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 |
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Recruitment Status :
Completed
First Posted : December 3, 2013
Results First Posted : November 27, 2018
Last Update Posted : October 10, 2019
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Sponsor:
UCB Biopharma S.P.R.L.
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )
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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 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
Genetics Home Reference related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
| Arm | Intervention/treatment |
|---|---|
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Experimental: USL261
5 mg intranasal midazolam
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Drug: USL261 |
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Placebo Comparator: Placebo
intranasal placebo
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Drug: Placebo |
Primary Outcome Measures :
- 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 :
- 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.
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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
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
Locations
Show 51 study locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
| Responsible Party: | UCB Biopharma S.P.R.L. |
| ClinicalTrials.gov Identifier: | NCT01999777 |
| Other Study ID Numbers: |
USL261-301 |
| First Posted: | December 3, 2013 Key Record Dates |
| Results First Posted: | November 27, 2018 |
| Last Update Posted: | October 10, 2019 |
| Last Verified: | October 2019 |
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
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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 Midazolam Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |