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

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ClinicalTrials.gov Identifier: NCT01999777
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Proximagen, LLC

Study Description
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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 Design
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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

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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants That Were Seizure-free [ Time Frame: 6 hours ]
    A participant was considered "seizure-free" if he or she completed the 6-hour Treatment Phase without seizures recorded, premature discontinuation of study drug, rescue intervention for acute central respiratory depression adverse event (AE), and alterations to background anti-epileptic drug (AED) therapy. Otherwise, the participant was included in the analysis for seizure-free events with the outcome of "seizure."


Secondary Outcome Measures :
  1. Time to First Seizure Following Treatment (TFSFT) [ Time Frame: 6 hours ]
    Time to first seizure following treatment was defined as time from treatment with study drug to the onset of the next seizure, rescue intervention (for acute central respiratory depression AE) to maintain subject safety, alterations to background AED therapy, early termination, or 6 hours, whichever came first.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01999777


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Sponsors and Collaborators
Proximagen, LLC
More Information
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Responsible Party: Proximagen, LLC
ClinicalTrials.gov Identifier: NCT01999777     History of Changes
Other Study ID Numbers: USL261-301
First Posted: December 3, 2013    Key Record Dates
Results First Posted: November 27, 2018
Last Update Posted: November 27, 2018
Last Verified: October 2018

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

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