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Study to Evaluate the Safety and Effectiveness 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:
NCT01390220
First received: July 6, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.


Condition Intervention Phase
Epilepsy
 Drug: USL261
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (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:
  • Proportion of subjects who meet the criteria for Treatment Success. [ Designated as safety issue: No ]
    Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after study drug administration, and 2) no recurrence of seizure(s) within 4 hours after study drug administration.


Secondary Outcome Measures:
  • Occurrence of seizure(s) within 6 hours after study drug administration.
  • Time to next seizure after study drug administration.
  • Frequency of seizure(s) within 6 hours after administration of study drug.

Estimated Enrollment: 155
Study Start Date: June 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261 Drug: USL261
Experimental: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   14 Years to 65 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 an established diagnosis of partial or generalized epilepsy that includes the following:

    • A documented history of seizure clusters lasting > 10 minutes and < 6 hours, with a pattern that is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity, if any;
    • 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 ≥ 4 seizure clusters during the year before Visit 1;
    • At least 1 seizure cluster occurring ≤ 3 months before Visit 1;
    • Seizure cluster pattern is confirmed by a central reviewer
  • Currently on a stable dosing regimen of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose

Exclusion Criteria:

  • Has a neurological disorder that is likely to progress in the next year
  • Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
  • Has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1 or has a history of seizure clusters progressing to status epilepticus despite therapeutic intervention
  • Have a history of acute narrow-angle glaucoma.
  • Has had an active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or any lifetime suicide attempt
  • Taking felbamate for less than 18 consecutive months before Visit 1 or has discontinued felbamate within 30 days before Visit 1
  • Currently taking or has taken vigabatrin within 1 year before Visit 1
  • Taken vigabatrin in the past and has either no documentation of visual field exam or documentation on an abnormal visual field exam
  • Currently using a VNS unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390220

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

  Show 73 Study Locations
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01390220     History of Changes
Other Study ID Numbers: P261-401, 2011-001318-32
Study First Received: July 6, 2011
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 June 17, 2013