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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

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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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Idaho
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Illinois
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Kansas
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Kentucky
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Michigan
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Minnesota
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Missouri
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North Carolina
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Baden-Wurttemberg
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Bayern
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Hessen
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Nordrhein-Westfalen
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Wetsfalen-Lippe
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Budapest
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Haifa
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Holon
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Israel
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Jerusalem
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Firenze
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Genova
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Milano
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Italy
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Napoli
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Italy
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Pavia
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Italy
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San Fermo della Battaglia
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Auklund
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Canterbury
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Gdansk
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Catalonia
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Madrid
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Ivano-Frankivsk
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Kharkiv
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Odessa
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Poltava
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Ternopil
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Ukraine
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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
Trial website
Trial related presentations / publications
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01390220