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
Completed · Phase 3 · NCT06118255
Conditions: Dravet Syndrome
At a glance
- Research payments reported, 2025
- $210,641
- U.S. investigators named
- 5
- Sites paid
- 5
- Planned or actual enrollment
- 25
About the trial
- Sponsor
- UCB BIOSCIENCES, Inc.
- Tested
- fenfluramine (drug)
- Dates
- Started 2024-05-21; completion 2026-09-01
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-09-17. Full record, eligibility and contacts (opens in a new tab)
Industry funding
UCB Biosciences Inc. reported $210,641 in research payments for this study in 2025 (5 payments).
Products named: Fintepla
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Maija-riikka Steenari, M.D. Pediatrics · Long Beach, CA
- Gautam S. Popli, M.D. Child Neurology · Winston Salem, NC
- James Wheless, MD Child Neurology · Memphis, TN
- Charuta N. Joshi, MBBS, MD Pediatrics · Dallas, TX
- Russ P. Saneto Child Neurology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Le Bonheur Childrens Hospital Foundation $97,283
- The University of Texas Southwestern Medical Center $59,503
- Seattle Children's Hospital, WA $33,658
- Wake Forest University Health Sciences $12,900
- Children's Hospital of Orange County, CA $7,298
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.