Effectiveness of Midazolam for Seizure Cluster Management: Kamil Detyniecki, MD

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"The majority of patients, 97% with one dose and 94% with 2 doses, returned to full functionality in a single day of midazolam nasal spray administration. The study suggests that as patients use midazolam nasal spray more frequently, they tend to recover to full functionality more quickly, possibly reflecting improved efficiency in medication administration over time."

UCB’s Midazolam (Nayzilam) received FDA approval in May 2019 for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from usual seizure patterns in patients with epilepsy 12 years of age and older, according to the company.¹ The efficacy of midazolam was established in a phase 3 randomized, double-blind, placebo-controlled trial (NCT01390220) that was conducted in 2 phases: an open-label test dose phase followed by a comparative phase.

Newly published in Epilepsy & Behavior, a post hoc analysis on the phase 3 open-label extension (OLE) study (NCT01529034) assessing midazolam revealed that 90 minutes was the estimated median time to return to full baseline functionality (RTFBF) regardless of treatment with 1 or 2 doses among patients who experienced seizure clusters (SCs).² In the analysis, investigators assessed the time to RTFBF within 24 hours of midazolam administration in SCEs treated with 1 or 2 doses, all treated SCEs, and by the number of SCEs treated for each participant over the course of the study.

Recently, lead author Kamil Detyniecki, MD, associate professor of clinical neurology at the University of Miami Miller School of Medicine, sat down in an interview with NeurologyLive® to discuss how the recovery time with midazolam compares between patients using 1 and 2 doses of the therapy. He also talked about the factors that contribute to the consistent and rapid recovery of functionality observed in patients across nearly 2000 seizure cluster episodes. Additionally, Detyniecki explained why the study suggests that increased usage of midazolam correlates with a shorter time for patients to return to full functionality.

REFERENCES
1. UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S. News Release. UCB. Published May 20, 2019. Accessed November 20, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-NAYZILAM-midazolam-nasal-spray-now-approved-by-FDA-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-with-epilepsy-in-the-U-S
2. Detyniecki K, Brunnert M, Campos R, Dimova S, Wheless JW. 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. Epilepsy Behav. 2023;148:109435. doi:10.1016/j.yebeh.2023.109483