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Trial record 3 of 6 for:    acute rescue therapy in epilepsy

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Upsher-Smith Laboratories
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01999777
First received: November 25, 2013
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: USL261
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Proportion of subjects that are seizure-free [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    The difference between the USL261- and placebo-treated groups in the proportion of subjects that are seizure-free (no clinically observable seizures) during the Treatment Phase


Secondary Outcome Measures:
  • Time to first seizure following treatment (TFSFT) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261
Placebo Comparator: Placebo
intranasal placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has been admitted to the institution's EMU for seizure characterization or pre-surgical evaluation, or such admission is planned within 28 days
  • Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive)
  • Subject has an established diagnosis of partial or generalized epilepsy

Exclusion Criteria:

  • Subject has history of status epilepticus in the 6 months prior to Screening
  • Subject has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS)disease that is likely to progress in the next 12 months
  • Subject has respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
  • Subject has acute narrow-angle glaucoma
  • Subject is receiving chronic benzodiazepine treatment (defined as an average of ≥ 4 administrations per week) and cannot safely withdraw from such treatment within the washout period prior to treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999777

Contacts
Contact: Yolonda Scales 1-800-908-6097

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States
Recruiting
Tuscon, Arizona, United States
United States, California
Recruiting
San Diego, California, United States
Recruiting
San Francisco, California, United States
United States, Colorado
Recruiting
Denver, Colorado, United States
United States, Florida
Recruiting
Tampa, Florida, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
Recruiting
Winfield, Illinois, United States
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States
United States, New Jersey
Recruiting
Edison, New Jersey, United States
United States, New York
Recruiting
Brooklyn, New York, United States
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States
Recruiting
Durham, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Recruiting
Columbus, Ohio, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Tennessee
Recruiting
Memphis, Tennessee, United States
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Recruiting
Temple, Texas, United States
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01999777     History of Changes
Other Study ID Numbers: USL261-301
Study First Received: November 25, 2013
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
Epilepsy
seizure clusters
acute repetitive seizures
rescue treatment

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014