Epilepsy MedDRA version: 21.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for long-term follow-up (LTFU) study participants only: - Study participants with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439] and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected; Inclusion criteria for directly enrolled (DE) study participants only: - Study participant is = 4 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for all study participants: - Study participant has, in the Investigator’s opinion, severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant; - Study participant has any medical condition including chronic liver disease, which in the Investigator’s opinion, warrants exclusion; - Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV). The use of antiepileptic drugs (AEDs) marketed for adults but not approved for pediatric use is not considered to be “investigational” for the purposes of this study; - Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study; Exclusion criteria for long-term follow-up (LTFU) study participants only: - Study participant had poor compliance with the visit schedule or medication intake in the BRV core study; - Study participant = 6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted 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 only: - Study participant has a history of primary generalized epilepsy; - Study participant has a history of status epilepticus in the 30 days immediately prior to the Screening Visit (ScrV) or during the Screening Period; - Study participant has history or presence of known psychogenic nonepileptic seizures; - Study participant has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary; - Study participant has any clinically significant acute or chronic illness as determined during the physical examination or from other information available to the Investigator (eg, bone marrow suppression, chronic hepatic disease, severe renal impairment, psychiatric disorder as per Investigator assessment); - 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, according to the judgment of the Investigator; - Study participant has a clinically significant ECG abnormality according to the Investigator; - Study participant had major surgery within 6 months prior to the ScrV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of BRV ;Secondary Objective: Not applicable ;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study; 2. Incidence of treatment-emergent serious adverse events (SAEs) during the study; 3. Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study.;Timepoint(s) of evaluation of this end point: 1-3. From Entry Visit (Day 1) until Safety Visits (up to 5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium, Czechia, Czech Republic, France, Germany, Hungary, Ireland, Italy, Japan, Mexico, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed