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Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Upsher-Smith Laboratories
Information provided by (Responsible Party):
Upsher-Smith Laboratories Identifier:
First received: February 3, 2012
Last updated: November 21, 2016
Last verified: November 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 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: 2 years ]
    Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS

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

Estimated Enrollment: 204
Study Start Date: July 2012
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
  • Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator

Exclusion Criteria:

  • Has experienced status epilepticus during or since the P261-401 study
  • In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
  • Has a neurological disorder that is likely to progress in the next year
  • Has a history of acute narrow-angle glaucoma
  • Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
  • Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
  • Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
  • Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
  • Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401
  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: NCT01529034

Contact: Gerrit Ross 1-866-372-0526

  Show 79 Study Locations
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

Responsible Party: Upsher-Smith Laboratories Identifier: NCT01529034     History of Changes
Other Study ID Numbers: P261-402
2011-004109-25 ( EudraCT Number )
Study First Received: February 3, 2012
Last Updated: November 21, 2016

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 processed this record on April 27, 2017