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Trial record 1 of 2 for:    NCT00464269
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Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT00464269
Recruitment Status : Completed
First Posted : April 23, 2007
Results First Posted : April 13, 2016
Last Update Posted : August 8, 2018
Sponsor:
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
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
Hide 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
Arm/Group Title Placebo BRV 5 mg/Day BRV 20 mg/Day BRV 50 mg/Day Total Title
Hide 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
Hide 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%
1.Primary Outcome
Title Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
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.
Hide 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
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
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Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
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
Hide 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   --/--      --/--      --/--      --/--    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Publications of Results:
Layout table for additonal information
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: August 8, 2018