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)

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.

Study Overview

• Status: Terminated
• Conditions: Lennox Gastaut Syndrome (LGS); Dravet Syndrome (DS)
• Intervention / Treatment: Drug: Soticlestat

Detailed Description

The drug being tested in this study is called soticlestat (TAK-935). Soticlestat administered long-term in pediatric and adult participants who participated in an antecedent soticlestat Phase 3 clinical study will be assessed for additional safety and tolerability data along with efficacy analysis, as well as palatability and acceptability of soticlestat in the pediatric population.

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.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Sydney Children's Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Queensland Childrens Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • UZ Antwerpen
  • Brabant Wallon
    • Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium, 1340
      • Centre Neurologique William Lennox
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1020
      • Hôpital Universitaire Des Enfants Reine Fabiola
• Brazil
  • São Paulo, Brazil, 04023-900
    • Universidade Federal de Sao Paulo
  • São Paulo, Brazil, 05403-010
    • Universidade de São Paulo
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba (INC)
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-887
      • Hospital das Clinicas - UNICAMP
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4H4
      • Child and Family Research Institute
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing Municipality, China, 100045
      • Beijing Children's Hospital，Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400014
      • Children's Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women and Children's Medical Center
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical Univeristy
    • Shenzhen, Guangdong, China, 518026
      • Shenzhen Children's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430010
      • Wuhan Childrens Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial Children's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Children's Hospital of Fudan University
    • Shanghai, Shanghai Municipality, China, 200040
      • Children's Hospital of Shanghai
• France
  • Paris, France, 75019
    • Hôpital Robert Debré
  • Paris, France, 75015
    • Hôpital Necker - Enfants Malades
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13005
      • Hopitaux de La Timone
  • Cote-d'Or
    • Dijon, Cote-d'Or, France, 21079
      • CHRU Dijon Hopital General
  • Nord
    • Lille, Nord, France, 59000
      • Hopital Roger Salengro
• Germany
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Alberta Childrens Hospital
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60528
      • Klinikum der Johann-Wolfgang Goethe-Universitat
  • North Rhine-Westphalia
    • Bielefeld, North Rhine-Westphalia, Germany, 33617
      • Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
  • Saxony
    • Radeberg, Saxony, Germany, 01454
      • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
• Greece
  • Larissa, Greece, 411 10
    • University General Hospital of Larissa
  • Thessaloniki, Greece, 546 42
    • Hippokration Hospital
  • Attica
    • Athens, Attica, Greece, 115 27
      • Childrens' Hospital of Athens 'P. and A. Kyriakou'
    • Chaïdári, Attica, Greece, 124 62
      • Attikon University General Hospital
• Hungary
  • Budapest, Hungary, 1145
    • Országos Klinikai Idegtudományi Intézet
  • Budapest, Hungary, 1023
    • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Budapest, Hungary, 1143
    • Bethesda Gyermekkorhaz
  • Baranya
    • Pécs, Baranya, Hungary, 7623
      • Pecsi Tudomanyegyetem
• Italy
  • Lazio
    • Rome, Lazio, Italy, 00185
      • Ospedale Bellaria
    • Rome, Lazio, Italy, 00197
      • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
    • Rome, Lazio, Italy
      • Fondazione Policlinico Universitario A Gemelli
  • Lombardy
    • Mantova, Lombardy, Italy, 46100
      • ASST di Mantova - Azienda Ospedaliera Carlo Poma
    • Pavia, Lombardy, Italy, 27100
      • ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
• Japan
  • Aiti
    • Nagakute-Shi, Aiti, Japan, 480-1195
      • Aichi Medical University Hospital
  • Hukuoka
    • Fukuoka, Hukuoka, Japan, 813-0017
      • Fukuoka Children's Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0066
      • Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 862-0947
      • Kumamoto-Ezuko Medical Center for The Severely Disabled
  • Nagasaki
    • Omura-Shi, Nagasaki, Japan, 856-0835
      • National Hospital Organization Nagasaki Medical Center
  • Niigata
    • Niigata, Niigata, Japan, 950-2074
      • National Hospital Organization Nishi-Niigata Chuo National Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Neyagawa, Osaka, Japan, 572-0085
      • Yasuhara Childrens Clinic
    • Osaka, Osaka, Japan, 534-0021
      • Osaka City General Hospital
    • Suita-Shi, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Shizuoka
    • Shizuoka, Shizuoka, Japan, 420-0953
      • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
  • Tokyo
    • Chuo-Ku, Tokyo, Japan, 104-0045
      • Hokkaido University Hospital
    • Kodaira-Shi, Tokyo, Japan, 187-0031
      • National Center of Neurology and Psychiatry
• Latvia
  • Riga, Latvia, LV-1004
    • Childrens University Hospital
• Mexico
  • Jalisco
    • El Retiro, Jalisco, Mexico, 44280
      • Hospital Civil Fray Antonio Alcalde
• Netherlands
  • North Brabant
    • Heeze, North Brabant, Netherlands, 5591 VE
      • Kempenhaeghe - PPDS
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 BV
      • Stichting Epilepsie Instellingen Nederland
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Poznan, Poland, 60-355
    • Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-363
      • Centrum Medyczne Plejady
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-091
      • Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
• Russia
  • Krasnoyarsk, Russia, 660022
    • Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
  • Moscow, Russia, 125412
    • Russian National Research Medical University n.a. N.I.Pirogov
  • Tyumen, Russia, 625023
    • Tyumen State Medical Academy
  • Yekaterinburg, Russia, 620144
    • UGMK-Zdorojie, LLC
  • Moscow
    • Moscow, Moscow, Russia, 117437
      • Russian National Research Medical University n.a. N.I.Pirogov
• Serbia
  • Belgrade, Serbia, 11000
    • Clinic for Neurology and Psychiatry for Children and Youth
  • Belgrade, Serbia, 11000
    • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
  • Niš, Serbia, 18 000
    • University Clinical Center Nis
  • Novi Sad, Serbia, 21 000
    • Children and Youth Health Care Institute of Vojvodina
• Spain
  • Almería, Spain, 04009
    • Hospital Regional Universitario de Malaga Hospital General
  • Barcelona, Spain, 8035
    • Hospital Universitario Vall d'Hebron - PPDS
  • Granada, Spain, 18008
    • Hospital Vithas La Salud
  • Seville, Spain, 41013
    • Centro de Neurologia Avanzada
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad Navarra
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76018
    • Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
  • Kyiv, Ukraine, 4080
    • CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
  • Kyiv, Ukraine, 4209
    • SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
  • Dnipropetrovsk Oblast
    • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49100
      • Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
    • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49101
      • Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Childrens Hospital
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • California
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at UCLA
    • San Francisco, California, United States, 94143
      • University of California Benioff Children's Hospital
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Children's Hospital
  • Florida
    • Winter Park, Florida, United States, 32789
      • Pediatric Neurology PA
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Clinical Integrative Research Center of Atlanta
    • Marietta, Georgia, United States, 30066
      • Sunrise Pediatric Neurology
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics - (CRS)
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Midatlantic Epilepsy and Sleep Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Epilepsy Group PA
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
  • New York
    • New York, New York, United States, 10016
      • NYU Comprehensive Epilepsy Center
    • New York, New York, United States, 10003
      • Boston Children's Health Physicians (BCHP)
    • New York, New York, United States, 10016
      • Northwell Health Physician Partners - Neurology at Lenox Hill
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19134
      • St. Christopher's Hospital for Children
    • York, Pennsylvania, United States, 17403
      • WellSpan Oncology Research
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Children Hospital - PIN
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center - Jane and John Justin Neurosciences Center
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah - Primary Children's Hospital - PPDS
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Tacoma, Washington, United States, 98402
      • MultiCare Institute for Research & Innovation (Tacoma)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant must have:

• Been previously enrolled in a phase 3 soticlestat clinical study.

Exclusion Criteria:

1. 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: Soticlestat; Soticlestat mini-tablets or tablets; Other Names: TAK-935

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.	Up to 4 years
Change from Baseline in Body Weight for All Age Groups		Up to 4 years
Change from Baseline in Height for All Age Groups		Up to 4 years
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score	C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation.	Up to 4 years
Absolute Value for Tanner Stage for Children 6 to 17 Years of Age During the Study	Tanner assessment score is used to document the stage of development of puberty by assessing the secondary sexual characteristics, rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).	Up to 4 years
Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study		Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change from Baseline in Total Seizure Frequency per 28 Days for DS and LGS Participants	Seizure frequency per 28 days is defined as total number of seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline is defined as (frequency of seizures per 28 days during Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100.	Up to 4 years
Percent Change from Baseline in Convulsive Seizure Frequency per 28 Days in DS Cohort	Convulsive seizure frequency per 28 days is defined as total number of convulsive seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of convulsive seizures per 28 days during Treatment Period - frequency of convulsive seizures per 28 days at Baseline) divided by the frequency of convulsive seizures per 28 days at Baseline multiplied by 100.	Up to 4 years
Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency per 28 Days in LGS Cohort	MMD seizure frequency per 28 days is defined as total number of MMD seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of MMD seizures per 28 days during the Treatment Period - frequency of MMD seizures per 28 days at Baseline) divided by the frequency of MMD seizures per 28 days at Baseline multiplied by 100.	Up to 4 years
Clinical Global Impression of Improvement (CGI-I) Score	The CGI-I Clinician is a 7-point Likert scale that the investigator uses to rate a participant's change (improvement) in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.	Up to 4 years
Caregiver Global Impression of Improvement (Care GI-I) Score	The Care GI-I is a 7-point Likert scale that the caregiver uses to rate improvement in overall seizure control, behavior, safety and tolerability after the initiation of study drug relative to Baseline (before treatment with study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). The parent/caregiver will complete the Care GI-I via interview. Higher score will indicate worse symptoms.	Up to 4 years
CGI-I Seizure Intensity and Duration Score	The CGI-I seizure intensity and duration instrument is used by the parent/caregiver to rate improvement in intensity and duration of convulsive seizures (DS Cohort) or MMD seizures (LGS Cohort) from Baseline. The participant's symptoms will be rated on 7-point scale as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.	Up to 4 years
CGI-I Nonseizure Symptoms Score	The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator uses to rate improvement in the symptoms and impacts in select nonseizure domains since initiating the study drug. The participant will be rated on 7-point scale by the investigator as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). At Baseline, a symptoms form is completed by the clinician in collaboration with the primary caregiver to assess the participants status based on the presence of any nonseizure symptoms. Higher score will indicate worse symptoms.	Up to 4 years
Change in Quality of Life Inventory-Disability (QI-Disability) Score	The QI-Disability tool is a parent/caregiver-reported questionnaire that evaluates quality of life in children with intellectual disabilities. It contains 32 items covering 6 domains of quality of life: physical health, positive emotions, negative emotions, social interaction, leisure and the outdoors, and independence. Scores are from a 5-point Likert scale and then are transformed to a scale of 0 to 100. Possible scores range from 0-100, with higher scores indicating better quality of life.	Up to 4 years

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Epileptic Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Epilepsy, Generalized; Epilepsy; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Epilepsies, Myoclonic; Lennox Gastaut Syndrome; soticlestat
• Other Study ID Numbers: TAK-935-3003; 2021-002482-17 (EudraCT Number); jRCT2051210182 (Registry Identifier: jRCT); 2022-502802-34-00 (Ctis: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No