Open-label, Pharmacokinetic, Safety and Efficacy Study of... | NCT00422422

ID	Type	Description	Link
2006-006536-22	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Brivaracetam	Experimental		Drug: Brivaracetam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brivaracetam	Drug	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During 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

Eligibility Module

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
108		Gulf Breeze	Florida		United States
110

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Brivaracetam (ES)	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Brivaracetam (ES)	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

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0006.3± 4.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00051
Male	BG00049

Weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00024.2± 16.2

Height

Mean

Standard Deviation

centimeters

Title

Denominators

Categories

Title	Measurements
	BG000111.8± 32.9

BMI

Median

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00017.1± 3.4

Racial Group

Number

participants

Title

Denominators

Categories

Black or African American

Title	Measurements
	BG0004

White

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Mean

Standard Deviation

ug/mL

Day 21

ID	Title	Description
OG000	Brivaracetam (PPS)	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

Units	Counts
Participants	OG00012

Title

Denominators

Categories

Title	Measurements
	OG0000.825± 0.826

Primary

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

Posted

Mean

Standard Deviation

ug/mL

Day 21

ID	Title	Description
OG000	Brivaracetam (PPS)	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

Units	Counts
Participants	OG000

Primary

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

Posted

Mean

Standard Deviation

ug/mL

Day 21

ID	Title	Description
OG000	Brivaracetam (PPS)	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

Units	Counts
Participants	OG000

Primary

Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years

Posted

Mean

Full Range

ug/mL

Day 21

ID	Title	Description
OG000	Brivaracetam (PPS)	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

Units	Counts
Participants	OG000

Primary

Mean Max Plasma Concentration for Age Range ≥2 to <12 Years

Posted

Mean

Full Range

ug/mL

Day 21

ID	Title	Description
OG000	Brivaracetam (PPS)	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

Units	Counts
Participants	OG000

Primary

Mean Max Plasma Concentration for Age Range ≥12 to <16 Years

Posted

Mean

Full Range

ug/mL

Day 21

ID	Title	Description
OG000	Brivaracetam (PPS)	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

Units	Counts
Participants	OG000

Secondary

Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period

Posted

Number

participants

Baseline to end of the 3-week evaluation period

ID	Title	Description
OG000	Brivaracetam (SS)	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

Units	Counts
Participants	OG000

Secondary

Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period

Posted

Number

participants

Baseline to end of the 3-week evaluation period

ID	Title	Description
OG000	Brivaracetam (FAS)	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

Units	Counts
Participants	OG000

Secondary

Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period

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.

Posted

Number

participants

Baseline to the end of the 3-week evaluation period

ID	Title	Description
OG000	Brivaracetam (SS)	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

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Brivaracetam (SS)	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			8	99	33	99

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected99 at risk
Pyrexia	General disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected99 at risk
Otitis media	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected99 at risk
Respiratory tract infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected99 at risk
Toxoplasmosis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected99 at risk
Cytomegalovirus test positive	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected99 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected99 at risk
Convulsion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0004 events4 affected99 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Irritability	General disorders	MedDRA15.0	Non-systematic Assessment	EG0009 events8 affected99 at risk
Pyrexia	General disorders	MedDRA15.0	Non-systematic Assessment	EG0008 events7 affected99 at risk
Fatigue	General disorders	MedDRA15.0	Non-systematic Assessment	EG0005 events5 affected99 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0005 events5 affected99 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0007 events7 affected99 at risk
Somnolence	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0009 events8 affected99 at risk
Convulsion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0007 events6 affected99 at risk

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases