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.
Age range
1 Year – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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