An Israeli study using a product that had 20 parts of CBD to 1 part of THC was performed in an open-label format for children up to age 18 years with hard to control epilepsy. A significant number of people reported seizure reduction with 7% stating seizures worsened.
A number of clinical trials are active and recruiting people, including studies using Epidiolex in people with Tuberous Sclerosis Complex and Sturge-Weber Syndrome.
On June 25, 2018, the U.S. Food & Drug Administration (FDA) approved EPIDIOLEX ® (cannabidiol, CBD) oral solution for the treatment of seizures associated with two epilepsy syndromes – Lennox-Gastaut syndrome and Dravet syndrome – in people two years of age or older. Epidiolex represents a new medication option for children with these types of epilepsy. It is also the first ever FDA approved medication to treat seizures in Dravet syndrome.
Are there ongoing CBD clinical trials?
Researchers studied this medicine in controlled clinical trials. These studies used a control group with some people taking a placebo while others were given CBD at different doses. Researchers did not know who was getting the placebo and who was getting CBD. These tpyes of studies are called “gold standard” studies.
It is important to know that even though marijuana is a plant, it is broken down in a person’s liver like many medicines. People mistakenly believe that marijuana is completely safe because it is a plant or oil from a plant. However, medication interactions can occur.
Providers do not need a special license or certificate to prescribe Epidiolex. Epidiolex is the first and only plant-based treatment derived from cannabis for use as a treatment for seizures with FDA approval. Other formulations of medical cannabis have not been approved by the FDA.
In this episode of Hallway Conversations, epilepsy.com Editor-In-Chief Dr. Joseph Sirven interviews Dr. Jose Cavazos MD, PhD, professor of neurology at the University of Texas Health Science Center in San Antonio. They discuss Dr. Cavazos’ experience serving as a panelist on the recent U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drug Advisory Committee review of Epidiolex ® for the treatment of Dravet and Lennox-Gastaut syndromes.
Comparator: Placebo capsules containing high-oleic sunflower oil and no active or medicinal ingredients.
Outcomes: Frequency of seizures; side effects; blood levels of AEDs, CBD, THC, and liver enzymes; impact on cognition and quality of life; genetics.
Background: Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) are the two major compounds found in the cannabis plant. Reports from patients, families, and the scientific community suggest that CBD (when used as an add-on therapy) decreases the number of convulsive seizures in children and adults with Dravet syndrome, Lennox-Gastaut syndrome, and Tuberous sclerosis complex.
Participants: Adults (18 years of age and older) with drug-resistant epilepsy, including patients with Dravet and Lennox Gastaut syndromes, and patients with frequent convulsive seizures (e.g., tonic, tonic-clonic, atonic, drop attacks, and focal motor seizures).
Sample size: A total of 80 participants (40 assigned to treatment and 40 to control group) recruited from Toronto Western Hospital in Toronto, and University Hospital in London, Ontario.
Interventions: Capsules containing a ratio of 16 CBD: 1 THC oil at a maximum total daily dose of approximately 300 mg of CBD per day, divided into equal doses in the morning and evening.
Trial design: Phase III, double-blind, randomized, placebo-controlled, parallel-group trial, followed by an open phase where treatment allocation will be revealed and all participants will either continue or begin receiving the active study drug.
The British Paediatric Neurology Association (BPNA) has drawn up interim guidance around epilepsy on behalf of NHS England.
There is also a wide range of other cannabis products available on the internet and in some commercial outlets such as health food outlets and from cannabis ‘dispensaries’ internationally. These products are of unknown quality and contain CBD and THC in varying quantities and proportions.
Guidance around prescribing cannabis-based products
A prescription for medicinal cannabis would only be given when all other treatment options have been tried or are considered unsuitable, and would only be given if the doctor considers it to be in your best interests.
On 1 November 2018, the Government's landmark decision to reschedule some cannabis based products for medicinal use, came into force. The change in law means that specialist doctors in the UK can now prescribe medicinal cannabis to people with a limited number of conditions, including epilepsy. Here we explain what the change in law means for people with epilepsy.
The BPNA guidance states that non-licensed medicinal cannabis should only be considered for children who: