RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures

Inclusion Criteria:

1. Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy StudyConsortium, Inc (ESCI);

2. Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriatelychosen, and adequately dosed ASM drug schedules;

3. Able to keep accurate Seizure eDiaries (with the aid of a caregiver as needed);

4. Has a body mass index (BMI) between 18.0 and 40.0 kg/m2;

5. Treatment with a stable dose of 1 to 4 current ASMs for ≥28 days prior to screening.If following a diet plan along with the ASM, the participant should have been on astable diet plan for at least 1 month prior to Visit 1. The diet plan should bemaintained throughout the duration of the study;

6. At least 4 clinically observable focal onset seizures accepted by the ESCI prior tothe first dose of SM (during the days of baseline Seizure eDiary data collection)and no more than a consecutive 21-day period that was seizure free. To be eligiblefor the study, participants must comply with the eDiary on at least 90% of the daysof baseline data collection;

Exclusion Criteria:

1. Has taken huperzine A within the past 6 months;

2. Prior diagnosis of combined focal and generalized epilepsy syndrome as evidenced bysevere developmental delay and multiple seizure types and confirmed byelectroencephalography (EEG) (eg, Lennox-Gastaut syndrome). Participants should alsobe excluded in case of nondiagnostic information;

3. History of or current nonepileptic events that could be confused by the participantand/or study staff as epileptic seizures;

4. Only has seizures that are difficult to count; for example, seizures that are notclinically observable;

5. History of uncountable seizures, such as seizures that happen in a cluster that aretoo rapid to be counted individually;

6. History of status epilepticus within 6 months prior to screening;

7. Vagus nerve stimulation, deep brain stimulation, responsive neurostimulator system,or other neurostimulation for epilepsy device implanted or activated within 1 yearprior to screening; or epilepsy surgery within 1 year prior to screening.Stimulation parameters for devices must have been stable for at least 3 months priorto Screening. Battery change for any epilepsy devices will be allowed; however,stimulation parameters must remain stable during the duration of the study;

8. Any suicidal behavior or suicidal ideation related to item 4 (active suicidalideation with some intent to act, without specific plan) or item 5 (active suicidalideation with specific plan and intent) based on the C-SSRS assessment in the 1 yearbefore screening; a suicide attempt in the last 2 years before screening; or morethan 1 lifetime suicide attempt;

9. Chronic concomitant therapy with non-ASMs that are cholinergic or anticholinergic.

10. History of >2 allergic reactions to an ASM or 1 serious hypersensitivity reaction toan ASM;

11. Any other reason which, in the opinion of the Investigator, would prevent theparticipant from taking part in the study.