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 |
LINK
|
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
|
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 |
NCT02823145 2016-002804-14 |
LINK LINK |
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 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 |
NCT03936777 2019-001331-31 |
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| 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 |
Devinsky O., et al. Epilepsia 2023; 64(Suppl. 2):304 | ||
| 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
|
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| Dravet Syndrome | A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine in Dravet Syndrome | N/A |
EP0220
Ongoing |
EUPAS48741 | |||
| Dravet Syndrome and Lennox-Gastaut Syndrome | A Registry of Patients Treated with Fintepla | N/A |
ZX008-2101 (EP0218)
Ongoing |
EUPAS105358 | |||
| Dravet Syndrome | A Drug Utilisation Study of Fenfluramine in Europe | N/A |
EP0219
Ongoing |