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• W3157748139 abstract "Objective: To assess the impact of treatment of seizure clusters (SCs) with one or two midazolam nasal spray (MDZ-NS) doses on the time to return to full baseline functionality (FBF) in patients with epilepsy, over repeated intermittent episodes. Background: The time to return to FBF after rescue medication use in patients with SCs is an important factor in assessing the efficacy and tolerability of a SC treatment. Design/Methods: Phase III, open-label extension trial ARTEMIS-2/P261-402 (NCT01529034) evaluated intermittent MDZ-NS use in the treatment of patients (≥12 years) with SCs in the outpatient setting. Caregivers administered a 5-mg dose when patients experienced a SC; a second dose (5 mg) could be given if seizures did not terminate within 10 min or recurred within 6 h post MDZ-NS administration. This post-hoc analysis assessed time to return to FBF within 24 h of MDZ-NS administration (Kaplan-Meier methodology) in SC episodes (SCEs) treated with one or two MDZ-NS doses. Results: A total of 1996 treated SCEs (one MDZ-NS dose: 1201 [60%]; two doses: 795 [40%]) in 161 patients were evaluable. In SCEs treated with one or two doses, 97.2% and 94.2% of patients returned to FBF within 24 h of MDZ-NS administration, respectively; the estimated median time was 1.2 h (Q1–Q3: 0.4–2.4) and 1.3 h (0.5–3.5), respectively. The profile of return to FBF was generally similar in SCEs treated with one and two MDZ-NS doses, with a slightly higher proportion of patients returning to FBF between 2–6 h after the administration of one MDZ-NS dose. Conclusions: The vast majority of patients returned to FBF within 24 h of intermittent administration of one or two MDZ-NS doses, with a similar median time to return to FBF. These return to FBF data further support the favorable profile of repeated intermittent MDZ-NS use in patients with SCs. Disclosure: Dr. Detyniecki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aquestive. Dr. Detyniecki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Detyniecki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Detyniecki has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich. Marcus Brunnert has received personal compensation for serving as an employee of UCB Biosciences GmbH. Rita Campos has received personal compensation for serving as an employee of UCB Inc. Rita Campos has received stock or an ownership interest from UCB Inc. Svetlana Dimova has received personal compensation for serving as an employee of UCB Pharma. Svetlana Dimova has received stock or an ownership interest from UCB Pharma. 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." @default.
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• W3157748139 date "2021-04-13" @default.
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• W3157748139 title "Return to Full Baseline Functionality After Repeated Intermittent Use of Midazolam Nasal Spray in Patients With Seizure Clusters: Post-Hoc Analysis of an Open-Label Extension Trial (1705)" @default.
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