A Dose-ranging Study With Brivaracetam in Patients From 1... | NCT00175825

Official Title

A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

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

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Matching Placebo tablets administered twice a day	Other: Placebo
Brivaracetam 5 mg/day	Experimental	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Drug: Brivaracetam
Brivaracetam 20 mg/day	Experimental	Brivaracetam 20 mg/day, 10 mg administered twice a day	Drug: Brivaracetam
Brivaracetam 50 mg/day	Experimental	Brivaracetam 50 mg/day, 25 mg administered twice a day	Drug: Brivaracetam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period	Calculated as 7-day partial onset seizure frequency.	During the 7-week Treatment Period

Secondary Outcomes

Measure	Description	Time Frame
Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period	Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
UCB Cares	+1 844 599 2273 (UCB)	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27265725	Result	Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.
35285519	Derived

Label	URL
Product Information	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Matching Placebo tablets administered twice a day
FG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Matching Placebo tablets administered twice a day
BG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
BG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
BG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day
BG004	Total Title

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0003 BG0014 BG0021 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00033.59± 11.26 BG00132.72± 12.16 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00030 BG00120 BG002

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

Secondary

Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period

Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

Posted

Median

Inter-Quartile Range

percentage of change

Baseline, during the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Units	Counts
Participants	OG00054 OG00150 OG00252 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-21.7(-42.99 to 12.04) OG001-29.91(-53.33 to -3.83) OG002-42.56(-67.92 to 0.44) OG003

Secondary

Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period

Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.

Posted

Median

Inter-Quartile Range

seizures per week

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Secondary

Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period

Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

Posted

Median

Inter-Quartile Range

seizures per week

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Secondary

Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period

Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

Posted

Median

Inter-Quartile Range

seizures per week

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Secondary

Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period

Posted

Median

Inter-Quartile Range

percentage of change

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Secondary

Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period

A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.

Posted

Number

percentage of participants

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Units	Counts

Secondary

Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period

Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.

Posted

Number

percentage of participants

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Units	Counts

Secondary

Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period

A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.

Posted

Number

percentage of participants

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Units	Counts
Participants

Secondary

Number of Seizure-free Days Per 4 Weeks

A day was considered seizure-free, if no seizure was reported during 24 hours.

Posted

Median

Inter-Quartile Range

Days/4 Weeks

Baseline, during the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Units	Counts
Participants

Secondary

Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period

Number of days to first, fifth, and tenth seizure after baseline.

Posted

Median

95% Confidence Interval

days

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Units	Counts
Participants

Primary

Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period

Calculated as 7-day partial onset seizure frequency.

Posted

Median

Inter-Quartile Range

Seizures per week

During the 7-week Treatment Period

ID	Title	Description
OG000	Placebo	Matching Placebo tablets administered twice a day
OG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
OG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day
OG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching Placebo tablets administered twice a day	54	0	54	15	54
EG001	Brivaracetam 5 mg/Day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	50	0	50	13	50
EG002	Brivaracetam 20 mg/Day	Brivaracetam 20 mg/day, 10 mg administered twice a day	52	1	52	8	52
EG003	Brivaracetam 50 mg/Day	Brivaracetam 50 mg/day, 25 mg administered twice a day	52	0	52	10	52

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Neurotoxicity	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected54 at risk EG0010 affected50 at risk EG0021 affected52 at risk EG0030 affected52 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected54 at risk EG0014 affected50 at risk EG0022 affected52 at risk EG0031 affected52 at risk
Fatigue	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected54 at risk EG0010 affected50 at risk EG0022 affected52 at risk EG003
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG0004 affected54 at risk EG0014 affected50 at risk EG0020 affected52 at risk EG003
Dizziness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0003 affected54 at risk EG0011 affected50 at risk EG0020 affected52 at risk EG003
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0004 affected54 at risk EG0014 affected50 at risk EG0022 affected52 at risk EG003
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0004 affected54 at risk EG0011 affected50 at risk EG0023 affected52 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

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