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

Last updated: June 4, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

3

Condition

Epilepsy

Treatment

Brivaracetam

Clinical Study ID

NCT04715646
EP0156
2020-003664-29
  • Ages > 1
  • All Genders

Study Summary

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Eligibility Criteria

Inclusion

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 whoparticipated 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 compatiblewith the diagnosis of focal epilepsy within the last 10 years

  • Study participant has uncontrolled partial-onset seizure (POS) after an adequatecourse of treatment with at least 1 antiepileptic drug (AED)

  • Study participant had at least 1 POS during the 4-week Screening Period

Exclusion

Exclusion Criteria:

Exclusion criteria for all study participants

  • Severe medical, neurological, or psychiatric disorders or laboratory values, whichmay have an impact on the safety of the study participant

  • Study participant is currently participating in another study of an investigationalmedication (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 hassuicidal ideation in the past 6 months as indicated on the Columbia Suicide SeverityRating Scale (C-SSRS)

Exclusion criteria for directly enrolled (DE) study participants in Japan only

  • Study participant has a history of primary generalized epilepsy, psychogenicnon-epileptic seizures, or febrile seizures

  • Study participant has a history of status epilepticus in the 30 days prior to theScreening Visit (ScrV) or during the Screening Period

  • Study participant has any clinically significant illness

  • Study participant has clinically significant laboratory abnormality that mayincrease the risk associated with study participation or may interfere with theinterpretation of study results

  • Study participant has a clinically significant ECG abnormality

  • Study participant had major surgery within 6 months prior to the ScrV

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Brivaracetam
Phase: 3
Study Start date:
March 11, 2021
Estimated Completion Date:
July 08, 2030

Study 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.

Connect with a study center

  • Ep0156 204

    Leuven,
    Belgium

    Site Not Available

  • Ep0156 240

    Praha,
    Czechia

    Site Not Available

  • Ep0156 240

    Praha 4,
    Czechia

    Site Not Available

  • Ep0156 207

    Loos,
    France

    Site Not Available

  • Ep0156 209

    Freiburg,
    Germany

    Site Not Available

  • Ep0156 210

    Budapest,
    Hungary

    Completed

  • Ep0156 247

    Budapest,
    Hungary

    Completed

  • Ep0156 232

    Miskolc,
    Hungary

    Completed

  • Ep0156 230

    Roma,
    Italy

    Completed

  • Ep0156 803

    Bunkyo-ku,
    Japan

    Site Not Available

  • Ep0156 803

    Bunkyō-Ku,
    Japan

    Site Not Available

  • Ep0156 808

    Chuo,
    Japan

    Site Not Available

  • Ep0156 800

    Gifu-City,
    Japan

    Site Not Available

  • Ep0156 807

    Hiroshima,
    Japan

    Site Not Available

  • Ep0156 813

    Kohshi,
    Japan

    Site Not Available

  • Ep0156 813

    Koshi,
    Japan

    Site Not Available

  • Ep0156 806

    Kyoto,
    Japan

    Site Not Available

  • Ep0156 813

    Kōshi,
    Japan

    Site Not Available

  • Ep0156 811

    Nagoya,
    Japan

    Site Not Available

  • Ep0156 811

    Nagoya city,
    Japan

    Site Not Available

  • Ep0156 811

    Nagoya-city,
    Japan

    Site Not Available

  • Ep0156 812

    Niigata,
    Japan

    Site Not Available

  • Ep0156 812

    Niigata city,
    Japan

    Site Not Available

  • Ep0156 812

    Niigata-city,
    Japan

    Site Not Available

  • Ep0156 818

    OBU,
    Japan

    Active - Recruiting

  • Ep0156 819

    Omura,
    Japan

    Active - Recruiting

  • Ep0156 817

    Osaka,
    Japan

    Active - Recruiting

  • Ep0156 805

    Sapporo,
    Japan

    Site Not Available

  • Ep0156 805

    Sapporo-city,
    Japan

    Site Not Available

  • Ep0156 809

    Shimots UKE,
    Japan

    Site Not Available

  • Ep0156 809

    Shimotsuke,
    Japan

    Site Not Available

  • Ep0156 814

    Shizuoka,
    Japan

    Active - Recruiting

  • Ep0156 804

    Tokyo,
    Japan

    Site Not Available

  • Ep0156 810

    Yokohama,
    Japan

    Site Not Available

  • Ep0156 802

    Yonago,
    Japan

    Completed

  • Ep0156 223

    Aguascalientes,
    Mexico

    Completed

  • Ep0156 611

    Chihuahua,
    Mexico

    Site Not Available

  • Ep0156 609

    Culiacan,
    Mexico

    Completed

  • Ep0156 609

    Culiacán,
    Mexico

    Site Not Available

  • Ep0156 603

    Guadala JARA,
    Mexico

    Site Not Available

  • Ep0156 603

    Guadalajara,
    Mexico

    Completed

  • Ep0156 406

    Kielce,
    Poland

    Completed

  • Ep0156 402

    Krakow,
    Poland

    Completed

  • Ep0156 402

    Kraków,
    Poland

    Site Not Available

  • Ep0156 401

    Poznan,
    Poland

    Completed

  • Ep0156 401

    Poznań,
    Poland

    Site Not Available

  • Ep0156 248

    Sevilla,
    Spain

    Completed

  • Ep0156 259

    Hawthorne, New York 10532
    United States

    Completed

  • Ep0156 259

    Sleepy Hollow, New York 10591
    United States

    Site Not Available

  • Ep0156 237

    Durham, North Carolina 27710
    United States

    Completed

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