Abstract Details

Title First Onset of any Treatment-emergent Adverse Event Over the Course of Repeated Midazolam Nasal Spray (MDZ-NS) use for the Treatment of Seizure Clusters: a Post hoc Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P3 - Poster Session 3 (12:00 PM-1:00 PM)

Poster/Presentation
Number 12-001

Objective Assess the proportion of patients reporting first onset of any treatment-emergent adverse event (TEAE) over the course of repeated midazolam nasal spray (MDZ-NS) use for outpatient treatment of seizure cluster episodes (SCEs).

Background The safety/efficacy of MDZ-NS for treatment of SCEs was assessed in a randomized controlled trial (ARTEMIS-1) and open-label extension (ARTEMIS-2). In ARTEMIS-2, 161 patients received ≥1 dose of MDZ-NS (5mg) over a median of 16.8 months; 40.4% of patients experienced TEAEs within 2 days of any MDZ-NS administration (Wheless et al 2019).

Design/Methods Analyses were performed for all patients who received ≥1 dose of MDZ-NS in ARTEMIS-2 (P261-402;NCT01529034); data were pooled with ARTEMIS-1 (P261-401;NCT01390220) to capture the first MDZ-NS-treated SCEs. TEAEs within 2 days of MDZ-NS administration were analyzed by number of SCE-treated (SCET) for the overall population and cohorts of patients with ≥5, 10, or 15 SCET.

Results Among 161 patients, 2136 SCEs were treated with MDZ-NS (ARTEMIS-1+ARTEMIS-2). In the 5-SCET (n=111), 10-SCET (n=70), and 15-SCET (n=47) cohorts, the range of proportion of patients reporting any TEAE was similar across individual treated episodes (5-SCET: 14.4%−18.9%; 10-SCET: 12.9%−18.6%; 15-SCET: 8.5%−19.1%). Overall, the proportion of patients reporting first onset of any TEAE during first, second, third, fourth, and fifth SCET was 21.1% (34/161), 11.4% (18/158), 4.4% (6/137), 3.4% (4/119), and 2.7% (3/111), respectively. The proportion of patients reporting first onset of any TEAE decreased from first to fifth SCET in each cohort (5-SCET: 16.2% to 2.7%; 10-SCET: 12.9% to 2.9%; 15-SCET: 10.6% to 2.1%). For subsequent SCET (after fifth), the number of patients reporting first onset of any TEAE varied between 0−2.

Conclusions The proportion of patients reporting first onset of any TEAE was highest during the first SCET, decreased through the fifth SCET, and was rare thereafter, supporting the tolerability of repeated MDZ-NS administration during acute treatment of SCEs.

Authors/Disclosures
Michael Gelfand, MD, PhD (University of Pennsylvania) PRESENTER	Dr. Gelfand has received personal compensation in the range of $0-$499 for serving as a Consultant for Aquestive. Dr. Gelfand has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Livanova. The institution of Dr. Gelfand has received research support from Aquestive. The institution of Dr. Gelfand has received research support from Xenon. The institution of Dr. Gelfand has received research support from Cerevel. The institution of Dr. Gelfand has received research support from UNEEG. The institution of Dr. Gelfand has received research support from Livanova. The institution of Dr. Gelfand has received research support from UCB. The institution of Dr. Gelfand has received research support from SK Pharma. The institution of Dr. Gelfand has received research support from Otsuka.
	No disclosure on file
	No disclosure on file
Aliceson King	Aliceson King has received personal compensation for serving as an employee of UCB Pharma. Aliceson King has stock in UCB.
	No disclosure on file

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