Actively Recruiting
Treatment of Refractory Infantile Spasms With Fenfluramine
Led by Children's Hospital of Orange County · Updated on 2026-04-15
10
Participants Needed
2
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Refractory Infantile Spasms With Fenfluramine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children ages 12 to 36 months, inclusive
- Clinical diagnosis of infantile spasms
- Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin
You will not qualify if you...
- 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 stimulator within 14 days of screening
- Initiation and maintenance of the ketogenic diet within 3 months of screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UCLA Health
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
Research Team
K
Kellie Bacon, MPH
CONTACT
V
Virginia Allhusen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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