A large international trial is underway to determine whether CBD can help improve behavioral symptoms in people with tuberous sclerosis complex (TSC), a condition that affects about 90% of patients with a group of neuropsychiatric symptoms known as TAND.
The study, called EpiCom, is a phase 3b/4 open-label trial taking place at around 20 sites across the United States, United Kingdom, Canada, and Poland. Researchers from institutions including Antwerp University Hospital, Massachusetts General Hospital, and Amsterdam UMC are leading the effort.
Participants between the ages of 1 and 65 (depending on country) must be starting CBD for TSC-related seizures and also experiencing moderate to severe behavioral challenges. They will receive a purified CBD oral solution (Epidiolex/Epidyolex) alongside their standard treatment for 26 weeks. Patients may then choose to continue for another 26 weeks.
The trial will assess changes in symptoms using tools like the Aberrant Behavior Checklist and TAND-SQ Checklist, with additional focus on executive function, sleep, family dynamics, seizure frequency and severity, and overall quality of life.
With a target enrollment of 75 participants, the study could help clarify whether CBD offers measurable benefit for the behavioral complications of TSC, not just its seizures.
