Epilepsy
Conditions
Keywords
Epilepsy, Brivaracetam, Partial Onset Seizures
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.
Interventions
OTHERPlacebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period
DRUGBrivaracetam
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
Sponsors
UCB Pharma SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period | From Baseline to 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
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | From Baseline to 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 | From Baseline to 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 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 | From Baseline to 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 | From Baseline to 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 | From Baseline to 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 | From Baseline to 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. | From Baseline to 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | Last Visit or Early Discontinuation Visit in the 12-week Treatment Period | 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 | Last Visit or Early Discontinuation Visit in the 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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 | From Baseline to 12-week Treatment Period | 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. |
Countries
Belgium, Finland, France, Germany, Hungary, India, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
This study started to enroll subjects in September 2007 and concluded in February 2009.
Pre-assignment details
Participant Flow refers to the Randomized Set.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching Placebo tablets administered twice a day | 100 |
| Brivaracetam 20 mg/Day Brivaracetam 20 mg/day, 10 mg administered twice a day | 99 |
| Brivaracetam 50 mg/Day Brivaracetam 50 mg/day, 25 mg administered twice a day | 100 |
| Brivaracetam 100 mg/Day Brivaracetam 100 mg/day, 50 mg administered twice a day | 100 |
| Total Title | 399 |
| Total | 798 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | AE, non-serious non-fatal | 3 | 4 | 4 | 5 |
| Overall Study | AE of unknown type | 0 | 0 | 2 | 0 |
| Overall Study | AE, serious fatal | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 | 0 |
| Overall Study | Other reason | 0 | 1 | 3 | 1 |
| Overall Study | Serious adverse event (SAE), non-fatal | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total Title | Brivaracetam 100 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 20 mg/Day | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 37.24 years STANDARD_DEVIATION 13.05 | 38.0 years STANDARD_DEVIATION 13.1 | 39.0 years STANDARD_DEVIATION 13.5 | 35.7 years STANDARD_DEVIATION 12.5 | 36.4 years STANDARD_DEVIATION 13 |
| Age, Customized <18 years | 5 participants | 1 participants | 0 participants | 2 participants | 2 participants |
| Age, Customized >=65 years | 11 participants | 3 participants | 3 participants | 3 participants | 2 participants |
| Age, Customized Between 18 and 65 years | 383 participants | 96 participants | 97 participants | 94 participants | 96 participants |
| Region of Enrollment Belgium | 6 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment Finland | 11 Participants | 4 Participants | 1 Participants | 3 Participants | 3 Participants |
| Region of Enrollment France | 60 Participants | 15 Participants | 11 Participants | 17 Participants | 17 Participants |
| Region of Enrollment Germany | 41 Participants | 9 Participants | 14 Participants | 10 Participants | 8 Participants |
| Region of Enrollment Hungary | 12 Participants | 3 Participants | 3 Participants | 2 Participants | 4 Participants |
| Region of Enrollment India | 91 Participants | 23 Participants | 23 Participants | 22 Participants | 23 Participants |
| Region of Enrollment Italy | 20 Participants | 5 Participants | 3 Participants | 8 Participants | 4 Participants |
| Region of Enrollment Netherlands | 7 Participants | 3 Participants | 1 Participants | 0 Participants | 3 Participants |
| Region of Enrollment Poland | 108 Participants | 27 Participants | 27 Participants | 28 Participants | 26 Participants |
| Region of Enrollment Spain | 22 Participants | 4 Participants | 6 Participants | 4 Participants | 8 Participants |
| Region of Enrollment Switzerland | 15 Participants | 5 Participants | 6 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United Kingdom | 6 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 171 Participants | 42 Participants | 45 Participants | 38 Participants | 46 Participants |
| Sex: Female, Male Male | 228 Participants | 58 Participants | 55 Participants | 61 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 100 | 31 / 99 | 35 / 99 | 37 / 100 |
| serious Total, serious adverse events | 6 / 100 | 2 / 99 | 4 / 99 | 2 / 100 |
Outcome results
Primary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period | 1.75 Seizure Frequency per Week |
| Brivaracetam 20 mg/Day | Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period | 1.34 Seizure Frequency per Week |
| Brivaracetam 50 mg/Day | Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period | 1.49 Seizure Frequency per Week |
| Brivaracetam 100 mg/Day | Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period | 1.26 Seizure Frequency per Week |
Comparison: In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.p-value: =0.26195% CI: [-5.2, 16.9]ANCOVA
Secondary
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).
Time frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period | 1.75 Times per week |
| Brivaracetam 20 mg/Day | All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period | 1.34 Times per week |
| Brivaracetam 50 mg/Day | All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period | 1.49 Times per week |
| Brivaracetam 100 mg/Day | All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period | 1.26 Times per week |
Secondary
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 %
Time frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | <= 25 % | 19.0 Percentage of Participants |
| Placebo | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | - 25 % to < 25 % | 41.0 Percentage of Participants |
| Placebo | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 25 % to < 50 % | 20.0 Percentage of Participants |
| Placebo | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 50 % to < 75 % | 12.0 Percentage of Participants |
| Placebo | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 75 % to < 100 % | 8.0 Percentage of Participants |
| Placebo | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 100 % | 0 Percentage of Participants |
| Brivaracetam 20 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 100 % | 2.0 Percentage of Participants |
| Brivaracetam 20 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 50 % to < 75 % | 18.2 Percentage of Participants |
| Brivaracetam 20 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | <= 25 % | 10.1 Percentage of Participants |
| Brivaracetam 20 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 25 % to < 50 % | 27.3 Percentage of Participants |
| Brivaracetam 20 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | - 25 % to < 25 % | 35.4 Percentage of Participants |
| Brivaracetam 20 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 75 % to < 100 % | 7.1 Percentage of Participants |
| Brivaracetam 50 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | - 25 % to < 25 % | 33.3 Percentage of Participants |
| Brivaracetam 50 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 25 % to < 50 % | 24.2 Percentage of Participants |
| Brivaracetam 50 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 50 % to < 75 % | 17.2 Percentage of Participants |
| Brivaracetam 50 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 100 % | 1.0 Percentage of Participants |
| Brivaracetam 50 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 75 % to < 100 % | 9.1 Percentage of Participants |
| Brivaracetam 50 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | <= 25 % | 15.2 Percentage of Participants |
| Brivaracetam 100 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 75 % to < 100 % | 18.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 100 % | 4.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | - 25 % to < 25 % | 33.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 50 % to < 75 % | 14.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | <= 25 % | 10.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period | 25 % to < 50 % | 21.0 Percentage of Participants |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 1.80 units on a scale | Standard Deviation 19.16 |
| Brivaracetam 20 mg/Day | 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 | 5.36 units on a scale | Standard Deviation 20.69 |
| Brivaracetam 50 mg/Day | 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 | 1.02 units on a scale | Standard Deviation 19.95 |
| Brivaracetam 100 mg/Day | 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 | 0.69 units on a scale | Standard Deviation 16.66 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | -2.09 units on a scale | Standard Deviation 20.26 |
| Brivaracetam 20 mg/Day | 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 | 3.35 units on a scale | Standard Deviation 19.72 |
| Brivaracetam 50 mg/Day | 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 | 3.09 units on a scale | Standard Deviation 20.79 |
| Brivaracetam 100 mg/Day | 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 | 3.50 units on a scale | Standard Deviation 22.52 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 3.80 units on a scale | Standard Deviation 18.71 |
| Brivaracetam 20 mg/Day | 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 | 3.75 units on a scale | Standard Deviation 15.94 |
| Brivaracetam 50 mg/Day | 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 | 3.13 units on a scale | Standard Deviation 19.35 |
| Brivaracetam 100 mg/Day | 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 | -2.45 units on a scale | Standard Deviation 18.55 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 3.49 units on a scale | Standard Deviation 19.22 |
| Brivaracetam 20 mg/Day | 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 | 3.53 units on a scale | Standard Deviation 17.04 |
| Brivaracetam 50 mg/Day | 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 | 1.95 units on a scale | Standard Deviation 20.74 |
| Brivaracetam 100 mg/Day | 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 | 1.99 units on a scale | Standard Deviation 20.42 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 6.6 units on a scale | Standard Deviation 16.3 |
| Brivaracetam 20 mg/Day | 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 | 6.9 units on a scale | Standard Deviation 20.1 |
| Brivaracetam 50 mg/Day | 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 | 9.7 units on a scale | Standard Deviation 19.8 |
| Brivaracetam 100 mg/Day | 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 | 4.9 units on a scale | Standard Deviation 18.1 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score | -1.54 units on a scale | Standard Deviation 3.89 |
| Brivaracetam 20 mg/Day | Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score | -0.59 units on a scale | Standard Deviation 3.89 |
| Brivaracetam 50 mg/Day | Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score | -0.41 units on a scale | Standard Deviation 3.82 |
| Brivaracetam 100 mg/Day | Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score | 0.08 units on a scale | Standard Deviation 3.6 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to the 12-week Treatment Period in Hospital Depression Score | -0.65 units on a scale | Standard Deviation 3.58 |
| Brivaracetam 20 mg/Day | Change From Baseline to the 12-week Treatment Period in Hospital Depression Score | -0.10 units on a scale | Standard Deviation 3.67 |
| Brivaracetam 50 mg/Day | Change From Baseline to the 12-week Treatment Period in Hospital Depression Score | 0.26 units on a scale | Standard Deviation 3.84 |
| Brivaracetam 100 mg/Day | Change From Baseline to the 12-week Treatment Period in Hospital Depression Score | -0.24 units on a scale | Standard Deviation 3.69 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 0.92 units on a scale | Standard Deviation 28.93 |
| Brivaracetam 20 mg/Day | 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 | 3.64 units on a scale | Standard Deviation 29.24 |
| Brivaracetam 50 mg/Day | 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 | -0.85 units on a scale | Standard Deviation 24.36 |
| Brivaracetam 100 mg/Day | 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 | 3.00 units on a scale | Standard Deviation 28.22 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 5.11 units on a scale | Standard Deviation 18.48 |
| Brivaracetam 20 mg/Day | 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 | 4.52 units on a scale | Standard Deviation 16.73 |
| Brivaracetam 50 mg/Day | 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 | 4.55 units on a scale | Standard Deviation 18.93 |
| Brivaracetam 100 mg/Day | 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 | 2.24 units on a scale | Standard Deviation 18.45 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 8.25 units on a scale | Standard Deviation 22.01 |
| Brivaracetam 20 mg/Day | 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 | 6.23 units on a scale | Standard Deviation 17.97 |
| Brivaracetam 50 mg/Day | 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 | 5.34 units on a scale | Standard Deviation 23.81 |
| Brivaracetam 100 mg/Day | 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 | 8.04 units on a scale | Standard Deviation 26.26 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 2.29 units on a scale | Standard Deviation 14.03 |
| Brivaracetam 20 mg/Day | 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 | 4.50 units on a scale | Standard Deviation 12.71 |
| Brivaracetam 50 mg/Day | 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 | 3.09 units on a scale | Standard Deviation 14.43 |
| Brivaracetam 100 mg/Day | 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 | 1.78 units on a scale | Standard Deviation 13.95 |
Secondary
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.
Time frame: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit | 4.78 units on a scale | Standard Deviation 1.2 |
| Brivaracetam 20 mg/Day | Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit | 4.99 units on a scale | Standard Deviation 1.15 |
| Brivaracetam 50 mg/Day | Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit | 4.99 units on a scale | Standard Deviation 1.1 |
| Brivaracetam 100 mg/Day | Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit | 5.34 units on a scale | Standard Deviation 1.12 |
Secondary
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?
Time frame: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Population: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit | 4.93 units on a scale | Standard Deviation 1.39 |
| Brivaracetam 20 mg/Day | Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit | 5.17 units on a scale | Standard Deviation 1.27 |
| Brivaracetam 50 mg/Day | Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit | 5.04 units on a scale | Standard Deviation 1.29 |
| Brivaracetam 100 mg/Day | Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit | 5.47 units on a scale | Standard Deviation 1.16 |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | -17.03 Percent change in seizures per week |
| Brivaracetam 20 mg/Day | Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | -30.03 Percent change in seizures per week |
| Brivaracetam 50 mg/Day | Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | -26.83 Percent change in seizures per week |
| Brivaracetam 100 mg/Day | Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | -32.45 Percent change in seizures per week |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period. | 45.9 percentage of participants |
| Brivaracetam 20 mg/Day | Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period. | 47.2 percentage of participants |
| Brivaracetam 50 mg/Day | Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period. | 62.5 percentage of participants |
| Brivaracetam 100 mg/Day | Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period. | 41.0 percentage of participants |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Non-responders | 80.0 Percentage of Participants |
| Placebo | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Responders | 20.0 Percentage of Participants |
| Brivaracetam 20 mg/Day | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Responders | 27.3 Percentage of Participants |
| Brivaracetam 20 mg/Day | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Non-responders | 72.7 Percentage of Participants |
| Brivaracetam 50 mg/Day | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Non-responders | 72.7 Percentage of Participants |
| Brivaracetam 50 mg/Day | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Responders | 27.3 Percentage of Participants |
| Brivaracetam 100 mg/Day | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Non-responders | 64.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period | Responders | 36.0 Percentage of Participants |
Secondary
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 frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Not Seizure-free | 100.0 Percentage of Participants |
| Placebo | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | No Seizures but non-completer | 0 Percentage of Participants |
| Placebo | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Seizure free | 0 Percentage of Participants |
| Brivaracetam 20 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Not Seizure-free | 98.0 Percentage of Participants |
| Brivaracetam 20 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | No Seizures but non-completer | 0 Percentage of Participants |
| Brivaracetam 20 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Seizure free | 2.0 Percentage of Participants |
| Brivaracetam 50 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Seizure free | 0 Percentage of Participants |
| Brivaracetam 50 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | No Seizures but non-completer | 1.0 Percentage of Participants |
| Brivaracetam 50 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Not Seizure-free | 99.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Not Seizure-free | 96.0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | No Seizures but non-completer | 0 Percentage of Participants |
| Brivaracetam 100 mg/Day | Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period | Seizure free | 4.0 Percentage of Participants |
Secondary
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 frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Fifth Type I Seizure During the 12-week Treatment Period | 19 Days |
| Brivaracetam 20 mg/Day | Time to Fifth Type I Seizure During the 12-week Treatment Period | 25 Days |
| Brivaracetam 50 mg/Day | Time to Fifth Type I Seizure During the 12-week Treatment Period | 24 Days |
| Brivaracetam 100 mg/Day | Time to Fifth Type I Seizure During the 12-week Treatment Period | 24 Days |
Secondary
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 frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Type I Seizure During the 12-week Treatment Period | 4 Days |
| Brivaracetam 20 mg/Day | Time to First Type I Seizure During the 12-week Treatment Period | 6 Days |
| Brivaracetam 50 mg/Day | Time to First Type I Seizure During the 12-week Treatment Period | 6 Days |
| Brivaracetam 100 mg/Day | Time to First Type I Seizure During the 12-week Treatment Period | 4 Days |
Secondary
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.
Time frame: From Baseline to 12-week Treatment Period
Population: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Tenth Type I Seizure During the 12-week Treatment Period | 39 Days |
| Brivaracetam 20 mg/Day | Time to Tenth Type I Seizure During the 12-week Treatment Period | 49 Days |
| Brivaracetam 50 mg/Day | Time to Tenth Type I Seizure During the 12-week Treatment Period | 40 Days |
| Brivaracetam 100 mg/Day | Time to Tenth Type I Seizure During the 12-week Treatment Period | 46 Days |