Fintepla 2.2 mg/ml oral solution
Sponsors
UCB Biosciences Inc., Zogenix International Limited, Universitaetsklinikum Schleswig-Holstein AöR, Universitaetsklinikum Schleswig-Holstein AöR
Conditions
CDKL5 Deficiency disorderDravet syndromeDravet syndrome or Lennox-Gastaut syndromeMyclonic-astatic epilepsyRett syndrome
Phase 2
Phase 3
Open-label, Single-arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to less Than 2 Years of Age with Dravet Syndrome
RecruitingCTIS2022-502359-75-00
Start: 2024-07-03Target: 14Updated: 2025-12-10
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIXED-DOSE, MULTICENTER STUDY TO EXAMINE THE EFFICACY AND SAFETY OF ZX008 IN SUBJECTS WITH CDKL5 DEFICIENCY DISORDER FOLLOWED BY AN OPEN-LABEL EXTENSION
Active, not recruitingCTIS2023-506269-78-00
Start: 2023-06-20Target: 62Updated: 2025-12-16
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome
CompletedCTIS2024-515680-61-00
Start: 2020-02-07End: 2025-05-08Target: 104Updated: 2025-01-31
A Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study with open-label extension to evaluate the efficacy and safety of fenfluramine hydrochloride in study participants with Rett syndrome
Not yet recruitingCTIS2025-523157-34-00
Target: 9Updated: 2026-04-15