A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
Primary Purpose
Epilepsy
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
USL261
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, seizure cluster, acute repetitive seizures, open-label, intranasal Midazolam, USL261, Upsher-Smith
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
USL261
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161185
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to slow enrollment. There were no safety concerns.
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, seizure cluster, acute repetitive seizures, open-label, intranasal Midazolam, USL261, Upsher-Smith
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
USL261
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
USL261
Other Intervention Name(s)
Intranasal Midazolam
Intervention Description
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Primary Outcome Measure Information:
Title
Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
Description
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
Time Frame
Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Secondary Outcome Measure Information:
Title
Treatment Success
Description
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.
Time Frame
Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TzeChiang Meng, MD
Organizational Affiliation
Proximagen, LLC
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Ventura
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Port Charlotte
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Saint Paul
State/Province
Minnesota
Country
United States
City
Reno
State/Province
Nevada
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
We'll reach out to this number within 24 hrs