Abstract Details

Title Treatment of Status Epilepticus At and After T1 With Diazepam Nasal Spray: A Combined Cohort Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 9-013

Objective To assess diazepam nasal spray (Valtoco^®) to treat early status epilepticus (SE) episodes in patients with epilepsy.

Background SE is defined as abnormally prolonged seizures continuing after time point T1 (per ILAE: 5 minutes for generalized; 10 for focal seizures). Treatment of seizure clusters with diazepam nasal spray ≥5 minutes after onset was shown to be effective for seizure termination. Diazepam nasal spray is approved for seizure-cluster treatment in patients with epilepsy aged ≥6y.

Design/Methods Data (April 20, 2024 cutoff) from an ongoing study of patients aged 2–5y and from the long-term safety study of patients 6–11y, 12–17y and, in a separate analysis, 18–65y were evaluated by age group and seizure type for time from treatment to seizure episode termination. Unclassified seizures were excluded.

Results

Proportions of generalized seizure episodes treated after T1 by age group were: 2–5y, 38.5% (35/91); 6–11y, 17.7% (107/606); 12–17y, 15.9% (102/641); ≥18y, 20.9% (63/301). Median times to termination were 1, 5, 6, and 15 minutes. Proportions of focal seizure episodes were: 2–5y, 12.0% (11/92); 6–11y, 7.1% (3/42); 12–17y, 9.6% (11/115); ≥18y, 26.5% (228/859). Median times to termination were 2, 110, 14, and 20 minutes. Eight SE episodes were reported as not treatment-related serious treatment-emergent adverse events (TEAEs) requiring hospitalization/prolongation by 5 patients 2–5y (n=36; 13.9%); 7 episodes in 5 patients 6–11y (n=45; 11.1%); 2 episodes in 1 patient 12–17y (n=33; 3.0%), and 1 episode in 1 patient ≥18y (n=85; 1.2%). Diazepam nasal spray’s safety profile was supported.

Conclusions In patients 2–65y with seizure episodes reaching T1, diazepam nasal spray provided consistent control, and the majority of these episodes were not associated with hospitalization as serious TEAEs. Diazepam nasal spray demonstrated safety and tolerability in patients 2–65y.

Authors/Disclosures
Delia Mancoci, MD (Lundbeck) PRESENTER	Dr. Mancoci has received personal compensation for serving as an employee of Neurelis. Dr. Mancoci has received personal compensation for serving as an employee of Eisai. Dr. Mancoci has received personal compensation for serving as an employee of Lundbeck.
Eric Segal, MD	Dr. Segal has received personal compensation for serving as an employee of Lundbeck. Dr. Segal has received personal compensation for serving as an employee of Eisai. Dr. Segal has received personal compensation for serving as an employee of Neurelis. Dr. Segal has received personal compensation for serving as an employee of Zogenix. Dr. Segal has received personal compensation for serving as an employee of Aquestive. Dr. Segal has received personal compensation for serving as an employee of Greenwich Biosciences. Dr. Segal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. Dr. Segal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Segal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Greenwhich Bioscience. Dr. Segal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Greenwhich Bioscience. Dr. Segal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelis.
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.
Danielle A. Becker, MD	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.
Tracy A. Glauser, MD (Childrens Hosp Med Ctr Dept of Neuro)	Dr. Glauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. Dr. Glauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for WebMD. The institution of Dr. Glauser has received research support from NIH. Dr. Glauser has received intellectual property interests from a discovery or technology relating to health care. Dr. Glauser has received publishing royalties from a publication relating to health care.
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.
Evelyn K. Shih, MD, PhD (Neurelis, Inc.)	Dr. Shih has received personal compensation for serving as an employee of Neurelis, Inc. Dr. Shih has received personal compensation for serving as an employee of SK Life Science, Inc.
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.
Adrian L. Rabinowicz, MD, FAAN (Neurelis, Inc.; Center for Molecular Biology and Biotechnology, Charles E. Schmidt College of Science, Florida Atlantic University)	Dr. Rabinowicz has received personal compensation for serving as an employee of Neurelis, Inc. Dr. Rabinowicz has stock in Neurelis, Inc.

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