Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

• ClinicalTrials.gov Identifier: NCT00464269
• Recruitment Status: Completed
• First Posted: April 23, 2007
• Results First Posted: April 13, 2016
• Last Update Posted: July 21, 2022
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Epilepsy
• Interventions: Other: Placebo; Drug: Brivaracetam 2.5 mg; Drug: Brivaracetam 10 mg; Drug: Brivaracetam 25 mg
• Enrollment: 400

Participant Flow

Recruitment Details	This study started to enroll subjects in September 2007 and concluded in January 2009. 400 subjects were randomized of which 396 are included in the Safety Population.
Pre-assignment Details	Participant Flow refers to the Randomized Set (RS).

Arm/Group Title	Placebo	BRV 5 mg/Day	BRV 20 mg/Day	BRV 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Period Title: Overall Study
Started	99	99	100	102
Completed	93	82	93	93
Not Completed	6	17	7	9
Reason Not Completed
Lack of Efficacy	1	0	0	0
Lost to Follow-up	0	4	0	1
Withdrawal by Subject	0	2	1	1
Other reason	3	3	1	1
AE, serious fatal	0	0	1	1
SAE, non-fatal	0	0	0	1
AE, non-serious non-fatal	2	8	3	4
SAE,non-fatal+AE,non-serious non-fatal	0	0	1	0

Baseline Characteristics

Arm/Group Title		Placebo	BRV 5 mg/Day	BRV 20 mg/Day	BRV 50 mg/Day	Total Title
Arm/Group Description		Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day	[Not Specified]
Overall Number of Baseline Participants		99	99	100	102	400
Baseline Analysis Population Description		Baseline Characteristics refer to Randomized Set.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	99 participants	99 participants	100 participants	102 participants	400 participants
		37.6 (12.6)	38.8 (11.6)	37.3 (13.3)	39.0 (12.3)	38.2 (12.5)
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	99 participants	99 participants	100 participants	102 participants	400 participants
< 18 years		7	0	5	2	14
18 - < 65 years		91	97	93	99	380
65 - < 85 years		1	2	2	1	6
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	99 participants	99 participants	100 participants	102 participants	400 participants
	Female	55 55.6%	49 49.5%	48 48.0%	50 49.0%	202 50.5%
	Male	44 44.4%	50 50.5%	52 52.0%	52 51.0%	198 49.5%

Outcome Measures

1. Primary Outcome

Title	Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Description	Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures; Complex partial seizures; Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Median (Inter-Quartile Range); Unit of Measure: seizures per week
	2.15; (1.43 to 4.15)	1.80; (0.99 to 5.59)	1.96; (1.05 to 5.45)	1.70; (0.91 to 4.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Modified Intention-to-Treat (Placebo Treated Subjects), Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
	Comments	The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.
Statistical Test of Hypothesis	P-Value	=0.025
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.
Method of Estimation	Estimation Parameter	% reduction over Placebo
	Estimated Value	12.8
	Confidence Interval	(2-Sided) 95%; 1.7 to 22.6
	Estimation Comments	The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Modified Intention-to-Treat (Placebo Treated Subjects), Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
	Comments	The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.
Statistical Test of Hypothesis	P-Value	=0.492
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.
Method of Estimation	Estimation Parameter	% reduction over Placebo
	Estimated Value	4.1
	Confidence Interval	(2-Sided) 95%; -8.1 to 15.0
	Estimation Comments	The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.

2. Secondary Outcome

Title	Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Description	The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Measure Type: Number; Unit of Measure: participants
Responders	16	21	23	33
Non-responders	80	75	76	68

3. Secondary Outcome

Title	All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period
Description	There are three different types of seizures: Type I: Partial seizures; Type II: Generalized seizures; Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Median (Inter-Quartile Range); Unit of Measure: seizures per week
	2.15; (1.45 to 4.23)	1.80; (0.99 to 5.59)	1.96; (1.05 to 5.85)	1.77; (0.99 to 4.80)

4. Secondary Outcome

Title	Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
Description	Percent change from Baseline was calculated as percent reduction by: (weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline). The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	95	96	99	101
Median (Inter-Quartile Range); Unit of Measure: Percent change in POS frequency
	17.75; (-5.11 to 37.07)	19.95; (-12.96 to 45.15)	22.52; (-4.56 to 46.51)	30.47; (11.40 to 59.78)

5. Secondary Outcome

Title	Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
Description	Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %. Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Measure Type: Number; Unit of Measure: percentage of participants
<-25 %	14.6	21.9	14.1	9.9
-25 % to < 25 %	44.8	31.3	38.4	31.7
25 % to < 50 %	24.0	25.0	24.2	25.7
50 % to < 75 %	12.5	12.5	15.2	19.8
75 % to < 100 %	4.2	8.3	6.1	8.9
100 %	0	1.0	2.0	4.0

6. Secondary Outcome

Title	Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
Description	Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as: (total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Measure Type: Number; Unit of Measure: percentage of participants
Seizure-free	0	1.0	1.0	4.0
No seizures but non-completer	0	0	1.0	0
Not seizure-free	100.0	99.0	98.0	96.0

7. Secondary Outcome

Title	Time to First Type I Seizure During the 12-week Treatment Period
Description	The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Median (95% Confidence Interval); Unit of Measure: days
	3; (2 to 3)	4; (2 to 5)	5; (3 to 7)	4; (3 to 6)

8. Secondary Outcome

Title	Time to Fifth Type I Seizure During the 12-week Treatment Period
Description	The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Median (95% Confidence Interval); Unit of Measure: days
	15; (12 to 16)	14; (12 to 18)	17; (14 to 21)	19; (16 to 25)

9. Secondary Outcome

Title	Time to Tenth Type I Seizure During the 12-week Treatment Period
Description	The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	96	96	99	101
Median (95% Confidence Interval); Unit of Measure: days
	28; (24 to 33)	30; (21 to 38)	34; (25 to 46)	37; (27 to 52)

10. Secondary Outcome

Title	Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period
Description	The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.

Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	32	34	36	33
Measure Type: Number; Unit of Measure: percentage of participants
	56.3	50.0	77.8	63.6

11. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	86	81	81	85
Mean (Standard Deviation); Unit of Measure: units on a scale
	3.88 (14.44)	4.07 (15.40)	5.19 (15.47)	2.88 (13.53)

12. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	84	84	86
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.36 (26.98)	3.34 (19.20)	3.69 (24.55)	5.97 (21.79)

13. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	84	84	87
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.97 (28.39)	7.03 (23.47)	7.73 (26.04)	2.06 (23.02)

14. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score
Description	The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	84	84	86
Mean (Standard Deviation); Unit of Measure: units on a scale
	7.44 (4.32)	7.32 (4.03)	6.55 (3.94)	7.99 (3.63)

15. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Hospital Depression Score
Description	The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.
Time Frame	Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	84	84	86
Mean (Standard Deviation); Unit of Measure: units on a scale
	5.36 (3.78)	4.97 (4.00)	4.82 (3.56)	5.81 (3.70)

16. Secondary Outcome

Title	Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Description	Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'
Time Frame	Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	84	81	80	86
Measure Type: Number; Unit of Measure: percentage of participants
Marked improvement	15.5	19.8	18.8	26.7
Moderate improvement	25.0	24.7	26.3	19.8
Slight improvement	23.8	18.5	21.3	22.1
No change	28.6	23.5	27.5	23.3
Slight worsening	4.8	6.2	1.3	4.7
Moderate worsening	1.2	7.4	3.8	1.2
Marked worsening	1.2	0	1.3	2.3

17. Secondary Outcome

Title	Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Description	The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'
Time Frame	Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	95	90	99	98
Measure Type: Number; Unit of Measure: percentage of participants
Marked improvement	12.6	12.2	17.2	16.3
Moderate improvement	20.0	18.9	18.2	27.6
Slight improvement	21.1	24.4	31.3	24.5
No change	41.1	34.4	32.3	25.5
Slight worsening	3.2	2.2	1.0	2.0
Moderate worsening	1.1	7.8	0	3.1
Marked worsening	1.1	0	0	1.0

18. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame	From Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	86	82	82	86
Mean (Standard Deviation); Unit of Measure: units on a scale
	6.41 (19.55)	2.24 (23.10)	3.94 (15.56)	0.45 (20.07)

19. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame	From Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	83	81	87
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.14 (18.28)	1.69 (21.61)	2.07 (19.10)	1.97 (17.29)

20. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame	From Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	83	84	86
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.79 (20.34)	4.26 (21.23)	6.36 (24.61)	3.37 (19.16)

21. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame	From Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	84	84	86
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.02 (34.05)	-2.61 (28.08)	0.73 (25.94)	6.07 (30.90)

22. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame	From Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	87	84	84	87
Mean (Standard Deviation); Unit of Measure: units on a scale
	5.49 (16.25)	3.39 (19.70)	3.66 (20.10)	2.33 (19.14)

23. Secondary Outcome

Title	Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame	From Baseline to 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.

Arm/Group Title	Modified Intention-to-Treat (Placebo Treated Subjects)	Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)	Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
Arm/Group Description:	Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.	Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Overall Number of Participants Analyzed	86	84	84	85
Mean (Standard Deviation); Unit of Measure: units on a scale
	8.1 (22.0)	6.9 (23.5)	7.3 (21.1)	5.5 (20.9)

Adverse Events

Time Frame	Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Event Reporting Description	Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title	Placebo		BRV 5 mg/Day		BRV 20 mg/Day		BRV 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day		Brivaracetam 5 mg/day, 2.5 mg administered twice a day		Brivaracetam 20 mg/day, 10 mg administered twice a day		Brivaracetam 50 mg/day, 25 mg administered twice a day
All-Cause Mortality
	Placebo		BRV 5 mg/Day		BRV 20 mg/Day		BRV 50 mg/Day
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events
	Placebo		BRV 5 mg/Day		BRV 20 mg/Day		BRV 50 mg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0.00%)		1/97 (1.03%)		3/100 (3.00%)		4/101 (3.96%)
Gastrointestinal disorders
Abdominal pain * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
Vomiting * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
General disorders
Chest pain * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
Pain * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
Infections and infestations
Bronchitis * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
Pneumonia * 1	0/98 (0.00%)	0	1/97 (1.03%)	1	0/100 (0.00%)	0	0/101 (0.00%)	0
Nervous system disorders
Grand mal convulsion * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
Syncope * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	1/100 (1.00%)	1	0/101 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Aspiration bronchial * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	1/100 (1.00%)	1	0/101 (0.00%)	0
Brain hypoxia * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
Bronchospasm * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	1/100 (1.00%)	1	0/101 (0.00%)	0
Dyspnoea * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	0/100 (0.00%)	0	1/101 (0.99%)	1
Respiratory failure * 1	0/98 (0.00%)	0	0/97 (0.00%)	0	1/100 (1.00%)	1	0/101 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA9.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		BRV 5 mg/Day		BRV 20 mg/Day		BRV 50 mg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/98 (32.65%)		49/97 (50.52%)		46/100 (46.00%)		51/101 (50.50%)
Gastrointestinal disorders
Nausea * 1	3/98 (3.06%)	3	4/97 (4.12%)	4	7/100 (7.00%)	8	6/101 (5.94%)	7
Diarrhoea * 1	2/98 (2.04%)	4	4/97 (4.12%)	4	4/100 (4.00%)	5	6/101 (5.94%)	6
General disorders
Fatigue * 1	2/98 (2.04%)	2	3/97 (3.09%)	3	13/100 (13.00%)	14	10/101 (9.90%)	12
Infections and infestations
Influenza * 1	1/98 (1.02%)	1	9/97 (9.28%)	10	6/100 (6.00%)	6	4/101 (3.96%)	4
Upper respiratory tract infection * 1	4/98 (4.08%)	4	5/97 (5.15%)	5	5/100 (5.00%)	5	0/101 (0.00%)	0
Urinary tract infection * 1	2/98 (2.04%)	2	3/97 (3.09%)	3	6/100 (6.00%)	6	1/101 (0.99%)	1
Nervous system disorders
Somnolence * 1	7/98 (7.14%)	7	14/97 (14.43%)	14	14/100 (14.00%)	15	17/101 (16.83%)	18
Dizziness * 1	9/98 (9.18%)	13	12/97 (12.37%)	16	14/100 (14.00%)	15	16/101 (15.84%)	17
Headache * 1	14/98 (14.29%)	21	11/97 (11.34%)	14	6/100 (6.00%)	8	13/101 (12.87%)	16
Psychiatric disorders
Insomnia * 1	2/98 (2.04%)	2	2/97 (2.06%)	2	3/100 (3.00%)	4	7/101 (6.93%)	7
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA9.0

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

• Name/Title: Clinical Trial Call Center
• Organization: UCB
• Phone: +1 877 822 9493

Publications of Results:

Biton V, Berkovic SF, Abou-Khalil B, Sperling MR, Johnson ME, Lu S. Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: a phase III randomized, double-blind, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):57-66. doi: 10.1111/epi.12433. Epub 2013 Nov 8.

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.

Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.

Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.

Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.

Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.

Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.

Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum In: Epilepsy Res. 2017 Nov;137:165-166.

Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.

Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.

Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.

Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.

Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00464269
• Other Study ID Numbers: N01253; 2006-006345-14 ( EudraCT Number )
• First Submitted: April 19, 2007
• First Posted: April 23, 2007
• Results First Submitted: March 14, 2016
• Results First Posted: April 13, 2016
• Last Update Posted: July 21, 2022