Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06118255
The ClinicalTrials.gov registry entry for NCT06118255 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 108-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (77% lower). The listed sponsor is UCB Biosciences, which has 39 total studies on file at ClinicalTrials.gov.
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 reports 12 study locations spanning 4 distinct geographic areas - top geographies include 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.
-
A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome
RECRUITING · Phase 3
-
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
RECRUITING · Phase 3
-
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
RECRUITING · Phase 3
-
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
COMPLETED · Phase 3
-
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
RECRUITING · Phase 1
-
GABA Biomarkers in Dravet Syndrome
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.