Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters

NCT01390220 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2019-10-10

Study results available
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Summary

The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.

Conditions

Interventions

DRUG

USL261

DRUG

Placebo

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01390220 on ClinicalTrials.gov