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 June 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: June 9, 2014
Last verified: June 2014
  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. ARTEMIS-1: Acute Rescue Therapy in Epilepsy With Midazolam Intranasal Spray-1

Resource links provided by NLM:


Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 155
Study Start Date: June 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261
Experimental: Placebo
Intranasal 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390220

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

  Hide Study Locations
Locations
United States, Arizona
United States, Arizona Recruiting
Phoenix, Arizona, United States
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United States, Arizona Terminated
Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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United States, Arkansas
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Little Rock, Arkansas, United States
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Loma Linda, California, United States
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Hungary
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Ukraine
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Ivano-Frankivsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Ukraine, Kharkiv Recruiting
Kharkiv, Ukraine
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Ukraine, Odessa Terminated
Odessa, Ukraine
Ukraine, Ternopil Recruiting
Ternopil, Ukraine
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Ukraine, Vinnytsya Recruiting
Vinnytsya, Ukraine
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Ukraine, Zaporizhzhya Withdrawn
Zaporizhzhya, Ukraine
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

Additional 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: June 9, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014