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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Drugs - USL261
Treatment: Drugs - Placebo

Experimental: USL261 - intranasal midazolam 5mg

Experimental: Placebo - Intranasal placebo


Treatment: Drugs: USL261


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
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) - Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after double-blind study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration. Participants who received the open-label second dose within 6 hours of administration of the double-blind dose were analyzed as having had a seizure.
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 - Participants with recurrence of seizure(s) >10 minutes and up to 4 hours after administration of the double-blind dose in the CP. Participants who received the open-label second dose within 4 hours of administration of the double-blind dose were analyzed as having had a seizure.
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 - Occurrence of next seizure with a start time >10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.
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 - Time to next seizure with a start time >10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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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/show/NCT01390220
Trial related presentations / publications
Public notes

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

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