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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Brivaracetam, Epilepsy, Child, Pharmacokinetics, Adolescents

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 108
  • 110
  • 103
  • 106
  • 101
  • 113
  • 105
  • 104
  • 107
  • 114
  • 109
  • 117
  • 202
  • 203
  • 201
  • 502
  • 504
  • 501
  • 602
  • 611
  • 609
  • 603
  • 604
  • 610
  • 607
  • 404
  • 403
  • 406
  • 402
  • 401
  • 408
  • 407
  • 405
  • 309
  • 306
  • 301
  • 304
  • 308
  • 303

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam

Arm Description

Outcomes

Primary Outcome Measures

Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
Mean Max Plasma Concentration for Age Range ≥12 to <16 Years

Secondary Outcome Measures

Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During 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
Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period

Full Information

First Posted
January 10, 2007
Last Updated
June 13, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00422422
Brief Title
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Brivaracetam, Epilepsy, Child, Pharmacokinetics, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
Time Frame
Day 21
Title
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
Time Frame
Day 21
Title
Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
Time Frame
Day 21
Title
Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
Time Frame
Day 21
Title
Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
Time Frame
Day 21
Title
Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period
Time Frame
Baseline to the end of the 3-week evaluation period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
108
City
Gulf Breeze
State/Province
Florida
Country
United States
Facility Name
110
City
Miami
State/Province
Florida
Country
United States
Facility Name
103
City
Wellington
State/Province
Florida
Country
United States
Facility Name
106
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
101
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
113
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
105
City
Buffalo
State/Province
New York
Country
United States
Facility Name
104
City
Rochester
State/Province
New York
Country
United States
Facility Name
107
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
114
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
109
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
117
City
Houston
State/Province
Texas
Country
United States
Facility Name
202
City
Brussels
Country
Belgium
Facility Name
203
City
Brussels
Country
Belgium
Facility Name
201
City
Leuven
Country
Belgium
Facility Name
502
City
Hradec Kralove
Country
Czechia
Facility Name
504
City
Ostrava Porubo
Country
Czechia
Facility Name
501
City
Praha 4
Country
Czechia
Facility Name
602
City
Aguascalientes
Country
Mexico
Facility Name
611
City
Chihuahua
Country
Mexico
Facility Name
609
City
Ciuliacan
Country
Mexico
Facility Name
603
City
Guadalajara
Country
Mexico
Facility Name
604
City
Mexico D.F.
Country
Mexico
Facility Name
610
City
Monterrey
Country
Mexico
Facility Name
607
City
San Luis Potosi
Country
Mexico
Facility Name
404
City
Bialystok
Country
Poland
Facility Name
403
City
Gdansk
Country
Poland
Facility Name
406
City
Kielce
Country
Poland
Facility Name
402
City
Krakow
Country
Poland
Facility Name
401
City
Poznan
Country
Poland
Facility Name
408
City
Rzeszow
Country
Poland
Facility Name
407
City
Szczecin
Country
Poland
Facility Name
405
City
Wroclaw
Country
Poland
Facility Name
309
City
Barcelona
Country
Spain
Facility Name
306
City
Madrid
Country
Spain
Facility Name
301
City
Palma de Mallorca
Country
Spain
Facility Name
304
City
Santander
Country
Spain
Facility Name
308
City
Valencia
Country
Spain
Facility Name
303
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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