Clinical trials of cannabis-based epilepsy medicine to start in the UK

Chuck Bednar for redOrbit.com – Your Universe Online

UK health officials have given the go-ahead for doctors to test a new treatment derived from the cannabis plant in children suffering from certain forms of severe epilepsy.

The new treatment is known as Epidiolex, and it does not contain the ingredient responsible for creating the high associated with recreational marijuana use, researchers from the University of Edinburgh explained. Instead, it is based off of one of the plant’s non-psychoactive components, cannabidiol (CBD), the health benefits of which have been examined in clinical trials.

The university explained that early studies conducted in the US have indicated that some epileptic children treated with CBD could experience less frequent and less severe seizures.

This will mark the first time that the treatment method has been tested in the UK, and it will involve a randomized controlled trial at the University of Edinburgh’s Muir Maxwell Epilepsy Centre. In addition, the Royal Hospital for Sick Children in Glasgow and Alder Hey Children’s Hospital in Liverpool will be involved in trial, as will facilities in the US, France and Poland.

“Many children with serious forms of epilepsy do not respond to the medications that we currently have available,” said Dr Richard Chin, Director of the Muir Maxwell Epilepsy Centre. “We need new means of treating these conditions so that we can give back some quality of life to these children and their families.”

“I welcome the launch of these trials as it marks an important milestone in our long journey towards understanding the condition and improving the treatment of those suffering this severe form of epilepsy,” added Ann Maxwell, founder of the Muir Maxwell Trust pediatric epilepsy charity. “As the mother of a teenager with this life altering condition, I strongly support the exploration of ground breaking medications that could seek out new ways to improve patients’ life quality.”

The initial focus of the research will be on children suffering from a rare, difficult-to-treat form of epilepsy known as Dravet Syndrome. Dravet Syndrome typically begins in infancy and causes seizures that often last for more than five minutes at a time. Patients are also at risk of a number of issues involving speech, growth, balance, movement and even sudden, unexplained death.

Some children participating in the study will receive Epidiolex, which was developed by British biotechnology company GW Pharmaceuticals, while others will be given a placebo. Future phases of the trial will study the treatment’s effects on Lennox-Gastaut Syndrome, a severe form of epilepsy which usually begins around age four and can be caused by brain malformations, severe head injury, central nervous system infection or inherited degenerative conditions.

“The 40,000 children with epilepsy in the UK have many different genetic causes for their seizures,” said Dr Sameer Zuberi, Clinical Lead of the Glasgow Epilepsy Genetics Service and Epilepsy Specialist at the Royal Hospital for Sick Children. “The opportunity to trial new treatments in children with specific gene changes gives families hope for better and more focused therapies.”

Professor Helen Cross, chief UK clinical investigator of the initial part of the trial, said that the study will give researchers the opportunity to “accurately test the viability of treatment with CBD in a safe and controlled way,” while Dr. Richard Appleton of Alder Hey Children’s Hospital in Liverpool noted that it was “crucial that research in children with epilepsy is undertaken far earlier than it has been in the past.”

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