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Abstract Details

Shorter Time to Treatment with Diazepam Nasal Spray Is Associated with Faster Seizure Termination: A Subpopulation Analysis
Epilepsy/Clinical Neurophysiology (EEG)
P9 - Poster Session 9 (8:00 AM-9:00 AM)
1-001
Diazepam nasal spray is approved for the acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. An earlier study-wide analysis found that shorter time from seizure-cluster start to treatment with diazepam nasal spray was associated with shorter seizure duration.
To investigate temporal patterns of seizure clusters treated with diazepam nasal spray (Valtoco®) in adult and pediatric subpopulations and in patients with ≥20 recorded seizure clusters.
Seizure-cluster data from a phase 3 safety study of diazepam nasal spray were analyzed post hoc based on the timing of seizure start, administration of treatment, and seizure cessation. Observations recording seizure duration >24 hours, negative duration, and invalid dose date/time values were excluded from the analysis. Medians were calculated.
Of 4466 observations (163 patients), 3225 were included; 1567 for adults (18–65 years) and 1658 for pediatric patients (6–17 years). For 2169 seizures treated in <5 minutes, median times from dose to seizure termination were 2 and 3 minutes, respectively. In comparison, for 727 seizures treated in 5–15 minutes, times from dosing to termination were 10 and 5 minutes, while for 329 seizures treated in ≥15 minutes, times from dosing to termination were 20 and 8 minutes. In 61 adult and pediatric patients with ≥20 observations (2484 total observations), of those treated in <5 minutes, time from dosing to termination was 3 minutes, while for those treated in ≥5 minutes, time from dosing to termination was 11 minutes. Overall, safety was similar to diazepam rectal gel.

For subpopulations based on age or treatment usage, shorter time (<5 min) to treatment with diazepam nasal spray was associated with shorter time to seizure cluster termination in this single-arm study. These findings warrant further exploration of their clinical implications and generalizability.

Authors/Disclosures
Steven T. Whitworth, PhD (Neurelis)
PRESENTER
Dr. Whitworth has received personal compensation for serving as an employee of Neurelis Inc..
Danielle A. Becker, MD (University of Pennsylvania) 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.
Randa G. Jarrar, MD Dr. Jarrar has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralis.
John M. Stern, MD, FAAN Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Science. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Ceribell. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz Pharma. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for LivaNova. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurelis. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for LivaNova. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Stern has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz. Dr. Stern has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Stern has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MedLink Neurology. Dr. Stern has stock in DEARhealth. Dr. Stern has stock in Ceribell. Dr. Stern has received publishing royalties from a publication relating to health care. Dr. Stern has received publishing royalties from a publication relating to health care. Dr. Stern has received publishing royalties from a publication relating to health care. Dr. Stern has received publishing royalties from a publication relating to health care.
Adrian L. Rabinowicz, MD, FAAN (Consulting) Dr. Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc. Dr. Rabinowicz has stock in Neurelis, Inc.
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 $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, .