CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
USL261 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01999777
NCT01999777Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Midazolam Intranasal Spray (USL261) for the Treatment of Intermittent Bouts of Increased Seizure Activity in the Epilepsy Monitoring Unit (EMU)

UCB Biopharma S.P.R.L.·interventional·Posted Dec 3, 2013·Updated Oct 10, 2019

In Brief

A Phase 3 clinical trial evaluating USL261 and Placebo for Epilepsy. Completed, enrolled 62 participants across 51 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Austria, Belgium, Czechia, Germany, Lithuania, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 3, 2013
Enrollment StartNov 1, 2013
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.6 years ago

Interventions

USL261drug

Placebodrug