Starting in 2025, the UK’s Natonal Health Service (NHS) will investigate cannabidiol (CBD) and tetrahydrocannabinol (THC) to assess their safety and effectiveness as an additional treatment for adults and children with epilepsy.
Researchers from University College London and Great Ormond Street Hospitals want to investigate whether these medicines are safe and effective in reducing the number and severity of seizures, alongside the effects they have on learning, sleep, behaviour, quality of life, stress, and anxiety.
The trials will last 24 weeks and be carried out with 500 adults and children from around the UK, all with medicine-resistant (refractory) early-onset and genetic generalised epilepsies. Subjects will be randomly assigned with CBD, CBD with a small amount of THC. or a placebo. The medical cannabis will be supplied by the company Ananda Developments and are known as MRX2 (CBD) and MRX2T (CBD+THC).
Ananda Developments said: “These will be the world’s first double blind randomised controlled trials to investigate the use of CBD and THC together for epilepsy, and the first to evaluate the medicines in children and adults who have a broad range of difficult-to-treat epilepsies.”
Currently, only the CBD medicine Epidyolex is licensed and recommended for use on the NHS for people with Dravet syndrome and Lennox-Gastaut.
If the 2025 trials are successful, the results may support applications to the Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulatory bodies for approval for use in refractory epilepsy.
The National Institute for Health and Care Excellence (NICE) has not yet recommended this medicine for severe and treatment-resistant epilepsies. They say more high-quality evidence is needed on safety and effectiveness of CBD and CBD in combination with THC.
The trials were proposed over 5 years ago
The deputy chief executive at Epilepsy Action, Rebekah Smith, said:
“It’s encouraging to see these long-anticipated trials for medicinal cannabis finally taking place. The NHS has had a cannabidiol product available since 2018, but there have been very few prescriptions, and it has only been approved for two rare forms of epilepsy.
The need for more research on the effectiveness and safety of both the CBD and THC elements of cannabis is much needed, and announcing this research is a source of hope for many families.
We are eager to understand how these clinical trials could advance the way we treat epilepsy, and while we recognise that this will take time, we will continue to inform and educate people about their options and support them in ways to access this and other forms of medication.”
The director of Medcan Family Foundation (a patient organisation working on behalf of families living with complex severe treatment resistant epilepsy), Matt Hughes, said:
“We are pleased to hear that the long-anticipated trials proposed by GOSH and UCL in 2019 will commence next year.
Research is a much-needed step in expanding access to CBD medicines for the treatment of drug-resistant epilepsy. The trials bring renewed hope for children and families affected by uncontrolled seizures.
A trial including THC is also crucial for addressing the questions posed by NICE.
However, it’s important to recognise that these trials do not include second generation, advanced cannabinoid medicines; the variety that is used by most families seeing significant and sustained improvements in seizure control and which have been shown through real-world data and observational trials to be the most effective.
For those for whom CBD and THC alone are not effective, and for those already privately prescribed advanced cannabinoid medicines, we continue to urge government support in creating a pathway for the licensing of these more advanced medications.”
- For more information about epilepsy and medical cannabis in the UK, see the Epilepsy Action Website
- Sourced from an article by Kami Kountcheva – Epilepsy Action
- Image: Adobe Firefly
