A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome

Exclusion Criteria

• •Participant has another genetic mutation or clinical comorbidity which could potentially confound the typical Dravet phenotype
• •Participant has a known central nervous system structural and/or vascular abnormality (indicated by an MRI or CT scan of the brain).
• •Participant has an abnormality that may interfere with CSF distribution and/or has an existing ventriculoperitoneal shunt.
• •Participant is currently taking or has taken antiseizure medications (ASMs) at a therapeutic dose that are contraindicated in Dravet syndrome, including sodium channel blockers.
• •Participant has experienced seizure freedom for a period of 4 consecutive weeks within the 90-day period prior to informed consent.
• •Participant has previously received gene or cell therapy.
• •Participant is currently enrolled in a clinical trial or receiving an investigational therapy.
• •Participant has clinically significant underlying liver disease.