Two London hospitals will launch trials next year to determine whether the active ingredients in medicinal cannabis could help treat people with treatment-resistant epilepsy.
Researchers from University College London and Great Ormond Street Hospital will investigate whether cannabidiol (CBD) and tetrahydrocannabinol (THC) could have a therapeutic effect for those with the condition.
There are 630,000 people with epilepsy living in the UK, according to Epilepsy Action. Each day, around 80 people are diagnosed with the disease, which causes seizures, uncontrollable jerking and shaking and stiffness.
Currently there is only one cannabis-based medicine that has been approved for treating epilepsy on the NHS, a pure CBD medicine named Epidyolex.
Some people living with uncontrolled seizures have reported beneficial effects when using medical cannabis, particularly strains that are rich in CBD.
Cannabis contains both CBD and THC, which trigger different physical and psychological effects. CBD is an antipsychotic compound that can cause muscle relaxation and relieve anxiety, while THC is a psychoactive compound that makes people feel “high”.
The trials will randomly assign CBD, CBD with a small amount of THC or placebo to a total of 500 adults and children with treatment-resistant epilepsy for 24 weeks.
Patients will be given the compounds in the form of an oil named MRX2 (CBD) and MRX2T (CBD+THC, manufactured by pharmaceutical firm Ananda Developments.
People will be recruited into the trial from NHS sites around the UK.
Researchers are seeking further detail on whether medicinal cannabis is effective at reducing the number and severity of seizures, and how they affect learning, sleep, behaviour, quality of life and anxiety.
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.
Rebekah Smith, deputy chief executive at Epilepsy Action, 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.”
Both GOSH and UCL initially proposed the trials in 2019.
Professor Finbar O’Callaghan, who is leading the trial at the Great Ormond Street Institute of Child Health, said: “For patients with difficult-to-treat epilepsies, cannabis-based medicinal products are promising treatments, but it is essential that we have high-quality evidence from robust clinical trials to be sure they are effective and do not have harmful effects.
“Only with this evidence will we establish whether these medicines might have a place alongside existing anti-seizure medications.”
