New hope for infants with severe epilepsy: fenfluramine trial launches

NCT ID NCT06118255

Ongoing Disease control Sponsor: UCB BIOSCIENCES, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This phase 3 trial is testing the safety and tolerability of fenfluramine (Fintepla) in 25 infants aged 1 to 2 years with Dravet syndrome, a severe form of epilepsy. The drug is given as an oral solution twice daily alongside other seizure medications. Researchers will monitor heart health, growth, and seizure frequency to see if the drug is safe and effective in this young age group.

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 treatment option for infants with Dravet syndrome to help reduce seizures.
What could go wrong: This is a small, single-arm study with no placebo group, so results may not be definitive. Fenfluramine has known risks for heart valve problems and other side effects.

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.

DRAVET SYNDROME

Contacts and locations

Locations

Ep0213 103

Seattle, Washington, 98105, United States
Ep0213 105

Memphis, Tennessee, 38103-2800, United States
Ep0213 107

Dallas, Texas, 75207, United States
Ep0213 201

Roma, Italy
Ep0213 202

Florence, Italy
Ep0213 203

Genova, Italy
Ep0213 204

Roma, Italy
Ep0213 303

Bielefeld, Germany
Ep0213 401

London, United Kingdom
Ep0213 403

Glasgow, United Kingdom
Ep0213 501

Edegem, Belgium
Ep0213 502

Brussels, Belgium

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