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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01529034
Recruitment Status : Terminated
First Posted : February 8, 2012
Last Update Posted : March 19, 2018
Information provided by (Responsible Party):
Proximagen, LLC

Brief Summary:
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters
Actual Study Start Date : July 2012
Actual Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261

Primary Outcome Measures :
  1. Long-term safety and tolerability [ Time Frame: 2 years ]
    Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01529034

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Sponsors and Collaborators
Proximagen, LLC

Responsible Party: Proximagen, LLC Identifier: NCT01529034     History of Changes
Other Study ID Numbers: P261-402
2011-004109-25 ( EudraCT Number )
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Proximagen, LLC:
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