Marijuana Constituent Significantly Reduces Severe Epileptic Seizures

Modesto Morganelli
Mag 17, 2018

Patients/caregivers were also significantly more likely to report an improvement in overall condition with both cannabidiol oral solution doses compared to placebo based on the Subject/Caregiver Global Impression of Change questionnaire, the firm noted.

Researchers investigated the use of CBD, when combined with regular epilepsy medication, for treating seizures among patients with Lennox-Gastaut syndrome.

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.

The biopharmaceutical company GW Pharmaceuticals (GWPH), along with its USA subsidiary Greenwich Biosciences, announced the publication of its Phase 3 study of cannabidiol oral solution in patients with Lennox-Gastaut syndrome (LGS) in The New England Journal of Medicine. All medications were administered in 2 equally divided doses daily, for 14 weeks.

Lennox-Gastaut Syndrome is a rare and severe form of childhood-onset epilepsy that typically persists into adulthood. Researchers reported a 41.9% reduction in "drop seizures" for those taking a 20mg/kg/d regimen and a 37.2% reduction in drop seizures in those on a 10 mg/kg/d regimen. The number of seizures was monitored beginning four weeks before the study for baseline assessment, then tracked throughout the 14-week study period and afterward for a four-week safety check. Side effects were generally reported as mild or moderate in severity and included sleepiness, decreased appetite, diarrhea, upper respiratory infection, fever, vomiting, nasopharyngitis, and status epilepticus.

Among the cannabidiol-prescribed patients, 14 experienced dose-related elevated liver aminotransferase concentrations; 7 participants withdrew from the cannabidiol group due to side effects compared to 1 participant in the placebo group.

"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. Epidiolex has been shown in multiple studies to help reduce seizures in even some of the most severe forms of epilepsy. Those findings represented the first large-scale, randomized clinical trial for the compound.

"We are now in the latter stages of the FDA's review of our New Drug Application and look forward to a decision from FDA in late June".

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