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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Epilepsy

In brief

The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.

Key facts

Study ID

NCT01390220

Run by

UCB Biopharma S.P.R.L.

People needed

292

Starts

2011-06-01

Expected to finish

2017-03-01

Last updated by the study team

2019-10-10

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• United States, Arizona — Tucson, Arizona, United States
• United States, Arkansas — Little Rock, Arkansas, United States
• United States, California — Fresno, California, United States
• United States, California — Irvine, California, United States
• United States, California — Loma Linda, California, United States
• United States, California — Sacramento, California, United States
• United States, California — Ventura, California, United States
• United States, Colorado — Aurora, Colorado, United States
• United States, Connecticut — New Haven, Connecticut, United States
• United States, Florida — Gainesville, Florida, United States
• United States, Florida — Gulf Breeze, Florida, United States
• United States, Florida — Port Charlotte, Florida, United States
• United States, Florida — Tampa, Florida, United States
• United States, Florida — Wellington, Florida, United States
• United States, Idaho — Boise, Idaho, United States
• United States, Illinois — Chicago, Illinois, United States
• United States, Kansas — Manhattan, Kansas, United States
• United States, Kentucky — Lexington, Kentucky, United States
• United States, Maryland — Baltimore, Maryland, United States
• United States, Michigan — Detroit, Michigan, United States
• United States, Minnesota — Saint Paul, Minnesota, United States
• United States, Missouri — Chesterfield, Missouri, United States
• United States, Missouri — St Louis, Missouri, United States
• United States, Nevada — Reno, Nevada, United States
• United States, Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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