Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01390220
• Date of registration: 06/07/2011
• Prospective Registration: No
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters ARTEMIS1
• 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
• Date of first enrolment: June 2011
• Target sample size: 292
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01390220
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Germany, Hungary, Israel, Italy, New Zealand, Poland, Spain, Ukraine, United States

Key inclusion & exclusion 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 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

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



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: USL261

Drug: Placebo

Primary Outcome(s)

Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP) [Time Frame: 6 hours]

Secondary Outcome(s)

Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose [Time Frame: 24 hours]

Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose [Time Frame: 4 hours]

Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose [Time Frame: 24 hours]

Secondary ID(s)

2011-001318-32

P261-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01390220