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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Tuberous Sclerosis Complex, Epilepsy

In brief

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.

Key facts

Study ID

NCT07680322

Run by

Aeovian Pharmaceuticals, Inc.

People needed

42

Starts

2026-09-01

Expected to finish

2027-12-21

Last updated by the study team

2026-07-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

Full record on ClinicalTrials.gov

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