Abstract Details

Title Exploring Proposed Recommendations for Acute Cluster Treatment and Rapid and Early Seizure Termination Using Data From a Long-Term Safety Study of Diazepam Nasal Spray

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P12 - Poster Session 12 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-004

Objective To examine whether a single immediate-use seizure medication for seizure clusters (SCs) in epilepsy could appropriately fit both medication categories recently recommended for preventing progression to a higher-level emergency.

Background Appropriate and prompt treatment of SCs is needed to reduce the risk of negative outcomes. Recent expert consensus recommendations focused on antiseizure medications for acute cluster treatment (ACT) to prevent further seizures in a cluster and rapid and early seizure termination (REST) of ongoing seizures.

Design/Methods We examined practical application of ACT and REST criteria using patient diary data from the long-term safety study (n=163 patients with epilepsy aged 6–65 years) of diazepam nasal spray. To explore ACT, use of second doses across 24 hours was a proxy for effectiveness. REST was investigated using time from administration to SC termination. Timing for termination of prolonged seizures (PSs) in clusters also was examined.

Results

For ACT, a single dose of diazepam nasal spray was used across 24 hours for 87.4% (3368/3853) of SCs (second doses were used for 12.6% of SCs). For REST, median time to administration of diazepam nasal spray (n=3225 occurrences) was 2 minutes, and median time to seizure termination was 3 minutes. Of the SCs with treatment administered within 5 minutes (n=2169 occurrences [67.3%]), median time to seizure termination was 2 minutes. For PSs with treatment administered 5–15 minutes after the SC began (n=727 occurrences), median time to administration was 6 minutes, and median time to termination was 7 minutes. Safety data for diazepam nasal spray were similar to that for diazepam rectal gel.

Conclusions

Data from the long-term safety study of diazepam nasal spray demonstrate its benefit in immediate use for both prevention of further seizures in SCs (ACT) and termination of an acute SC and PS in a cluster (REST).

Authors/Disclosures
Steven T. Whitworth, PhD (Neurelis) PRESENTER	Dr. Whitworth has received personal compensation for serving as an employee of Neurelis Inc..
Michael Chez, MD, FAAN (Sutter Medical Group)	Dr. Chez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ucb. Dr. Chez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for marinus. Dr. Chez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Catalyst. Dr. Chez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelsi. Dr. Chez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SK Pharma. Dr. Chez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ucb. Dr. Chez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Catalyst.
Pavel Klein, MD, FAAN (Mid-atlantic Epilepsy and Sleep Center)	The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Sience. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alliance. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle Therapeutics. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Aquestive. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Klein has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for PrevEp. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Fenwick . Dr. Klein has received research support from DOD/CURE.
Danielle A. Becker, MD	Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurelis, Inc. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sk life Science. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus Pharmaceuticals. Dr. Becker has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurelis, Inc. Dr. Becker has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sk Life Science. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz pharmaceuticals. Dr. Becker has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UBC. Dr. Becker has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for LivaNova. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neuropace. Dr. Becker has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus Pharmaceuticals.
Jurriaan Peters, MD (Boston Childrens Hospital)	Dr. Peters has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Peters has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurelis. Dr. Peters has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals. Dr. Peters has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurelis. Dr. Peters has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for CRICO. Dr. Peters has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for UCB.
Enrique Carrazana (Neurelis, Inc.)	Enrique Carrazana has received personal compensation for serving as an employee of Neurelis. Enrique Carrazana has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Hawaii-Biotech, CND Life Sciences, Apex Labs. Enrique Carrazana has stock in Neurelis, CND, Apex.
Adrian L. Rabinowicz, MD, FAAN (Neurelis, Inc.; Center for Molecular Biology and Biotechnology, Charles E. Schmidt College of Science, Florida Atlantic University)	Dr. Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc. Dr. Rabinowicz has stock in Neurelis, Inc.

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