Abstract
•Post hoc analysis of open-label extension trial in patients with seizure clusters.•>94% patients returned to full baseline functionality ≤24h of MDZ-NS administration.•Time to return to full baseline functionality was similar after 1 or 2 5-mg doses.•Profile of return was similar in seizure cluster episodes treated with 1 or 2 doses.•Thus, the dose (5 or 10 mg) does not seem to be a key influencer of time to return.
To characterize time to return to full baseline functionality (RTFBF) in seizure cluster episodes (SCEs) treated with one or two midazolam nasal spray (MDZ-NS/Nayzilam®) doses over the course of repeated intermittent use in patients with seizure clusters (SCs).
Post hoc analysis of open-label extension trial in patients (≥12 years) with SCs (ARTEMIS-2/P261-402: NCT01529034, 2011‐004109‐25). Caregivers administered MDZ‐NS 5 mg when patients experienced an SC; second 5-mg dose could be given if seizures did not terminate within 10 min or recurred within 10 min–6 h. Outcomes: time to RTFBF within 24 h of MDZ-NS administration in SCEs treated with one or two doses, overall (all treated SCEs), and by number of treated SCEs for each patient over the course of the trial (Kaplan-Meier analyses). Time to RTFBF was assessed from time of MDZ-NS administration in SCEs treated with one dose, and from time of second dose in SCEs treated with two doses.
1,996 treated SCEs (one dose: 1,201 [60.2%]; two doses: 795 [39.8%]) in 161 patients were evaluable. In SCEs treated with one or two doses, RTFBF within 24 h of MDZ-NS administration was observed in 97.2% and 94.2% patients; estimated median time was 1.2 and 1.3 h and stable from 1–45 treated SCEs. RTFBF profile was generally similar in SCEs treated with one or two doses (30% patients estimated to RTFBF within 30 min, almost 50% within 1 h); proportion of patients with RTFBF between 2–6 h was slightly higher with one versus two doses.
In almost all patients, RTFBF was observed within 24 h of MDZ-NS administration. Median time to RTFBF was similar in SCEs treated with one or two doses, and stable over the course of repeated intermittent use. Thus, dose (5 or 10 mg) does not seem to be a key influencer of time to RTFBF after repeated intermittent use.
