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Study identifier: NCT04289467 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Treatment of Refractory Infantile Spasms With Fenfluramine

Condition: Infantile Spasm  ·  Sponsor: Children's Hospital of Orange County

PhasePhase 2
Planned participants10
Who can joinAll sexes, 12 Months to 36 Months
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

Kellie Bacon, MPH  ·  714-509-8972  ·  kellie.bacon@choc.org

Virginia Allhusen, PhD  ·  vallhusen@choc.org

Always discuss trial participation with your own doctor first.

Locations (2)

UCLA HealthLos Angeles, California, United StatesNot Yet Recruiting
Children's Hospital of Orange CountyOrange, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04289467