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Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

NCT01364597 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2025-10-17

Study results available
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Summary

This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.

Conditions

Interventions

DRUG

Brivaracetam (BRV)

The max BRV dose will be 5.0 mg/kg/day, not to exceed a dose of 200 mg/day for subjects with body weight \>40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights \>50kg) is reached.

Sponsors & Collaborators

  • UCB Pharma SA

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 877 822 9493 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-01
Primary Completion
2022-02-03
Completion
2022-02-03
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01364597 on ClinicalTrials.gov