Clinical Trial

Treatment of Refractory Infantile Spasms With Fenfluramine

Recruiting Phase 2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-02-26; most recent amendment 2026-04-13.
Status change: Not Yet Recruiting → Recruiting 2024-02-05
Trial Details
NCT Number NCT04289467
Lead Sponsor Children's Hospital of Orange County
Conditions Infantile Spasm
Enrollment 10 participants
Start Date 2023-06-16
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-15