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Trial record 3 of 6 for:    acute rescue therapy in epilepsy

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

This study has been completed.
Information provided by (Responsible Party):
Upsher-Smith Laboratories Identifier:
First received: November 25, 2013
Last updated: June 15, 2016
Last verified: June 2016
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 Intervention Phase
Drug: USL261
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Proportion of subjects that are seizure-free [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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:
  • Time to first seizure following treatment (TFSFT) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: November 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261
Placebo Comparator: Placebo
intranasal placebo
Drug: Placebo


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01999777

  Show 51 Study Locations
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

Responsible Party: Upsher-Smith Laboratories Identifier: NCT01999777     History of Changes
Other Study ID Numbers: USL261-301 
Study First Received: November 25, 2013
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration
Australia:Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care (AGES)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control (SUKL)
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Spain: Spanish Agency of Medicines Product and Health Devices
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Upsher-Smith Laboratories:
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
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 25, 2016