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A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters

This study has been terminated.
(Study terminated due to slow enrollment. There were no safety concerns.)
Information provided by (Responsible Party):
Upsher-Smith Laboratories Identifier:
First received: June 9, 2014
Last updated: June 17, 2016
Last verified: June 2016
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Condition Intervention Phase
Drug: USL261
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters

Resource links provided by NLM:

Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Long-term safety and tolerability [ Time Frame: approximately 2 years ]
    Adverse Events, clinical laboratory results, vital signs, respiration rate, the number of subjects requiring emergency rescue treatment, C-SSRS, physical, nasal, olfactory and neurological examination results

Secondary Outcome Measures:
  • Treatment success [ Time Frame: Approximately 2 years ]
    Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration

Enrollment: 7
Study Start Date: May 2014
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
USL261 Drug: USL261
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Other Name: Intranasal Midazolam


Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
  2. Has an established diagnosis of partial or generalized epilepsy that includes all the following:

    • A documented history of seizure clusters lasting a minumum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
    • A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition
    • A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
    • A seizure cluster pattern established >3 months before Visit 1
    • A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1
    • At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1
  3. Currently on a stable regimen of AED(s) that includes a benzodiazepine
  4. Weight is 40kg to 125 kg, inclusive

Exclusion Criteria:

  1. Has a neurological disorder that is likely to progress in the next year
  2. Has a severe chronic cardio-respiratory disease
  3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
  4. Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
  5. Has a history of acute narrow-angle glaucoma
  6. Has had active suicidal plan/intent or active sucidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02161185

United States, Arizona
Tucson, Arizona, United States
United States, California
Fresno, California, United States
Ventura, California, United States
United States, Colorado
Auroroa, Colorado, United States
United States, Florida
Port Charlotte, Florida, United States
Tampa, Florida, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Minnesota
St. Paul, Minnesota, United States
United States, Nevada
Reno, Nevada, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Upsher-Smith Laboratories
Study Director: Denis F Darko, M.D., F.A.C.P., D.F.A.P.A Upsher-Smith Laboratories, Inc.
  More Information

Responsible Party: Upsher-Smith Laboratories Identifier: NCT02161185     History of Changes
Other Study ID Numbers: P261-408
2014-001604-22 ( EudraCT Number )
Study First Received: June 9, 2014
Last Updated: June 17, 2016

Keywords provided by Upsher-Smith Laboratories:
seizure cluster
acute repetitive seizures
intranasal Midazolam

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 March 30, 2017