Home › NCT04289467

Treatment of Refractory Infantile Spasms With Fenfluramine

A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms

Who can join

12 Months – 36 Months · All sexes

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

About the study

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.

What is being tested

• Fenfluramine (drug)

Sponsor: Children's Hospital of Orange County · Participants: 10 · Started: Jun 16, 2023

Contact the study team

• Kellie Bacon, MPH · Phone: 714-509-8972

Official record on ClinicalTrials.gov — NCT04289467

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.