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Trial record 1 of 3 for:    NCT00504881
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Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

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ClinicalTrials.gov Identifier: NCT00504881
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : March 17, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

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
Enrollment 480
Recruitment Details This multicenter study was conducted in 15 countries. It started in October 2007 and concluded in December 2008.
Pre-assignment Details The Participant Flow refers to the Randomized Set (RS).
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description Matching Placebo tablets administered twice a day A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Period Title: Overall Study
Started 121 359
Completed 111 323
Not Completed 10 36
Reason Not Completed
Lack of Efficacy             1             5
Lost to Follow-up             0             2
Withdrawal by Subject             1             4
Non-Compliance             1             0
No Birth Control             0             1
Safety Visit not performed             0             1
AE, serious fatal             0             1
SAE, non-fatal             2             6
AE, non-serious non-fatal             4             14
SAE,non-fatal+AE,non-serious non-fatal             0             2
AE of unknown type             1             0
Arm/Group Title Placebo Brivaracetam Total Title
Hide Arm/Group Description Matching Placebo tablets administered twice a day A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day [Not Specified]
Overall Number of Baseline Participants 121 359 480
Hide Baseline Analysis Population Description
Baseline characteristics refer to the Randomized Set (RS).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 359 participants 480 participants
<=18 years
3
   2.5%
5
   1.4%
8
   1.7%
Between 18 and 65 years
116
  95.9%
352
  98.1%
468
  97.5%
>=65 years
2
   1.7%
2
   0.6%
4
   0.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 359 participants 480 participants
36.5  (11.5) 35.6  (11.5) 35.85  (11.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 359 participants 480 participants
Female
52
  43.0%
178
  49.6%
230
  47.9%
Male
69
  57.0%
181
  50.4%
250
  52.1%
1.Primary Outcome
Title Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame Week 2 to the end of the Treatment Period (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 121 359
Measure Type: Number
Unit of Measure: percentage of participants
66.1 66.6
2.Primary Outcome
Title Partial Onset Seizure (Type I) Frequency Per Week Over the 16-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 (Week 0) to the end of the Treatment Period (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Median (Inter-Quartile Range)
Unit of Measure: seizures per week
1.86
(1.00 to 3.98)
1.74
(0.86 to 4.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam
Comments ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.125
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Reduction over Placebo
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
-2.2 to 15.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period
Hide Description The responder rate was presented as the percentage 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 (Week 0) to the end of Treatment Period (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Measure Type: Number
Unit of Measure: percentage of participants
Responders 16.7 30.3
Non-Responders 83.3 69.7
4.Secondary Outcome
Title Seizure Frequency (All Seizure Types) Per Week Over the 16-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 (Week 0) to the end of Treatment Period (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Median (Inter-Quartile Range)
Unit of Measure: number of seizures per week
1.87
(1.00 to 4.59)
1.74
(0.86 to 4.04)
5.Secondary Outcome
Title Percent Change From Baseline to the 16-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).

A negative value in percent Change from Baseline indicates an improvement from Baseline.

The higher the negative values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline.

Time Frame Baseline (Week 0) to end of Treatment Period (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Median (Inter-Quartile Range)
Unit of Measure: percent change
-18.93
(-39.05 to -7.83)
-26.92
(-55.98 to 11.44)
6.Secondary Outcome
Title Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-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 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Measure Type: Number
Unit of Measure: percentage of participants
<- 25 % 14.8 18.3
-25 % to < 25 % 44.4 29.1
25 % to < 50 % 24.1 22.3
50 % to < 75 % 13.9 17.0
75 % to < 100 % 2.8 11.8
100 % 0 1.5
7.Secondary Outcome
Title Seizure Freedom Rate (All Seizure Types) Over the 16-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 (Week 0) to the end of Treatment Period (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Measure Type: Number
Unit of Measure: percentage of participants
Seizure-free 0 1.5
No Seizure but non-completer 0 0
Not Seizure free 100.0 98.5
8.Secondary Outcome
Title Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-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 16-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 Placebo Brivaracetam
Hide Arm/Group Description:

Matching Placebo tablets administered twice a day

Placebo: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period

A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day

Brivaracetam: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period

Overall Number of Participants Analyzed 35 94
Measure Type: Number
Unit of Measure: percentage of participants
54.3 47.9
9.Secondary Outcome
Title Time to First Type I Seizure During the 16-week Treatment Period
Hide Description Time to first Type I seizure during the 16-week Treatment Period was measured in days.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Median (95% Confidence Interval)
Unit of Measure: days
3
(2 to 4)
4
(4 to 5)
10.Secondary Outcome
Title Time to Fifth Type I Seizure During the 16-week Treatment Period
Hide Description Time to fifth Type I seizure during the 16-week Treatment Period was measured in days.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Median (95% Confidence Interval)
Unit of Measure: days
14
(11 to 19)
18
(16 to 21)
11.Secondary Outcome
Title Time to Tenth Type I Seizure During Treatment Period
Hide Description Time to tenth Type I seizure during the 16-week Treatment Period was measured in days.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 323
Median (95% Confidence Interval)
Unit of Measure: days
36
(23 to 44)
38
(31 to 43)
12.Secondary Outcome
Title Change From Baseline to the 16-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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 98 284
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.04  (12.58) 4.22  (13.73)
13.Secondary Outcome
Title Change From Baseline to the 16-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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 99 291
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.66  (23.23) 10.29  (21.99)
14.Secondary Outcome
Title Change From Baseline to the 16-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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 99 290
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.61  (21.87) 2.66  (23.48)
15.Secondary Outcome
Title Change From Baseline to the 16-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 Anxiety and Depression. 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 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 97 286
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.57  (3.35) -0.85  (3.62)
16.Secondary Outcome
Title Change From Baseline to the 16-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 Anxiety and Depression. 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 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 97 285
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.30  (3.08) -0.41  (3.54)
17.Secondary Outcome
Title Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Hide Description The 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 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Evaluable subjects are subjects who completed the GES at last treatment period visit.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 99 282
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.73  (1.37) 5.07  (1.36)
18.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 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Evaluable subjects are subjects for whom the GES was completed by the investigator at last treatment period visit.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 108 319
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.79  (1.14) 5.00  (1.22)
19.Secondary Outcome
Title Change From Baseline to the 16-week Treatment Period in Energy/Fatigue 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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 99 286
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.98  (18.00) 3.34  (19.06)
20.Secondary Outcome
Title Change From Baseline to the 16-week Treatment Period in Emotional Well-being 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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 99 287
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.97  (19.29) 2.84  (18.07)
21.Secondary Outcome
Title Change From Baseline to the 16-week Treatment Period in Cognitive 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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 99 290
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.28  (19.88) 5.51  (18.55)
22.Secondary Outcome
Title Change From Baseline to the 16-week Treatment Period in Overall 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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 98 291
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.48  (17.40) 4.08  (19.23)
23.Secondary Outcome
Title Change From Baseline to the 16-week Treatment Period in Medication Effects 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 7 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. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.
Time Frame Baseline to 16-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.

Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.

Arm/Group Title Placebo Brivaracetam
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Overall Number of Participants Analyzed 99 290
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.83  (27.21) -0.24  (25.84)
Time Frame Adverse Events (AEs) were collected up to 24 weeks from Visit 1 (Week -4) to the Safety Visit (Week 20).
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 Brivaracetam
Hide Arm/Group Description Matching Placebo tablets administered twice a day A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
All-Cause Mortality
Placebo Brivaracetam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Brivaracetam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/121 (7.44%)      20/359 (5.57%)    
Blood and lymphatic system disorders     
Neutropenia * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Cardiac disorders     
Myocardial ischaemia * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Ear and labyrinth disorders     
Vertigo * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Gastrointestinal disorders     
Abdominal pain * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
General disorders     
Chest pain * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Drowning * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Fatigue * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Infections and infestations     
Hepatitis B * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Pyelonephritis acute * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Injury, poisoning and procedural complications     
Drug toxity * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Overdose * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Ankle fracture * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Burns second degree * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Face injury * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Fall * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Head injury * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Skin laceration * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Spinal fracture * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Metabolism and nutrition disorders     
Diabetis mellitus inadequate control * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Nervous system disorders     
Headache * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Tremor * 1  1/121 (0.83%)  1 0/359 (0.00%)  0
Dizziness * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Postictal state * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
Convulsion * 1  1/121 (0.83%)  1 7/359 (1.95%)  9
Status epilepticus * 1  0/121 (0.00%)  0 1/359 (0.28%)  3
Pregnancy, puerperium and perinatal conditions     
Pregnancy * 1  0/121 (0.00%)  0 2/359 (0.56%)  2
Psychiatric disorders     
Depression * 1  1/121 (0.83%)  1 1/359 (0.28%)  1
Psychotic disorder * 1  0/121 (0.00%)  0 1/359 (0.28%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Brivaracetam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/121 (33.06%)      139/359 (38.72%)    
Gastrointestinal disorders     
Nausea * 1  11/121 (9.09%)  14 20/359 (5.57%)  26
General disorders     
Fatigue * 1  5/121 (4.13%)  5 27/359 (7.52%)  31
Infections and infestations     
Nasopharyngitis * 1  8/121 (6.61%)  10 14/359 (3.90%)  16
Musculoskeletal and connective tissue disorders     
Back pain * 1  8/121 (6.61%)  9 11/359 (3.06%)  11
Nervous system disorders     
Dizziness * 1  7/121 (5.79%)  9 31/359 (8.64%)  36
Headache * 1  24/121 (19.83%)  45 52/359 (14.48%)  79
Somnolence * 1  5/121 (4.13%)  7 40/359 (11.14%)  47
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00504881    
Other Study ID Numbers: N01254
2006-006346-34 ( EudraCT Number )
First Submitted: July 19, 2007
First Posted: July 20, 2007
Results First Submitted: March 14, 2016
Results First Posted: March 17, 2017
Last Update Posted: April 3, 2018