A study published in Neurology questioned how long patients needed to return to full baseline functionality (FBF) after repeated intermittent use of midazolam nasal spray (MDZ-NS) to treat seizure clusters (SCs).
“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,” the study authors explained.
ARTEMIS-2/P261-402 was a phase III, open-label extension trial to determine the safety of intermittent MDZ-NS use among patients aged ≥12 years. Patients received MDZ-NS 5 mg for an SC and received a second 5 mg dose if their seizure did not stop within 10 minutes or recurred within six hours.
Overall, 1,996 SC episodes (SCEs), including 1,201 for which one MDZ-NS dose was required and 795 that necessitated two doses, occurred in 161 patients. Within 24 hours of MDZ-NS administration, among patients who received one dose, 97.2% returned to FBF within 24 hours; in the two-dose group, 94.2% of patients were back to FBF within 24 hours of administration. The median time to FBF was 1.2 hours in the single-dose group and 1.3 hours in the double-dose group. There were no significant differences in the profile of return to FBF between the groups.
“The vast majority of patients returned to FBF within 24 [hours] 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,” the study authors wrote in their conclusion.
Source: Neurology (https://n.neurology.org/content/96/15_Supplement/1705.abstract)