The UMC Utrecht Brain Center, in collaboration with various organizations in the Netherlands, will receive about $1.5 million (€1.4 million) from the Dutch government. Bedrocan announced the study on March 20. Previous research shows that CBD reduced seizures in children with specific epilepsy-related syndromes.
U.K.-based Cannabis Health News reports that via the government’s or ZonMW’s Good Use of Medicines program, researchers will use the money and launch a four-year research project delving into the effects of high-CBD oil in children living with severe epilepsy.
Researchers will administer whole-plant high-CBD oil, Bedrolite from the Dutch Transvaal pharmacy, which is made using cannabis produced by Bedrocan. Fifty participants will join the trial which is planned to kick off in the summer. The first patients are expected to begin by the end of the year.
Researchers will study if the oil is effective in reducing frequency of seizures. They’ll also monitor other “quality of life markers” such as seizure length, sleep, and alertness. Patients must not have previously used CBD oil for the treatment of epilepsy and/or seizures and must have a minimum of eight seizures or more every four weeks.
“Our research focuses on the individual. Instead of looking at a group, we look at whether the drug is effective per patient,” said lead researcher, Floor Jansen, who is a pediatric neurologist. “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.”
Rare, intractable forms of epilepsy have not been studied well enough. Researchers will look at individual cases instead of looking at a group as a whole in order to determine whether the drug is effective for each patient.
Intractable Epilepsy is a charity that raises funding to assist families pay for private cannabis prescriptions. Jo Griffiths, chair of Intractable Epilepsy said she would like to see the U.K. match the €1.4 million for randomized control trials (RCTs) on Bedrocan products.
“Intractable Epilepsy supports families with private medicinal cannabis costs, once it has been prescribed for at least six months,” Griffiths said. “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 U.K. government to match the Dutch government’s €1.4 million 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 U.K. over the past four years, while others pay privately and some families are looking to the unregulated black market,” she said.
Alongside RCTs, Intractable Epilepsy is seeking an observational study to examine the effects of whole-plant cannabis oils on people who have already found success with the compound.
“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.”
The study will launch this summer, and the first patients are expected to be treated by the end of 2023.