Phase II Study of Fenfluramine to Treat Infantile Spasms in Children Aged 12 to 36 Months

What this Trial Is About

Researchers are studying fenfluramine in a phase II clinical trial for children with refractory infantile spasms, also known as epileptic spasms or West syndrome. The study focuses on children whose spasms have not improved despite treatment with vigabatrin and ACTH. The goal is to evaluate fenfluramines effectiveness, safety, and tolerability in this difficult-to-treat condition. Participants will receive open-label fenfluramine, with the dose increased up to 0.8 mg per kilogram of body weight per day. The initial treatment period lasts 21 days, during which participants will have baseline and follow-up video-EEG tests to assess response. Those who respond well may continue treatment for up to six months. During the study, children will undergo video-EEG monitoring before and after treatment to evaluate the electroclinical response. Researchers will also track safety and tolerability by noting any treatment-related side effects over 12 months. The total study duration includes follow-up assessments to monitor ongoing effects and adverse events.

Treatment of Refractory Infantile Spasms With Fenfluramine