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Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters (ARTEMIS1)
This study has been terminated.
Sponsor:
Upsher-Smith Laboratories
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01390220
First received: July 6, 2011
Last updated: April 24, 2017
Last verified: April 2017
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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: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
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 ]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 ]
- Time to next seizure with a start time > 10 minutes after study drug administration. [ Time Frame: 24 hours ]
| Enrollment: | 201 |
| Study Start Date: | June 2011 |
| 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) |
| 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
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
Show 133 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390220
Show 133 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 ( EudraCT Number ) |
| Study First Received: | July 6, 2011 |
| Last Updated: | April 24, 2017 |
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 June 23, 2017