Abstract Details

Title An Open-Label Pilot Trial Assessing the Safety and Efficacy of SPN-817 (Huperzine A Extended-Release) in Adults with Treatment-Resistant Focal Impaired Awareness Seizures

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P12 - Poster Session 12 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-003

Background Despite a recent increase in available anti-seizure medications (ASM), approximately 30% of the patients do not achieve adequate seizure control. SPN-817 is a multifunctional compound that has been shown to reduce the frequency and severity of seizures in nonclinical studies. SPN-817 is known to be a potent acetylcholinesterase inhibitor with possible downstream activity on the GABAergic system. Nevertheless, its anticonvulsant mechanism of action remains to be fully elucidated. Here we report the clinical outcome of three adult subjects with chronic drug-resistant epilepsy receiving long-term adjunctive SPN-817 treatment.

Objective To assess the safety and efficacy of SPN-817 (Huperzine A extended-release) as an adjunctive therapy for the treatment of focal impaired awareness seizures (FIAS) in adults.

Design/Methods

This is an ongoing, open-label, add-on pilot study in adult subjects with frequent FIAS receiving stable doses (for at least 4 weeks) of 1–4 currently available ASM. The study consisted of a 96-hour baseline continuous video electroencephalogram monitoring (VEM) period, a one-month outpatient dose escalation treatment period, and a second 96-hour continuous VEM treatment period. Upon completion, subjects had the option to enroll in a long-term maintenance period. In addition to the safety evaluation, the efficacy was evaluated with the mean change from baseline in the 28-day seizure rate as an endpoint.

Results During the long-term SPN-817 maintenance period, the mean reduction in 28-day seizure rate was 71% after 15 months (N=3) and 90% after 32 months (N=2). One subject has been seizure-free for several months. Another subject was discontinued during the maintenance period due to psychiatric reasons that were determined to be unrelated to the study drug. Mild and transient adverse events reported were nausea, difficulty in sleeping, unsteadiness, and nystagmus.

Conclusions SPN-817 was well tolerated and has an anticonvulsant effect in three subjects with drug-resistant FIAS.

Authors/Disclosures
Jeanelle Portelli, PhD (Supernus Pharmaceuticals, Inc.) PRESENTER	Dr. Portelli has received personal compensation for serving as an employee of Supernus Pharmaceuticals, Inc..
Lovingly Q. Park, PhD (UC Davis Medical Center-neurology)	Dr. Park has received personal compensation for serving as an employee of Supernus Pharmaceuticals.
Brendan Lujan, PhD	Dr. Lujan has received personal compensation for serving as an employee of Supernus Pharmaceuticals, Inc..
Gregory Busse	Gregory Busse has received personal compensation for serving as an employee of Supernus Pharmaceuticals.
Jonathan Rubin, MD (Supernus Pharmaceuticals)	Dr. Rubin has received personal compensation for serving as an employee of Supernus Pharmaceuticals. Dr. Rubin has received stock or an ownership interest from Supernus Pharmaceuticals. Dr. Rubin has received stock or an ownership interest from Atentiv.
	No disclosure on file