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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.
Verified April 2013 by Upsher-Smith Laboratories
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01529034
First received: February 3, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Epilepsy
 Drug: USL261
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
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:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Long-term safety and tolerability [ Designated as safety issue: Yes ]
    Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS


Secondary Outcome Measures:
  • Treatment Success [ Designated as safety issue: No ]
    Termination of seizure(s) within 10 minutes and no recurrence within 4 hours after study drug administration


Estimated Enrollment: 155
Study Start Date: July 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261 Drug: USL261

  Eligibility

Ages Eligible for Study:   14 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529034

Contacts
Contact: Gerrit Ross 1-866-372-0526

  Show 31 Study Locations
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01529034     History of Changes
Other Study ID Numbers: P261-402, 2011-004109-25
Study First Received: February 3, 2012
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
Epilepsy
seizure clusters
acute repetitive seizures
rescue treatment

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013