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NCT05163314TerminatedPhase 3

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Reason given: Due to negative results from phase 3 SKYLINE and SKYWAY studies and unrelated to patient safety it has been determined that supplementary data from TAK-935-3003 study is no longer necessary. Therefore, Takeda has made a decision to close this study

Brief summary (registry, in English)

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
352 (actual)
First submitted
15 Dec 2021
Start date
4 Mar 2022
Primary completion date
24 Sept 2025
Lead sponsor
Takeda
Diseases
Epilepsy
NCT number
NCT05163314
EU CT number
2022-502802-34-00
EudraCT number
2021-002482-17

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.

Lab values

  • Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.

Age

  • Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.

Who the study is looking for

  • Participant must have:
  • Been previously enrolled in a phase 3 soticlestat clinical study.

Age in the registry: 2 years to 56 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (115)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Queensland Childrens HospitalBrisbaneAustraliaUnknown status
Austin HospitalHeidelbergAustraliaUnknown status
Alfred HospitalMelbourneAustraliaUnknown status
Sydney Children's HospitalRandwickAustraliaUnknown status
Hòpital Universitaire des Enfants Reine FabiolaBrusselsBelgiumUnknown status
UZ AntwerpenEdegemBelgiumUnknown status
Centre Neurologique William LennoxOttignies-Louvain-la-NeuveBelgiumUnknown status
Hospital das Clinicas - UNICAMPCampinasBrazilUnknown status
Instituto de Neurologia de Curitiba (INC)CuritibaBrazilUnknown status
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)Porto AlegreBrazilUnknown status
Universidade de Sao PauloSão PauloBrazilUnknown status
Universidade Federal de Sao PauloSão PauloBrazilUnknown status
Hospital for Sick ChildrenTorontoCanadaUnknown status
Child and Family Research InstituteVancouverCanadaUnknown status
Peking University First HospitalBeijingChinaUnknown status
Beijing Children's Hospital, Capital Medical UniversityBeijingChinaUnknown status
The First Hospital of Jilin UniversityChangchunChinaUnknown status
Xiangya Hospital of Central South UniversityChangshaChinaUnknown status
Children's Hospital of Chongqing Medical UniversityChongqingChinaUnknown status
The Second Affiliated Hospital of Guangzhou Medical UniveristyGuangzhouChinaUnknown status
Guangzhou Women and Children's medical centerGuangzhouChinaUnknown status
Jiangxi Provincial Children's HospitalNanchangChinaUnknown status
Children's Hospital of ShanghaiShanghaiChinaUnknown status
Children's Hospital Of Fudan UniversityShanghaiChinaUnknown status
Shenzhen Children's HospitalShenzhenChinaUnknown status
Wuhan Childrens HospitalWuhanChinaUnknown status
Krankenhaus Mara gGmbH - Epilepsiezentrum BethelBielefeldGermanyUnknown status
Klinikum der Johann Wolfgang Goethe-UniversitätFrankfurt am MainGermanyUnknown status
Alberta Childrens HospitalFreiburg im BreisgauGermanyUnknown status
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige GmbhRadebergGermanyUnknown status
Hospital Regional Universitario de Malaga Hospital GeneralAlmeríaSpainUnknown status
Hospital Universitario Vall d'Hebron - PPDSBarcelonaSpainUnknown status
Hospital Vithas La SaludGranadaSpainUnknown status
Clinica Universidad NavarraPamplonaSpainUnknown status
Centro de Neurologia AvanzadaSevilleSpainUnknown status
Hospital Universitari i Politecnic La Fe de ValenciaValenciaSpainUnknown status
CHRU Dijon Hopital GeneralDijonFranceUnknown status
Hopital Roger SalengroLilleFranceUnknown status
Hopitaux de La TimoneMarseilleFranceUnknown status
Hopital Robert DebreParisFranceUnknown status
Hopital Necker Enfants MaladesParisFranceUnknown status
Childrens' Hospital of Athens 'P. and A. Kyriakou'AthensGreeceUnknown status
Attikon University General HospitalChaïdáriGreeceUnknown status
University General Hospital of LarissaLarissaGreeceUnknown status
Hippokration HospitalThessalonikiGreeceUnknown status
Szent Janos Korhaz es Eszak-Budai Egyesitett KorhazakBudapestHungaryUnknown status
Országos Klinikai Idegtudományi IntézetBudapestHungaryUnknown status
Bethesda GyermekkorhazBudapestHungaryUnknown status
Pécsi TudományegyetemPécsHungaryUnknown status
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PINFlorenceItalyUnknown status
ASST di Mantova - Azienda Ospedaliera Carlo PomaMantuaItalyUnknown status
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCSPaviaItalyUnknown status
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PINRomeItalyUnknown status
Ospedale BellariaRomeItalyUnknown status
Fondazione Policlinico Universitario A GemelliRomeItalyUnknown status
Hokkaido University HospitalChuo-KuJapanUnknown status
Fukuoka Children's HospitalFukuokaJapanUnknown status
National Center of Neurology and PsychiatryKodaira-shiJapanUnknown status
Kumamoto-Ezuko Medical Center for The Severely DisabledKumamotoJapanUnknown status
Aichi Medical University HospitalNagakute-shiJapanUnknown status
Yasuhara Childrens ClinicNeyagawaJapanUnknown status
National Hospital Organization Nishi-Niigata Chuo National HospitalNiigataJapanUnknown status
Okayama University HospitalOkayamaJapanUnknown status
National Hospital Organization Nagasaki Medical CenterOmura-ShiJapanUnknown status
Osaka City General HospitalOsakaJapanUnknown status
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological DisordersShizuokaJapanUnknown status
Osaka University HospitalSuita-shiJapanUnknown status
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical CenterYokohamaJapanUnknown status
Childrens University HospitalRigaLatviaUnknown status
Hospital Civil Fray Antonio AlcaldeEl RetiroMexicoUnknown status
Kempenhaeghe - PPDSHeezeNetherlandsUnknown status
Stichting Epilepsie Instellingen NederlandZwolleNetherlandsUnknown status
Uniwersyteckie Centrum KliniczneGdanskPolandUnknown status
Centrum Medyczne PlejadyKrakowPolandUnknown status
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w PoznaniuPoznanPolandUnknown status
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w WarszawieWarsawPolandUnknown status
Mother and Child Health Care Institute of Serbia Dr Vukan CupicBelgradeSerbiaUnknown status
Clinic for Neurology and Psychiatry for Children and YouthBelgradeSerbiaUnknown status
University Clinical Center NISNišSerbiaUnknown status
Children and Youth Health Care Institute of VojvodinaNovi SadSerbiaUnknown status
Krasnoyarsk State Medical University n.a. V.F. Voyno-YsenetskiyKrasnoyarskRussiaUnknown status
Russian National Research Medical University n.a. N.I.PirogovMoscowRussiaUnknown status
Tyumen State Medical AcademyTyumenRussiaUnknown status
UGMK-Zdorojie, LLCYekaterinburgRussiaUnknown status
Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCCDniproUkraineUnknown status
Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRCDniproUkraineUnknown status
Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RCIvano-FrankivskUkraineUnknown status
SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of UkrKyivUkraineUnknown status
CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSAKyivUkraineUnknown status
Clinical Integrative Research Center of AtlantaAtlantaUnited StatesUnknown status
Midatlantic Epilepsy and Sleep CenterBethesdaUnited StatesUnknown status
Medical University of South Carolina Children Hospital - PINCharlestonUnited StatesUnknown status
Colorado Children's HospitalDenverUnited StatesUnknown status
Cook Children's Medical Center - Jane and John Justin Neurosciences CenterFort WorthUnited StatesUnknown status
University of Iowa Hospitals & Clinics - (CRS)Iowa CityUnited StatesUnknown status
Institute of Neurology and Neurosurgery at Saint Barnabas, LLCLivingstonUnited StatesUnknown status
David Geffen School of Medicine at UCLALos AngelesUnited StatesUnknown status
Sunrise Pediatric NeurologyMariettaUnited StatesUnknown status
NYU Comprehensive Epilepsy CenterNew YorkUnited StatesUnknown status
Boston Children's Health Physicians (BCHP)New YorkUnited StatesUnknown status
Northwell Health Physician Partners - Neurology at Lenox HillNew YorkUnited StatesUnknown status
Thomas Jefferson UniversityPhiladelphiaUnited StatesUnknown status
St. Christopher's Hospital for ChildrenPhiladelphiaUnited StatesUnknown status
Children's Hospital of PhiladelphiaPhiladelphiaUnited StatesUnknown status
Phoenix Childrens HospitalPhoenixUnited StatesUnknown status
Oregon Health and Science UniversityPortlandUnited StatesUnknown status
Minnesota Epilepsy Group PASaint PaulUnited StatesUnknown status
University of Utah - Primary Children's Hospital - PPDSSalt Lake CityUnited StatesUnknown status
University of California Benioff Children's HospitalSan FranciscoUnited StatesUnknown status
Seattle Children's HospitalSeattleUnited StatesUnknown status
MultiCare Institute for Research & Innovation - TacomaTacomaUnited StatesUnknown status
University of ToledoToledoUnited StatesUnknown status
Center for NeurosciencesTucsonUnited StatesUnknown status
Pediatric Neurology PAWinter ParkUnited StatesUnknown status
WellSpan Oncology ResearchYorkUnited StatesUnknown status

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