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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: April 17, 2015
Last verified: April 2015
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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration

Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Primary Completion Date: June 2016 (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
Genders Eligible for Study:   Both
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 
Study First Received: June 9, 2014
Last Updated: April 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
seizure cluster
acute repetitive seizures
intranasal Midazolam
Upsher-Smith processed this record on May 26, 2016