Treatment of Refractory Infantile Spasms With Fenfluramine

Recruiting now · Phase 2

Conditions studied: Infantile Spasm

In brief

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.

Key facts

Study ID

NCT04289467

Run by

Children's Hospital of Orange County

People needed

10

Starts

2023-06-16

Expected to finish

2026-12-31

Last updated by the study team

2026-04-15

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children ages 12 to 36 months, inclusive
• Clinical diagnosis of infantile spasms
• Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• UCLA Health — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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