Clinical trial NCT01529034: Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
Official title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
seizure clusters
acute repetitive seizures
rescue treatment
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 175
Sex: ALL
Minimum age (years): 12
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.

Detailed description: Participants who completed study P261-401 (NCT01390220), a randomized double-blind study of USL261 (intranasal midazolam) versus placebo to acutely treat a seizure cluster episode, were eligible to to enroll in this open-label extension study (P261-402). The participant's caregiver administered a USL261 5 milligram (mg) dose for a seizure episode meeting study criteria. A second USL261 5 mg dose could be administered after 10 minutes and up to 6 hours after the first dose for persistent or recurrent seizures, unless the participant met exclusions to administration of the second dose. A participant could have more than 1 seizure cluster episode treated during his/her study participation.

Eligibility criteria: 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

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

Primary outcomes:
measure: Duration of Safety Observation
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Participants Meeting Predefined Safety Criteria for Vital Signs
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Participants With Laboratory Abnormalities Meeting Predefined Criteria
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Participants With Clinically Significant Abnormalities Physical Examination
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Participants With Clinically Significant Abnormalities on Neurologic Examination
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Participants With Clinically Significant Abnormalities on Nasal Examination
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Participant Change in B-SIT Score
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Participants With Suicidal Ideation
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
measure: Emergency Room/Emergency Medical Service Visits
timeFrame: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
Secondary outcomes:
measure: Number of Treated Seizure Clusters Meeting Criteria for Treatment Success
timeFrame: 6 hours after first dose of USL261 for each treated seizure cluster
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: United States, Arizona
state: Arizona
city: Scottsdale
country: United States
facility: United States, Arizona
state: Arizona
city: Tucson
country: United States
facility: United States, Arizona
state: Arizona
city: Little Rock
country: United States
facility: United States, Arkansas
state: Arkansas
city: Fresno
country: United States
facility: United States, California
state: California
city: Sacramento
country: United States
facility: United States, California
state: California
city: Ventura
country: United States
facility: United States, California
state: California
city: Aurora
country: United States
facility: United States, Colorado
state: Colorado
city: New Haven
country: United States
facility: United States, Connecticut
state: Connecticut
city: Port Charlotte
country: United States
facility: United States, Florida
state: Florida
city: Wellington
country: United States
facility: United States, Florida
state: Florida
city: Boise
country: United States
facility: United States, Idaho
state: Idaho
city: Chicago
country: United States
facility: United States, Illinois
state: Illinois
city: Lexington
country: United States
facility: United States, Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: United States, Maryland
state: Maryland
city: Detroit
country: United States
facility: United States, Michigan
state: Michigan
city: Saint Paul
country: United States
facility: United States, Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: United States, Missouri
state: Missouri
city: Lebanon
country: United States
facility: United States, New Hampshire
state: New Hampshire
city: Hackensack
country: United States
facility: United States, New Jersey
state: New Jersey
city: Bronx
country: United States
facility: United States, New York
state: New York
city: New York
country: United States
facility: United States, New York
state: New York
city: Stony Brook
country: United States
facility: United States, New York
state: New York
city: Durham
country: United States
facility: United States, North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: United States, North Carolina
state: North Carolina
city: Oklahoma City
country: United States
facility: United States, Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: United States, Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: United States, Tennessee
state: Tennessee
city: Nashville
country: United States
facility: United States, Tennessee
state: Tennessee
city: Dallas
country: United States
facility: United States, Texas
state: Texas
city: Greenville
country: United States
facility: United States, Texas
state: Texas
city: Randwick
country: Australia
facility: Australia, New South Wales
state: New South Wales
city: Heidelberg west
country: Australia
facility: Australia, Victoria
state: Victoria
city: Parkville
country: Australia
facility: Australia, Victoria
state: Victoria
city: Montreal
country: Canada
facility: Canada
state: Ontario
city: Toronto
country: Canada
facility: Canada, Toronto
state: Ontario
city: Toronto
country: Canada
facility: Canada
state: Quebec
city: Munchen
country: Germany
facility: Germany
state: Bayern
city: Marberg
country: Germany
facility: Germany
state: Hessen
city: Bonn
country: Germany
facility: Germany
state: Nordrhein-Westfalen
city: Bielefeld
country: Germany
facility: Germany
state: Westfalen-Lippe
city: Budapest
country: Hungary
facility: Hungary
city: Haifa
country: Israel
facility: Israel
city: Petah Tikvah
country: Israel
facility: Israel
city: Ramat Gan
country: Israel
facility: Israel
city: Christchurch
country: New Zealand
facility: New Zealand
state: Canterbury
city: Gdansk
country: Poland
facility: Poland
city: Katowice
country: Poland
facility: Poland
city: Lublin
country: Poland
facility: Poland
city: Sevilla
country: Spain
facility: Spain
state: Andalucia
city: Gerona
country: Spain
facility: Spain
state: Cataluyna
city: Madrid
country: Spain
facility: Spain
city: Ivano-Frankivsk
country: Ukraine
facility: Ukraine
city: Kharkiv
country: Ukraine
facility: Ukraine
city: Odessa
country: Ukraine
facility: Ukraine
city: Poltava
country: Ukraine
facility: Ukraine
city: Ternopil
country: Ukraine
facility: Ukraine
city: Vinnytsa
country: Ukraine
facility: Ukraine
Study officials:
References:
citation: 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.
citation: 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.