Brivaracetam: 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
Study summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Eligibility
Sex
ALL
Min age
1 Month
Max age
—
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
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 outcome measure(s)
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.
Trial sites (36)
Facility
City
Region
Status
Ep0156 259
Hawthorne
New York
Completed
Ep0156 237
Durham
North Carolina
Completed
Ep0156 204
Leuven
Belgium
Withdrawn
Ep0156 240
Prague
Czechia
Withdrawn
Ep0156 207
Loos
France
Withdrawn
Ep0156 209
Freiburg im Breisgau
Germany
Withdrawn
Ep0156 210
Budapest
Hungary
Completed
Ep0156 247
Budapest
Hungary
Completed
Ep0156 232
Miskolc
Hungary
Completed
Ep0156 230
Roma
Italy
Completed
Ep0156 803
Bunkyō City
Japan
Active Not Recruiting
Ep0156 808
Chūō
Japan
Active Not Recruiting
Ep0156 800
Gifu
Japan
Active Not Recruiting
Ep0156 807
Hiroshima
Japan
Active Not Recruiting
Ep0156 815
Kodaira-shi
Japan
Recruiting
Ep0156 813
Kōshi
Japan
Active Not Recruiting
Ep0156 806
Kyoto
Japan
Active Not Recruiting
Ep0156 811
Nagoya
Japan
Active Not Recruiting
Ep0156 812
Niigata
Japan
Active Not Recruiting
Ep0156 817
Osaka
Japan
Recruiting
Ep0156 818
Ōbu
Japan
Recruiting
Ep0156 819
Ōmura
Japan
Recruiting
Ep0156 805
Sapporo
Japan
Active Not Recruiting
Ep0156 816
Sendai
Japan
Recruiting
Ep0156 809
Shimotsuke
Japan
Active Not Recruiting
Ep0156 814
Shizuoka
Japan
Recruiting
Ep0156 804
Tokyo
Japan
Active Not Recruiting
Ep0156 810
Yokohama
Japan
Active Not Recruiting
Ep0156 802
Yonago
Japan
Completed
Ep0156 223
Aguascalientes
Mexico
Completed
Ep0156 609
Culiacán
Mexico
Completed
Ep0156 603
Guadalajara
Mexico
Completed
Ep0156 406
Kielce
Poland
Completed
Ep0156 402
Krakow
Poland
Completed
Ep0156 401
Poznan
Poland
Completed
Ep0156 248
Seville
Spain
Completed
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.