A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)

Percentage of Participants Who Experience At least one Adverse Event (AE)

时间窗: Up to 6 years

An Adverse Event (AE) is 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 (for example, an abnormal laboratory finding, vital sign or ECG evaluation), symptom, or disease temporally associated with the use of a medicinal product, whether considered related to this medicinal product.

Change 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

时间窗: Up to 6 years

Change from Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS)

时间窗: Up to 6 years

The VABS, 3rd edition, Parent Caregiver Form (VABS-3 Parent Caregiver Form), is a parent-report questionnaire of adaptive functioning or how an individual behaves in their day-to-day life at home and in the community.

Change from Baseline in Behavior Measures Using Total Scores and Subscale Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants ≥6 Years of age

时间窗: Up to 6 years

Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE)

时间窗: From screening up to end of the study (up to approximately 84 months)

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.

Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS)

时间窗: Baseline, Week 338

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.

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

时间窗: Baseline, Week 338

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.

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

时间窗: Baseline, Week 338

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.

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

时间窗: Baseline, Week 338

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.

Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Grams Per Liter (g/L))

时间窗: Baseline, Week 338

BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.

Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Units Per Liter (U/L))

时间窗: Baseline, Week 338

BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.

Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Micromoles Per Liter (µmol/L))

时间窗: Baseline, Week 338

BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.

Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Millimoles Per Liter (mmol/L))

时间窗: Baseline, Week 338

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.

Change From Baseline in Clinical Laboratory Parameters: Haematology (10^9 Cells Per Liter (10^9 Cells/L))

时间窗: Baseline, Week 338

BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.

Change From Baseline in Clinical Laboratory Parameters: Haematology (Percentage (%) of Cells)

时间窗: Baseline, Week 338

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.

Change From Baseline in Clinical Laboratory Parameters: Haematology (Liter Per Liter (L/L))

时间窗: Baseline, Week 338

BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.

Change From Baseline in Clinical Laboratory Parameters: Haematology (Grams Per Liter (g/L))

时间窗: Baseline, Week 338

BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.

Change From Baseline in Clinical Laboratory Parameters: Haematology (10^12 Cells Per Liter (10^12/L))

时间窗: Baseline, Week 338

BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories.

Change From Baseline in Vital Signs: Blood Pressure

时间窗: Baseline, Week 338

BL denotes BL, CFB denotes Change from baseline and W denotes Week for the reported categories.

Change From Baseline in Vital Signs: Heart Rate

时间窗: Baseline, Week 338

Change From Baseline in Vital Signs: Respiratory Rate

时间窗: Baseline, Week 338

Change From Baseline in Vital Signs: Temperature

时间窗: Baseline, Week 338

Change From Baseline in Body Weight

时间窗: Baseline, Week 338

Change From Baseline in Electrocardiogram (ECG) Parameters: ECG Heart Rate

时间窗: Baseline, Week 338

Change From Baseline in ECG Parameters: PR Interval

时间窗: Baseline, Week 338

Change From Baseline in ECG Parameters: QRS Duration

时间窗: Baseline, Week 338

Change From Baseline in ECG Parameters: QT Interval

时间窗: Baseline, Week 338

Change From Baseline in ECG Parameters: QTcF Interval

时间窗: Baseline, Week 338

Change From Baseline in ECG Parameters: RR Interval

时间窗: Baseline, Week 338

Number of Participants With Potentially Clinically Significant Clinical Safety Laboratory Test Values

时间窗: Baseline to Week 338

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.

Number of Participants With Potentially Clinically Significant Vital Signs

时间窗: Baseline to Week 338

Data is reported only for participants who had potentially clinically significant values.

Number of Participants With Potentially Clinically Significant Weight and Height

时间窗: Baseline to Week 338

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.

Number of Participants With Potentially Clinically Significant ECG Evaluations

时间窗: Baseline to Week 338