Addition of Cannabidiol May Cut Drop Seizures in Lennox-Gastaut

Orrin Devinsky MD professor of neurology neurosurgery and psychiatry NYU School of Medicine and director of NYU Langone comprehensive epilepsy center

Orrin Devinsky MD professor of neurology neurosurgery and psychiatry NYU School of Medicine and director of NYU Langone comprehensive epilepsy center

In a double-blind, placebo-controlled trial conducted at 30 clinical centers, researchers randomly selected 225 patients diagnosed with LGS, with an age range of 2 to 55 years, who had two or more drop seizures per week. Lennox-Gastaut syndrome is a severe form of epilepsy which primarily affects young children and most commonly results in "drop seizures" - during which the patient will fall suddenly to the ground and lose all muscle tone, thereby going limp. Patients were randomized to cannabidiol oral solution at a dose of 20mg/kg (76 patients) or 10mg/kg of body weight (73 patients) or matching placebo (76 patients).

The New England Journal of Medicine has published the second of two late stage studies showing that GW Pharma's cannabinoid Epidiolex cut seizures in patients with the rare childhood epilepsy Lennox-Gastaut Syndrome. All medications were administered in 2 equally divided doses daily, for 14 weeks.

During the 28-day baseline observation period, the combined average of drop seizures for all groups combined was 85.

The number of seizures were monitored beginning 4 weeks prior to the study for baseline assessment, then tracked through the 14-week study period, and afterward for a 4-week safety follow-up.

The effects described were mild or moderate in severity, and those that occurred in more than 10% of patients included somnolence, decreased appetite, diarrhea, upper respiratory infection, fever, vomiting, nasopharyngitis and status epilepticus. A total of six patients from the 20mg group and one patient from the 10mg had to withdraw from the study due to the side effect. Additionally, 14 patients who received Epidiolex had elevated liver aminotransferase concentrations.

"This landmark study provides data and evidence that Epidiolex can be an effective and safe treatment for seizures seen in patients with Lennox-Gastaut syndrome, a very hard to control epilepsy syndrome", noted co-lead study investigator, Anup Patel, M.D., chief of neurology at Nationwide Children's Hospital. Open-label CBD studies led by Dr. Devinsky also have shown positive results for treatment-resistant epilepsies.

In April, a US Food and Drug Administration (FDA) advisory panel unanimously voted to recommend approval of a new drug application for Epidiolex cannabidiol oral solution.

Researchers concluded that the 20-mg cannabidiol group reported the greatest reduction from baseline in drop-seizure frequency during treatment. The FDA will decide whether to approve the medication in late June.

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