New hope for infants with severe epilepsy: fenfluramine trial launches

NCT ID NCT06118255

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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