A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
NCT ID: NCT05163314
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
352 participants
INTERVENTIONAL
2022-03-04
2025-09-24
Brief Summary
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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.
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Detailed Description
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The study will enroll approximately 400 participants.
All participants will receive soticlestat based on their weight in the 2-week Titration Period (for participants who roll over from an antecedent double-blind study). Following the Titration Period, participants will continue to receive the same dose in the Maintenance Period. At the end of maintenance period, the dose will be down-tapered (unless already at the lowest dose) and then stopped. Participants not tolerating minimum dose of 100 mg twice a day (BID) will be discontinued from the study.
This multi-center trial will be conducted worldwide. The overall time to participate in the study will be approximately 4 years, or until the study is stopped at the discretion of the sponsor, or the product is approved and launched. Participants who discontinue study drug treatment before the completion of the study, will continue to be followed per protocol and maintain a daily seizure diary until the final follow-up phone call.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Soticlestat
Soticlestat mini-tablets or tablets
Interventions
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Soticlestat
Soticlestat mini-tablets or tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Been previously enrolled in a phase 3 soticlestat clinical study.
Exclusion Criteria
2. 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.
3. 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.
2 Years
56 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Phoenix Childrens Hospital
Phoenix, Arizona, United States
Center For Neurosciences
Tucson, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California Benioff Children's Hospital
San Francisco, California, United States
Colorado Children's Hospital
Denver, Colorado, United States
Pediatric Neurology PA
Winter Park, Florida, United States
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States
Sunrise Pediatric Neurology
Marietta, Georgia, United States
University of Iowa Hospitals & Clinics - (CRS)
Iowa City, Iowa, United States
Midatlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Minnesota Epilepsy Group PA
Saint Paul, Minnesota, United States
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey, United States
Boston Children's Health Physicians (BCHP)
New York, New York, United States
Northwell Health Physician Partners - Neurology at Lenox Hill
New York, New York, United States
NYU Comprehensive Epilepsy Center
New York, New York, United States
University of Toledo
Toledo, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
WellSpan Oncology Research
York, Pennsylvania, United States
Medical University of South Carolina Children Hospital - PIN
Charleston, South Carolina, United States
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth, Texas, United States
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
MultiCare Institute for Research & Innovation (Tacoma)
Tacoma, Washington, United States
Sydney Children's Hospital
Randwick, New South Wales, Australia
Queensland Childrens Hospital
Brisbane, Queensland, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
UZ Antwerpen
Edegem, Antwerpen, Belgium
Centre Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium
Hopital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, Brazil
Universidade Federal de Sao Paulo
São Paulo, , Brazil
Universidade de Sao Paulo
São Paulo, , Brazil
Child and Family Research Institute
Vancouver, British Columbia, Canada
Hospital For Sick Children
Toronto, Ontario, Canada
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Guangzhou Medical Univeristy
Guangzhou, Guangdong, China
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Wuhan Childrens hospital
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, France
CHRU Dijon Hopital General
Dijon, Cote-d'Or, France
Hopital Roger Salengro
Lille, Nord, France
Hopital Necker - Enfants Malades
Paris, , France
Hopital Robert Debre
Paris, , France
Alberta Childrens Hospital
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, Germany
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld, North Rhine-Westphalia, Germany
Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
Radeberg, Saxony, Germany
Childrens' Hospital of Athens 'P. and A. Kyriakou'
Athens, Attica, Greece
Attikon University General Hospital
Chaïdári, Attica, Greece
University General Hospital of Larissa
Larissa, , Greece
Hippokration Hospital
Thessaloniki, , Greece
Pecsi Tudomanyegyetem
Pécs, Baranya, Hungary
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest, , Hungary
Bethesda Gyermekkorhaz
Budapest, , Hungary
Orszagos Klinikai Idegtudomanyi Intezet
Budapest, , Hungary
Ospedale Bellaria
Rome, Lazio, Italy
IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
Rome, Lazio, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
ASST di Mantova - Azienda Ospedaliera Carlo Poma
Mantova, Lombardy, Italy
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, Italy
Aichi Medical University Hospital
Nagakute-Shi, Aiti, Japan
Fukuoka Children's Hospital
Fukuoka, Hukuoka, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Kumamoto-Ezuko Medical Center for The Severely Disabled
Kumamoto, Kumamoto, Japan
National Hospital Organization Nagasaki Medical Center
Omura-Shi, Nagasaki, Japan
National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, Niigata, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Yasuhara Childrens Clinic
Neyagawa, Osaka, Japan
Osaka City General Hospital
Osaka, Osaka, Japan
Osaka University Hospital
Suita-Shi, Osaka, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, Japan
Hokkaido University Hospital
Chuo-Ku, Tokyo, Japan
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, Japan
Childrens University Hospital
Riga, , Latvia
Hospital Civil Fray Antonio Alcalde
El Retiro, Jalisco, Mexico
Kempenhaeghe - PPDS
Heeze, North Brabant, Netherlands
Stichting Epilepsie Instellingen Nederland
Zwolle, Overijssel, Netherlands
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, Poland
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, , Poland
Russian National Research Medical University n.a. N.I.Pirogov
Moscow, Moscow, Russia
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Krasnoyarsk, , Russia
Russian National Research Medical University n.a. N.I.Pirogov
Moscow, , Russia
Tyumen State Medical Academy
Tyumen, , Russia
UGMK-Zdorojie, LLC
Yekaterinburg, , Russia
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, , Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, , Serbia
University Clinical Center Nis
Niš, , Serbia
Children and Youth Health Care Institute of Vojvodina
Novi Sad, , Serbia
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Regional Universitario de Malaga Hospital General
Almería, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Vithas La Salud
Granada, , Spain
Centro de Neurologia Avanzada
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
Dnipro, Dnipropetrovsk Oblast, Ukraine
Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
Dnipro, Dnipropetrovsk Oblast, Ukraine
Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
Ivano-Frankivsk, , Ukraine
CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
Kyiv, , Ukraine
SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
Kyiv, , Ukraine
Countries
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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2021-002482-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2051210182
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-502802-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-935-3003
Identifier Type: -
Identifier Source: org_study_id
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