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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1206-5522 | Other Identifier | World Health Organization | |
| 2018-002484-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Healx AI | INDUSTRY |
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The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
The drug being tested in this study is called TAK-935 (OV935). This randomized, double-blind study will assess the effects of TAK-935 (OV935), compared to placebo, on efficacy, safety, and tolerability in pediatric participants with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS). This multi-center trial will be conducted worldwide and will enroll approximately 126 participants.
Participants will be randomized based on their diagnosis in 2 categories; DS or LGS. The study will consist of 2 periods: Screening Period and Treatment Period. The overall duration of Treatment Period is up to 20 weeks including 8-week Dose Optimization Period and 12-week Maintenance Period. The overall time to participants in this study is approximately 30 weeks.
Participants completing this study will have an option to enroll in the open-label extension study, under a separate protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20. |
|
| TAK-935 | Experimental | TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-935 | Drug | TAK-935 tablets or mini-tablets. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period | Seizure frequency per 28 days is defined as total number of seizures (convulsive seizures for DS, drop seizures for LGS) 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 maintenance period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement. | Baseline; Maintenance Period: Weeks 9 to 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period | Seizure Frequency per 28 days is defined as total number of Seizures reported (convulsive seizures for DS, drop seizures for LGS) 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 frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35841234 | Derived | Hahn CD, Jiang Y, Villanueva V, Zolnowska M, Arkilo D, Hsiao S, Asgharnejad M, Dlugos D. A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA). Epilepsia. 2022 Oct;63(10):2671-2683. doi: 10.1111/epi.17367. Epub 2022 Aug 4. |
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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.
Participants with a diagnosis of Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) were enrolled and randomized in a 1:1 ratio to double-blind treatment with TAK-935 or matching placebo for up to the 20-week Treatment Period (8-week Dose Optimization Period and 12-week Maintenance Period).
Participants took part in the study at 45 investigative sites globally from 8 August 2018 to 20 July 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20. |
| FG001 | TAK-935 |
| 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 14, 2019 | Jan 19, 2021 |
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| Drug |
TAK-935 placebo-matching tablets or mini-tablets. |
|
| Baseline; Treatment Period: Weeks 0 to 20 |
| Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period | 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 (%) is defined as [(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency] multiplied by 100. Negative percent change from Baseline indicates improvement. | Baseline; Maintenance Period: Weeks 9 to 20 |
| Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period | Drop seizure frequency per 28 days is defined as total number of drop 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 [(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency] multiplied by 100. Negative percent change from Baseline indicates improvement. | Baseline; Maintenance Period: Weeks 9 to 20 |
| Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period | Responders are defined as having over 50% drop seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as [(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline. | Maintenance Period: Weeks 9 to 20 |
| Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period | Responders are defined as having over 50% convulsive seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as [(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline. | Maintenance Period: Weeks 9 to 20 |
| Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) Responses of Investigator Reported Impression of Efficacy and Tolerability of Study Drug | The CGI-Severity (CGI-S) focuses on clinicians' observations of the participant's cognitive, functional, and behavioral performance since the beginning of the study. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill participants). A negative change from Baseline indicates improvement. | Baseline and Week 20 |
| Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935 | CGI-Change (CGI-C) treatment response ratings should take account of both therapeutic efficacy and treatment-related AEs. Each component of the CGI is rated separately; the instrument does not yield a global score. The CGI-C is rated on a 7-point scale, where, 0 = Marked improvement and no side-effects, 1 = Marked improvement and minimal side-effects, 2 = No Change, 3 = Minimal improvement and marked side-effects and 4 = Unchanged or worse and side-effects outweigh the therapeutic effect. Lower scores indicated improvement. | Week 20 |
| Percentage of Participants With Caregiver Global Impression of Change (Care GI-C) Responses as Per the Parent/Family Reported Impression of Efficacy and Tolerability of TAK-935 | The Care GI-C is rated on a 7-point scale, with the severity of illness scale where, 1 = Very much improved, 2 = Much improved, 3 = Slightly improved, 4 = No change, 5 = Slightly worse, 6 = Much worse and 7 = Very much worse. Lower scores indicated improvement. | Week 20 |
| Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy | A negative change from Baseline indicates improvement. | Baseline and Week 24 |
| Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy | Seizure frequency was based on convulsive seizures for the participants in the Dravet Syndrome Indication and Drop Seizures for the participants in the LGS Indication. Seizure frequency per 28 days = (total number of seizures reported during the period) / (number of days during the period seizures were assessed) * 28. A negative change from Baseline indicates improvement. | Baseline and Week 20 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Colorado Children's Hospital | Aurora | Colorado | 80045 | United States |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | United States |
| Pediatric Neurology PA | Orlando | Florida | 32819 | United States |
| Rare Disease Research, LLC | Atlanta | Georgia | 30318 | United States |
| Center for Rare Neurological Diseases | Norcross | Georgia | 30093 | United States |
| Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Mayo Clinic - PPDS | Rochester | Minnesota | 55905 | United States |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | United States |
| Children's Hospital at Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Monash Children's Hospital | Clayton | Victoria | 3168 | Australia |
| Austin Hospital | Heidelberg West | Victoria | 3081 | Australia |
| Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Peking University First Hospital | Beijing | 100034 | China |
| Capital Medical University (CMU) - Beijing Children's Hospital | Beijing | 100045 | China |
| Beijing Children's Hospital,Capital Medical University | Beijing | 100069 | China |
| Xiangya Hospital Central South University | Changsha | 410078 | China |
| Children's Hospital of Fudan University | Shanghai | 201102 | China |
| Shenzhen Children's Hospital | Shenzhen | 518026 | China |
| Sheba Medical Center-PPDS | Tel Litwinsky | Ramat Gan | 52621 | Israel |
| Soroka University Medical Centre | Bear Sheva | 84101 | Israel |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Edith Wolfson Medical Center | Holon | 58100 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Schneider Childrens Medical Center of Israel | Petah Tikva | 49202 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Poznan | Greater Poland Voivodeship | 60-355 | Poland |
| Uniwersyteckie Centrum Kliniczne - PPDS | Gdansk | Pomeranian Voivodeship | 80-211 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie | Warsaw | 02-091 | Poland |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | 04-730 | Poland |
| NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki | Kielce | Świętokrzyskie Voivodeship | 25-316 | Poland |
| Centro Hospitalar Lisboa Central- Hospital Dona Estefania | Lisbon | 1169-045 | Portugal |
| Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte | Porto | 4050-651 | Portugal |
| Clinica Universidad Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Vithas La Salud | Granada | 18008 | Spain |
| Hospital Ruber Internacional | Madrid | 28034 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.
| COMPLETED |
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| NOT COMPLETED |
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Randomized Analysis Set included all participants who were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | TAK-935 placebo-matching tablets, orally or via G-tube/PEG, BID up to Week 20. |
| BG001 | TAK-935 | TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| 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 |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Number analyzed are the number of participants with data available for height at Baseline. | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | BMI= weight (kg)/height (m^2). | Number analyzed are the number of participants with data available for BMI at Baseline. | Mean | Standard Deviation | (kg/m^2) |
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| Clinical Global Impression of Severity (CGI-S) Responses of Investigator | The CGI-Severity (CGI-S) focuses on clinicians' observations of the participant's cognitive, functional, and behavioral performance since the beginning of the study. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill participants). | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. | Mean | Full Range | score on a scale |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period | Seizure frequency per 28 days is defined as total number of seizures (convulsive seizures for DS, drop seizures for LGS) 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 maintenance period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement. | Efficacy Analysis Set included all Modified Intent-to-Treat (mITT) participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | Posted | Median | Full Range | percent change | Baseline; Maintenance Period: Weeks 9 to 20 |
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| Secondary | Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period | Seizure Frequency per 28 days is defined as total number of Seizures reported (convulsive seizures for DS, drop seizures for LGS) 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 frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. | Posted | Median | Full Range | percent change | Baseline; Treatment Period: Weeks 0 to 20 |
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| Secondary | Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period | 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 (%) is defined as [(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency] multiplied by 100. Negative percent change from Baseline indicates improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | Posted | Median | Full Range | percent change | Baseline; Maintenance Period: Weeks 9 to 20 |
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| Secondary | Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period | Drop seizure frequency per 28 days is defined as total number of drop 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 [(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency] multiplied by 100. Negative percent change from Baseline indicates improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | Posted | Median | Full Range | percent change | Baseline; Maintenance Period: Weeks 9 to 20 |
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| Secondary | Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period | Responders are defined as having over 50% drop seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as [(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Only participants with LGS stratum indication were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Maintenance Period: Weeks 9 to 20 |
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| Secondary | Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period | Responders are defined as having over 50% convulsive seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as [(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Only participants with Dravet syndrome stratum indication were analyzed for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Maintenance Period: Weeks 9 to 20 |
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| Secondary | Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) Responses of Investigator Reported Impression of Efficacy and Tolerability of Study Drug | The CGI-Severity (CGI-S) focuses on clinicians' observations of the participant's cognitive, functional, and behavioral performance since the beginning of the study. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill participants). A negative change from Baseline indicates improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | Posted | Least Squares Mean | Standard Deviation | score on scale | Baseline and Week 20 |
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| Secondary | Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935 | CGI-Change (CGI-C) treatment response ratings should take account of both therapeutic efficacy and treatment-related AEs. Each component of the CGI is rated separately; the instrument does not yield a global score. The CGI-C is rated on a 7-point scale, where, 0 = Marked improvement and no side-effects, 1 = Marked improvement and minimal side-effects, 2 = No Change, 3 = Minimal improvement and marked side-effects and 4 = Unchanged or worse and side-effects outweigh the therapeutic effect. Lower scores indicated improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | percentage of participants | Week 20 |
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| Secondary | Percentage of Participants With Caregiver Global Impression of Change (Care GI-C) Responses as Per the Parent/Family Reported Impression of Efficacy and Tolerability of TAK-935 | The Care GI-C is rated on a 7-point scale, with the severity of illness scale where, 1 = Very much improved, 2 = Much improved, 3 = Slightly improved, 4 = No change, 5 = Slightly worse, 6 = Much worse and 7 = Very much worse. Lower scores indicated improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | percentage of participants | Week 20 |
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| Secondary | Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy | A negative change from Baseline indicates improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2, with available data. Number analyzed is the number of participants with Baseline and Week 24 data available for analyses. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
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| Secondary | Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy | Seizure frequency was based on convulsive seizures for the participants in the Dravet Syndrome Indication and Drop Seizures for the participants in the LGS Indication. Seizure frequency per 28 days = (total number of seizures reported during the period) / (number of days during the period seizures were assessed) * 28. A negative change from Baseline indicates improvement. | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2, with available data. Number analyzed is the number of participants with Baseline and Week 24 data available for analyses. | Posted | Median | Full Range | seizures per 28 days | Baseline and Week 20 |
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From the first dose to 30 days post-last dose of study treatment (Up to 24 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | TAK-935 placebo-matching tablets, orally or via G-tube/PEG, BID up to Week 20. | 0 | 70 | 13 | 70 | 52 | 70 |
| EG001 | TAK-935 | TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20. | 0 | 71 | 11 | 71 | 55 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tonic convulsion | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Feeding disorder | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Basophilia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Amblyopia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Excessive eye blinking | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Periorbital swelling | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Salivary gland enlargement | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased activity | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gingival abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Benzodiazepine drug level increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Drug level increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram P wave abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram T wave amplitude decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Nitrite urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Red blood cells urine | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebellar ataxia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Change in seizure presentation | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chorea | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Clonic convulsion | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myoclonic epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Defiant behaviour | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Impulsive behaviour | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Negativism | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Poverty of speech | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypercalciuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Erection increased | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tonic convulsion | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2020 | Jan 19, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004831 | Epilepsies, Myoclonic |
| D065768 | Lennox Gastaut Syndrome |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014402 | Tuberous Sclerosis |
| C564064 | CDKL5 deficiency disorder |
| D020925 | Hypoxia-Ischemia, Brain |
| D013036 | Spasms, Infantile |
| D054220 | Malformations of Cortical Development |
| D012640 | Seizures |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D000073376 | Epileptic Syndromes |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006222 | Hamartoma |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D065703 | Malformations of Cortical Development, Group I |
| D009421 | Nervous System Malformations |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D000013 | Congenital Abnormalities |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
Not provided
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