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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01390220




Registration number
NCT01390220
Ethics application status
Date submitted
6/07/2011
Date registered
8/07/2011
Date last updated
10/10/2019

Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
Scientific 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
Secondary ID [1] 0 0
2011-001318-32
Secondary ID [2] 0 0
P261-401
Universal Trial Number (UTN)
Trial acronym
ARTEMIS1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: USL261 - intranasal midazolam 5mg

Experimental: Placebo - Intranasal placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP)
Timepoint [1] 0 0
6 hours
Secondary outcome [1] 0 0
Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose
Timepoint [1] 0 0
4 hours
Secondary outcome [2] 0 0
Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose
Timepoint [2] 0 0
24 hours
Secondary outcome [3] 0 0
Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose
Timepoint [3] 0 0
24 hours

Eligibility
Key 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 anti-epileptic drugs (AEDs) with 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 40 kg to 125 kg, inclusive
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australia, New South Wales - Chatswood
Recruitment hospital [2] 0 0
Australia, New South Wales - Randwick
Recruitment hospital [3] 0 0
Australia, Queensland - Herston
Recruitment hospital [4] 0 0
Australia, Vctoria - Heidelberg West
Recruitment hospital [5] 0 0
Australia, Victoria - Parkville
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Heidelberg West
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment outside Australia
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Arizona
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Hessen
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Jerusalem
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Petach Tikva
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Ramat Gan
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Pavia
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Auklund
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Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma S.P.R.L.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.
Trial website
https://clinicaltrials.gov/study/NCT01390220
Trial related presentations / publications
Detyniecki K, Van Ess PJ, Sequeira DJ, Wheless JW, Meng TC, Pullman WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters-a randomized, double-blind, placebo-controlled trial. Epilepsia. 2019 Sep;60(9):1797-1808. doi: 10.1111/epi.15159. Epub 2019 May 29.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01390220