Study Stopped
Study terminated due to slow enrollment. There were no safety concerns.
A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters
2 other identifiers
interventional
7
1 country
16
Brief Summary
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2014
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
January 14, 2019
CompletedOctober 10, 2019
October 1, 2019
1 year
June 9, 2014
September 25, 2018
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Treatment Success
Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Study Arms (1)
USL261
OTHERInterventions
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Ventura, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Port Charlotte, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Saint Paul, Minnesota, United States
Unknown Facility
Reno, Nevada, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination due to poor enrollment leading to small numbers of subjects analyzed for safety. Efficacy was not analyzed.
Results Point of Contact
- Title
- David Sequeira,
- Organization
- Proximagen, LLC
Study Officials
- STUDY DIRECTOR
TzeChiang Meng, MD
Proximagen, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2014
First Posted
June 11, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 10, 2019
Results First Posted
January 14, 2019
Record last verified: 2019-10