Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy (RESTOR-1)
Key facts
- Where
- London, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- London Health Sciences CentreLondon, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aeovian Pharmaceuticals, Inc.
- Trial code
- NCT07680322
- Record updated
- 29 September 2026
- Original description
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.Read full original descriptionShow less
A Parallel-Group, Phase 2, Double-Blind, Placebo-Controlled, Randomized Study of the Safety and Efficacy of Oral AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy
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.
Inclusion: 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.
Exclusion: 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; 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.