Localization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classification MedDRA version: 21.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
UCB Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, all of the following criteria must be met as specified. Inclusion criteria for all subjects - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the parent(s) or legal representative(s). The Consent form or a specific Assent form, where required, will be signed and dated by minors. - Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake (including BRV oral solution or tablets) according to the judgment of the Investigator. - For female subjects, the subject is 1)Not of childbearing potential OR Of childbearing potential, and Is not sexually active,Has a negative pregnancy test OR 2)Of childbearing potential, and Is sexually active, Has a negative pregnancy test - Understands the consequences and potential risks of inadequately protected sexual activity, understands and properly uses contraceptive methods, and is willing to inform the Investigator of any contraception changes. Medically acceptable contraceptive methods for the study include, but are not limited to: Oral or depot contraceptive treatment with at least ethinylestradiol 30µg per intake or ethinylestradiol 50µg per intake if also taking one of the following: carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John's Wort, or rifampicin Barrier contraception: intrauterine device, diaphragm with spermicide, male or female condom with spermicide Abstinence from sexual intercourse Inclusion criteria for LTFU subjects only - Male or female subjects having participated in a core study with a confirmed diagnosis of epilepsy and for whom a reasonable benefit from long-term administration of BRV is expected. Inclusion criteria for directly enrolled subjects only - Subject is a male or female =4 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are not permitted to enroll in the study if any of the following criteria are met as specified. Exclusion criteria for all subjects -Subject is a pregnant or nursing female. -Subject has severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the subject. -Subject has planned participation in any clinical study of another investigational drug or device. -Subject has any medical condition, which in the Investigator’s opinion, warrants exclusion. -Subject has >1.5x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >1.0xULN total bilirubin (=1.5xULN total bilirubin if known Gilbert’s syndrome). -Subject has chronic liver disease. Exclusion criteria for LTFU subjects only - Subject had hypersensitivity to BRV or excipients or comparative drugs as stated in this protocol during the course of the core study. - Subject had poor compliance with the visit schedule or medication intake in the core study. - Subject =6 years of age has a lifetime history of suicide attempt (including actual attempt,interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the EV. If a subject has active suicidal ideation without a specific plan as indicated by a positive response (“Yes”) to Question 4 of Columbia-Suicide Severity Rating Scale (C-SSRS) at the EV, the subject should be referred immediately to a Mental Healthcare Professional and may be excluded from the study based upon the Investigator’s judgment of benefit/risk of continuing the subject in the study/on study medication. Exclusion criteria for directly enrolled subjects only - Subject has previously received BRV. - Subject had concomitant use of LEV at the ScrV. In addition, the use of LEV is prohibited for at least 4 weeks prior to the ScrV. - Subject has epilepsy secondary to a progressive cerebral disease or tumor, or any other progressively neurodegenerative disease. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable according to Investigator’s opinion. - Subject has a history of primary generalized epilepsy. - Subject has a history of status epilepticus in the month immediately prior to the ScrV or during the Up Titration Period. - Subject has a history or presence of pseudoseizures. - Subject is suffering only from febrile seizures. - Subject is on felbamate with less than 18 months continuous exposure. Subject who has taken felbamate for a combined duration of treatment and wash out of <18 months before the ScrV. - Subjects treated with vigabatrin who have visual field defects. - Subject has an allergy to pyrrolidone derivatives or investigational product excipients or a history of multiple drug allergies. - Subject 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 depression, chronic hepatic disease, severe renal impairment, psychiatric disorder). - Subject has an underlying disease or is receiving a treatment that may interfere with the absorption, distribution, metabolism, and elimination of the study drug. - Subject has any medical condition that might interfere with his/her study participation (eg, serious infect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document the long-term safety and tolerability of BRV;Secondary Objective: To assess the efficacy of BRV during long-term exposure;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;Timepoint(s) of evaluation of this end point: 1-2: From Baseline to end of Study (up to 10 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For subjects =2 years of age (based on daily record card (DRC) data): 1. Absolute change in 28-days adjusted partial-onset seizures (POS) frequency from Baseline to the end of the Evaluation Period in subjects with POS only 2. Percent change in 28-days adjusted partial-onset seizures (POS) frequency from Baseline to the end of the Evaluation Period in subjects with POS only 3. 50% responder rate for total seizures (all types) For subjects <2 years of age (based on EEG data [recorded at least 24 hours]) or subjects with typical absence seizures (based on EEG data): 4. Absolute change in average daily frequency of partial-onset-seizures (POS) in subjects with POS only 5. Percent change in average daily frequency of partial-onset-seizures (POS) in subjects with POS only 6. 50% responder rate for total seizures (all types);Timepoint(s) of evaluation of this end point: 1-2: From Baseline to the end of the Evaluation Period (up to 10 years) 3-6: From Baseline to end of Study (up to 10 years) | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactCT Registries & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed