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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Brivaracetam
Brivaracetam
Brivaracetam
Sponsored by
UCB Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Brivaracetam, Partial Onset Seizures

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
  • Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
  • Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
  • Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
  • Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

Exclusion Criteria:

  • History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
  • History or presence of status epilepticus during the year preceding Visit 1 or during Baseline

Sites / Locations

  • 13
  • 19
  • 12
  • 10
  • 44
  • 41
  • 42
  • 43
  • 60
  • 56
  • 62
  • 57
  • 53
  • 52
  • 64
  • 54
  • 51
  • 61
  • 55
  • 76
  • 73
  • 79
  • 78
  • 74
  • 75
  • 77
  • 70
  • 72
  • 71
  • 94
  • 90
  • 92
  • 256
  • 257
  • 253
  • 258
  • 255
  • 250
  • 259
  • 251
  • 270
  • 104
  • 105
  • 101
  • 103
  • 107
  • 124
  • 125
  • 122
  • 142
  • 143
  • 153
  • 147
  • 151
  • 141
  • 150
  • 148
  • 144
  • 152
  • 146
  • 145
  • 140
  • 149
  • 187
  • 181
  • 182
  • 184
  • 183
  • 185
  • 201
  • 205
  • 203
  • 202
  • 204
  • 223
  • 224

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Brivaracetam 20 mg/day

Brivaracetam 50 mg/day

Brivaracetam 100 mg/day

Arm Description

Matching Placebo tablets administered twice a day

Brivaracetam 20 mg/day, 10 mg administered twice a day

Brivaracetam 50 mg/day, 25 mg administered twice a day

Brivaracetam 100 mg/day, 50 mg administered twice a day

Outcomes

Primary Outcome Measures

Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.

Secondary Outcome Measures

Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period
Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week. The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline.
All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period
There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).
Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
The categories are: <= 25 % - 25 % to < 25 % 25 % to < 50 % 50 % to < 75 % 75 % to < 100 % 100 %
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.
Time to First Type I Seizure During the 12-week Treatment Period
The time to first Type I Seizure during the 12-week Treatment Period was measured in days.
Time to Fifth Type I Seizure During the 12-week Treatment Period
The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.
Time to Tenth Type I Seizure During the 12-week Treatment Period
The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.
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.
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
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.
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
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.
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
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.
Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both 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 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.
Change From Baseline to the 12-week Treatment Period in Hospital Depression Score
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both 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 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
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 not mentally impaired had to complete it by answering the following question: "Overall, has there been a change in your seizures since the start of the study medication?"
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
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 reference time point. The Investigator was to complete it by answering the following question: "Assess the Overall change in the severity of patient's illness, compared to start of study medication."
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.

Full Information

First Posted
June 21, 2007
Last Updated
July 14, 2022
Sponsor
UCB Pharma SA
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1. Study Identification

Unique Protocol Identification Number
NCT00490035
Brief Title
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Official Title
A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Brivaracetam, Partial Onset Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
399 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo tablets administered twice a day
Arm Title
Brivaracetam 20 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 20 mg/day, 10 mg administered twice a day
Arm Title
Brivaracetam 50 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 50 mg/day, 25 mg administered twice a day
Arm Title
Brivaracetam 100 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 100 mg/day, 50 mg administered twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.
Primary Outcome Measure Information:
Title
Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Description
Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.
Time Frame
From Baseline to 12-week Treatment Period
Secondary Outcome Measure Information:
Title
Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period
Description
Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week. The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline.
Time Frame
From Baseline to 12-week Treatment Period
Title
All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period
Description
There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).
Time Frame
From Baseline to 12-week Treatment Period
Title
Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
Description
The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.
Time Frame
From Baseline to 12-week Treatment Period
Title
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
Description
The categories are: <= 25 % - 25 % to < 25 % 25 % to < 50 % 50 % to < 75 % 75 % to < 100 % 100 %
Time Frame
From Baseline to 12-week Treatment Period
Title
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
Description
Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.
Time Frame
From Baseline to 12-week Treatment Period
Title
Time to First Type I Seizure During the 12-week Treatment Period
Description
The time to first Type I Seizure during the 12-week Treatment Period was measured in days.
Time Frame
From Baseline to 12-week Treatment Period
Title
Time to Fifth Type I Seizure During the 12-week Treatment Period
Description
The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.
Time Frame
From Baseline to 12-week Treatment Period
Title
Time to Tenth Type I Seizure During the 12-week Treatment Period
Description
The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.
Time Frame
From Baseline to 12-week Treatment Period
Title
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.
Description
The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.
Time Frame
From Baseline to 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The 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
Title
Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The 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
Title
Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The 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
Title
Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score
Description
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both 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 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.
Time Frame
From Baseline to 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Hospital Depression Score
Description
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both 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 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.
Time Frame
From Baseline to 12-week Treatment Period
Title
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
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 not mentally impaired had to complete it by answering the following question: "Overall, has there been a change in your seizures since the start of the study medication?"
Time Frame
Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Title
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Description
The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: "Assess the Overall change in the severity of patient's illness, compared to start of study medication."
Time Frame
Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame
From Baseline to 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame
From Baseline to 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame
From Baseline to 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame
From Baseline to 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame
From Baseline to 12-week Treatment Period
Title
Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Description
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Time Frame
From Baseline to 12-week Treatment Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification) Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1 Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED Exclusion Criteria: History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3 History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
13
City
Gent
Country
Belgium
Facility Name
19
City
La Louviere
Country
Belgium
Facility Name
12
City
Liege
Country
Belgium
Facility Name
10
City
Saint-Vith
Country
Belgium
Facility Name
44
City
Kuopio
Country
Finland
Facility Name
41
City
Oulu
Country
Finland
Facility Name
42
City
Seinajoki
Country
Finland
Facility Name
43
City
Tampere
Country
Finland
Facility Name
60
City
Angers Cedex 9
Country
France
Facility Name
56
City
Bethune
Country
France
Facility Name
62
City
Bron
Country
France
Facility Name
57
City
Dijon
Country
France
Facility Name
53
City
Lille
Country
France
Facility Name
52
City
Montpellier Cedex
Country
France
Facility Name
64
City
Nancy
Country
France
Facility Name
54
City
Paris
Country
France
Facility Name
51
City
Rennes
Country
France
Facility Name
61
City
Roanne
Country
France
Facility Name
55
City
Strasbourg
Country
France
Facility Name
76
City
Bad Berka
Country
Germany
Facility Name
73
City
Berlin
Country
Germany
Facility Name
79
City
Bernau
Country
Germany
Facility Name
78
City
Bielefeld
Country
Germany
Facility Name
74
City
Freiburg
Country
Germany
Facility Name
75
City
Kehl-Kork
Country
Germany
Facility Name
77
City
Mainz
Country
Germany
Facility Name
70
City
Munchen
Country
Germany
Facility Name
72
City
Radeberg
Country
Germany
Facility Name
71
City
Ulm
Country
Germany
Facility Name
94
City
Budapest
Country
Hungary
Facility Name
90
City
Debrecen
Country
Hungary
Facility Name
92
City
Pecs
Country
Hungary
Facility Name
256
City
Bangalore
Country
India
Facility Name
257
City
Bangalore
Country
India
Facility Name
253
City
Hyderabad
Country
India
Facility Name
258
City
Jaipur
Country
India
Facility Name
255
City
Kolkata
Country
India
Facility Name
250
City
Lucknow
Country
India
Facility Name
259
City
Mumbai
Country
India
Facility Name
251
City
Pune Maharashtra
Country
India
Facility Name
270
City
Pune
Country
India
Facility Name
104
City
Bologna
Country
Italy
Facility Name
105
City
Foggia
Country
Italy
Facility Name
101
City
Perugia
Country
Italy
Facility Name
103
City
Roma
Country
Italy
Facility Name
107
City
Roma
Country
Italy
Facility Name
124
City
Breda
Country
Netherlands
Facility Name
125
City
Den Haag
Country
Netherlands
Facility Name
122
City
Zwolle
Country
Netherlands
Facility Name
142
City
Bialystok
Country
Poland
Facility Name
143
City
Gdansk
Country
Poland
Facility Name
153
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
147
City
Katowice
Country
Poland
Facility Name
151
City
Katowice
Country
Poland
Facility Name
141
City
Kielce
Country
Poland
Facility Name
150
City
Krakow
Country
Poland
Facility Name
148
City
Lodz
Country
Poland
Facility Name
144
City
Lublin
Country
Poland
Facility Name
152
City
Poznan
Country
Poland
Facility Name
146
City
Szczecin
Country
Poland
Facility Name
145
City
Warsaw
Country
Poland
Facility Name
140
City
Warszawa
Country
Poland
Facility Name
149
City
Warszawa
Country
Poland
Facility Name
187
City
Alcorcon
Country
Spain
Facility Name
181
City
Barcelona
Country
Spain
Facility Name
182
City
Madrid
Country
Spain
Facility Name
184
City
San Sebastian
Country
Spain
Facility Name
183
City
Vigo
Country
Spain
Facility Name
185
City
Zaragoza
Country
Spain
Facility Name
201
City
Biel
Country
Switzerland
Facility Name
205
City
Geneve
Country
Switzerland
Facility Name
203
City
St Gallen
Country
Switzerland
Facility Name
202
City
Tschugg
Country
Switzerland
Facility Name
204
City
Zürich
Country
Switzerland
Facility Name
223
City
Liverpool
Country
United Kingdom
Facility Name
224
City
Middlesborough
Country
United Kingdom

12. IPD Sharing Statement

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Learn more about this trial

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

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