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Abstract Details

Results for the Quality of Life in Epilepsy Scale From a Long-Term Safety Study of Diazepam Nasal Spray for Seizure Clusters
Epilepsy/Clinical Neurophysiology (EEG)
P13 - Poster Session 13 (8:00 AM-9:00 AM)
10-001
This analysis of a long-term safety study of diazepam nasal spray examines results of the patient-reported Quality of Life in Epilepsy (QOLIE) questionnaire among adults with seizure clusters.
Burden of seizure clusters affects patient quality of life, but few studies have examined this impact. Diazepam nasal spray (Valtoco®) is approved for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. 
Patients aged 6-65 years in a long-term, open-label safety study of diazepam nasal spray used 5–20-mg doses (age- and weight-based) to treat seizure clusters. Patients ≥18 years old completed the QOLIE-31-P, an epilepsy-specific quality-of-life instrument, at baseline and days 30, 150, 270, and 365, recording responses covering the prior 4 weeks. 

Among 163 treated patients, 74 adults (mean age 35.6 years; 59.5% female) provided QOLIE-31-P data for ≥1 timepoint. Exposure was a mean of 2.4 doses/month and was ≥12 months for 60 patients (range, 3.1-40.4 months). Mean QOLIE-31-P scores were similar or increased slightly (indicating better quality of life) across time, with maximum at day 365 in both the All Data (n=53-71 by assessment and timepoint) and QOLIE-31-P Completer (n=48) analyses. The mean increase in the total score from day 0 to 365 was 5.20 (All Data) and 2.21 (Completers). Subscore mean changes for All Data and Completers were greatest for Seizure Worry (8.75 and 5.88, respectively) and Social Functioning (8.10 and 6.29, respectively). Safety was similar to the full study cohort.
Adults with highly refractory epilepsy treated with diazepam nasal spray for seizure clusters maintained QOLIE scores across the 12-month study period, generally with small numeric improvement. Seizure Worry and Social Functioning subscale scores showed numerical improvements over time. Availability of diazepam nasal spray for out-of-hospital seizures has potential to improve patients’ sense of empowerment to treat seizure clusters. 
Authors/Disclosures
Sunita N. Misra, MD (SK Life Science)
PRESENTER 		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.
R E. Faught, Jr., MD, FAAN (Emory University) Dr. Faught has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurelis. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SK Life Science. Dr. Faught has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Gideon, Essary, Tardio and Carter PLC, Nashville TN TN law firm. Dr. Faught has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Friedman Dazio and Zulanas Law Firm Birmingham AL. The institution of Dr. Faught has received research support from UCB Pharma. The institution of Dr. Faught has received research support from Cognizance.
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.
No disclosure on file