A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
About this trial
This is an interventional treatment trial for Dravet Syndrome (DS) focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
1. Participant must have:
- Been previously enrolled in soticlestat clinical study TAK-935-3001 (NCT04940624) or TAK-935-3002 (NCT04938427).
Exclusion Criteria:
- 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.
- 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.
- 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.
Sites / Locations
- Phoenix Childrens Hospital
- Center For Neurosciences
- David Geffen School of Medicine at UCLA
- University of California Benioff Children's HospitalRecruiting
- Colorado Children's Hospital
- Pediatric Neurology PA
- Clinical Integrative Research Center of AtlantaRecruiting
- Sunrise Pediatric Neurology
- University of Iowa Hospitals & Clinics - (CRS)Recruiting
- Midatlantic Epilepsy and Sleep CenterRecruiting
- Minnesota Epilepsy Group PA
- Institute of Neurology and Neurosurgery at Saint Barnabas, LLCRecruiting
- Boston Children's Health Physicians (BCHP)
- Northwell Health Physician Partners - Neurology at Lenox Hill
- NYU Comprehensive Epilepsy Center
- University of Toledo
- Oregon Health and Science University
- Children's Hospital of Philadelphia
- Thomas Jefferson University
- St. Christopher's Hospital for Children
- WellSpan Oncology ResearchRecruiting
- Medical University of South Carolina Children Hospital - PINRecruiting
- Cook Children's Medical Center - Jane and John Justin Neurosciences CenterRecruiting
- University of Utah - Primary Children's Hospital - PPDS
- Seattle Children's Hospital
- MultiCare Institute for Research & Innovation (Tacoma)
- Sydney Children's Hospital
- Queensland Childrens Hospital
- Austin Hospital
- Alfred Hospital
- UZ Antwerpen
- UZ Antwerpen
- Centre Neurologique William Lennox
- Hopital Universitaire des Enfants Reine Fabiola
- Instituto de Neurologia de Curitiba (INC)
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
- Hospital das Clinicas - UNICAMP
- Universidade Federal de Sao Paulo
- Universidade de Sao Paulo
- Child and Family Research Institute
- Hospital For Sick Children
- Peking University First HospitalRecruiting
- Beijing Children's Hospital,Capital Medical UniversityRecruiting
- Children's Hospital of Chongqing Medical UniversityRecruiting
- The Second Affiliated Hospital of Guangzhou Medical UniveristyRecruiting
- Guangzhou Women And Children's Medical CenterRecruiting
- Shenzhen Children's HospitalRecruiting
- Wuhan Childrens hospitalRecruiting
- Xiangya Hospital of Central South UniversityRecruiting
- Jiangxi Provincial Children's HospitalRecruiting
- The First Hospital of Jilin University
- The First Hospital of Jilin University
- Children's Hospital of Shanghai
- Children's Hospital of Fudan University
- Hopitaux de La Timone
- CHRU Dijon Hopital General
- Hopital Roger SalengroRecruiting
- Hopital Necker - Enfants MaladesRecruiting
- Hopital Robert DebreRecruiting
- Alberta Childrens Hospital
- Klinikum der Johann-Wolfgang Goethe-Universitat
- Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
- Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
- Childrens' Hospital of Athens 'P. and A. Kyriakou'
- Attikon University General HospitalRecruiting
- University General Hospital of Larissa
- Hippokration Hospital
- Pecsi TudomanyegyetemRecruiting
- Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
- Bethesda GyermekkorhazRecruiting
- Orszagos Klinikai Idegtudomanyi IntezetRecruiting
- Ospedale Bellaria
- IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
- Fondazione Policlinico Universitario A Gemelli
- ASST di Mantova - Azienda Ospedaliera Carlo Poma
- ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
- Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PINRecruiting
- Aichi Medical University HospitalRecruiting
- Fukuoka Children's HospitalRecruiting
- Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
- Kumamoto-Ezuko Medical Center for The Severely DisabledRecruiting
- National Hospital Organization Nagasaki Medical CenterRecruiting
- National Hospital Organization Nishi-Niigata Chuo National HospitalRecruiting
- Okayama University Hospital
- Yasuhara Childrens ClinicRecruiting
- Osaka City General HospitalRecruiting
- Osaka University HospitalRecruiting
- National Hospital Organization Shizuoka Institute of Epilepsy and Neurological DisordersRecruiting
- Hokkaido University Hospital
- National Center of Neurology and PsychiatryRecruiting
- Childrens University HospitalRecruiting
- Hospital Civil Fray Antonio Alcalde
- Kempenhaeghe - PPDSRecruiting
- Stichting Epilepsie Instellingen NederlandRecruiting
- Centrum Medyczne PlejadyRecruiting
- Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
- Uniwersyteckie Centrum Kliniczne
- Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
- Russian National Research Medical University n.a. N.I.Pirogov
- UGMK-Zdorojie, LLC
- Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
- Russian National Research Medical University n.a. N.I.Pirogov
- Tyumen State Medical Academy
- Clinic for Neurology and Psychiatry for Children and YouthRecruiting
- Mother and Child Health Care Institute of Serbia Dr Vukan CupicRecruiting
- University Clinical Center NisRecruiting
- Children and Youth Health Care Institute of VojvodinaRecruiting
- Clinica Universidad NavarraRecruiting
- Hospital Regional Universitario de Malaga Hospital General
- Hospital Universitario Vall d'Hebron - PPDSRecruiting
- Hospital Vithas La Salud
- Centro de Neurologia Avanzada
- Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
- Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
- Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
- Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
- CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
- SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
Arms of the Study
Arm 1
Experimental
Soticlestat
Participants with DS and LGS will receive:Participants weighing <45kg:Soticlestat,mini-tablets,titrated from lower dose level(60mg to 140mg) to higher dose(100mg to 200mg) twice daily(BID),based on body weight,orally/via enteral feeding tubes including but not limited to nasogastric(NG)-tube,gastrostomy tube(G-tube),MIC-KEY button,upto 2 weeks in Titration Period. Will continue to receive dose they are on at end of Titration Period,for approximately 4 years in Maintenance Period.Dose will be tapered down to lower dose(not less than lowest dose level based on weight)every 3 days until study drug is discontinued(upto 1week) in Taper Period.Participants weighing ≥45kg/adults:Soticlestat mini-tablets/tablets with starting dose of 200mg BID followed by 300mg BID,up to 2 weeks in Titration Period.Will continue to receive 300mg BID for approximately 4 years in Maintenance Period.Dose will be tapered down upto 100mg every 3 days until study drug is discontinued(up to 1 week) in Taper Period.