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ACTIVE NOT RECRUITING
NCT04666610
PHASE3

A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Official title: A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Key Details

Gender

All

Age Range

2 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2021-07-29

Completion Date

2026-08-24

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Brivaracetam

* Pharmaceutical form: Oral solution * Route of administration: Oral use Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.

OTHER

Placebo

Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Locations (35)

N01269 115

Birmingham, Alabama, United States

N01269 105

Orange, California, United States

N01269 116

Denver, Colorado, United States

N01269 111

Miami, Florida, United States

N01269 101

Tampa, Florida, United States

N01269 104

Winter Park, Florida, United States

N01269 110

Augusta, Georgia, United States

N01269 100

New Brunswick, New Jersey, United States

N01269 109

Winston-Salem, North Carolina, United States

N01269 106

Philadelphia, Pennsylvania, United States

N01269 400

Tbilisi, Georgia

N01269 401

Tbilisi, Georgia

N01269 402

Tbilisi, Georgia

N01269 403

Tbilisi, Georgia

N01269 405

Tbilisi, Georgia

N01269 323

Messina, Italy

N01269 321

Milan, Italy

N01269 324

Milan, Italy

N01269 320

Pavia, Italy

N01269 322

Roma, Italy

N01269 325

Roma, Italy

N01269 326

Verona, Italy

N01269 562

Bucharest, Romania

N01269 563

Bucharest, Romania

N01269 560

Iași, Romania

N01269 561

Timişoara, Judeţ Timiş, Romania

N01269 632

Bardejov, Slovakia

N01269 630

Dubnica nad Váhom, Slovakia

N01269 631

Nové Zámky, Slovakia

N01269 354

Terrassa, Spain

N01269 600

Dnipro, Ukraine

N01269 601

Dnipro, Ukraine

N01269 604

Kharkiv, Ukraine

N01269 607

Uzhhorod, Ukraine

N01269 602

Vinnytsia, Ukraine