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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01529034




Registration number
NCT01529034
Ethics application status
Date submitted
3/02/2012
Date registered
8/02/2012
Date last updated
20/01/2023

Titles & IDs
Public title
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
Scientific title
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters
Secondary ID [1] 0 0
2011-004109-25
Secondary ID [2] 0 0
P261-402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: USL261 - Intranasal midazolam 5 mg
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Safety Observation
Timepoint [1] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [2] 0 0
Participants Meeting Predefined Safety Criteria for Vital Signs
Timepoint [2] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [3] 0 0
Participants With Laboratory Abnormalities Meeting Predefined Criteria
Timepoint [3] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [4] 0 0
Participants With Clinically Significant Abnormalities Physical Examination
Timepoint [4] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [5] 0 0
Participants With Clinically Significant Abnormalities on Neurologic Examination
Timepoint [5] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [6] 0 0
Participants With Clinically Significant Abnormalities on Nasal Examination
Timepoint [6] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [7] 0 0
Participant Change in B-SIT Score
Timepoint [7] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [8] 0 0
Participants With Suicidal Ideation
Timepoint [8] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Primary outcome [9] 0 0
Emergency Room/Emergency Medical Service Visits
Timepoint [9] 0 0
From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Secondary outcome [1] 0 0
Number of Treated Seizure Clusters Meeting Criteria for Treatment Success
Timepoint [1] 0 0
6 hours after first dose of USL261 for each treated seizure cluster

Eligibility
Key inclusion criteria
* Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
* Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has experienced status epilepticus during or since the P261-401 study
* In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
* Has a neurological disorder that is likely to progress in the next year
* Has a history of acute narrow-angle glaucoma
* Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
* Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
* Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
* Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
* Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Australia, New South Wales - Randwick
Recruitment hospital [2] 0 0
Australia, Victoria - Heidelberg west
Recruitment hospital [3] 0 0
Australia, Victoria - Parkville
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Heidelberg west
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Germany
State/province [24] 0 0
Bayern
Country [25] 0 0
Germany
State/province [25] 0 0
Hessen
Country [26] 0 0
Germany
State/province [26] 0 0
Nordrhein-Westfalen
Country [27] 0 0
Germany
State/province [27] 0 0
Westfalen-Lippe
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Israel
State/province [29] 0 0
Haifa
Country [30] 0 0
Israel
State/province [30] 0 0
Petah Tikvah
Country [31] 0 0
Israel
State/province [31] 0 0
Ramat Gan
Country [32] 0 0
New Zealand
State/province [32] 0 0
Canterbury
Country [33] 0 0
Poland
State/province [33] 0 0
Gdansk
Country [34] 0 0
Poland
State/province [34] 0 0
Katowice
Country [35] 0 0
Poland
State/province [35] 0 0
Lublin
Country [36] 0 0
Spain
State/province [36] 0 0
Andalucia
Country [37] 0 0
Spain
State/province [37] 0 0
Cataluyna
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Ukraine
State/province [39] 0 0
Ivano-Frankivsk
Country [40] 0 0
Ukraine
State/province [40] 0 0
Kharkiv
Country [41] 0 0
Ukraine
State/province [41] 0 0
Odessa
Country [42] 0 0
Ukraine
State/province [42] 0 0
Poltava
Country [43] 0 0
Ukraine
State/province [43] 0 0
Ternopil
Country [44] 0 0
Ukraine
State/province [44] 0 0
Vinnytsa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma S.P.R.L.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01529034
Trial related presentations / publications
Meng TC, Szaflarski JP, Chen L, Brunnert M, Campos R, Van Ess P, Pullman WE, Fakhoury T. Psychosocial outcomes of repeated treatment of seizure clusters with midazolam nasal spray: Results of a phase 3, open-label extension trial. Epilepsy Behav. 2023 Jan;138:108989. doi: 10.1016/j.yebeh.2022.108989. Epub 2022 Nov 18.
Wheless JW, Meng TC, Van Ess PJ, Detyniecki K, Sequeira DJ, Pullman WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters: An open-label extension trial. Epilepsia. 2019 Sep;60(9):1809-1819. doi: 10.1111/epi.16300. Epub 2019 Jul 29.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01529034