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NCT04715646PHASE3Recruiting

A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

UCB Biopharma SRL

Start Date

3/11/2021

Completion Date

7/8/2030

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DRUG

Brivaracetam

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Conditions

Epilepsy

Locations

Ep0156 259

Hawthorne, New York 10532

United States

Ep0156 237

Durham, North Carolina 27710

United States

Ep0156 204

Leuven,

Belgium

Ep0156 240

Prague,

Czechia

Ep0156 207

Loos,

France

Ep0156 209

Freiburg im Breisgau,

Germany

Ep0156 210

Budapest,

Hungary

Ep0156 247

Budapest,

Hungary

Ep0156 232

Miskolc,

Hungary

Ep0156 230

Roma,

Italy

Ep0156 803

Bunkyō City,

Japan

Ep0156 808

Chūō,

Japan

Ep0156 800

Gifu,

Japan

Ep0156 807

Hiroshima,

Japan

Ep0156 815

Kodaira-shi,

Japan

Ep0156 813

Kōshi,

Japan

Ep0156 806

Kyoto,

Japan

Ep0156 811

Nagoya,

Japan

Ep0156 812

Niigata,

Japan

Ep0156 817

Osaka,

Japan

Ep0156 818

Ōbu,

Japan

Ep0156 819

Ōmura,

Japan

Ep0156 805

Sapporo,

Japan

Ep0156 816

Sendai,

Japan

Ep0156 809

Shimotsuke,

Japan

Ep0156 814

Shizuoka,

Japan

Ep0156 804

Tokyo,

Japan

Ep0156 810

Yokohama,

Japan

Ep0156 802

Yonago,

Japan

Ep0156 223

Aguascalientes,

Mexico

Ep0156 609

Culiacán,

Mexico

Ep0156 603

Guadalajara,

Mexico

Ep0156 406

Kielce,

Poland

Ep0156 402

Krakow,

Poland

Ep0156 401

Poznan,

Poland

Ep0156 248

Seville,

Spain