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

NCT ID: NCT04715646

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2030-07-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brivaracetam

LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.

Group Type EXPERIMENTAL

Brivaracetam

Intervention Type DRUG

Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses.

Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral

Oral solution Concentration: 10 mg/ml Route of administration: oral

Interventions

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Brivaracetam

Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses.

Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral

Oral solution Concentration: 10 mg/ml Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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BRV Briviact

Eligibility Criteria

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Inclusion Criteria

* Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]


* 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

* 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).


\- 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)


* 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
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

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Ep0156 259

Hawthorne, New York, United States

Site Status COMPLETED

Ep0156 237

Durham, North Carolina, United States

Site Status COMPLETED

Ep0156 204

Leuven, , Belgium

Site Status WITHDRAWN

Ep0156 240

Prague, , Czechia

Site Status WITHDRAWN

Ep0156 207

Loos, , France

Site Status WITHDRAWN

Ep0156 209

Freiburg im Breisgau, , Germany

Site Status WITHDRAWN

Ep0156 210

Budapest, , Hungary

Site Status COMPLETED

Ep0156 247

Budapest, , Hungary

Site Status COMPLETED

Ep0156 232

Miskolc, , Hungary

Site Status COMPLETED

Ep0156 230

Roma, , Italy

Site Status COMPLETED

Ep0156 803

Bunkyō City, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 808

Chūō, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 800

Gifu, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 807

Hiroshima, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 815

Kodaira-shi, , Japan

Site Status RECRUITING

Ep0156 813

Kōshi, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 806

Kyoto, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 811

Nagoya, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 812

Niigata, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 817

Osaka, , Japan

Site Status RECRUITING

Ep0156 818

Ōbu, , Japan

Site Status RECRUITING

Ep0156 819

Ōmura, , Japan

Site Status RECRUITING

Ep0156 805

Sapporo, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 816

Sendai, , Japan

Site Status RECRUITING

Ep0156 809

Shimotsuke, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 814

Shizuoka, , Japan

Site Status RECRUITING

Ep0156 804

Tokyo, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 810

Yokohama, , Japan

Site Status ACTIVE_NOT_RECRUITING

Ep0156 802

Yonago, , Japan

Site Status COMPLETED

Ep0156 223

Aguascalientes, , Mexico

Site Status COMPLETED

Ep0156 609

Culiacán, , Mexico

Site Status COMPLETED

Ep0156 603

Guadalajara, , Mexico

Site Status COMPLETED

Ep0156 406

Kielce, , Poland

Site Status COMPLETED

Ep0156 402

Krakow, , Poland

Site Status COMPLETED

Ep0156 401

Poznan, , Poland

Site Status COMPLETED

Ep0156 248

Seville, , Spain

Site Status COMPLETED

Countries

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United States Belgium Czechia France Germany Hungary Italy Japan Mexico Poland Spain

Central Contacts

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UCB Cares

Role: CONTACT

[email protected]
0018445992273

Other Identifiers

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2020-003664-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EP0156

Identifier Type: -

Identifier Source: org_study_id

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