Actively Recruiting
A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms
Led by Children's Hospital of Orange County · Updated on 2026-04-15
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying fenfluramine in a phase II clinical trial for children with refractory infantile spasms, also known as epileptic spasms or West syndrome. The study focuses on children whose spasms have not improved despite treatment with vigabatrin and ACTH. The goal is to evaluate fenfluramine's effectiveness, safety, and tolerability in this difficult-to-treat condition. Participants will receive open-label fenfluramine, with the dose increased up to 0.8 mg per kilogram of body weight per day. The initial treatment period lasts 21 days, during which participants will have baseline and follow-up video-EEG tests to assess response. Those who respond well may continue treatment for up to six months. During the study, children will undergo video-EEG monitoring before and after treatment to evaluate the electroclinical response. Researchers will also track safety and tolerability by noting any treatment-related side effects over 12 months. The total study duration includes follow-up assessments to monitor ongoing effects and adverse events.
CONDITIONS
Brief 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 simulator 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days initially, with an option to continue up to 6 months
Participants receive open-label fenfluramine treatment with dosage titrated to 0.8 mg/kg/day for an initial duration of 21 days. Those with a favorable response may continue treatment for up to 6 months.
Visits as required for dosage titration and monitoring during treatment
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
V
Virginia Allhusen, PhD
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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