SEIzure InterVAL (SEIVAL) Between Seizure Clusters and Quality of Life Across Time From a Phase 3 Safety Study of Diazepam Nasal Spray for Seizure Clusters (P9-1.002)

Abstract

<h3>Objective:</h3> To examine duration between seizure clusters (SEIVAL) and quality of life in patients receiving diazepam nasal spray (Valtoco^®) rescue therapy. <h3>Background:</h3> The long-term effect of intermittent rescue therapy on SEIVAL and potential interaction with quality of life (QoL) is unclear. We examined SEIVAL and QoL across time in a phase 3 safety study of diazepam nasal spray. Diazepam nasal spray is approved for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. <h3>Design/Methods:</h3> Patients (aged 6–65 years) received age- and weight-based doses of diazepam nasal spray for seizure clusters. SEIVAL was assessed using 90-day periods in patients treated with ≥2 doses/period in each of 4 periods. The Quality of Life in Epilepsy (QOLIE)-31-P survey was used to measure QoL in adult patients (aged ≥18 years). <h3>Results:</h3> Of 163 treated patients, 76 had ≥1 SEIVAL in each of 4 consecutive periods (consistent cohort) of whom 35 also had QOLIE-31-P data at baseline and day 365. In the full consistent cohort, mean SEIVAL increased by 12.9 days (<i>P</i>≤0.001) from Periods 1 to 4, while a similar increase in SEIVAL (12.2 days; <i>P</i>=0.022) was noted in the subgroup with QOLIE-31-P data. Overall, 71 treated adults completed the QOLIE-31-P at baseline, while 53 completed it at day 365. Changes in QOLIE-31-P scores were similar for all patients with QOLIE-31-P data (from 64.0 to 63.9) and for those in the consistent cohort (58.4 to 60.4). Seizure Worry and Social Functioning scores clinically improved for all patients (46.3 to 55.0, 52.9 to 61.0; respectively). <h3>Conclusions:</h3> In the safety study of diazepam nasal spray, no change in overall QOLIE-31-P scores was observed. However, key QoL domains of Seizure Worry and Social Functioning improved over time, which paralleled increases in SEIVAL. These results will support future studies of factors that may affect QoL in patients using diazepam nasal spray. <b>Disclosure:</b> Dr. Misra has received personal compensation for serving as an employee of Neurelis, Inc. An immediate family member of Dr. Misra has received personal compensation for serving as an employee of Neurocrine Biosciences. Dr. Misra has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RubiconMD. Dr. Misra has received intellectual property interests from a discovery or technology relating to health care. 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 . Dr. Rao has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for NeuroPace, Inc.. Dr. Rao has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for LivaNova. Dr. Rao has stock in Novela Neurotechnologies. The institution of Dr. Rao has received research support from NeuroPace, Inc.. The institution of Dr. Rao has received research support from Medtronic. 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 $10,000-$49,999 for serving on a Speakers Bureau for Neurelis. Enrique Carrazana has received personal compensation for serving as an employee of Neurelis. Enrique Carrazana has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Neurelis, Alexza, Zogenix. 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. Enrique Carrazana has stock in Neurelis, Marinus, . Adrian Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc.. Adrian Rabinowicz has received stock or an ownership interest from Neurelis.