Fenfluramine Safety in Young Children with Dravet Syndrome

This study is looking at the safety of fenfluramine, a cherry-flavored liquid medicine, in children with Dravet syndrome who are between 12 and 24 months old. Fenfluramine is already approved for older children with Dravet syndrome and has been shown to reduce seizures. This study aims to see if it's safe for very young children. Doctors will need to provide information about your child's health, including their genetic test results and heart ultrasound (echocardiogram) before they can be considered for the study. The main goal is to track any side effects over 12 months.

Study design
This is an interventional study planning to enroll 5 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to track any adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06598449

Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

Recruiting
PHASE4Ages 12–24InterventionalTreatment
University of Colorado, Denver
~5 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:fenfluramine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants that have at least one adverse event
Measured over 12 months
Dravet Syndrome (DS)
Children Under 2 Years
1 sites across 1 states
Colorado1
  • Kelly Knupp, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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  • Percentage of participants that have at least one adverse event12 months

    A description of the percentage of participants that have at least one adverse event.