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Treatment of Refractory Infantile Spasms With Fenfluramine
Sponsor: Children's Hospital of Orange County
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.
Official title: A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms
Key Details
Gender
All
Age Range
12 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2023-06-16
Completion Date
2026-12-31
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
Fenfluramine
Open-label
Locations (2)
UCLA Health
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States