The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
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Change in the most problematic behavior Numerical Rating Score (NRS) score within the TAND-SQ
Timeframe: Baseline, Week 13, Week 26, Week 52
Change in Tuberous Sclerosis Complex Associated Neuropsychiatric Disorders Self-report, Quantified Checklist (TAND-SQ) score
Timeframe: Baseline, Week 13, Week 26, Week 52
Change in Aberrant Behavior Checklist (ABC) score
Timeframe: Baseline, Week 13, Week 26, Week 52
Change in Child Behavior Checklist (CBCL) score
Timeframe: Baseline, Week 26, Week 52
Change in Adult Behavior Checklist (ABCL) score
Timeframe: Baseline, Week 26, Week 52
Change in Adult Self-Report (ASR) score
Timeframe: Baseline, Week 26, Week 52
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) domains score
Timeframe: Baseline, Week 26, Week 52
Change in sleep characteristics using the Children's Sleep Habits Questionnaire (CSHQ)
Timeframe: Baseline, Week 26
Change in sleep characteristics using the Pittsburgh Sleep Quality Index (PSQI)
Timeframe: Baseline, Week 26
Change in executive function using Behavior Rating Inventory of Executive Function (BRIEF)
Timeframe: Baseline, Week 26
Change in caregiver-reported assessment of Quality of Life (QOL) using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Timeframe: Baseline, Week 26
Change in caregiver-reported assessment of family functioning using Pediatric Quality of Life Survey Family Impact Module (PedsQL FIM)
Timeframe: Baseline, Week 26
Change in assessment of QOL using Pediatric Quality of Life Inventory (PedsQL)
Timeframe: Baseline, Week 26
Change in caregiver impression of overall severity of symptoms (behavior and seizure control) using the Caregiver Global Impression of Severity (CareGI-S)
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Change in participant impression of overall severity of symptoms (behavior and seizure control) using the Patient Global Impression of Severity (PGI-S)
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Change in clinician impression of overall severity of symptoms (behavior and seizure control) using the Clinician Global Impression of Severity (CGI-S)
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Retention Rate
Timeframe: Baseline, Week 13, Week 26, Week 52
Number of participants considered treatment responders
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of seizure-free days
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participants experiencing a worsening, no change, or improvement in seizure frequency
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Change in ideation score per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the C-SSRS
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Change in ideation score per the Children's C-SSRS
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Change in number of suicide attempts per the Children's C-SSRS
Timeframe: Baseline, Week 4, Week 13, Week 26, Week 52
Number of participant inpatient hospitalizations due to epilepsy
Timeframe: Up to Week 52
Number of withdrawals due to Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to Week 52