When you think about our outstanding neurology team at Texas Children’s Epilepsy Center – one of the largest Level 4 epilepsy centers in the nation – one particular attribute comes to mind: their passion for innovation.
“Our focus has always been to discover new and innovative ways to treat and cure children with various forms of epilepsy,” said Dr. Angus Wilfong, a Texas Children’s neurologist who is leading the hospital’s first worldwide clinical trial of a cannabis-derived experimental drug to treat pediatric Dravet Syndrome.
The syndrome, which occurs in about one in every 30,000 births, is a rare and catastrophic form of intractable epilepsy that causes patients to experience dozens or even hundreds of seizures a day. If left untreated, children struggle with developmental delays, serious health complications and death.
That’s the grim reality 6-year-old Izaiah Ruiz faces daily. His grandmother, Lori Fountain, says Ruiz’s epilepsy is so severe that despite taking numerous seizure medications, nothing seems to produce long-term relief. Ruiz’s first seizure occurred when he was 2 months old, and since then, he’s almost lost his life twice. “I want him to be a normal little boy without having to worry about a seizure every time he goes to the playground or when he gets a runny nose,” said Fountain.
Ruiz is one of 30 patients worldwide enrolled in Texas Children’s study to examine the safety and efficacy of Epidiolex®, a highly purified cannabis extract that contains pure Cannobidiol (CBD). Although it is derived from the cannibas plant, Epidiolex contains no tetrahydrocannabional (THC), the psychoactive chemical in marijuana. GW Pharmaceuticals, who will fund the trial, is the only company in the world that produces pure plant-derived CBD, which is believed to help control seizures in children. The CBD medication is administered orally as a suspension or via feeding tube.
Wilfong, who is the study’s lead investigator and the first physician to administer Epidiolex in Texas, says the trial will be conducted in two stages. The first phase will determine the ideal dosage for children with Dravet Syndrome and the second phase will evaluate the drug’s safety and efficacy in this patient population.
“We are hopeful that in the next year, the results of this trial will show this drug has a positive impact on enrolled patients and that it will have implications for patients with other forms of intractable epilepsy,” said Dr. Gary Clark, chief of Neurology and Developmental Neuroscience at Texas Children’s.
Texas Children’s first began using Epidiolex in April of this year under a compassionate use protocol approved by the Food and Drug Administration for patients with catastrophic forms of epilepsy who were not responsive to seizure medications.
Wilfong said, “Initial trials of Epidiolex demonstrate promising signs of efficacy in children with treatment-resistant epilepsy. We are excited to partner with GW Pharmaceuticals in the first worldwide trial for this group of patients with such a catastrophoic form of epilepsy.”
Fountain hopes her grandson receives the experimental CBD medication rather than a placebo, but she knows that if he doesn’t, he’ll get the drug soon thereafter.
“If this drug could reduce Izaiah’s seizures and give him any semblance of a normal life, I can’t tell you how ecstatic I’ll be,” said Fountain.
Currently, Texas Children’s Epidiolex trial is accepting only pediatric patients with confirmed Dravet Syndrome. To learn more, click here or call Christina Tally, BS, CCRP, at Ext. 2-1276.
Click the link for more information about Texas Children’s Epilepsy Center.