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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01999777

Public ClinicalTrials.gov record NCT01999777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 9:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01999777
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
UCB Biopharma S.P.R.L.
Industry
Enrollment
62 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2013 (Type not available)
Primary completion
Aug 2015 (Actual)
Completion
Aug 2015 (Actual)
Last update posted
Oct 10, 2019

2013 – 2015

United States locations

U.S. sites
37
U.S. states
24
U.S. cities
37
Facility City State ZIP Site status
Not listed Phoenix Arizona — —
Not listed Tucson Arizona — —
Not listed La Jolla California — —
Not listed Orange California — —
Not listed San Francisco California — —
Not listed Denver Colorado — —
Not listed Englewood Colorado — —
Not listed New Haven Connecticut — —
Not listed Tampa Florida — —
Not listed Augusta Georgia — —
Not listed Chicago Illinois — —
Not listed Winfield Illinois — —
Not listed Wichita Kansas — —
Not listed New Orleans Louisiana — —
Not listed Boston Massachusetts — —
Not listed Ann Arbor Michigan — —
Not listed Grand Rapids Michigan — —
Not listed Jackson Mississippi — —
Not listed St Louis Missouri — —
Not listed Lebanon New Hampshire — —
Not listed Edison New Jersey — —
Not listed Brooklyn New York — —
Not listed Rochester New York — —
Not listed Chapel Hill North Carolina — —
Not listed Durham North Carolina — —
Not listed Winston-Salem North Carolina — —
Not listed Columbus Ohio — —
Not listed Oklahoma City Oklahoma — —
Not listed Portland Oregon — —
Not listed Hershey Pennsylvania — —
Not listed Philadelphia Pennsylvania — —
Not listed Memphis Tennessee — —
Not listed Nashville Tennessee — —
Not listed Dallas Texas — —
Not listed San Antonio Texas — —
Not listed Temple Texas — —
Not listed Madison Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01999777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 10, 2019 · Synced Oct 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01999777 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →