CL-078-201
Research type
Research Study
Full title
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
IRAS ID
1013759
Contact name
Sue Green
Contact email
Sponsor organisation
Aeovian Pharmaceuticals, Inc.
Eudract number
2025-522330-31
Research summary
This clinical trial is being conducted to access the safety and effectiveness of the study drug, AV078, in people with refractory epilepsy due to tuberous sclerosis complex (TSC). The study involves a screening period (lasting up to six weeks) that will collect information on the frequency of seizures. This will be followed by a treatment period lasting 12 weeks where participants will be randomly assigned to be given with the study drug or a placebo with a follow up visit conducted 14 days after this, via telephone. Potential participants need to be at least 12 years of age with a confirmed diagnosis of refractory epilepsy due to TSC - other criteria for inclusion in the study will be outlines in the patient information and consent form. The study itself will involve around 42 people across multiple countries - all sites in the UK will be NHS hospitals. Participation will involve taking blood samples, completing questionnaires and keeping a diary of symptoms. Information on the trial will be publicly available on ClinTrials.gov.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0066
Date of REC Opinion
29 Apr 2026
REC opinion
Further Information Favourable Opinion