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Trial record 1 of 3 for:    NCT01261325
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Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01261325
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : August 15, 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 Drug: Placebo
Drug: Brivaracetam
Drug: Antiepileptic drugs with market authorization available per country
Enrollment 768
Recruitment Details Recruitment for the N01358 study began in December 2010. The study concluded in May 2014.
Pre-assignment Details The Participant Flow and Baseline Demographics data is taken from the Randomized Set (RS). The RS consists of all subjects who were randomized.
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description Matching placebo tablets administered twice daily Brivaracetam 50 mg administered twice daily Brivaracetam 100 mg administered twice daily
Period Title: Overall Study
Started 263 254 251
Completed 246 225 225
Not Completed 17 29 26
Reason Not Completed
Lack of Efficacy             1             1             0
Withdrawal by Subject             2             2             4
SAE, non-fatal             1             5             1
AE, non-serious non-fatal             9             15             13
SAE, non-fatal+AE, non-serious non-fatal             0             1             1
Non Compliance             2             0             0
Patient Randomized by Mistake             0             1             0
Erroneously Randomized             1             0             0
Screen Failure             1             0             0
Randomized in Error             0             0             1
Protocol Violation             0             3             1
Lost to Follow-up             0             1             3
AE, serious fatal             0             0             2
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day Total Title
Hide Arm/Group Description Matching placebo tablets administered twice daily Brivaracetam 50 mg administered twice daily Brivaracetam 100 mg administered twice daily [Not Specified]
Overall Number of Baseline Participants 263 254 251 768
Hide Baseline Analysis Population Description
Baseline Characteristics consist of the Randomized Set (RS). The RS includes all subjects that were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 263 participants 254 participants 251 participants 768 participants
39.8  (12.8) 39.0  (13.4) 39.7  (12.8) 39.5  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 254 participants 251 participants 768 participants
Female
128
  48.7%
152
  59.8%
117
  46.6%
397
  51.7%
Male
135
  51.3%
102
  40.2%
134
  53.4%
371
  48.3%
Weight  
Median (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 263 participants 254 participants 251 participants 768 participants
76.1  (19.9) 74.1  (16.8) 75.5  (19.0) 75.2  (18.6)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 263 participants 254 participants 251 participants 768 participants
168.4  (10.0) 166.6  (9.8) 168.7  (9.9) 167.9  (9.9)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 263 participants 254 participants 251 participants 768 participants
26.6  (5.7) 26.7  (5.6) 26.4  (6.0) 26.6  (5.8)
Racial Group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 263 participants 254 participants 251 participants 768 participants
American Indian or Alaska Native 10 8 11 29
Asian 32 32 29 93
Black or African American 11 8 7 26
White 190 183 183 556
Other 17 21 18 56
Missing 3 2 3 8
1.Primary Outcome
Title Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Hide Description Primary endpoint: United States of America (FDA)
Time Frame 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.
Arm/Group Title Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day Placebo
Hide Arm/Group Description:
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Matching placebo tablets administered twice daily
Overall Number of Participants Analyzed 252 249 259
Measure Type: Number
Unit of Measure: Percentage of reduction
22.8 23.2 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brivaracetam 100 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Type I error rate of 0.05 based on a Hochberg multiple comparison procedure would be considered statistically significant" or similar, as accurate and appropriate.
Method ANCOVA
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Percent reduction over PBO
Estimated Value 22.8
Confidence Interval (2-Sided) 95%
13.3 to 31.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brivaracetam 200 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.
Method ANCOVA
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Percent reduction over PBO
Estimated Value 23.2
Confidence Interval (2-Sided) 95%
13.8 to 31.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Hide Description Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.
Time Frame Baseline to 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Measure Type: Number
Unit of Measure: Percentage of subjects
Responders 21.6 38.9 37.8
Non-Responders 78.4 61.1 62.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 100 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.
Method Regression, Logistic
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Odds ratio (BRV versus PBO)
Estimated Value 2.39
Confidence Interval (2-Sided) 95%
1.6 to 3.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 200 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.
Method Regression, Logistic
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Odds ratio (BRV versus PBO)
Estimated Value 2.19
Confidence Interval (2-Sided) 95%
1.5 to 3.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period
Hide Description [Not Specified]
Time Frame Baseline to 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Median (Inter-Quartile Range)
Unit of Measure: percentage of change
17.6
(-8.3 to 46.0)
37.2
(0.1 to 69.4)
35.6
(4.8 to 66.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 100 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant at a nominal 0.050 significance level.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median difference vs placebo
Estimated Value 15.8
Confidence Interval (2-Sided) 95%
7.6 to 24.2
Estimation Comments Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 200 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant at a nominal 0.050 significance level.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median difference vs placebo
Estimated Value 18.1
Confidence Interval (2-Sided) 95%
10.4 to 26.4
Estimation Comments Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.
4.Secondary Outcome
Title Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period
Hide Description [Not Specified]
Time Frame Baseline to 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Measure Type: Number
Unit of Measure: percentage of subjects
<-25 % 16.6 14.3 10.8
-25 % to <25 % 40.5 28.6 29.3
25 % to <50 % 21.2 18.3 22.1
50 % to <75 % 13.9 19.0 18.1
75 % to <100 % 6.9 13.9 13.7
100 % 0.8 6.0 6.0
5.Secondary Outcome
Title Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period
Hide Description [Not Specified]
Time Frame 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Measure Type: Number
Unit of Measure: percentage of subjects
Seizure free 0.8 5.2 4.0
No seizures but discontinued 0.4 1.2 1.2
Not seizure free 98.8 93.7 94.8
6.Secondary Outcome
Title All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period
Hide Description [Not Specified]
Time Frame 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Median (Inter-Quartile Range)
Unit of Measure: number of seizures/ 28-day
8.7
(4.3 to 23.6)
6.3
(2.7 to 17.8)
5.8
(2.3 to 14.2)
7.Secondary Outcome
Title Time to the First Type I Seizure During the Treatment Period
Hide Description [Not Specified]
Time Frame 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Median (95% Confidence Interval)
Unit of Measure: days
3
(2 to 3)
5
(3 to 7)
6
(4 to 7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 100 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant at a nominal 0.050 significance level.
Method Semi-parametric hazards regression model
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.56 to 0.82
Estimation Comments Hazard ratio is Brivaracetam versus Placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 200 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant at a nominal 0.050 significance level.
Method Semi-parametric hazards regression model
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.54 to 0.79
Estimation Comments Hazard ratio is Brivaracetam versus Placebo.
8.Secondary Outcome
Title Time to the Fifth Type I Seizure During the Treatment Period
Hide Description [Not Specified]
Time Frame 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Median (95% Confidence Interval)
Unit of Measure: days
16
(12 to 19)
21
(17 to 25)
23
(20 to 26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 100 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant at a nominal 0.050 significance level.
Method Semi-parametric hazards regression model
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.53 to 0.80
Estimation Comments Hazard ratio is Brivaracetam versus Placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 200 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant at a nominal 0.050 significance level.
Method Semi-parametric hazards regression model
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.47 to 0.71
Estimation Comments Hazard ratio is Brivaracetam versus Placebo.
9.Secondary Outcome
Title Time to the Tenth Type I Seizure During the Treatment Period
Hide Description [Not Specified]
Time Frame 12 week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice daily
Brivaracetam 50 mg administered twice daily
Brivaracetam 100 mg administered twice daily
Overall Number of Participants Analyzed 259 252 249
Median (95% Confidence Interval)
Unit of Measure: days
32
(24 to 36)
37
(29 to 46)
43
(36 to 49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 100 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Statistically significant at a nominal 0.050 significance level.
Method Semi-parametric hazards regression model
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.60 to 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 200 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistically significant at a nominal 0.050 significance level.
Method Semi-parametric hazards regression model
Comments Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.55 to 0.85
Estimation Comments [Not Specified]
Time Frame Treatment-emergent Adverse Events (TEAE) were collected during the study up to week 18
Adverse Event Reporting Description

TEAEs are comprised of the Safety Population, which consists of all randomized subjects who receive at least 1 dose of study medication.

The Non-serious Adverse Events section represents a >= 5% threshold of subjects experiencing Non-serious TEAEs in any treatment group and not the total population.

 
Arm/Group Title Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Hide Arm/Group Description Matching placebo tablets administered twice daily Brivaracetam 50 mg administered twice daily Brivaracetam 100 mg administered twice daily
All-Cause Mortality
Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/261 (3.45%)      8/253 (3.16%)      8/250 (3.20%)    
Cardiac disorders       
Acute myocardial infarction * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Coronary artery stenosis * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
General disorders       
Death * 1  0/261 (0.00%)  0 0/253 (0.00%)  0 1/250 (0.40%)  1
Sudden unexplained death in epilepsy * 1  0/261 (0.00%)  0 0/253 (0.00%)  0 1/250 (0.40%)  1
Infections and infestations       
Localised infection * 1  0/261 (0.00%)  0 0/253 (0.00%)  0 1/250 (0.40%)  1
Meningitis viral * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
Pneumonia * 1  1/231 (0.43%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
Injury, poisoning and procedural complications       
Fall * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 2/250 (0.80%)  2
Craniocerebral injury * 1  0/261 (0.00%)  0 0/253 (0.00%)  0 1/250 (0.40%)  1
Humerus fracture * 1  0/261 (0.00%)  0 0/253 (0.00%)  0 1/250 (0.40%)  1
Rib fracture * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Traumatic renal injury * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Clavicle fracture * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
Joint dislocation * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thymoma * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
Nervous system disorders       
Grand mal convulsion * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 1/250 (0.40%)  1
Seizure cluster * 1  0/261 (0.00%)  0 0/253 (0.00%)  0 1/250 (0.40%)  1
Status epilepticus * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Epilepsy * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
Postictal state * 1  1/261 (0.38%)  1 0/253 (0.00%)  0 0/250 (0.00%)  0
Psychiatric disorders       
Adjustment disorder * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 1/250 (0.40%)  1
Agitation * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Conversion disorder * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Epileptic psychosis * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Psychotic disorder * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
Vascular disorders       
Haematoma * 1  0/261 (0.00%)  0 1/253 (0.40%)  1 0/250 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Brivaracetam 100 mg/Day Brivaracetam 200 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/261 (23.37%)      96/253 (37.94%)      97/250 (38.80%)    
General disorders       
Fatigue * 1  10/261 (3.83%)  10 19/253 (7.51%)  19 29/250 (11.60%)  32
Infections and infestations       
Urinary tract infection * 1  8/261 (3.07%)  8 13/253 (5.14%)  13 2/250 (0.80%)  2
Nervous system disorders       
Somnolence * 1  20/261 (7.66%)  20 49/253 (19.37%)  53 42/250 (16.80%)  43
Dizziness * 1  13/261 (4.98%)  14 26/253 (10.28%)  27 36/250 (14.40%)  38
Headache * 1  22/261 (8.43%)  30 17/253 (6.72%)  18 20/250 (8.00%)  21
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01261325    
Other Study ID Numbers: N01358
2010-019361-28 ( EudraCT Number )
First Submitted: December 9, 2010
First Posted: December 16, 2010
Results First Submitted: March 14, 2016
Results First Posted: August 15, 2016
Last Update Posted: August 8, 2018