A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters

Study Overview
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Brief Summary
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The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Official Title
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An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: USL261


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes Has an established diagnosis of partial or generalized epilepsy that includes all 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 occurs within 6 hours from the time of 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 stereotyped seizure clusters during the year before Visit 1 At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1 Currently on a stable regimen of AED(s) that includes a benzodiazepine Weight is 40 kg to 125 kg, inclusive Exclusion Criteria: Has a neurological disorder that is likely to progress in the next year Has a severe chronic cardio-respiratory disease Has a 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 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: USL261<br> | Drug: USL261<br>* 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol<br>* Other names: Intranasal Midazolam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation | Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study | Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success | Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration. Due to early termination of the study, this data was not analyzed. | Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, seizure cluster, acute repetitive seizures, open-label, intranasal Midazolam, USL261, Upsher-Smith