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Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters (ARTEMIS1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Upsher-Smith Laboratories
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01390220
First received: July 6, 2011
Last updated: October 27, 2014
Last verified: October 2014

July 6, 2011
October 27, 2014
June 2011
October 2014   (final data collection date for primary outcome measure)
Proportion of subjects who meet the criteria for Treatment Success. [ Time Frame: 6 hours ] [ 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) beginning 10 minutes after study drug administration to 6 hours after study drug administration.
Proportion of subjects who meet the criteria for Treatment Success.
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.
Complete list of historical versions of study NCT01390220 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with recurrence of seizure(s) beginning 10 minutes after study drug administration to 4 hours after study drug administration. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Time to next seizure with a start time > 10 minutes after study drug administration. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
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. ARTEMIS-1: Acute Rescue Therapy in Epilepsy With Midazolam Intranasal Spray-1

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

Not Provided
Interventional
Phase 3
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Epilepsy
  • Drug: USL261
  • Drug: Placebo
  • Experimental: USL261
    5 mg intranasal midazolam
    Intervention: Drug: USL261
  • Experimental: Placebo
    Intranasal placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
155
Not Provided
October 2014   (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 an established diagnosis of partial or generalized epilepsy that includes the following:

    • A documented history of seizure clusters lasting a minimum of 10 minutes
    • Seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
    • A second seizure in the seizure cluster typically occurring within 6 hours from the time of cluster recognition
    • 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 ≥ 3 seizure clusters during the year before Visit 1
    • At least 1 seizure cluster occurring ≤ 4 months before Visit 1
    • Seizure cluster pattern is confirmed by a central reviewer
  • Currently on a stable regimen of AEDs (no changes in type of AEDs) since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose
  • Weight is 40kg to 125kg, inclusive

Exclusion Criteria:

  • Has a neurological disorder that is likely to progress in the next year
  • Has severe chronic cardio-respiratory disease
  • 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
  • Has a history of acute narrow-angle glaucoma.
  • Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
  • 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
Both
14 Years to 65 Years
No
Contact: Gerrit Ross 1-866-372-0526
United States,   Australia,   Canada,   Germany,   Hungary,   Israel,   Italy,   New Zealand,   Poland,   Spain,   Ukraine
 
NCT01390220
P261-401, 2011-001318-32
Yes
Upsher-Smith Laboratories
Upsher-Smith Laboratories
Not Provided
Not Provided
Upsher-Smith Laboratories
October 2014

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