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Trial record 1 of 1 for:    NCT00422422
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Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00422422
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : January 9, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Brivaracetam
Enrollment 100
Recruitment Details The N01263 study began recruitment in July 2011, with subjects enrolled in the European Union, Mexico, and the United States. The study concluded in March 2013.
Pre-assignment Details  
Arm/Group Title Brivaracetam (ES)
Hide Arm/Group Description

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Period Title: Overall Study
Started 100
Completed 90
Not Completed 10
Reason Not Completed
Lack of Efficacy             1
Protocol Violation             1
Withdrawal by Subject             2
SAE, non-fatal             1
AE, non-serious non-fatal             5
Arm/Group Title Brivaracetam (ES)
Hide Arm/Group Description

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
Baseline Characteristics consists of the Enrolled Subjects analysis set, which is comprised of all subjects enrolled into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
6.3  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
51
  51.0%
Male
49
  49.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 100 participants
24.2  (16.2)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 100 participants
111.8  (32.9)
BMI  
Median (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 100 participants
17.1  (3.4)
Racial Group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Black or African American 4
White 80
Other 16
1.Primary Outcome
Title Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
Hide Description [Not Specified]
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (PPS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ug/mL
0.825  (0.826)
2.Primary Outcome
Title Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
Hide Description [Not Specified]
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (PPS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: ug/mL
0.967  (0.536)
3.Primary Outcome
Title Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
Hide Description [Not Specified]
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (PPS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ug/mL
1.117  (0.400)
4.Primary Outcome
Title Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
Hide Description [Not Specified]
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (PPS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: ug/mL
2.071
(0.320 to 4.305)
5.Primary Outcome
Title Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
Hide Description [Not Specified]
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (PPS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 22
Mean (Full Range)
Unit of Measure: ug/mL
2.673
(0.561 to 5.418)
6.Primary Outcome
Title Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
Hide Description [Not Specified]
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (PPS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: ug/mL
2.861
(2.627 to 3.371)
7.Secondary Outcome
Title Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period
Hide Description [Not Specified]
Time Frame Baseline to end of the 3-week evaluation period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: participants
66
8.Secondary Outcome
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
Hide Description [Not Specified]
Time Frame Baseline to end of the 3-week evaluation period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam (FAS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participants
17
9.Secondary Outcome
Title Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period
Hide Description [Not Specified]
Time Frame Baseline to the end of the 3-week evaluation period
Hide Outcome Measure Data
Hide Analysis Population Description
Although 99 subjects were in the Safety Set and confirmed to have taken at least one dose of BRV, details on study drug intake were not able to be collected for 2 subjects. Therefore compliance could only be calculated for 97 subjects.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: participants
<80 % 5
80 % to 120 % 90
>120 % 2
Time Frame Treatment-emergent Adverse Events (TEAEs) were collected during the course of the study up to day 49.
Adverse Event Reporting Description

The Safety Set is all enrolled subjects who took at least 1 dose of study drug.

Subjects had the ability to report more than one event. The Serious Adverse Events and Non-serious Adverse Events sections are reported in this manner.

 
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description

Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:

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
All-Cause Mortality
Brivaracetam (SS)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Brivaracetam (SS)
Affected / at Risk (%) # Events
Total   8/99 (8.08%)    
Gastrointestinal disorders   
Diarrhoea * 1  1/99 (1.01%)  1
General disorders   
Pyrexia * 1  1/99 (1.01%)  1
Infections and infestations   
Otitis media * 1  1/99 (1.01%)  1
Respiratory tract infection * 1  1/99 (1.01%)  1
Toxoplasmosis * 1  1/99 (1.01%)  1
Investigations   
Cytomegalovirus test positive * 1  1/99 (1.01%)  1
Metabolism and nutrition disorders   
Dehydration * 1  2/99 (2.02%)  2
Nervous system disorders   
Convulsion * 1  4/99 (4.04%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brivaracetam (SS)
Affected / at Risk (%) # Events
Total   33/99 (33.33%)    
General disorders   
Irritability * 1  8/99 (8.08%)  9
Pyrexia * 1  7/99 (7.07%)  8
Fatigue * 1  5/99 (5.05%)  5
Infections and infestations   
Pharyngotonsillitis * 1  5/99 (5.05%)  5
Metabolism and nutrition disorders   
Decreased appetite * 1  7/99 (7.07%)  7
Nervous system disorders   
Somnolence * 1  8/99 (8.08%)  9
Convulsion * 1  6/99 (6.06%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00422422    
Other Study ID Numbers: N01263
2006-006536-22 ( EudraCT Number )
First Submitted: January 10, 2007
First Posted: January 17, 2007
Results First Submitted: March 14, 2016
Results First Posted: January 9, 2017
Last Update Posted: July 11, 2018