Trial Profile
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 18 Jan 2023
Price :
$35 *
At a glance
- Drugs Fenfluramine (Primary)
- Indications Dravet syndrome
- Focus Registrational; Therapeutic Use
- Sponsors Zogenix
- 01 Jan 2023 Results (n=61) assessing whether fenfluramine is associated with improvement in everyday executive function self-regulation-in preschool-aged children with Dravet syndrome from phase III studies (first study: placebo, FFA 0.2 mg/kg/day, or FFA 0.7 mg/kg/day added to stiripentol-free standard-of-care regimens; second study: placebo or FFA 0.4 mg/kg/day added to stiripentol-inclusive regimens), published in the Epilepsy and Behavior.
- 06 Dec 2022 Results of post-hoc, pooled analysis from two identical phase 3 clinical trials (NCT02682927, NCT02826863) using an alternative time-to-event (TTE) analysis of efficacy and focusing on the number of seizure-free days and the maximum duration of seizure-free intervals presented at the 76th Annual Meeting of the American Epilepsy Society
- 21 Sep 2022 Status changed from active, no longer recruiting to completed.