Trial record 2 of 4 for:    USL261

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01999777
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : September 27, 2017
Information provided by (Responsible Party):
Proximagen, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: USL261 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Study Start Date : November 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261
Placebo Comparator: Placebo
intranasal placebo
Drug: Placebo

Primary Outcome Measures :
  1. Proportion of subjects that are seizure-free [ Time Frame: 6 hours ]
    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 :
  1. Time to first seizure following treatment (TFSFT) [ Time Frame: 6 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01999777

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Sponsors and Collaborators
Proximagen, LLC

Responsible Party: Proximagen, LLC Identifier: NCT01999777     History of Changes
Other Study ID Numbers: USL261-301
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: June 2016

Keywords provided by Proximagen, LLC:
seizure clusters
acute repetitive seizures
rescue treatment

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