What is this study about?

This study is designed to help children who have two specific types of epilepsy, called Dravet Syndrome or Lennox-Gastaut Syndrome. These conditions can cause severe seizures. Some children with these conditions currently use a type of cannabis-based product called 'artisanal' cannabidiol (CBD) to help manage their seizures. 'Artisanal' means it's not a regulated medicine and can vary in strength and quality.

The main goal of this research is to figure out the best and safest way for these children to switch from their 'artisanal' CBD to a regulated, approved CBD medicine called Epidiolex. Epidiolex is a consistent and high-quality medication. Doctors want to understand if a slow changeover works best, if the amount of Epidiolex needed is similar to what they were taking before, and to keep a close eye on any problems or side effects that might come up during this switch.

By carefully studying this process, the researchers hope to find clear guidance for doctors and families. This will help ensure that children who need to switch to a regulated medicine like Epidiolex can do so as smoothly and safely as possible, aiming to continue helping them control their seizures effectively.

Key takeaways

This study helps children with severe epilepsy switch from unregulated CBD to a regulated CBD medicine (Epidiolex).
It aims to find the safest way to make this change and check for side effects.
Children will slowly switch medicines and attend regular clinic visits over 20 weeks.
A diary will be kept to track seizures and symptoms.
Participants must have Dravet or Lennox-Gastaut Syndrome and be taking 'artisanal' CBD and other seizure medicines.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for children and teenagers aged between 2 and 18 years old. They must have been diagnosed with either Dravet Syndrome or Lennox-Gastaut Syndrome. For Dravet Syndrome, their seizures usually started in their first year of life and are often triggered by fever, with other types of seizures appearing later, and some developmental delays.

For Lennox-Gastaut Syndrome, doctors will need to see records of specific brainwave patterns (EEG) and a history of different kinds of seizures, including 'drop attacks'. Importantly, participants must already be taking a stable dose of an 'artisanal' CBD product for at least three months, and this product needs to have a high CBD to THC ratio. They also need to be taking at least one other anti-seizure medication, and these medications should have been at a stable dose for at least four weeks before starting the study.

Parents or legal guardians must be willing and able to give written permission for their child to take part in the study. All these rules are in place to make sure that the study includes the right participants to get reliable results and keep everyone safe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 2 and 18 years old?
Has your child been diagnosed with Dravet Syndrome or Lennox-Gastaut Syndrome?
Is your child currently taking an 'artisanal' (unregulated) CBD product for seizures, and has been for at least 3 months?
Does your child also take at least one other prescribed anti-seizure medicine?
Are you able to bring your child to a clinic for five visits over 20 weeks?
Are you willing to keep a daily record of your child's seizures and symptoms?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will gradually switch from their 'artisanal' CBD to Epidiolex. This means they will slowly increase the Epidiolex dose while carefully reducing the 'artisanal' CBD until they are only taking Epidiolex. The study will last 20 weeks in total.

During these 20 weeks, your child will need to visit the clinic five times for check-ups and tests. These visits help the doctors monitor your child's health and how the new medicine is working. You will also be asked to keep a diary. In this diary, you'll record details about your child's seizures, any symptoms they experience, and how often they might need rescue medication for seizures. This regular tracking helps the research team understand your child's progress throughout the study.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining access to a regulated, consistent CBD medicine (Epidiolex) under close medical supervision, which could lead to better seizure control. However, there are also potential risks, including side effects from Epidiolex or withdrawal symptoms from the 'artisanal' CBD, or the possibility that the new treatment isn't as effective. You will be closely monitored for any problems, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (1)

The Hospital for Sick Children
Verified postcode
Toronto, Canada

Common questions

What does 'artisanal' CBD mean?

'Artisanal' CBD refers to cannabis-based products that are not regulated medicines. Their strength and quality can be inconsistent, unlike approved medicines like Epidiolex.

What are Dravet Syndrome and Lennox-Gastaut Syndrome?

These are both serious types of epilepsy that start in childhood, causing different kinds of seizures and often affecting development.

Will my child stop their other seizure medicines?

No, your child must continue their other anti-seizure medicines at a stable dose throughout the study, unless a doctor decides a change is needed for safety.

How long will the study last for my child?

Your child's participation in the study will last for a total of 20 weeks, including clinic visits and diary keeping.

Can we change our minds about participating?

Yes, you can choose to withdraw your child from the study at any time, for any reason, and it will not affect their medical care.

How to find out more

Laura MacDougall, PhD

laura.macdougall@sickkids.ca 416-813-7996 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.