Extension study evaluates use of adjunctive fenfluramine in Dravet syndrome

Researchers have reported interim findings confirming the safety and efficacy of adjunctive fenfluramine for reducing seizures in children with Dravet syndrome.

At the ICNA/CNS 2020 virtual conference, Dr Joseph Sullivan from the University of California San Francisco (UCSF) Benioff Children’s Hospital, USA, presented interim findings from an ongoing open-label extension study of fenfluramine.

A total of 330 patients, who had taken part in one of three previous trials, had a 2-week transition to a standard 0.2 mg/Kg/day dose. This could be increased later in the study up to 0.7 mg/Kg/day, for example as concomitant anti-epileptic drugs (AEDs) were removed, although all subjects had to remain on at least one background AED.

Dr Sullivan reported that the mean age of patients in the study was 9.0 years, and 54.5% were male. The median baseline convulsive seizure frequency was 15.3 per 28 days. Overall, the patients received a median of 445 days of treatment with fenfluramine (range 7-899 days).