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 May 2016 by Upsher-Smith Laboratories

Sponsor:

Information provided by (Responsible Party):

Upsher-Smith Laboratories

ClinicalTrials.gov Identifier:

NCT01390220

First received: July 6, 2011

Last updated: May 25, 2016

Last verified: May 2016

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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Midazolam maleate Midazolam hydrochloride

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. [ 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:	204
Study Start Date:	June 2011
Estimated Primary Completion Date:	March 2017 (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:	12 Years and older (Child, Adult, Senior)
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

Show 127 Study Locations

Sponsors and Collaborators

Upsher-Smith Laboratories

More Information


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:	May 25, 2016
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 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

ClinicalTrials.gov processed this record on September 27, 2016

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