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

• 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: Proximagen, LLC
• Information provided by (Responsible Party): Proximagen, LLC

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

• 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

  Show 51 Study Locations

Sponsors and Collaborators

Proximagen, LLC

More Information

• Responsible Party: Proximagen, LLC
• ClinicalTrials.gov Identifier: NCT01999777 History of Changes
• Other Study ID Numbers: USL261-301
• First Posted: December 3, 2013
• 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:

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