| Primary | Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE) | An Adverse Event (AE) was defined any untoward medical occurrence in a subject or clinical study subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign vital sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to this medicinal product. A TEAE is defined as any AE that starts or increases in severity during or after the first dose of study drug. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. | Posted | | Number | | percentage of participants | | From screening up to end of the study (up to approximately 84 months) | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | VABS,3rd edition,Parent Caregiver Form:parent-report questionnaire of adaptive functioning/how is individual's routine behaviour at home & in community.4 domains(Communication,Daily Living,Social Skills&Relationships,Problem Behaviors) contained 12 subdomains including items(each scored 0-2).Subdomain scores=sum of item scores within that subdomain.Ranges of subdomain scores are:Communication:Listening&Understanding(0-78);Talking(0-98);Reading&Writing(0-76),Daily Living:Caring for Self(0-110);Caring for Home(0-60);Living in Community(0-116),Social Skills&Relationships:Relating to Others(0-86);Playing&Using Leisure Time(0-72);Adapting(0-66),Problem Behaviors:Section A(0-26);Section B(0-22),Section C(0-40).For 1st 3 domains,higher subdomain scores=higher adaptive functioning,positive CFB=improvement.For Problem Behaviors,higher subdomain scores=more problem behaviors,negative CFB=improvement(reduction in problem behaviors).No subdomain scores combined to compute any total score. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. Baseline is denoted as BL, change from baseline as CFB and Week as W for the reported categories. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Behavior Measures Using Total Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age | The ABC-C measures psychiatric symptoms and behavioral disturbance exhibited by individuals across 5 subscales with 58 items: Irritability subscale (15 items); Lethargy/Social Withdrawal subscale (16 items); Stereotypic Behavior subscale (7 items); Hyperactivity subscale (16 items); and Inappropriate Speech subscale (4 items). Each item is rated on a scale of 0 to 3 ("not at all a problem" to "the problem is severe in degree"). The total score was calculated by summing the scores on all 58 items where the total scores ranged from 0 to 174. Higher scores indicate more severity in psychiatric symptoms and behavioral disturbance. Negative change from baseline scores represents improvement. Positive change from baseline scores represents worsening. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Behavior Measures Using Subscale Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age | The ABC-C measures psychiatric symptoms and behavioral disturbance exhibited by individuals across 5 subscales with 58 items: Irritability subscale (15 items: Ranges from 0 to 45); Lethargy/Social Withdrawal subscale (16 items: Ranges from 0 to 48); Stereotypic Behavior subscale (7 items: Ranges from 0 to 21); Hyperactivity subscale (16 items: Ranges from 0 to 48); and Inappropriate Speech subscale (4 items: Ranges from 0 to 12). Each item is rated on a scale of 0 to 3 ("not at all a problem" to "the problem is severe in degree"). Subscale scores are calculated as the sum of items within the subscale. Higher subscale scores indicate more severity in psychiatric symptoms and behavioral disturbance. Negative change from baseline score represents improvement. Positive change from baseline score represents worsening. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Number of Participants With Changes From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Categorization Based on Columbia Classification Algorithm of Suicide Assessment Categories 1,2,3,4, and 5 for Participants ≥6 Years of Age | Suicidal ideation and behavior was assessed in participants with at least 6 years of age using the C-SSRS. The C-SSRS is a 3-part scale that measures suicidal ideation (eg, participants endorses thoughts about a wish to be dead or has other thoughts of suicide), intensity of ideation (frequency), and suicidal behavior (actually, interrupted, and aborted attempts at suicide). SI=Suicidal Ideation; SB=Suicidal Behavior and NSSJB=Non-suicidal Self-injurious Behavior for the categories reported. BL denotes Baseline, V denotes Visit and W denotes Week in the categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Only participants with change from baseline in C-SSRS are included in the categories. | Posted | | Count of Participants | | Participants | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Grams Per Liter (g/L)) | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Units Per Liter (U/L)) | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | U/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Micromoles Per Liter (µmol/L)) | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | µmol/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Millimoles Per Liter (mmol/L)) | BL denotes Baseline, CFB denotes Change from Baseline, W denotes Week, HDL denotes High Density Lipid and LDL denotes Low Density Lipid for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Haematology (10^9 Cells Per Liter (10^9 Cells/L)) | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis at baseline. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Haematology (Percentage (%) of Cells) | The percentage of the specified blood cells relative to total leukocyte count was determined and reported. BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall Number analyzed is the number of participants with data available for analysis at baseline. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | % of cells | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Haematology (Liter Per Liter (L/L)) | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall Number analyzed is the number of participants with data available for analysis at baseline. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | L/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Haematology (Grams Per Liter (g/L)) | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall Number analyzed is the number of participants with data available for analysis at baseline. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Clinical Laboratory Parameters: Haematology (10^12 Cells Per Liter (10^12/L)) | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall Number analyzed is the number of participants with data available for analysis at baseline. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Vital Signs: Blood Pressure | BL denotes BL, CFB denotes Change from baseline and W denotes Week for the reported categories. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Vital Signs: Heart Rate | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Vital Signs: Respiratory Rate | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | breaths per minute | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Vital Signs: Temperature | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | degree Celsius (̊C) | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Body Weight | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis as per the specified age groups at the specified time points. | Posted | | Mean | Standard Deviation | kilograms (kg) | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in Electrocardiogram (ECG) Parameters: ECG Heart Rate | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in ECG Parameters: PR Interval | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | milliseconds (msec) | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in ECG Parameters: QRS Duration | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | msec | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in ECG Parameters: QT Interval | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | msec | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in ECG Parameters: QTcF Interval | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | msec | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Change From Baseline in ECG Parameters: RR Interval | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. | Posted | | Mean | Standard Deviation | msec | | Baseline, Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Number of Participants With Potentially Clinically Significant Clinical Safety Laboratory Test Values | ALT: Alanine Aminotransferase, AST: Aspartate Aminotransferase, HGB: Hemoglobin, ULN: Upper limit of normal, LLN: Lower limit of normal and UREAN: Urea Nitrogen for the specified categories. mmol/L indicates millimoles per liter. Data is reported only for participants who had potentially clinically significant values. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Baseline to Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Number of Participants With Potentially Clinically Significant Vital Signs | Data is reported only for participants who had potentially clinically significant values. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Baseline to Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Number of Participants With Potentially Clinically Significant Weight and Height | The criteria for defining clinical significance for weight category was the participants less than equal to (<=)10 years of age with weight below minus (-)2standard deviation (SD) of the median weight of the same age and gender per world health organization (WHO) growth chart and for height category was the participants less than (<)18 years of age with height below -2SD of the median weight of the same age and gender per WHO growth chart. | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number of participants with height (in participants < 18 years old) and weight (in participants <= 10 years old) below -2SD of the median height or weight of the same age and gender per WHO growth chart have been reported. | Posted | | Count of Participants | | Participants | | Baseline to Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Primary | Number of Participants With Potentially Clinically Significant ECG Evaluations | | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Baseline to Week 338 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Secondary | Percent Change From Baseline in All Seizure 28-day Frequency | Change from Baseline is denoted as CFB. | 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. Overall number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | | Mean | Standard Deviation | percent (%) of change | | Baseline, Week 252 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Secondary | Percent Change From Baseline in Drop Seizure 28-day Frequency (Lennox-Gastaut Syndrome [LGS] Participants) | Change from Baseline is denoted as CFB. | 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 antecedent soticlestat study TAK-935-2002 with data available for analysis at the specified timepoints. | Posted | | Mean | Standard Deviation | % of change | | Baseline, Week 252 | | | | ID | Title | Description |
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| OG000 | TAK-935-2002: LGS | Participants from the antecedent soticlestat study TAK-935-2002 with LGS received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Secondary | Percent Change From Baseline in Convulsive Seizure 28-day Frequency (Dravet Syndrome [DS] Participants) | Change from Baseline is denoted as CFB. | 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 antecedent soticlestat study TAK-935-2002 with data available for analysis at the specified timepoint. | Posted | | Mean | Standard Deviation | % of change | | Baseline, Week 252 | | | | ID | Title | Description |
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| OG000 | TAK-935-2002: DS | Participants from the antecedent soticlestat study TAK-935-2002 with DS received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Secondary | Percent Change From Baseline in Motor Seizure 28-day Frequency | | mITT Analysis Set: 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 are the participants from antecedent study TAK-935-18-002 (NCT03694275) with with either chromosome 15q duplication (Dup 15q) or Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) with data available for analysis. | Posted | | Mean | Standard Deviation | percent of change | | Baseline, Week 252 | | | | ID | Title | Description |
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| OG000 | TAK-935-18-002: Chromosome Dup15Q | Participants from the antecedent soticlestat study TAK-935-18002 with chromosome 15q duplication (Dup 15q) received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. | | OG001 | TAK-935-18-002: CDD | Participants from the antecedent soticlestat study TAK-935-18002 with CDD received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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| Secondary | Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) | CGI-S is used to obtain an assessment of symptom severity, focusing on clinicians' observations of the subject's current cognitive, functional, and behavioral performance. 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 (among the most severely ill participants). BL denotes BL, CFB denotes Change from baseline and W denotes Week for the reported categories. | 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. Only participants with change from baseline in CGI-S are included in the categories. Number analyzed is the number of participants with data available for analysis at the specified timepoints. | Posted | | Count of Participants | | Participants | | Baseline, Week 336 | | | | ID | Title | Description |
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| OG000 | Soticlestat | Participants received soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasted until development was stopped by the sponsor, or the product was approved for marketing, or at any time at the discretion of the sponsor. |
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