Two national NHS clinical trials will investigate the safety and efficacy of cannabidiol (CBD) and tetrahydrocannabinol (THC) in adults and children with treatment-resistant epilepsy.
Professor Finbarr O'Callaghan and Professor Helen Cross from University College London (UCL) and Great Ormond Street Hospital (GOSH) will co-lead the trial, which is expected to begin in 2025.
In this study, a total of 500 adults and children with drug-resistant (refractory) early-onset generalized epilepsy and hereditary generalized epilepsy were randomly assigned to receive CBD, CBD containing small amounts of THC, or a placebo. It will run for 24 weeks. Participants in this trial will be recruited from NHS facilities across the UK. The study will use Ananda Developments' formulations known as MRX2 (CBD) and MRX2T (CBD+THC).
Researchers are investigating whether these drugs are safe and effective at reducing the number and severity of attacks, and what effects they have on learning, sleep, behavior, quality of life, stress, and anxiety. I would like to investigate.
Ananda Developments said: “These are the world's first double-blind, randomized controlled trials investigating the combination of CBD and THC for epilepsy, and the first to evaluate the drugs in children and adults with a wide range of difficult-to-treat diseases.” Epilepsy. ”
If successful, the results of the trial could support an application to the Medicines and Healthcare products Regulatory Agency (MHRA) or other regulatory bodies for approval for use in refractory epilepsy.
At present, the CBD drug Epidiolex is approved and recommended by the NHS for use in patients with Dravet syndrome and Lennox-Gastaut syndrome.
The National Institute for Health and Care Excellence (NICE) currently does not recommend this drug for severe treatment-resistant epilepsy. The institute says higher quality evidence is needed about the safety and effectiveness of CBD in combination with THC for severe, treatment-resistant epilepsy.
Research desperately needed
Rebekah Smith, Deputy Chief Executive Officer of Epilepsy Action, said: The NHS has made cannabidiol products available since 2018, but there are few prescriptions and they are only approved for two rare forms of epilepsy.
“Further research is needed into the efficacy and safety of both the CBD and THC components of cannabis, and the publication of this study is a source of hope for many families.
“We are keen to understand how these clinical trials can advance the way we treat epilepsy, and while we recognize that this will take time, we are We will continue to inform and educate people about their options and support them on how to access this and other forms of medicine. ”
Matt Hughes, co-founder and director of the Medcan Family Foundation, said:
“The study is a much-needed step in expanding access to CBD medicine in the treatment of drug-resistant epilepsy. This trial brings new hope to children and families affected by uncontrollable seizures. Masu.
“Tests involving THC are also important to address the questions raised by NICE.
“However, it is important to recognize that these trials did not include second-generation advanced cannabinoid medicines. This variety, which is used by most families, provides significant and long-lasting relief in seizure control. It has shown significant improvements and has been proven to be the most effective through real-world data and observational trials.
“For people for whom CBD and THC alone do not work, and for those who are already privately prescribed advanced cannabinoid medicines, we are working with the government to create a path for approval of these more advanced medicines. I will continue to ask for support.”
For more information about medical cannabis in the UK, please visit the Epilepsy Action website.
