AV078 for Epilepsy Due to Tuberous Sclerosis
(RESTOR-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people aged 12 and older who have tuberous sclerosis complex (TSC) and still have seizures even after trying at least two different anti-seizure medications. Participants must be on a stable dose of their current seizure medicines.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- AV078
Trial Overview
The study tests an oral drug called AV078 compared to a placebo in people with TSC-related epilepsy that hasn't responded to other treatments. Participants are randomly assigned, with most getting AV078, and neither doctors nor patients know which treatment they receive.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive oral AV078 once daily in addition to their stable background anti-seizure medication regimen for 12 weeks. Dosing will be titrated based on measured drug concentrations to achieve target exposure levels.
Participants will receive matching oral placebo once daily in addition to their stable background anti-seizure medication regimen for 12 weeks. Dose adjustments may be performed in a manner similar to active treatment to maintain blinding.
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Who Is Running the Clinical Trial?
Aeovian Pharmaceuticals, Inc.
Lead Sponsor
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