RecruitingPhase 3NCT04715646

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

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


Sponsor

UCB Biopharma SRL

Enrollment

70 participants

Start Date

Mar 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 Month

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Brivaracetam for people with epilepsy. The study is currently recruiting participants at 36 locations. People eligible for this study include aged 1 Month and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrivaracetam

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


Locations(36)

Ep0156 259

Hawthorne, New York, United States

Ep0156 237

Durham, North Carolina, 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

View Full Details on ClinicalTrials.gov

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NCT04715646


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