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NCT06118255 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Dravet Syndrome, sponsored by UCB Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
- 12
- Study locations
NCT06118255: Active Phase 3 study of Dravet Syndrome, sponsored by UCB Biosciences.
NCT06118255 is a Phase 3 study of Dravet Syndrome that is active but no longer recruiting, run by UCB Biosciences. The registered enrollment target is 25 participants, below the 108-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (77% lower). The trial reports 12 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06118255, a Phase 3 study of Dravet Syndrome, is active but no longer recruiting, sponsored by UCB Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
- 12
- Study locations
Study Summary
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.
Primary Outcome
QTcF is the QT interval corrected for heart rate according to Fridericia's formula. Higher values correspond to prolongation of QT interval.
Conditions Studied
Interventions
- DRUG fenfluramine
Study Locations (12)
Other
- Ep0213 502 - Brussels
- Ep0213 501 - Edegem
- Ep0213 303 - Bielefeld
- Ep0213 202 - Florence
- Ep0213 203 - Genova
- Ep0213 201 - Roma
- Ep0213 204 - Roma
- Ep0213 403 - Glasgow
- Ep0213 401 - London
Tennessee
- Ep0213 105 - Memphis
Texas
- Ep0213 107 - Dallas
Washington
- Ep0213 103 - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-05-21 |
| Est. Completion | 2026-12-16 |
| Phase | Phase 3 |
What the registry record for NCT06118255 still lists
NCT06118255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 108-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Dravet Syndrome appearing as the primary indexed condition, and to 1 intervention - of which fenfluramine is the first listed.
NCT06118255 lists 12 locations in 4 states (Other, Tennessee, Texas).
Frequently Asked Questions
What is clinical trial NCT06118255 about?
NCT06118255 is a clinical study titled "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". 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.
What is the current status of trial NCT06118255?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2024-05-21. Estimated completion is 2026-12-16.
What conditions does trial NCT06118255 study?
This clinical trial studies the following conditions: Dravet Syndrome.
What interventions are being tested in trial NCT06118255?
The interventions under investigation include: fenfluramine (DRUG).
Who is sponsoring clinical trial NCT06118255?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06118255 being conducted?
This trial has 12 study locations across Tennessee, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dravet Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06118255's enrollment target sits among peer trials
25 11th of 12 higher than 2 of 12 other Dravet Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dravet Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
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A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
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-
GABA Biomarkers in Dravet Syndrome
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