Dutch government donates $1.5 million to fund CBD epilepsy study

The UMC Utrecht Brain Center will receive around 1.5 million US dollars (1.4 million euros) from the Dutch government in cooperation with various organizations in the Netherlands. Bedrocan announced the study on March 20. Previous research shows that CBD reduces seizures in children with specific epilepsy-related syndromes.

UK-based Cannabis Health News reports that researchers through the government’s Good Use of Medicines program or ZonMW will use the money and start a four-year research project looking at the effects of high-CBD oil in children with severe dealing with epilepsy.

Researchers will administer CBD-rich vegetable oil Bedrolite from Dutch Transvaal Pharmacy, made from cannabis produced by Bedrocan. 50 participants will take part in the study, which is scheduled to start in the summer. The first patients are expected to begin by the end of the year.

The researchers will study whether the oil is effective in reducing the frequency of seizures. They also monitor other “quality markers” such as seizure length, sleep, and alertness. Patients must not have previously used CBD oil to treat epilepsy and/or seizures and must have at least eight seizures or more every four weeks.

“Our research focuses on the individual. Rather than looking at a group, we look at whether the drug is effective per patient,” said lead researcher, Floor Jansen, a pediatric neurologist. “We want to study whether the number of attacks decreases, but we also look for other important outcomes for a patient. Think less use of rescue medication for ongoing attacks, a change in alertness, or a better night’s sleep.”

Rare, intractable forms of epilepsy have not been studied well enough. Researchers will look at individual cases, rather than looking at a group as a whole, to determine if the drug is effective for each patient.

Intractable Epilepsy is a charity that raises funds to help families pay for private cannabis prescriptions. Jo Griffiths, Chair of Intractable Epilepsy, said she would like to see the UK fund the €1.4 million for randomized controlled trials (RCTs) of Bedrocan products.

“Intractable Epilepsy supports families with private medical cannabis costs once it has been prescribed for at least six months,” Griffiths said. “But some families cannot even afford private counseling. To give every child and young adult with intractable epilepsy access to full extract medicinal cannabis, government and healthcare providers say gold-standard RCTs are needed. We are therefore calling on the UK government to match the Dutch government’s €1.4m trials and run an NHS trial of the same oils.”

“The NHS has been prescribing the exact same oils to two children in the UK in the last four years while others pay privately and some families look to the unregulated black market,” she said.

In addition to RCTs, Intractable Epilepsy is aiming for an observational study to examine the effects of whole plant cannabis oils on people who have had success with the compound.

“Alongside a UK RCT, we would like to see the observational study recommended by the Health Select Committee in 2019 for those already taking whole extract oils,” she added.

“It would be wise for the Government and the NHS to take part in these trials to build up the evidence base that over 50 children have demonstrated over the last four years.”

The study will start this summer and the first patients should be treated by the end of 2023.