๐๏ธ Verified NIH Record โข 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
๐ต Active, Not Recruiting Phase3 ๐ Investigational Drug / Biologic Sponsor: UCB BIOSCIENCES, Inc.
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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,
๐ฐ 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.
More studies in Dravet Syndrome
- An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome โ San Francisco, California
- A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome โ Birmingham, Alabama
- The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project โ Houston, Texas
- ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome โ Ann Arbor, Michigan
- GABA Biomarkers in Dravet Syndrome โ Fort Worth, Texas
Explore by condition: All Dravet Syndrome clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.