Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

June 13, 2018 updated by: UCB Pharma

Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy

Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • 202
      • Brussels, Belgium
        • 203
      • Leuven, Belgium
        • 201
  • Czechia
      • Hradec Kralove, Czechia
        • 502
      • Ostrava Porubo, Czechia
        • 504
      • Praha 4, Czechia
        • 501
  • Mexico
      • Aguascalientes, Mexico
        • 602
      • Chihuahua, Mexico
        • 611
      • Ciuliacan, Mexico
        • 609
      • Guadalajara, Mexico
        • 603
      • Mexico D.F., Mexico
        • 604
      • Monterrey, Mexico
        • 610
      • San Luis Potosi, Mexico
        • 607
  • Poland
      • Bialystok, Poland
        • 404
      • Gdansk, Poland
        • 403
      • Kielce, Poland
        • 406
      • Krakow, Poland
        • 402
      • Poznan, Poland
        • 401
      • Rzeszow, Poland
        • 408
      • Szczecin, Poland
        • 407
      • Wroclaw, Poland
        • 405
  • Spain
      • Barcelona, Spain
        • 309
      • Madrid, Spain
        • 306
      • Palma de Mallorca, Spain
        • 301
      • Santander, Spain
        • 304
      • Valencia, Spain
        • 308
      • Zaragoza, Spain
        • 303
  • United States
    • Florida
      • Gulf Breeze, Florida, United States
        • 108
      • Miami, Florida, United States
        • 110
      • Wellington, Florida, United States
        • 103
    • Massachusetts
      • Boston, Massachusetts, United States
        • 106
    • Minnesota
      • Saint Paul, Minnesota, United States
        • 101
    • Missouri
      • Chesterfield, Missouri, United States
        • 113
    • New York
      • Buffalo, New York, United States
        • 105
      • Rochester, New York, United States
        • 104
    • Ohio
      • Cincinnati, Ohio, United States
        • 107
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 114
    • Tennessee
      • Nashville, Tennessee, United States
        • 109
    • Texas
      • Houston, Texas, United States
        • 117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of epilepsy
  • Subject having at least 1 seizure (any type) during the 3 weeks before first visit
  • Stable dosing of 1-3 concomitant antiepileptic drugs

Exclusion Criteria:

  • Pregnant or nursing females
  • Concomitant use of Levetiracetam
  • Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
  • History of status epilepticus
  • Clinically significant acute or chronic illness, underlying disease or medication condition
  • History of suicide attempt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brivaracetam
Drug: Brivaracetam

Oral solution

Evaluation period (3 weeks up-titration):

For subjects ≥8 years:

  • ~0.4 mg/kg bid for Week 1
  • ~0.8 mg/kg bid for Week 2
  • ~1.6 mg/kg bid for Week 3

For subjects <8 years:

  • ~0.5 mg/kg bid for Week 1
  • ~1.0 mg/kg bid for Week 2
  • ~2.0 mg/kg bid for Week 3

Down-titration period (up to 2 weeks):

For subjects ≥8 years:

  • ~0.8 mg/kg bid for Week 4
  • ~0.4 mg/kg bid for Week 5

For subjects <8 years:

  • ~1.0 mg/kg bid for Week 4
  • ~0.5 mg/kg bid for Week 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
Time Frame: Day 21
Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
Time Frame: Day 21
Day 21
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
Time Frame: Day 21
Day 21
Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
Time Frame: Day 21
Day 21
Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
Time Frame: Day 21
Day 21
Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
Time Frame: Day 21
Day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period
Time Frame: Baseline to end of the 3-week evaluation period
Baseline to end of the 3-week evaluation period
Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period
Time Frame: Baseline to end of the 3-week evaluation period
Baseline to end of the 3-week evaluation period
Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period
Time Frame: Baseline to the end of the 3-week evaluation period
Baseline to the end of the 3-week evaluation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01263
  • 2006-006536-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe