Clinical trial NCT02161185: A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
Official title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
seizure cluster
acute repetitive seizures
open-label
intranasal Midazolam
USL261
Upsher-Smith
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
2. 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
3. Currently on a stable regimen of AED(s) that includes a benzodiazepine
4. Weight is 40 kg to 125 kg, inclusive

Exclusion Criteria:

1. Has a neurological disorder that is likely to progress in the next year
2. Has a severe chronic cardio-respiratory disease
3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
4. Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
5. Has a history of acute narrow-angle glaucoma
6. 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

Primary outcomes:
measure: Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
timeFrame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Secondary outcomes:
measure: Treatment Success
timeFrame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Port Charlotte
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Saint Paul
country: United States
state: Minnesota
city: Reno
country: United States
state: Nevada
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Proximagen, LLC
name: TzeChiang Meng, MD
role: STUDY_DIRECTOR
References: