Fenfluramine (Fintepla) | UCB
UCB's Global Corporate Website

Fenfluramine (Fintepla)

Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available)
Lennox-Gastaut Syndrome  A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome Phase 3 ZX008-1601
Ongoing
NCT03355209 Knupp K.G et al. JAMA Neurol 2022; 79(6):554–64
Dravet Syndrome 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 Phase 3 ZX008-1504
Completed
NCT02926898
2016-000474-38
LINK
LINK
Nabbout R., et al. JAMA Neurol 2020; 77(3):300–8
Dravet Syndrome A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome   Phase 3 ZX008-1501
Completed
NCT02682927
Dravet Syndrome Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome Phase 3 ZX008-1502
Completed
2015-004167-37 LINK
Dravet Syndrome 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   Phase 3 ZX008-1503
Ongoing
NCT02823145
2016-002804-14
Dravet Syndrome & Lennox-Gastaut Syndrome A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol Phase 1 ZX008-1602
Completed
NCT03467113
Dravet Syndrome & Lennox-Gastaut Syndrome 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 Phase 3 ZX008-1900
Ongoing
NCT03936777
2019-001331-31
 CDKL5 Deficiency Disorder A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder Phase 3 ZX008-2103
Ongoing
NCT05064878
2021-003222-76
Dravet Syndrome A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome Phase 3 ZX008-1503-SS01
Terminated
NCT03299842