Treatment of Refractory Infantile Spasms With Fenfluramine
Status:
Not yet recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a phase II clinical trial in which children with refractory infantile spasms (also
called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate
efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to
treatment with vigabatrin and ACTH we will be invited to participate. Study participants will
undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo
repeat video-EEG to determine effectiveness. Patients with favorable response will have the
opportunity to continue treatment for up to 6 months.