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A Phase 2 Study of the Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy

NCT07680322

Not Yet RecruitingPhase 2

Sponsor: Aeovian Pharmaceuticals, Inc.

Conditions: Tuberous Sclerosis Complex, Epilepsy

Interventions: AV078, Placebo

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.
* Treatment with medicines that suppress the immune system.
* Treatment with medicines that may significantly affect the way the body handles the study drug.