CBD gel reduces seizures in children with encephalopathies
Cannabidiol transdermal gel improved outcomes among children with developmental and epileptic encephalopathies, according to results of a nonrandomized controlled trial published in JAMA Network Open. According to the researchers, challenges remain for orally administered treatments among patients with developmental and epileptic encephalopathies, warranting consideration of alternative drug delivery methods.

In a study conducted at two centers in Australia and New Zealand. Researchers sought to evaluate the safety and tolerability of CBD transdermal gel among 48 children in this patient population, as well as to evaluate seizure frequency, sleep, and quality of life. They included children and adolescents aged 3 to 18 years with developmental and epileptic encephalopathies who were receiving a stable regimen of one to four antiseizure medications. Patients underwent 5.5 months of flexible-dosing maintenance following 1-month baseline and titration periods, totaling 6.5 months of treatment. The researchers analyzed data throughout the 6.5 months of treatment.

The intervention consisted of two applications per day of CBD transdermal gel at doses of 125 mg to 500 mg for the treatment period. Scheffer and colleagues conducted safety and tolerability assessments that included adverse events and examination of the skin. Median percentage change from baseline in monthly seizure frequency or focal impaired awareness seizures (FIAS) and tonic-clonic seizures (TCS) over 6.5 months served as the outcome for seizures.

Results showed 60% of participants had at least one treatment-related adverse event over 6.5 months, with 96% considered mild or moderate. Application-site dryness, application-site pain, and somnolence were each reported by 8% of patients. One patient reported diarrhea, which was the only treatment-related gastrointestinal adverse event. CBD treatment correlated with reductions in FIAS and TCS, with a median reduction in seizures of 58% at 5 months and 43.5% over the 6.5-month study period. Parent- and caregiver-reported improvements included social or interpersonal engagement and irritability (77%); alertness, energy, and sleep (53%); and cognition or concentration (47%).

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