Fenfluramine (Fintepla) Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available) Dravet Syndrome 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 (ORCHID) Phase 3 EP0213 Ongoing NCT061182552022-502359-75-00 Wheless J. et al. [abstract 1.435] 77th Annual Meeting of American Epilepsy Society (AES), December 01-05, 2023; Orlando, USA available on Annual Meeting Abstract Database www.aesnet.org Dravet Syndrome A Drug Utilisation Study of Fenfluramine in Europe N/A EP0219 Ongoing Dravet Syndrome A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine in Dravet Syndrome N/A EP0220 Ongoing EUPAS48741 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 LINK PDF Lagae, L.; et al. Lancet 2019; 394:2243–54 Sullivan J., et al. Epilepsia 2023; 64(10):2653–66 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 PDF Sullivan J., et al. Epilepsia 2023; 64(10):2653–66 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 Completed NCT028231452016-002804-14 LINKLINK Sullivan J. et al Epilepsia 2020; 61:2396–404 Sanchez-Carpintero R., et al.[abstract 3.277] 77th Annual Meeting of American Epilepsy Society (AES), December 01-05, 2023; Orlando, USA available on Annual Meeting Abstract Database www.aesnet.org 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 LINK 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 NCT029268982016-000474-38 LINKLINK PDF Nabbout R., et al. JAMA Neurol 2020; 77(3):300–8 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 Completed NCT03355209 Knupp K.G et al. JAMA Neurol 2022; 79(6):554–64 Dravet Syndrome and 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 and 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 NCT039367772019-001331-31 Dravet Syndrome and Lennox-Gastaut Syndrome A Registry of Patients Treated with Fintepla N/A ZX008-2101 (EP0218) Ongoing EUPAS105358 CDKL5 Deficiency Disorder A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder Phase 3 ZX008-2103 Ongoing NCT050648782021-003222-76 Devinsky O., et al. Epilepsia 2023; 64(Suppl. 2):304
