Back to resultsStudy to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
USL261
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, seizure clusters, acute repetitive seizures, rescue treatment
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
USL261
Placebo
Arm Description
5 mg intranasal midazolam
intranasal placebo
Outcomes
Primary Outcome Measures
Number of Participants That Were Seizure-free
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
Time to First Seizure Following Treatment (TFSFT)
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.
Full Information
NCT ID
NCT01999777
First Posted
November 25, 2013
Last Updated
October 8, 2019
Sponsor
UCB Biopharma S.P.R.L.
1. Study Identification
Unique Protocol Identification Number
NCT01999777
Brief Title
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
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 Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, seizure clusters, acute repetitive seizures, rescue treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
USL261
Arm Type
Experimental
Arm Description
5 mg intranasal midazolam
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
intranasal placebo
Intervention Type
Drug
Intervention Name(s)
USL261
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants That Were Seizure-free
Description
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."
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Time to First Seizure Following Treatment (TFSFT)
Description
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.
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
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Phoenix
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Vilnius
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Barcelona
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Madrid
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Spain
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Valencia
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Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33140403
Citation
Spencer DC, Sinha SR, Choi EJ, Cleveland JM, King A, Meng TC, Pullman WE, Sequeira DJ, Van Ess PJ, Wheless JW. Safety and efficacy of midazolam nasal spray for the treatment of intermittent bouts of increased seizure activity in the epilepsy monitoring unit: A double-blind, randomized, placebo-controlled trial. Epilepsia. 2020 Nov;61(11):2415-2425. doi: 10.1111/epi.16704. Epub 2020 Nov 2.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
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