EP0156 Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy Brief summary The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam. Medical Condition Epilepsy Min. Age 1 Months Max. Age - Who Can Join? All Status Active, not recruiting 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 Study Medication Description Study Medication: Briviact® Other Descriptive Name: brivaracetam Placebo No Comparator: No Share this study Share Facebook Share Twitter Share LinkedIn Refer to a friend Via email Study Dates March 2021 Actual Start Date of Enrollment July 2029 Planned Study Completion Date General Information Study ID: EP0156 EudraCT Number: 2020-003664-29 CT.gov Number: NCT04715646 Phase: Phase 3 Locations Click here to find out where the clinical study is conducted Interested in our clinical studies? Just contact us Austria UCBCares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium UCBCares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) www.ucbcares.be Bulgaria UCBCares.BG@ucb.com +359 2 962 9933 www.ucbcares.bg Canada +1 866 709 8444 Czech Republic UCBCares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) www.ucbcares.cz Denmark UCBCares.DK@ucb.com +45 32462480 80 253827 (freephone) www.ucbcares.dk Finland UCBCares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) www.ucbcares.fi France UCBCares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) www.ucbcares.fr Germany UCBCares.DE@ucb.com +49 2173 48 48 48 www.ucbcares.de Greece UCBCares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) www.ucbcares.gr Hungary UCBCares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) www.ucbcares.hu Ireland UCBCares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) www.ucbcares.co.uk Italy UCBCares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) www.ucbcares.it Japan https://ucbcares.jp Luxemburg UCBCares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway UCBCares.NO@ucb.com +45 32462482 800-10101 (freephone) www.ucbcares.no Poland UCBCares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) www.ucbcares.pl Portugal UCBCares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia UCBCares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) www.ucbcares.sk Spain UCBCares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) www.ucbcares.es Sweden UCBCares.SE@ucb.com +45 32462481 0200 898 671 (freephone) www.ucbcares.se Switzerland +41 58 822 3180 The Netherlands UCBCares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) www.ucbcares.nl UK UCBCares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) www.ucbcares.co.uk USA UCBCares@ucb.com +1-844-599-2273 www.ucb-usa.com/Patients/Patients Email Print Back to results