WellSpan Health recently participated in a clinical trial designed to determine the effectiveness of Epidiolex, a purified form of cannabidiol, in epilepsy patients.
Lennox-Gastaut syndrome causes debilitating seizures, and many patients living with this form of epilepsy do not respond to standard treatments. WellSpan Health has been selected as a site for a Phase 3 clinical trial to determine the effectiveness of Epidiolex, a purified form of cannabidiol, in treating the seizure disorder.
“We reached out to the company, GW Pharmaceuticals, and after a number of conversations, they asked us if we would want to be a site for the Dravet syndrome trial and then the Lennox-Gastaut trial,” says Todd Barron, MD, a pediatric neurologist with WellSpan Health. “We decided this was a very important trial to participate in because we have a number of patients with those two syndromes.”
WellSpan joined both trials. However, the three patients with Dravet syndrome failed initial screening and WellSpan was unable to participate in the Dravet trial. WellSpan then turned its attention to the Lennox-Gastaut trial and recruited 14 participants for the double-blind placebo controlled trial and 13 for the open-label portion.
While the age range of the overall trial was from 2 year to 55 years, patients participating through WellSpan ranged in age from 6 to mid-20s. During the double-blind portion of the trial, patients received between 10 and 20 milligrams of Epidiolex per kilogram of body weight per day, while in the open-label portion dosage went as high as 30 milligrams per kilogram.
The drug was well-tolerated, both in the WellSpan trial and overall, with the most common side effects in WellSpan’s group being fatigue and decreased appetite. Most side effects appeared to be due to interactions with concomitant anti-seizure medications such as clobazam and divalproex sodium.
“It was very clear that there were patients who, during the double-blind phase, had absolutely no response and then there were patients who had a significant response,” Dr. Barron says. “Once we entered the open-label trial, when patients all received [the] drug, it was clear that overall they had at least a 40 to 50 percent reduction, and we had some children who had a very dramatic reduction in seizures in the range of 90 to 100 percent.”
Trial-wide, GW Pharmaceuticals reported that patients receiving Epidiolex for Lennox-Gastaut experienced a median reduction in monthly drop seizures by 44 percent, compared to 22 percent for patients given the placebo.
Medical Research and Clinical Trials at WellSpan
WellSpan participates in clinical trials as a way to broaden therapy options for patients.
“By doing [trials] here at WellSpan, we can provide these novel treatments locally, as opposed to sending [patients] to Philadelphia or Baltimore,” Dr. Barron says. “It’s wonderful that our system is willing to participate in these trials so we can offer what is considered care you might get at an academic center here at our local health system.”
For more information, contact the WellSpan Neurology at 717-851-5503.