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ZX008 (Fenfluramine Hydrochloride)

DRUG5 trials

Sponsors

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc., Zogenix, Inc.

Conditions

Dravet SyndromeEpileptic EncephalopathyLennox Gastaut SyndromeSeizure Disorder

Phase 3

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
CompletedNCT02682927
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Dravet Syndrome, Seizure Disorder
Start: 2016-01-15End: 2020-07-29Updated: 2023-09-28
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
CompletedNCT02823145
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Dravet Syndrome
Start: 2016-06-08End: 2023-01-27Updated: 2025-07-14
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
CompletedNCT02926898
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Dravet Syndrome
Start: 2017-01-27End: 2018-06-05Updated: 2022-11-02
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
TerminatedNCT03299842
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Dravet Syndrome
Start: 2017-07-12End: 2018-07-05Updated: 2023-11-13
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
CompletedNCT03936777
Zogenix, Inc.Dravet Syndrome, Epileptic Encephalopathy, Lennox Gastaut Syndrome
Start: 2019-04-22End: 2025-05-08Updated: 2025-11-17

Related Papers

Prolonged fenfluramine use in open‐label studies of Dravet or Lennox–Gastaut syndromes: Long‐term safety, tolerability, patient global functioning, and considerations for interpreting effectiveness
Epilepsia2026-07-04
074 No valvular heart disease or pulmonary artery hypertension with fenfluramine for up to 3 years
Journal of Neurology Neurosurgery & Psychiatry2022-08-12
1119 Serial echocardiographic assessment of patients with dravet syndrome treated with fenfluramine for up to 3 years: no incidence of valvular heart disease or pulmonary artery hypertension
2022-08-011 citations
Long-term cardiovascular safety of fenfluramine in patients with Dravet syndrome treated for up to 3 years: Findings from serial echocardiographic assessments.
2022-05-2423 citations
Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome
Seizure2021-11-0276 citations
Fenfluramine responder analyses and numbers needed to treat: Translating epilepsy trial data into clinical practice
European Journal of Paediatric Neurology2021-01-2210 citations
Long-Term (2-Year) Safety and Efficacy of Adjunctive ZX008 (Fenfluramine Hydrochloride Oral Solution) for Dravet Syndrome: Interim Results of an Ongoing Open-Label Extension Study (4684)
Neurology2020-04-145 citations
Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial.
2019-12-17237 citations
Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens
JAMA Neurology2019-12-02228 citations
Fenfluramine HCl (Fintepla®) Provides Long-Term Clinically Meaningful Reduction in Seizure Frequency: Results of an Open-Label Extension Study
Neuropediatrics2019-09-014 citations
Long-term Data on the Cardiovascular Safety Profile of Fenfluramine in the Treatment of Dravet Syndrome: Interim Analysis of an Open-label Safety Extension Study
Neuropediatrics2019-09-01