EpiCom study: the first commercial clinical trial using the TAND-SQ as outcome measure

We are excited to announce the recent publication of a protocol paper for the EpiCom (Epilepsy Comorbidities) study, a multicenter, open-label, phase 3b/4 study, designed in collaboration with patient advisory groups and healthcare professionals. The study is investigating the impact of adjunctive cannabidiol (CBD) treatment on TAND in individuals with TSC-associated seizures. Outcomes include overall symptom severity on the Aberrant Behavior Checklist (e.g., irritability subscale) and the TAND-SQ. A range of other changes in executive function, sleep, QoL, family functioning, seizure outcomes (severity, responder rates, seizure-free days), retention rate, and safety are being evaluated. The results will inform future studies evaluating pharmacotherapy for behavioral outcomes in similar populations. This is the first commercial clinical trial that is using the TAND-SQ, developed by the TAND consortium, as an outcome measure.