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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

NCT04666610 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-03-13

No results posted yet for this study

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).

Conditions

  • Childhood Absence Epilepsy
  • Juvenile Absence Epilepsy

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.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2026-08-24
Completion
2026-08-24
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Italy
  • Romania
  • Slovakia
  • Spain
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04666610 on ClinicalTrials.gov