A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
- Registration Number
- NCT04715646
- Lead Sponsor
- UCB Biopharma SRL
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam Brivaracetam LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) during the study From Evaluation Visit (Day 1) until Safety Visits (up to 5 years) An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Incidence of treatment-emergent serious adverse events (SAEs) during the study From Evaluation Visit (Day 1) until Safety Visits (up to 5 years) A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
* Results in death
* Is life-threatening
* Requires inpatient hospitalization or prolongation of existing hospitalization
* Results in persistent disability/incapacity
* Is a congenital anomaly or birth defect
* Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the aboveIncidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study From Evaluation Visit (Day 1) until Safety Visits (up to 5 years) An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Ep0156 814
🇯🇵Shizuoka, Japan
Ep0156 259
🇺🇸Hawthorne, New York, United States
Ep0156 237
🇺🇸Durham, North Carolina, United States
Ep0156 210
🇭🇺Budapest, Hungary
Ep0156 247
🇭🇺Budapest, Hungary
Ep0156 232
🇭🇺Miskolc, Hungary
Ep0156 230
🇮🇹Roma, Italy
Ep0156 803
🇯🇵Bunkyo-ku, Japan
Ep0156 808
🇯🇵Chuo, Japan
Ep0156 800
🇯🇵Gifu-City, Japan
Ep0156 807
🇯🇵Hiroshima, Japan
Ep0156 813
🇯🇵Koshi, Japan
Ep0156 806
🇯🇵Kyoto, Japan
Ep0156 811
🇯🇵Nagoya, Japan
Ep0156 818
🇯🇵OBU, Japan
Ep0156 223
🇲🇽Aguascalientes, Mexico
Ep0156 812
🇯🇵Niigata-city, Japan
Ep0156 819
🇯🇵Omura, Japan
Ep0156 805
🇯🇵Sapporo-city, Japan
Ep0156 817
🇯🇵Osaka, Japan
Ep0156 804
🇯🇵Tokyo, Japan
Ep0156 810
🇯🇵Yokohama, Japan
Ep0156 809
🇯🇵Shimotsuke, Japan
Ep0156 802
🇯🇵Yonago, Japan
Ep0156 609
🇲🇽Culiacan, Mexico
Ep0156 603
🇲🇽Guadalajara, Mexico
Ep0156 406
🇵🇱Kielce, Poland
Ep0156 402
🇵🇱Krakow, Poland
Ep0156 401
🇵🇱Poznan, Poland
Ep0156 248
🇪🇸Sevilla, Spain