Epilepsy
Conditions
Keywords
Epilepsy, Brivaracetam, Pediatric, Child
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.
Interventions
DRUGBrivaracetam
Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 above |
| Incidence 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. |
Countries
Belgium, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Spain, United States
Contacts
CONTACTUCB Cares
STUDY_DIRECTORUCB Cares
001 844 599 2273 (UCB)
Outcome results
None listed