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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01529034
First received: February 3, 2012
Last updated: May 19, 2017
Last verified: May 2017
February 3, 2012
May 19, 2017
July 2012
April 2017   (Final data collection date for primary outcome measure)
Long-term safety and tolerability [ Time Frame: 2 years ]
Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS
Long-term safety and tolerability
Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS
Complete list of historical versions of study NCT01529034 on ClinicalTrials.gov Archive Site
Treatment Success [ Time Frame: 6 hours ]
Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration
Treatment Success
Termination of seizure(s) within 10 minutes and no recurrence within 4 hours after study drug administration
Not Provided
Not Provided
 
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Epilepsy
Drug: USL261
Experimental: USL261
5 mg intranasal midazolam
Intervention: Drug: USL261
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
175
Not Provided
April 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Germany,   Hungary,   Israel,   Italy,   New Zealand,   Poland,   Spain,   Ukraine,   United States
 
 
NCT01529034
P261-402
2011-004109-25 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Upsher-Smith Laboratories
Upsher-Smith Laboratories
Not Provided
Not Provided
Upsher-Smith Laboratories
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP