New hope for babies with severe epilepsy: fenfluramine safety trial launches

NCT ID NCT06598449

Recruiting now Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing the safety of fenfluramine, a drug already approved for children 2 and older with Dravet syndrome, in younger children aged 12 to 23 months. Dravet syndrome is a severe genetic epilepsy that starts in the first year of life. The study will enroll 5 children and monitor them for side effects, aiming to provide early access to a potentially helpful treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: fenfluramine (oral solution)
What this could lead to: If successful, this could provide a safe treatment option for young children with Dravet syndrome, potentially reducing seizures and improving quality of life.
What could go wrong: This is a very small study (only 5 participants) focused on safety, not effectiveness. Fenfluramine may cause side effects, and results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHILDREN UNDER 2 YEARS DRAVET SYNDROME (DS)

Contacts and locations

Locations

Children's Hospital Colorado
RECRUITING

Aurora, Colorado, 80045, United States

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