Abstract Details

Title Results for the Quality of Life in Epilepsy Scale From a Long-Term Safety Study of Diazepam Nasal Spray for Seizure Clusters

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P13 - Poster Session 13 (8:00 AM-9:00 AM)

Poster/Presentation
Number 10-001

Background 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.

Objective 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.

Design/Methods 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.

Results

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.

Conclusions 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 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.
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 as a Consultant for Azurity. 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.
Enrique Carrazana	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