Not currently recruiting at University of California Health

Treatment of Refractory Infantile Spasms With Fenfluramine

a study on Epilepsy Infantile Spasms

Summary

Eligibility
for people ages 12 months to 36 months (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Shaun A Hussain, MD (ucla)

Description

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

Keywords

Infantile Spasm, Spasm, Infantile Spasms, Fenfluramine

Eligibility

You can join if…

Open to people ages 12 months to 36 months

You CAN'T join 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

Locations

  • UCLA Health not yet accepting patients
    Los Angeles California 90095 United States
  • Children's Hospital of Orange County accepting new patients
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Shaun A Hussain, MD (ucla)
    Hs Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 45 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital of Orange County
ID
NCT04289467
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated