Clinical Trials Logo
  1. Home
  2. Dravet Syndrome
  3. NCT02823145

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

Dravet Syndrome Clinical Trial

Official title:
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

Clinical Trial Summary

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

Clinical Trial Description

This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who participated in one of the core studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an extended period of time. This trial will consist of a 36-month Open-Label Extension (OLE) Treatment Period and a 2-week Post-Dosing Period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02823145
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 3
Start date June 8, 2016
Completion date January 27, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05651204 - GABA Biomarkers in Dravet Syndrome
Withdrawn NCT02910297 - The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy
Recruiting NCT04462770 - EPX-100 (Clemizole Hydrochloride) as Add-on Therapy to Control Convulsive Seizures in Patients With Dravet Syndrome Phase 2
Completed NCT02896608 - Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome
Withdrawn NCT05140122 - LEONIDaS Caregivers Study
Recruiting NCT05635266 - A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed NCT02091206 - A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1) Phase 2
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Recruiting NCT05472389 - Neurodevelopmental Impact of Epilepsy on Autonomic Function in Dravet Syndrome N/A
Recruiting NCT05626634 - Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Phase 2
Recruiting NCT01858285 - Genetics of Epilepsy and Related Disorders
Recruiting NCT04614506 - Transcranial Magnetic Stimulation to Measure Cortical Excitability in Dravet Syndrome
Recruiting NCT06118255 - 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 Phase 3
Recruiting NCT04611438 - Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome Phase 3
Completed NCT02091375 - Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1) Phase 3
Completed NCT05364021 - Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies Phase 1/Phase 2
Recruiting NCT06112275 - A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome (Australia Only) Phase 1/Phase 2
Withdrawn NCT03254680 - Turmeric as Treatment in Epilepsy N/A
Terminated NCT02187809 - Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome Phase 3
Withdrawn NCT02174094 - Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome Phase 3