In the United Kingdom, approximately 40,000 children have been diagnosed with epilepsy, and many do not receive relief from the strong pharmaceuticals on the market today. In an attempt to further treatment education, trials will begin for a new epilepsy treatment medication, called Epidiolex, in several locations throughout the United Kingdom.
Epidiolex is a purified cannabis extract containing only the cannabinoid, cannabibiol (CBD). It does not contain any amount of the psychoactive cannabinoid, tetrahydrocannabinol (THC), which is known to produce a feeling of being “high.” Cannabidiol (CBD) is the cannabinoid that has been showing positive results in the treatment of many debilitating medical conditions including epilepsy. CBD trials in the United States have shown that the cannabinoid can reduce the frequency and severity of epileptic seizures.
Facilities participating in the trial include the Royal Hospital for Sick Children in Glasgow, Alder Hey Children’s Hospital in Liverpool, Edinburgh University’s Muir Maxwell Epilepsy Centre, and the Great Ormond Street Hospital in London.
When asked about the study, Dr. Richard Chin, Director of the Muir Maxwell Epilepsy Centre explained,
“Many children with serious forms of epilepsy do not respond to the medications that we currently have available. We need new means of treating these conditions so that we can give back some quality of life to these children and their families.”
The trials, funded by the creator and manufacturer of Epidiolex, GW Pharmaceuticals, have been approved to begin enrolling children suffering from the severe form of epilepsy known as Dravet Syndrome in facilities in Scotland and England. These studies are specifically seeking participants who have not seen results from commonly prescribed pharmaceuticals. In each set of ten participants, eight will be treated with Epidiolex, and two participants will be given a placebo instead. This phase of the trial will last for a total of twenty-one days. Out of thirty participants, twenty-four will be treated with one of three different dosage amounts of the CBD medication. The purpose of this phase of the study is to determine the ideal dosage for children suffering from Dravet Syndrome.
The U.S. Food and Drug Administration approved trials for this same medicine, Epidiolex, in the United States last month. The FDA also approved a study of cannabidiol (CBD) oil, derived directly from cannabis plants, to begin at the University of Alabama at Birmingham. These trials are not starting soon enough, as many children have already lost their lives to epilepsy without ever having the chance to try cannabinoid therapy because it is illegal throughout much of the world.
photo credit: mnepilepsy
The first FDA-authorized clinical trial for a cannabis therapy medication, Epidiolex, is recruiting children with Dravet Syndrome, a severe form of epilepsy, to test the efficacy of the new drug. Epidiolex is a purified cannabis extract containing only the cannabinoid, Cannabibiol (CBD). It does not contain any amount of the psychoactive cannabinoid, Tetrahydrocannabinol (THC).
The trials, funded by Epidiolex producer, GW Pharmaceuticals, are being hosted by three different children’s hospitals in the United States. The first location is in Texas, center two is in Georgia, and the third is in Illinois. Each location is currently seeking to enroll ten participants between the ages of four and ten years old, for a total of thirty participants nationwide. In each set of ten participants, eight will be treated with Epidiolex, and two participants will be given a placebo instead. This phase of the trial will last for a total of twenty-one days. Out of thirty participants, twenty-four will be treated with one of three different dosage amounts of the CBD medication. The purpose of this phase of the study is to determine the ideal dosage for children suffering from Dravet Syndrome. This phase is anticipated to conclude before the end of the year.
Phase II of this clinical trial will be used to determine the safety and efficacy of long term use, once the appropriate dosage has been determined in Phase I. The second phase will increase participation from thirty to eighty children, and increase duration from three weeks to three months.
Texas Children’s Hospital was selected to be the trial location center in Texas, and Dr. Angus Wilfong, neurologist at the hospital, is the first physician in Texas certified to administer the medication, Epidiolex, to pediatric patients. Dr. Wilfong told KHOU11,
“As one of the largest epilepsy centers in the country, our focus has always been to find new and innovative ways to treat and cure children with various forms of epilepsy. Initial trials of Epidiolex have shown promising signals of efficacy in children with treatment- resistant epilepsy, and we are pleased to have the opportunity to partner with GW Pharmaceuticals in the first worldwide trial for this group of patients with such a catastrophic form of epilepsy.”
One of the patients, enrolled in the trial last week to be treated at Texas Children’s Hospital is six year old, Izaiah Ruiz, pictured below with his grandmother, Lori Fountain. Izaiah has a confirmed case of Dravet Syndrome, and suffers from daily seizures as a result. These daily seizures have caused Izaiah to develop at a much slower pace than other children who do not suffer from epilepsy. Developmentally, Izaiah is only about two years old. His grandmother, Lori, is also hopeful that this CBD medication may improve Izaiah’s quality of life.
She told KHOU11 that she is does not care what other people think about Izaiah’s participation in the study because she would try anything to give him the chance to live the life that most children are able to live, and grow to have a better quality of life as a teenager and eventually a man.
photo credit: Celebstoner, Houston Chronicle