This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.
Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI);
Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules;
Able to keep accurate Seizure electronic diaries [eDiaries] (with the aid of a caregiver as needed);
Has a body mass index (BMI) between 18.0 and 40.0 kg/m2;
Has taken huperzine A within the past 6 months;
Prior diagnosis of combined focal and generalized epilepsy syndrome as evidenced by severe developmental delay and multiple seizure types and confirmed by electroencephalography (EEG) (eg, Lennox-Gastaut syndrome). Participants should also be excluded in case of nondiagnostic information;
History of or current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures;
Only has seizures that are difficult to count; for example, seizures that are not clinically observable;