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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: USL261; Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	201 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
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
Study Start Date :	June 2011
Actual Primary Completion Date :	March 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: USL261; 5 mg intranasal midazolam	Drug: USL261
Experimental: Placebo; Intranasal placebo	Drug: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Proportion of subjects who meet the criteria for Treatment Success. [ Time Frame: 6 hours ]
   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 :

1. 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 ]
2. Time to next seizure with a start time > 10 minutes after study drug administration. [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 133 Study Locations

Sponsors and Collaborators

Proximagen, LLC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Proximagen, LLC
ClinicalTrials.gov Identifier:	NCT01390220 History of Changes
Other Study ID Numbers:	P261-401; 2011-001318-32 ( EudraCT Number )
First Posted:	July 8, 2011
Last Update Posted:	March 19, 2018
Last Verified:	March 2018

Keywords provided by Proximagen, LLC:

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; Hypnotics and Sedatives; Central Nervous System Depressants	Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action