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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161185
Recruitment Status : Terminated (Study terminated due to slow enrollment. There were no safety concerns.)
First Posted : June 11, 2014
Results First Posted : January 14, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE June 11, 2014
Results First Submitted Date  ICMJE September 25, 2018
Results First Posted Date  ICMJE January 14, 2019
Last Update Posted Date October 10, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation [ Time Frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months. ]
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
Long-term safety and tolerability [ Time Frame: approximately 2 years ]
Adverse Events, clinical laboratory results, vital signs, respiration rate, the number of subjects requiring emergency rescue treatment, C-SSRS, physical, nasal, olfactory and neurological examination results
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Treatment Success [ Time Frame: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months. ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
Treatment Success [ Time Frame: Approximately 2 years ]
Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
Official Title  ICMJE An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters
Brief Summary The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: USL261
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Other Name: Intranasal Midazolam
Study Arms  ICMJE USL261
Intervention: Drug: USL261
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 17, 2016)
7
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2014)
50
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02161185
Other Study ID Numbers  ICMJE P261-408
2014-001604-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: TzeChiang Meng, MD Proximagen, LLC
PRS Account UCB Pharma
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP