Abstract Details

Title Early Intervention with Midazolam Nasal Spray and Efficacy in Patients with Seizure Clusters: Post-hoc Analysis of an Open-label Extension Trial

Topic Epilepsy/Clinical Neurophysiology (EEG)

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

Poster/Presentation
Number 10-007

Background There are no standard SC treatment guidelines for when to administer rescue medication.

Objective To assess impact of early intervention with midazolam nasal spray (MDZ-NS) on its efficacy in patients with seizure clusters (SCs) during repeated intermittent use.

Design/Methods Post-hoc analysis of Phase III open-label extension trial in SC patients aged ≥12 years (ARTEMIS-2/P261-402/NCT01529034) assessed efficacy outcomes (seizure termination within 10min, no seizure recurrence between 10min and 24h) by time from seizure cluster episode (SCE) identification to administration of first 5mg MDZ-NS dose (<1, 1-3, 4-10, >10min). For SCEs treated with two doses, outcomes were assessed after second dose.

Results 1996 SCEs in 161 patients were included; 60.1% and 39.9% SCEs were treated with one and two MDZ-NS doses, respectively. 92.4% SCEs terminated within 10min of MDZ-NS administration (95.6% of SCEs treated with one dose, 87.7% of SCEs treated with two doses). In 85.1% SCEs, no seizure recurrence was observed between 10min and 24h after MDZ-NS administration (84.2% of SCEs treated with one dose, 86.6% of SCEs treated with two doses). 93.2%/93.3%/92.0%/90.5% of SCEs were terminated within 10min after one or two MDZ-NS doses in SCEs with first MDZ-NS dose administered <1/1-3/4-10/>10 min from SCE identification, respectively. Sustained seizure control between 10min and 24h (after one or two MDZ-NS doses) was observed in 89.7%/85.9%/84.2%/80.1% of SCEs with first MDZ-NS dose administered <1/1-3/4-10/>10min from SCE identification, respectively. Time from SCE identification to MDZ-NS administration had a more pronounced effect on sustained 24-h seizure control after one dose, but may also have impacted sustained 24-h seizure control after two doses.

Conclusions The time from SCE identification to initial treatment with MDZ-NS did not affect proportion of SCEs that terminated within 10min. However, sustained 24-h seizure control was more likely when MDZ-NS treatment was administered earlier after SCE identification, highlighting the importance of early treatment of SCs

Authors/Disclosures
James W. Wheless, MD, FAAP, FAAN (UTHSC-Pediatric Neurology) PRESENTER	Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aquestive. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for LivaNova. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Greenwich. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BioMarin. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zogenix. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelius.
	No disclosure on file
Florin Floricel (UCB Biosciences GmbH)	No disclosure on file
	No disclosure on file
	No disclosure on file