The two trials2 Jan 2025 23:32
Two national NHS clinical trials will investigate the safety and effectiveness of cannabidiol (CBD) and tetrahydrocannabinol (THC) in adults and children with treatment-resistant epilepsy.
Prof Finbar O’Callaghan and Prof Helen Cross from University College London (UCL) and Great Ormond Street Hospitals (GOSH) will co-lead the trials, which are due to start in 2025.
The trials will randomly assign CBD, CBD with a small amount of THC or placebo to a total of 500 adults and children with medicine-resistant (refractory) early-onset and genetic generalised epilepsies for 24 weeks. People will be recruited into the trial from NHS sites around the UK. The trial will use formulations by the company Ananda Developments, known as MRX2 (CBD) and MRX2T (CBD+THC).
The researchers want to investigate whether these medicines are safe and effective in reducing number and severity of seizures, and how they affect learning, sleep, behaviour, quality of life, stress and anxiety.
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.”
If successful, the results of the trials may support applications to the Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulatory bodies for approval for use in refractory epilepsy.
At the moment, the CBD medicine Epidyolex is licensed and recommended for use on the NHS for people with Dravet syndrome and Lennox-Gastaut .
Currently, the National Institute for Health and Care Excellence (NICE) has not recommended this medicine for severe and treatment-resistant epilepsies. The institute says more high-quality evidence is needed on safety and effectiveness of CBD and CBD in combination with THC for severe treatment-resistant epilepsy.
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