Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU

NCT01999777 ↗

Phase 3 Completed 62 enrolled UCB Biopharma S.P.R.L.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.

Timeline

Start: 2013-11
Primary completion: 2015-08
Completion: 2015-08

Outcome

Missed primary endpoint

registry analysis (superiority test); USL261 vs Placebo; p = 0.1972; Wald asymptotic NCT01999777 ↗

paper the 16.1% difference was not statistically significant (P = .1972). PMID 33140403 ↗

Publications

Spencer DC, Sinha SR, Choi EJ, Cleveland JM, King A, Meng TC, Pullman WE, Sequeira DJ, Van Ess PJ, Wheless JW. Safety and efficacy of midazolam nasal spray for the treatment of intermittent bouts of increased seizure activity in the epilepsy monitoring unit: A double-blind, randomized, placebo-controlled trial. Epilepsia. 2020 Nov;61(11):2415-2425. doi: 10.1111/epi.16704. Epub 2020 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	5 mg	Intranasal