A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome

Inclusion Criteria:

1. Has documented clinical diagnosis of DS.

2. Had ≥12 convulsive seizures over 12 weeks before screening based on the historicalinformation and has had ≥4 convulsive seizures per 28 days during the 4- to 6-weekprospective baseline period.

3. Weighs ≥10 kg at the screening visit (Visit 1).

4. Failure to control seizures despite appropriate trials of at least 1 ASM based onhistorical information and is currently on an antiseizure therapy or other treatmentoptions considered as SOC.

5. Artisanal cannabidiols are allowed at a stable dose for at least 4 weeks before thescreening visit (Visit 1); the dosing regimen and manufacturer should remainconstant throughout the study (Artisanal cannabidiols will not be counted as ASMs.).

6. Currently taking 0 to 4 ASMs at stable doses for at least 4 weeks before thescreening visit (Visit 1); benzodiazepines used chronically (daily) to treatseizures are considered ASMs. Fenfluramine and cannabidiol (Epidiolex) are allowedwhere available and should be counted as an ASM. ASM dosing regimen must remainconstant throughout the study.

Exclusion Criteria:

1. Unstable, clinically significant neurologic (other than the disease being studied),psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic,gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease,malignancy including progressive tumors, or other abnormality that may impact theability to participate in the study or that may potentially confound the studyresults. It is the responsibility of the investigator to assess the clinicalsignificance; however, consultation with the medical monitor may be warranted.