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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002482-17 | EudraCT Number | ||
| jRCT2051210182 | Registry Identifier | jRCT | |
| 2022-502802-34-00 | EU Trial (CTIS) Number | EU CTIS |
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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
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soticlestat | Experimental | Participants with DS and LGS received:Participants weighing<45 kilograms(kg):Soticlestat,mini-tablets,titrated from lower dose level (60milligrams[mg]-140mg)to higher dose level(100mg-200mg) twice daily(BID),based on body weight,orally or via enteral feeding tubes including but not limited to nasogastric(NG) tube,gastrostomy tube(G-tube),MIC-KEY button,up to 2 weeks in Titration Period(TP).Participants continued to receive the dose they were on at end of TP,for approximately 4 years in Maintenance Period(MP).Dose was tapered down to lower dose(not less than lowest dose level based on weight) every 3 days until study drug was discontinued(up to 1 week) in Taper Period.Participants weighing≥45kg/adults:Soticlestat, mini-tablets/tablets with starting dose of 200mgBID followed by 300mgBID,up to 2 weeks in TP.Participants continued to receive 300mgBID for approximately 4years in MP.Dose was tapered down to 100mg every 3 days until study drug was discontinued(up to 1 week) in Taper Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soticlestat | Drug | Soticlestat mini-tablets or tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) | An Adverse Event (AE) was 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 was therefore 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 was considered related to the drug. A TEAE was defined as any AE that started or increased in severity after the first dose of the study drug in this open label extension (OLE) study. | Up to end of study (approximately 3.6 years) |
| Number of Participants in Each Category of the Columbia-Suicide Severity Rating Scale (C-SSRS) Over Time | C-SSRS systematically tracks suicidal ideation and behavior. Responses to questions in the C-SSRS at baseline and each post-baseline time point were collected for participants ≥6 years of age. C-SSRS incidences were categorized as follows: No Suicidal Ideation or Suicidal Behavior or Non-suicidal Self-injurious Behavior (No SI or SB or NSSJB), Non-suicidal Self-injurious Behavior (NSSJB), Suicidal Ideation (SI), and Suicidal Behavior (SB). For each visit (V), the "Yes" answer to the question with the highest severity rank was used to determine the C-SSRS category of a participant. The category Missing indicates the number of participants for whom no data was collected at the particular time point. For each time point only categories with at least 1 participant are presented. BL denotes Baseline and W denotes Week for the reported categories. | At first visit post-baseline (Visit 1 [V1], Day 1 of the current study), Week 13 (V4), Week 26 (V5), Week 52 (V7), Week 78 (V9), Week104 (v11), Week 130 (V12) and Week 156 (V13) |
| Change From Baseline in Body Weight for All Age Groups | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | From Baseline to Week 104 |
| Change From Baseline in Height for All Age Groups |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Seizure Frequency Per 28 Days | Seizure frequency per 28 days was 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 was 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. |
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Inclusion Criteria:
1. Participant must have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States | ||
| Center For Neurosciences |
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| Label | URL |
|---|---|
| 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. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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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.
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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.
A total of 352 participants with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) who had participated in phase 3 clinical studies, TAK-935-3001 (NCT04940624), or TAK-935-3002 (NCT04938427), respectively, and who continued to receive standard-of-care (SOC) antiseizure therapy were enrolled in the study for added treatment with soticlestat.
Participants took part in the study at various investigative sites globally from 04 March 2022 to 24 September 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Soticlestat | Participants with DS and LGS received: Participants weighing <45 kilograms (kg): Soticlestat, mini-tablets, titrated from lower dose level (60 milligrams [mg]-140 mg)to higher dose level (100 mg-200 mg) twice daily (BID), based on body weight, orally or via enteral feeding tubes including but not limited to nasogastric (NG) tube, gastrostomy tube (G-tube), MIC-KEY button, up to 2 weeks in Titration Period (TP). Participants continued to receive the dose they were on at end of TP, for approximately 4 years in Maintenance Period (MP). Dose was tapered down to lower dose (not less than lowest dose level based on weight) every 3 days until study drug was discontinued (up to 1 week) in Taper Period. Participants weighing ≥45 kg/adults: Soticlestat, mini-tablets/tablets with starting dose of 200 mg BID followed by 300 mg BID, up to 2 weeks in TP. Participants continued to receive 300 mg BID for approximately 4years in MP. Dose was tapered down to 100mg every 3 days until study drug was discontinued (up to 1 week) in Taper Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2023 | Feb 26, 2026 |
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BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. |
| Baseline to Week 104 |
| Number of Participants in Each Tanner Stage for Children 6 to 17 Years of Age During the Study | Tanner assessment scores were 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) by age (6 to 17 years of age) and sex (boys and girls) during the study. Tanner scale boy clinical classification test names for each stage are reported as follows: TANN02-Genitalia and TANN02-Pubic Hair. Tanner scale girl clinical classification test names for each stage are reported as follows: TANN01-Breast and TANN01-Pubic Hair. | From Baseline to Week 130 |
| Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study | Absolute values of IGF1 were summarized descriptively as a continuous variable by age and by sex (male and female). If multiple assessments for a participant at different visits at a particular age were available, then the average of all data for that participant were used for the summary. | From Baseline to Week 130 |
| From Baseline to Week 156 |
| Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in DS Cohort | Convulsive seizure frequency per 28 days was 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 was 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. | From Baseline to Week 156 |
| Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days in LGS Cohort | MMD seizure frequency per 28 days was defined as the total number of MMD seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from baseline was 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. | From Baseline to Week 144 |
| Number of Participants With Improvement in the 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 in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with study drug). The participants were 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). Reported here is the number of participants with improvement, which includes the CGI-I responses: very much improved, much improved, minimally improved. | From Baseline to Week 156 |
| Number of Participants With Improvement in the Caregiver Global Impression of Improvement (Care GI-I) Score | The Care GI-I is a 7-point Likert scale that the caregiver used to rate a participant's change in overall seizure control, behavior, safety and tolerability after the initiation of study drug relative to Baseline (before treatment with study drug). The participants were 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 completed the Care GI-I via interview. Reported here is the number of participants with improvement, which includes the Care GI-I responses: very much improved, much improved, minimally improved. | From Baseline to Week 156 |
| Number of Participants With Improvement in the CGI-I Seizure Intensity and Duration Score | The CGI-I seizure intensity and duration instrument was used by the parent/caregiver to rate a participant's change in intensity and duration of convulsive seizures (DS Cohort) or MMD seizures (LGS Cohort) from Baseline. The participant's symptoms were 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). Reported here is the number of participants with improvement, which includes the CGI-I Seizure responses: very much improved, much improved, minimally improved. | From Baseline to Week 156 |
| Number of Participants With Improvement in CGI-I Nonseizure Symptoms Score | The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator used to rate a participant's change in the caregiver-identified symptoms and impacts in select nonseizure domains since initiating the study drug. The participants were 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 was completed by the clinician in collaboration with the primary caregiver to assess the participants status based on the presence of any nonseizure symptoms. Reported here is the number of participants with improvement, which includes the CGI-I nonseizure symptoms responses: very much improved, much improved, minimally improved. | From Baseline to Week 156 |
| Change From Baseline 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. Items were rated on a 5-point Likert scale and then transformed to a scale of 0 to 100. Possible scores range from 0-100, with higher scores indicating better quality of life. Negative change from baseline indicates worsening of quality of life. | From Baseline to Week 156 |
| Tucson |
| Arizona |
| 85718 |
| United States |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States |
| University of California Benioff Children's Hospital | San Francisco | California | 94143 | United States |
| Colorado Children's Hospital | Denver | Colorado | 80218 | United States |
| Pediatric Neurology PA | Winter Park | Florida | 32789 | United States |
| Clinical Integrative Research Center of Atlanta | Atlanta | Georgia | 30328 | United States |
| Sunrise Pediatric Neurology | Marietta | Georgia | 30066 | United States |
| University of Iowa Hospitals & Clinics - (CRS) | Iowa City | Iowa | 52242 | United States |
| Midatlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Minnesota Epilepsy Group PA | Saint Paul | Minnesota | 55102 | United States |
| Institute of Neurology and Neurosurgery at Saint Barnabas, LLC | Livingston | New Jersey | 07039 | United States |
| Boston Children's Health Physicians (BCHP) | New York | New York | 10003 | United States |
| Northwell Health Physician Partners - Neurology at Lenox Hill | New York | New York | 10016 | United States |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| WellSpan Oncology Research | York | Pennsylvania | 17403 | United States |
| Medical University of South Carolina Children Hospital - PIN | Charleston | South Carolina | 29425 | United States |
| Cook Children's Medical Center - Jane and John Justin Neurosciences Center | Fort Worth | Texas | 76104 | United States |
| University of Utah - Primary Children's Hospital - PPDS | Salt Lake City | Utah | 84113 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| MultiCare Institute for Research & Innovation (Tacoma) | Tacoma | Washington | 98402 | United States |
| Sydney Children's Hospital | Randwick | New South Wales | 2031 | Australia |
| Queensland Childrens Hospital | Brisbane | Queensland | 4101 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| UZ Antwerpen | Edegem | Antwerpen | 2650 | Belgium |
| Centre Neurologique William Lennox | Ottignies-Louvain-la-Neuve | Brabant Wallon | 1340 | Belgium |
| Hopital Universitaire des Enfants Reine Fabiola | Brussels | Brussels Capital | 1020 | Belgium |
| Instituto de Neurologia de Curitiba (INC) | Curitiba | Paraná | 81210-310 | Brazil |
| Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital das Clinicas - UNICAMP | Campinas | São Paulo | 13083-887 | Brazil |
| Universidade Federal de Sao Paulo | São Paulo | 04023-900 | Brazil |
| Universidade de Sao Paulo | São Paulo | 05403-010 | Brazil |
| Child and Family Research Institute | Vancouver | British Columbia | V5Z 4H4 | Canada |
| Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Beijing Children's Hospital,Capital Medical University | Beijing | Beijing Municipality | 100045 | China |
| Children's Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400014 | China |
| The Second Affiliated Hospital of Guangzhou Medical Univeristy | Guangzhou | Guangdong | 510260 | China |
| Guangzhou Women And Children's Medical Center | Guangzhou | Guangdong | 510623 | China |
| Shenzhen Children's Hospital | Shenzhen | Guangdong | 518026 | China |
| Wuhan Childrens hospital | Wuhan | Hubei | 430010 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| Jiangxi Provincial Children's Hospital | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Children's Hospital of Shanghai | Shanghai | Shanghai Municipality | 200040 | China |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| Hopitaux de La Timone | Marseille | Bouches-du-Rhone | 13005 | France |
| CHRU Dijon Hopital General | Dijon | Cote-d'Or | 21079 | France |
| Hopital Roger Salengro | Lille | Nord | 59000 | France |
| Hopital Necker - Enfants Malades | Paris | 75015 | France |
| Hopital Robert Debre | Paris | 75019 | France |
| Alberta Childrens Hospital | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Klinikum der Johann-Wolfgang Goethe-Universitat | Frankfurt am Main | Hesse | 60528 | Germany |
| Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel | Bielefeld | North Rhine-Westphalia | 33617 | Germany |
| Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh | Radeberg | Saxony | 01454 | Germany |
| Childrens' Hospital of Athens 'P. and A. Kyriakou' | Athens | Attica | 115 27 | Greece |
| Attikon University General Hospital | Chaïdári | Attica | 124 62 | Greece |
| University General Hospital of Larissa | Larissa | 411 10 | Greece |
| Hippokration Hospital | Thessaloniki | 546 42 | Greece |
| Pecsi Tudomanyegyetem | Pécs | Baranya | 7623 | Hungary |
| Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak | Budapest | 1023 | Hungary |
| Bethesda Gyermekkorhaz | Budapest | 1143 | Hungary |
| Orszagos Klinikai Idegtudomanyi Intezet | Budapest | 1145 | Hungary |
| Ospedale Bellaria | Rome | Lazio | 00185 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN | Rome | Lazio | 00197 | Italy |
| Fondazione Policlinico Universitario A Gemelli | Rome | Lazio | Italy |
| ASST di Mantova - Azienda Ospedaliera Carlo Poma | Mantua | Lombardy | 46100 | Italy |
| ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN | Florence | Tuscany | 50139 | Italy |
| Aichi Medical University Hospital | Nagakute-Shi | Aiti | 480-1195 | Japan |
| Fukuoka Children's Hospital | Fukuoka | Hukuoka | 813-0017 | Japan |
| Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center | Yokohama | Kanagawa | 232-0066 | Japan |
| Kumamoto-Ezuko Medical Center for The Severely Disabled | Kumamoto | Kumamoto | 862-0947 | Japan |
| National Hospital Organization Nagasaki Medical Center | Omura-Shi | Nagasaki | 856-0835 | Japan |
| National Hospital Organization Nishi-Niigata Chuo National Hospital | Niigata | Niigata | 950-2074 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Yasuhara Childrens Clinic | Neyagawa | Osaka | 572-0085 | Japan |
| Osaka City General Hospital | Osaka | Osaka | 534-0021 | Japan |
| Osaka University Hospital | Suita-Shi | Osaka | 565-0871 | Japan |
| National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders | Shizuoka | Shizuoka | 420-0953 | Japan |
| Hokkaido University Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| National Center of Neurology and Psychiatry | Kodaira-Shi | Tokyo | 187-0031 | Japan |
| Childrens University Hospital | Riga | LV-1004 | Latvia |
| Hospital Civil Fray Antonio Alcalde | El Retiro | Jalisco | 44280 | Mexico |
| Kempenhaeghe - PPDS | Heeze | North Brabant | 5591 VE | Netherlands |
| Stichting Epilepsie Instellingen Nederland | Zwolle | Overijssel | 8025 BV | Netherlands |
| Centrum Medyczne Plejady | Krakow | Lesser Poland Voivodeship | 30-363 | Poland |
| Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie | Warsaw | Masovian Voivodeship | 02-091 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Poznan | 60-355 | Poland |
| Russian National Research Medical University n.a. N.I.Pirogov | Moscow | Moscow | 117437 | Russia |
| Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy | Krasnoyarsk | 660022 | Russia |
| Russian National Research Medical University n.a. N.I.Pirogov | Moscow | 125412 | Russia |
| Tyumen State Medical Academy | Tyumen | 625023 | Russia |
| UGMK-Zdorojie, LLC | Yekaterinburg | 620144 | Russia |
| Clinic for Neurology and Psychiatry for Children and Youth | Belgrade | 11000 | Serbia |
| Mother and Child Health Care Institute of Serbia Dr Vukan Cupic | Belgrade | 11000 | Serbia |
| University Clinical Center Nis | Niš | 18 000 | Serbia |
| Children and Youth Health Care Institute of Vojvodina | Novi Sad | 21 000 | Serbia |
| Clinica Universidad Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Regional Universitario de Malaga Hospital General | AlmerÃa | 04009 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | 8035 | Spain |
| Hospital Vithas La Salud | Granada | 18008 | Spain |
| Centro de Neurologia Avanzada | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC | Dnipro | Dnipropetrovsk Oblast | 49100 | Ukraine |
| Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC | Dnipro | Dnipropetrovsk Oblast | 49101 | Ukraine |
| Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC | Ivano-Frankivsk | 76018 | Ukraine |
| CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA | Kyiv | 4080 | Ukraine |
| SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr | Kyiv | 4209 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Soticlestat | Participants with DS and LGS received: Participants weighing <45 kg: Soticlestat, mini-tablets, titrated from lower dose level (60 mg-140 mg) to higher dose level (100 mg-200 mg) BID, based on body weight, orally or via enteral feeding tubes including but not limited to NG tube, G-tube, MIC-KEY button, up to 2 weeks in TP. Participants continued to receive the dose they were on at end of TP, for approximately 4 years in MP. Dose was tapered down to lower dose (not less than lowest dose level based on weight) every 3 days until study drug was discontinued (up to 1 week) in Taper Period. Participants weighing ≥45 kg/adults: Soticlestat, mini-tablets/tablets with starting dose of 200 mg BID followed by 300 mg BID, up to 2 weeks in TP. Participants continued to receive 300 mg BID for approximately 4years in MP. Dose was tapered down to 100mg every 3 days until study drug was discontinued (up to 1 week) in Taper Period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | centimeter (cm) |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram(kg) |
| |||||||||||||||||
| Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS systematically tracks suicidal ideation and behavior. Responses to questions in the C-SSRS at baseline and each post-baseline time point were collected for participants ≥6 years of age. C-SSRS incidences were categorized as follows: No Suicidal Ideation or Suicidal Behavior or Non-suicidal Self-injurious Behavior (No SI or SB or NSSJB), Non-suicidal Self-injurious Behavior (NSSJB), Suicidal Ideation (SI), and Suicidal Behavior (SB). | Number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) | An Adverse Event (AE) was 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 was therefore 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 was considered related to the drug. A TEAE was defined as any AE that started or increased in severity after the first dose of the study drug in this open label extension (OLE) study. | Safety analysis set included participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to end of study (approximately 3.6 years) |
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| Primary | Number of Participants in Each Category of the Columbia-Suicide Severity Rating Scale (C-SSRS) Over Time | C-SSRS systematically tracks suicidal ideation and behavior. Responses to questions in the C-SSRS at baseline and each post-baseline time point were collected for participants ≥6 years of age. C-SSRS incidences were categorized as follows: No Suicidal Ideation or Suicidal Behavior or Non-suicidal Self-injurious Behavior (No SI or SB or NSSJB), Non-suicidal Self-injurious Behavior (NSSJB), Suicidal Ideation (SI), and Suicidal Behavior (SB). For each visit (V), the "Yes" answer to the question with the highest severity rank was used to determine the C-SSRS category of a participant. The category Missing indicates the number of participants for whom no data was collected at the particular time point. For each time point only categories with at least 1 participant are presented. BL denotes Baseline and W denotes Week for the reported categories. | Safety analysis set included participants who received at least 1 dose of study drug Number analyzed is the number of participants with data available for analysis for the specified categories. | Posted | Count of Participants | Participants | At first visit post-baseline (Visit 1 [V1], Day 1 of the current study), Week 13 (V4), Week 26 (V5), Week 52 (V7), Week 78 (V9), Week104 (v11), Week 130 (V12) and Week 156 (V13) |
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| Primary | Change From Baseline in Body Weight for All Age Groups | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety analysis set included participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for baseline and the specified time point for the specified age group. | Posted | Mean | Standard Deviation | kilogram (kg) | From Baseline to Week 104 |
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| Primary | Change From Baseline in Height for All Age Groups | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety analysis set included participants who received at least 1 dose of study drug. Overall number analyzed is the number of participants with data available for baseline as well as the specified time points for the reported age groups. Number analyzed is the number of participants with data available for baseline and the specified time point for the specified age group. | Posted | Mean | Standard Deviation | centimeter (cm) | Baseline to Week 104 |
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| Primary | Number of Participants in Each Tanner Stage for Children 6 to 17 Years of Age During the Study | Tanner assessment scores were 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) by age (6 to 17 years of age) and sex (boys and girls) during the study. Tanner scale boy clinical classification test names for each stage are reported as follows: TANN02-Genitalia and TANN02-Pubic Hair. Tanner scale girl clinical classification test names for each stage are reported as follows: TANN01-Breast and TANN01-Pubic Hair. | Safety analysis set included participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with data available for analysis for this outcome measure. A participant may be counted more than once as data for a participant can be reported in multiple age groups over the length of time frame for this outcome measure. Therefore,total number of participants in all reported categories can exceed overall number of participants analyzed. | Posted | Count of Participants | Participants | From Baseline to Week 130 |
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| Primary | Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study | Absolute values of IGF1 were summarized descriptively as a continuous variable by age and by sex (male and female). If multiple assessments for a participant at different visits at a particular age were available, then the average of all data for that participant were used for the summary. | Safety analysis set included participants who received at least 1 dose of study drug. Overall number of participants analyzed are the number of participants with data available for analysis for this outcome measure. A participant may be counted more than once as data for a participant can be reported in multiple age groups over the length of time frame for this outcome measure. Therefore,total number of participants in all reported categories can exceed overall number of participants analyzed. | Posted | Mean | Standard Deviation | Nanomoles per liter (nmol/L) | From Baseline to Week 130 |
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| Secondary | Percent Change From Baseline in Total Seizure Frequency Per 28 Days | Seizure frequency per 28 days was 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 was 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. | Modified Intent-to-Treat (mITT) analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | percent change | From Baseline to Week 156 |
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| Secondary | Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in DS Cohort | Convulsive seizure frequency per 28 days was 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 was 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. | mITT analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Overall number of participants analyzed is the number of participants with DS from the TAK-935-3001 study. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | percent change | From Baseline to Week 156 |
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| Secondary | Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days in LGS Cohort | MMD seizure frequency per 28 days was defined as the total number of MMD seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from baseline was 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. | mITT analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Overall number of participants analyzed is the number of participants with LGS from the TAK-935-3002 study. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | percent change | From Baseline to Week 144 |
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| Secondary | Number of Participants With Improvement in the 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 in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with study drug). The participants were 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). Reported here is the number of participants with improvement, which includes the CGI-I responses: very much improved, much improved, minimally improved. | mITT analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Count of Participants | Participants | From Baseline to Week 156 |
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| Secondary | Number of Participants With Improvement in the Caregiver Global Impression of Improvement (Care GI-I) Score | The Care GI-I is a 7-point Likert scale that the caregiver used to rate a participant's change in overall seizure control, behavior, safety and tolerability after the initiation of study drug relative to Baseline (before treatment with study drug). The participants were 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 completed the Care GI-I via interview. Reported here is the number of participants with improvement, which includes the Care GI-I responses: very much improved, much improved, minimally improved. | mITT analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Count of Participants | Participants | From Baseline to Week 156 |
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| Secondary | Number of Participants With Improvement in the CGI-I Seizure Intensity and Duration Score | The CGI-I seizure intensity and duration instrument was used by the parent/caregiver to rate a participant's change in intensity and duration of convulsive seizures (DS Cohort) or MMD seizures (LGS Cohort) from Baseline. The participant's symptoms were 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). Reported here is the number of participants with improvement, which includes the CGI-I Seizure responses: very much improved, much improved, minimally improved. | mITT analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Count of Participants | Participants | From Baseline to Week 156 |
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| Secondary | Number of Participants With Improvement in CGI-I Nonseizure Symptoms Score | The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator used to rate a participant's change in the caregiver-identified symptoms and impacts in select nonseizure domains since initiating the study drug. The participants were 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 was completed by the clinician in collaboration with the primary caregiver to assess the participants status based on the presence of any nonseizure symptoms. Reported here is the number of participants with improvement, which includes the CGI-I nonseizure symptoms responses: very much improved, much improved, minimally improved. | mITT analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Count of Participants | Participants | From Baseline to Week 156 |
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| Secondary | Change From Baseline 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. Items were rated on a 5-point Likert scale and then transformed to a scale of 0 to 100. Possible scores range from 0-100, with higher scores indicating better quality of life. Negative change from baseline indicates worsening of quality of life. | mITT analysis set included all enrolled participants who had received at least 1 dose of study drug and had been assessed for seizures for at least 1 day in the treatment period. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Median | 95% Confidence Interval | score on scale | From Baseline to Week 156 |
|
Up to end of study (approximately 3.6 years)
Safety analysis set included participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soticlestat | Participants with DS and LGS received: Participants weighing <45 kg: Soticlestat, mini-tablets, titrated from lower dose level (60 mg-140 mg) to higher dose level (100 mg-200 mg) BID, based on body weight, orally or via enteral feeding tubes including but not limited to NG tube, G-tube, MIC-KEY button, up to 2 weeks in TP. Participants continued to receive the dose they were on at end of TP, for approximately 4 years in MP. Dose was tapered down to lower dose (not less than lowest dose level based on weight) every 3 days until study drug was discontinued (up to 1 week) in Taper Period. Participants weighing ≥45 kg/adults: Soticlestat, mini-tablets/tablets with starting dose of 200 mg BID followed by 300 mg BID, up to 2 weeks in TP. Participants continued to receive 300 mg BID for approximately 4years in MP. Dose was tapered down to 100mg every 3 days until study drug was discontinued (up to 1 week) in Taper Period. | 4 | 352 | 86 | 352 | 214 | 352 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fibrinous bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Severe myoclonic epilepsy of infancy | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2024 | Feb 26, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004831 | Epilepsies, Myoclonic |
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712808 | soticlestat |
Not provided
Not provided
Not provided
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| SI |
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| SB |
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| NSSJB |
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| Participants |
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