Clinical trial NCT04715646: A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Official title: Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Brivaracetam
Pediatric
Child
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-01-20
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Detailed description: EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 \[NCG03325439\] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 \[NCT01364597\]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for long-term follow-up (LTFU) study participants only

* Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]

Inclusion criteria for directly enrolled (DE) study participants in Japan only

* Study participant is ≥ 4 years to \< 16 years of age
* Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
* Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
* Study participant had at least 1 POS during the 4-week Screening Period

Exclusion Criteria:

Exclusion criteria for all study participants

* Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
* Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).

Exclusion criteria for long-term follow-up (LTFU) study participants only

- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)

Exclusion criteria for directly enrolled (DE) study participants in Japan only

* Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
* Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
* Study participant has any clinically significant illness
* Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
* Study participant has a clinically significant ECG abnormality
* Study participant had major surgery within 6 months prior to the ScrV

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) during the study
timeFrame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
measure: Incidence of treatment-emergent serious adverse events (SAEs) during the study
timeFrame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
measure: Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study
timeFrame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Ep0156 259
state: New York
city: Durham
country: United States
facility: Ep0156 237
state: North Carolina
city: Leuven
country: Belgium
facility: Ep0156 204
city: Praha 4
country: Czechia
facility: Ep0156 240
city: Loos
country: France
facility: Ep0156 207
city: Freiburg
country: Germany
facility: Ep0156 209
city: Budapest
country: Hungary
facility: Ep0156 210
city: Budapest
country: Hungary
facility: Ep0156 247
city: Miskolc
country: Hungary
facility: Ep0156 232
city: Roma
country: Italy
facility: Ep0156 230
city: Bunkyo-ku
country: Japan
facility: Ep0156 803
city: Chuo
country: Japan
facility: Ep0156 808
city: Gifu-City
country: Japan
facility: Ep0156 800
city: Hiroshima
country: Japan
facility: Ep0156 807
city: Koshi
country: Japan
facility: Ep0156 813
city: Kyoto
country: Japan
facility: Ep0156 806
city: Nagoya
country: Japan
facility: Ep0156 811
city: Niigata-city
country: Japan
facility: Ep0156 812
city: OBU
country: Japan
facility: Ep0156 818
city: Omura
country: Japan
facility: Ep0156 819
city: Osaka
country: Japan
facility: Ep0156 817
city: Sapporo-city
country: Japan
facility: Ep0156 805
city: Shimotsuke
country: Japan
facility: Ep0156 809
city: Shizuoka
country: Japan
facility: Ep0156 814
city: Tokyo
country: Japan
facility: Ep0156 804
city: Yokohama
country: Japan
facility: Ep0156 810
city: Yonago
country: Japan
facility: Ep0156 802
city: Aguascalientes
country: Mexico
facility: Ep0156 223
city: Culiacan
country: Mexico
facility: Ep0156 609
city: Guadalajara
country: Mexico
facility: Ep0156 603
city: Kielce
country: Poland
facility: Ep0156 406
city: Krakow
country: Poland
facility: Ep0156 402
city: Poznan
country: Poland
facility: Ep0156 401
city: Sevilla
country: Spain
facility: Ep0156 248
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: