Back to Trials
NCT04289467PHASE2Recruiting

Treatment of Refractory Infantile Spasms With Fenfluramine

Children's Hospital of Orange County

Start Date

6/16/2023

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Children ages 12 to 36 months, inclusive * Clinical diagnosis of infantile spasms * Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin. Exclusion Criteria: * Significant preexisting cardiovascular disease * Exposure to any cannabinoid product within 14 days of screening * Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening. * Implantation of a vagal nerve simulator within 14 days of screening * Initiation and maintenance of the ketogenic diet within 3 months of screening

Interventions

DRUG

Fenfluramine

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Infantile Spasm

Locations

UCLA Health

Los Angeles, California 90095

United States

Children's Hospital of Orange County

Orange, California 92868

United States