RecruitingPhase 2NCT04289467

Treatment of Refractory Infantile Spasms With Fenfluramine

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


Sponsor

Children's Hospital of Orange County

Enrollment

10 participants

Start Date

Jun 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 MonthsMax Age: 36 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fenfluramine for people with infantile spasm. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 12 Months to 36 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFenfluramine

Open-label


Locations(2)

UCLA Health

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

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NCT04289467


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