This Phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and efficacy of oral AV078 in participants with refractory epilepsy due to tuberous sclerosis complex (TSC). Approximately 42 participants will be randomized in a 5:1 ratio to receive AV078 or placebo.
The study will include a Screening Period collecting 4 weeks of pre-treatment Baseline data on seizure frequency, and progress to a 12-week Treatment Period, followed by an in person final follow-up visit approximately 2 weeks after the last dose.
Participants aged 12 years and above.
Diagnosis of TSC based on International TSC Consensus Group criteria.
History of failure to adequately control seizures despite having been treated by two or more regimens of anti-seizure medications (ASMs).
Receiving a stable dose of ASMs for at least 4 weeks at the start of the Screening Period and for the duration of the study.
History of any infection requiring use of antibiotics within the last four weeks.
Current or history of any clinically significant mental or physical illness or condition other than TSC that the Investigator believes would create significant risk for participation in the study.
Recent epilepsy surgery/major surgery or planned surgery during the study.
Treatment with medicines which act in a similar way.