First FDA-Authorized Clinical Trial for Cannabis Therapy Enrolling Now
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.