Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy

This is a multicenter, three-phase, long-term open-label study assessing the safety and tolerability of SPN-817 (huperzine A, an acetylcholinesterase inhibitor) in adults 18-70 years of age with treatment resistant epilepsy. The Screening period is up to 8 weeks in duration, followed by a Titration Period of 9 weeks and a Maintenance Period of 12 weeks (total Treatment Period of 21 weeks) for eligible participants. The Treatment Period will be followed by an optional Open-Label Extension period which is up to 52 weeks in duration. Schedule A will enroll participants with treatment resistant seizures, and Schedule B will enroll with treatment resistant seizures who will receive SPN-817 along with a concomitant medication to assess pharmacological approaches to managing cholinergic AEs.