search
Back to results

Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
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 aged from 16 to 70 years, inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
  • Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy according to the International League Against Epilepsy (ILAE) classification
  • For subjects suffering from localization-related Epilepsy: subjects had at least 2 Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during the 3 months preceding Visit 1 according to the ILAE classification
  • For subjects suffering from localization-related Epilepsy: subjects had at least 4 Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week Baseline Period according to the ILAE classification
  • For subjects suffering from generalized Epilepsy: subjects had at least 2 Type II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE classification
  • For subjects suffering from generalized Epilepsy: subjects had at least 4 Type II-seizure days during the 4 week Baseline Period according to the ILAE classification
  • Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

Exclusion Criteria:

  • For subjects who suffered from localization-related Epilepsy: history or presence of Seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2 or occurring only as Type IA non-motor
  • Subjects with a history or presence of Status Epilepticus during the year preceding Visit 1 or during Baseline

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Brivaracetam

Arm 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

Outcomes

Primary Outcome Measures

Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period
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.
Partial Onset Seizure (Type I) Frequency Per Week Over the 16-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 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)

Secondary Outcome Measures

Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period
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.
Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period
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)
Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
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.
Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period
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.
Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period
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)
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-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.
Time to First Type I Seizure During the 16-week Treatment Period
Time to first Type I seizure during the 16-week Treatment Period was measured in days.
Time to Fifth Type I Seizure During the 16-week Treatment Period
Time to fifth Type I seizure during the 16-week Treatment Period was measured in days.
Time to Tenth Type I Seizure During Treatment Period
Time to tenth Type I seizure during the 16-week Treatment Period was measured in days.
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
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.
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
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.
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
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.
Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score
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.
Change From Baseline to the 16-week Treatment Period in Hospital Depression Score
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.
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 completed it by answering to the following: '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 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.'
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
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.
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
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.
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
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.
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
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.
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
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.

Full Information

First Posted
July 19, 2007
Last Updated
March 8, 2018
Sponsor
UCB Pharma SA
search

1. Study Identification

Unique Protocol Identification Number
NCT00504881
Brief Title
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
Official Title
An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (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 compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.

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
480 (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
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
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 16-week Treatment Period
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period
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)
Title
Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period
Description
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures Complex partial seizures Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)
Time Frame
Baseline (Week 0) to the end of the Treatment Period (Week 16)
Secondary Outcome Measure Information:
Title
Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period
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)
Title
Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period
Description
There are three different types of seizures: Type I: Partial seizures Type II: Generalized seizures Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)
Time Frame
Baseline (Week 0) to the end of Treatment Period (Week 16)
Title
Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
Description
Percent change from Baseline was calculated as percent reduction by: (weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline). 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)
Title
Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period
Description
Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %. Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category.
Time Frame
Baseline to 16-week Treatment Period
Title
Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period
Description
Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as: (total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)
Time Frame
Baseline (Week 0) to the end of Treatment Period (Week 16)
Title
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period
Description
The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.
Time Frame
Baseline to 16-week Treatment Period
Title
Time to First Type I Seizure During the 16-week Treatment Period
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
Title
Time to Fifth Type I Seizure During the 16-week Treatment Period
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
Title
Time to Tenth Type I Seizure During Treatment Period
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
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
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
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
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
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
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
Title
Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score
Description
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression. The HADS was developed as a self-administered scale to assess the presence and severity of 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
Title
Change From Baseline to the 16-week Treatment Period in Hospital Depression Score
Description
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression.The HADS was developed as a self-administered scale to assess the presence and severity of 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
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 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
Title
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Description
The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7= Marked improvement) with the start of the study medication as the reference time point. The Investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'
Time Frame
Baseline to Last Visit or Early Discontinuation Visit in the 16-week Treatment Period
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
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
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
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
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
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
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
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
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
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

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 aged from 16 to 70 years, inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy according to the International League Against Epilepsy (ILAE) classification For subjects suffering from localization-related Epilepsy: subjects had at least 2 Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during the 3 months preceding Visit 1 according to the ILAE classification For subjects suffering from localization-related Epilepsy: subjects had at least 4 Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week Baseline Period according to the ILAE classification For subjects suffering from generalized Epilepsy: subjects had at least 2 Type II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE classification For subjects suffering from generalized Epilepsy: subjects had at least 4 Type II-seizure days during the 4 week Baseline Period according to the ILAE classification Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED Exclusion Criteria: For subjects who suffered from localization-related Epilepsy: history or presence of Seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2 or occurring only as Type IA non-motor Subjects with a 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:
City
Graz
Country
Austria
City
Innsbrick
Country
Austria
City
Linz
Country
Austria
City
Vienna
Country
Austria
City
Wien
Country
Austria
City
Brugge
Country
Belgium
City
Godinne
Country
Belgium
City
Leuven
Country
Belgium
City
Montignies Sur Sambre
Country
Belgium
City
Beroun
Country
Czechia
City
Brno
Country
Czechia
City
Ostrava Trebovice
Country
Czechia
City
Praha 2
Country
Czechia
City
Praha 5
Country
Czechia
City
Zlin
Country
Czechia
City
Berlin
Country
Germany
City
Bernau
Country
Germany
City
Bielefeld
Country
Germany
City
Erlangen
Country
Germany
City
Göttingen
Country
Germany
City
Jena
Country
Germany
City
München
Country
Germany
City
Hong Kong
Country
Hong Kong
City
Bangalore
Country
India
City
Hyderabad
Country
India
City
Mumbai
Country
India
City
New Delhi
Country
India
City
Pune Maharashtra
Country
India
City
Tirupati
Country
India
City
Bari
Country
Italy
City
Milano
Country
Italy
City
Pavia
Country
Italy
City
Roma
Country
Italy
City
Siena
Country
Italy
City
Gwangju
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Bergen
Country
Norway
City
Fredrikstad
Country
Norway
City
Oslo
Country
Norway
City
Sandvika
Country
Norway
City
Trondheim
Country
Norway
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Samara
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavi
Country
Russian Federation
City
Singapore
Country
Singapore
City
Cape Town
Country
South Africa
City
George
Country
South Africa
City
Johannesburg
Country
South Africa
City
Tygeberg
Country
South Africa
City
Göteborg
Country
Sweden
City
Stockholm
Country
Sweden
City
Umea
Country
Sweden
City
Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taoyuan Hsien
Country
Taiwan
City
Donetsk
Country
Ukraine
City
Kharkov
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Lviv
Country
Ukraine
City
Odessa
Country
Ukraine
City
Uzhgorod
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
24116853
Citation
Kwan P, Trinka E, Van Paesschen W, Rektor I, Johnson ME, Lu S. Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial. Epilepsia. 2014 Jan;55(1):38-46. doi: 10.1111/epi.12391. Epub 2013 Oct 3.
Results Reference
result
PubMed Identifier
28004320
Citation
Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.
Results Reference
result
PubMed Identifier
35285519
Citation
Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.
Results Reference
derived
PubMed Identifier
33461041
Citation
Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.
Results Reference
derived

Learn more about this trial

Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

We'll reach out to this number within 24 hrs