Abstract Details

Title Significant Improvements in SEIzure InterVAL (Time Between Seizure Clusters) Across Time Irrespective of Age or Change in Concomitant Treatments in a Long-Term, Open-Label Safety Study of Diazepam Nasal Spray

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P9 - Poster Session 9 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-010

Objective To characterize time between seizure clusters in patients using diazepam nasal spray (Valtoco^®) intermittent rescue therapy.

Background Metrics for effectiveness of rescue therapies for seizure clusters across multiple days are lacking. We explored a novel measure of effectiveness, SEIzure interVAL (SEIVAL; time between seizure clusters) in a long-term safety study of diazepam nasal spray, which is approved for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years.

Design/Methods

A post hoc analysis of a long-term, open-label, repeat-dose safety study of diazepam nasal spray in patients aged 6–65 years with epilepsy and frequent seizure clusters evaluated SEIVAL across 4 consecutive 90-day periods (total 360 days). Paired t tests assessed statistical significance.

Results

Of 175 enrolled patients, 163 received ≥1 dose of diazepam nasal spray, and 120 had SEIVAL data in period 1 and another period. A consistent cohort (n=76) had data in all 4 periods. In the 120 patients, mean SEIVAL increased from 14.8 to 35.8 days (Period 1 to 4). In the consistent cohort, mean SEIVAL increased from 13.9 to 26.8 days (P≤0.001). In pediatric patients (age 6–17 years, n=32), mean SEIVAL increased from 13.0 to 25.9 days (P=0.02). In adults (n=44), mean SEIVAL increased from 14.6 to 27.5 days (P=0.01). Mean SEIVAL also increased in patients with (n=56; from 13.9–25.8 days) and without (n=20; from 14.1–29.6 days) changes in concomitant antiseizure drug (ASD) therapy during the study.

Conclusions Across 12 months, a statistically significant change in SEIVAL was observed, which may reflect a beneficial effect of intermittent rescue therapy with diazepam nasal spray and appears to be independent of age or concomitant ASDs. These findings may reflect patient behavior or other factors, including a change in the underlying biology of seizure clusters; these hypotheses warrant further study.

Authors/Disclosures
Adrian L. Rabinowicz, MD, FAAN (Neurelis, Inc.; Center for Molecular Biology and Biotechnology, Charles E. Schmidt College of Science, Florida Atlantic University) PRESENTER	Dr. Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc. Dr. Rabinowicz has stock in Neurelis, Inc.
Michael R. Sperling, MD, FAAN (Thomas Jefferson University)	Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. The institution of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medscape. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for International Medical Press. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Projects for Knowledge. The institution of Dr. Sperling has received research support from SK Life Science. The institution of Dr. Sperling has received research support from UCB Pharma . The institution of Dr. Sperling has received research support from Takeda. The institution of Dr. Sperling has received research support from Neurelis. The institution of Dr. Sperling has received research support from Engage Therapeutics . The institution of Dr. Sperling has received research support from Medtronic. The institution of Dr. Sperling has received research support from Cavion. The institution of Dr. Sperling has received research support from Xenon Pharma. The institution of Dr. Sperling has received research support from Cerevel. The institution of Dr. Sperling has received research support from National Institutes of Health . The institution of Dr. Sperling has received research support from DARPA. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Vice President with Epilepsy Consortium .
Sunita N. Misra, MD (SK Life Science)	Dr. Misra has received personal compensation for serving as an employee of SK Life Science, Inc. An immediate family member of Dr. Misra has received personal compensation for serving as an employee of Neurocrine Biosciences.
Vikram Rao, MD (UC San Francisco)	Dr. Rao has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Precisis GmbH. Dr. Rao has received personal compensation in the range of $500-$4,999 for serving as a Consultant for iVEAcare. Dr. Rao has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NeuroPace, Inc.. Dr. Rao has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Rao has stock in Novela Neurotechnologies. Dr. Rao has stock in EnlitenAI. Dr. Rao has stock in Doximity, Inc. Dr. Rao has stock in Theta Neurotech. Dr. Rao has stock in Encephalogix.
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.

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