๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-06

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome (NCT06118255)

Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: UCB BIOSCIENCES, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.

Who can join: Review the eligibility criteria below.

Location: Ep0213 105 โ€” Memphis, Tennessee

Age range: 1 Year to 23 Months

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (12 Sites)

  • Ep0213 105 โ€” Memphis, Tennessee
  • Ep0213 107 โ€” Dallas, Texas
  • Ep0213 103 โ€” Seattle, Washington
  • Ep0213 502 โ€” Brussels,
  • Ep0213 501 โ€” Edegem,
  • Ep0213 303 โ€” Bielefeld,
  • Ep0213 202 โ€” Florence,
  • Ep0213 203 โ€” Genova,
  • Ep0213 201 โ€” Roma,
  • Ep0213 204 โ€” Roma,
  • Ep0213 403 โ€” Glasgow,
  • Ep0213 401 โ€” London,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Dravet Syndrome clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—