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;
Parallel
SPN-817
DrugSPN-817 starting at 0.25 mg bid up to 4.00 mg bid
Placebo
DrugPlacebo, bid
Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance Period
Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline
Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline.
PCH from baseline in focal onset seizure frequency per 28 days over the entire Treatment Period
Percent change in 28-day frequency of focal seizures during the entire Treatment Period (Titration Period + Maintenance Period) relative to baseline
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline
Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the Treatment Period (Titration Period + Maintenance Period) relative to baseline.
Longest seizure-free interval over the entire Treatment Period
The longest intervals in days between two seizures during the entire Treatment Period.
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