The Dutch government has pledged €1.4million for research into the effects of medicinal cannabis oil in children with treatment-resistant epilepsy.
The UMC Utrecht Brain Center, in collaboration with various organisations in the Netherlands, has been allocated €1.4million from the government’s Good Use of Medicines programme for a four-year research project into the effects of high-CBD oil in children with severe epilepsy.
The drug which will be administered in the trial is the whole-plant high-CBD oil, Bedrolite from the Dutch Transvaal pharmacy, which is made using medicinal cannabis produced by Bedrocan.
Researchers will examine the effects of the oil on seizure reduction, as well as other quality of life markers such as seizure length, sleep and alertness.
A total of 50 participants will take part in the trial which is due to get underway in the summer of 2023, with the first patients expected to be treated by the end of the year.
In order to qualify for the study, patients must not have previously used CBD oil to treat epileptic seizures and must experience a minimum of eight seizures every four weeks.
Lead researcher on the study, Floor Jansen
Lead researcher, Floor Jansen, hopes that after the research, neurologists will be able to better predict for which patients CBD may be an effective treatment.
She commented: “Our research focuses on the individual. Instead of looking at a group, we look at whether the drug is effective per patient. We want to investigate whether the number of attacks decreases, but we also pay attention to other important outcomes for a patient. Think of less use of emergency medication against prolonged attacks, a change in alertness or a better night’s sleep.”
Calls for the UK government to follow their lead
Bedrolite is prescribed to a number of children with treatment-resistant epilepsy in the UK, including two children who are prescribed it through the NHS.
While many of these have seen a significant reduction in their seizures and improvements to their quality of life, regulators have repeatedly called for more ‘high quality’ evidence before these products can be prescribed more widely through the healthcare system.
The news from the Netherlands has led to calls for the UK government to invest in much-needed clinical trials.
Jo Griffiths, chair of the charity Intractable Epilepsy, which raises money to help families fund private cannabis prescriptions, would like to see the UK match the €1.4million for randomised control trials (RCTs) on Bedrocan products.
She told Cannabis Health: “Intractable Epilepsy supports families with private medicinal cannabis costs, once it has been prescribed for at least six months. But some families cannot even afford a private consultation. To help every child and young adult with intractable epilepsy access full-extract medicinal cannabis, the government and health providers are saying gold standard RCTs are needed.
“Therefore, we are calling on the UK government to match the Dutch government’s €1.4million towards trials, and to run an NHS trial using the same oils.
“The NHS has prescribed the very same oils to two children in the UK over the past four years, while others pay privately and some families are looking to the unregulated black market.”
Guidance from the British Paediatric Neurology Association (BPNA) does not recommend the prescribing of cannabis-based medicines, other than Epidiolex for seizures related to Lennox-Gastaut syndrome and Dravet syndrome. This, it claims, is due to there being ‘no evidence’ for the safety and efficacy of these products.
Intractable has written to the BPNA and was told that the organisation is ‘willing to collaborate’ with colleagues in the Netherlands to produce a ‘larger evidence base’.
Alongside RCTs, Intractable is calling for an observational study to examine the effects of whole-plant cannabis oils on those who have been taking them with positive outcomes for a number of years.
“Alongside a UK RCT, we would like to see the observational trial recommended by the Health Select Committee in 2019, for those already taking full-extract oils,” she added.
“It would be prudent of the government and the NHS to take part in these trials to build the evidence base that over 50 children have proven over the last four years.”
No further update on NHS trials promised last year
Speaking in Parliament in March 2022, the then Minister for Care and Mental Health Gillian Keegan, said the NHS and the National Institute for Health Research (NIHR) were “working closely” on two RCTs to compare the effects of medicines containing CBD, and CBD with THC, and a placebo.
There is yet to be any further announcements on the progress of these trials.
Cannabis Health has approached the Department of Health and Social Care, NHS England and NIHR for comment.
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