Epilepsy
Conditions
Keywords
Epilepsy, Brivaracetam, Partial Onset Seizures
Brief summary
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
Interventions
DRUGPlacebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period
DRUGBrivaracetam
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
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period | Week 2 to the end of the Treatment Period (Week 16) | 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 | Baseline (Week 0) to the end of the Treatment Period (Week 16) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | Baseline (Week 0) to end of Treatment Period (Week 16) | 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 | Baseline to 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 | Baseline (Week 0) to the end of Treatment Period (Week 16) | 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 | Baseline to 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 | Baseline to 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 | Baseline to 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 | Baseline to 16-week 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 | Baseline to 16-week Treatment Period | 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 | Baseline to 16-week Treatment Period | 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. |
| Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | 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. |
| Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score | Baseline to 16-week Treatment Period | 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 | Baseline to 16-week Treatment Period | 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 | Baseline to last visit or early discontinuation visit in the 16-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 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 | Baseline to Last Visit or Early Discontinuation Visit in the 16-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 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 | Baseline to 16-week Treatment Period | 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 | Baseline to 16-week Treatment Period | 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 | Baseline to 16-week Treatment Period | 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 | Baseline to 16-week Treatment Period | 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 | Baseline to 16-week Treatment Period | 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 | Baseline to 16-week Treatment Period | 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. |
| Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | 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) |
Countries
Austria, Belgium, Czechia, Germany, Hong Kong, India, Italy, Norway, Russia, Singapore, South Africa, South Korea, Sweden, Taiwan, Ukraine
Participant flow
Recruitment details
This multicenter study was conducted in 15 countries. It started in October 2007 and concluded in December 2008.
Pre-assignment details
The Participant Flow refers to the Randomized Set (RS).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching Placebo tablets administered twice a day | 121 |
| Brivaracetam 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 | 359 |
| Total Title | 480 |
| Total | 960 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | AE, non-serious non-fatal | 4 | 14 |
| Overall Study | AE of unknown type | 1 | 0 |
| Overall Study | AE, serious fatal | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 5 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | No Birth Control | 0 | 1 |
| Overall Study | Non-Compliance | 1 | 0 |
| Overall Study | SAE, non-fatal | 2 | 6 |
| Overall Study | SAE,non-fatal+AE,non-serious non-fatal | 0 | 2 |
| Overall Study | Safety Visit not performed | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Placebo | Brivaracetam | Total Title |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants | 352 Participants | 468 Participants |
| Age, Continuous | 36.5 years STANDARD_DEVIATION 11.5 | 35.6 years STANDARD_DEVIATION 11.5 | 35.85 years STANDARD_DEVIATION 11.52 |
| Sex: Female, Male Female | 52 Participants | 178 Participants | 230 Participants |
| Sex: Female, Male Male | 69 Participants | 181 Participants | 250 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 121 | 139 / 359 |
| serious Total, serious adverse events | 9 / 121 | 20 / 359 |
Outcome results
Primary
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)
Time frame: Baseline (Week 0) to the end of the Treatment Period (Week 16)
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period | 1.86 seizures per week |
| Brivaracetam | Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period | 1.74 seizures per week |
Comparison: ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.p-value: =0.12595% CI: [-2.2, 15.9]ANCOVA
Primary
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.
Time frame: Week 2 to the end of the Treatment Period (Week 16)
Population: The Safety Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period | 66.1 percentage of participants |
| Brivaracetam | Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period | 66.6 percentage of participants |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 25 % to < 50 % | 24.1 percentage of participants |
| Placebo | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 100 % | 0 percentage of participants |
| Placebo | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 50 % to < 75 % | 13.9 percentage of participants |
| Placebo | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | -25 % to < 25 % | 44.4 percentage of participants |
| Placebo | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 75 % to < 100 % | 2.8 percentage of participants |
| Placebo | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | <- 25 % | 14.8 percentage of participants |
| Brivaracetam | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 100 % | 1.5 percentage of participants |
| Brivaracetam | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | <- 25 % | 18.3 percentage of participants |
| Brivaracetam | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | -25 % to < 25 % | 29.1 percentage of participants |
| Brivaracetam | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 25 % to < 50 % | 22.3 percentage of participants |
| Brivaracetam | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 50 % to < 75 % | 17.0 percentage of participants |
| Brivaracetam | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | 75 % to < 100 % | 11.8 percentage of participants |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 2.28 units on a scale | Standard Deviation 19.88 |
| Brivaracetam | 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 | 5.51 units on a scale | Standard Deviation 18.55 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 5.61 units on a scale | Standard Deviation 21.87 |
| Brivaracetam | 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 | 2.66 units on a scale | Standard Deviation 23.48 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 1.97 units on a scale | Standard Deviation 19.29 |
| Brivaracetam | 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 | 2.84 units on a scale | Standard Deviation 18.07 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 2.98 units on a scale | Standard Deviation 18 |
| Brivaracetam | 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 | 3.34 units on a scale | Standard Deviation 19.06 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score | -0.57 units on a scale | Standard Deviation 3.35 |
| Brivaracetam | Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score | -0.85 units on a scale | Standard Deviation 3.62 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to the 16-week Treatment Period in Hospital Depression Score | 0.30 units on a scale | Standard Deviation 3.08 |
| Brivaracetam | Change From Baseline to the 16-week Treatment Period in Hospital Depression Score | -0.41 units on a scale | Standard Deviation 3.54 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 2.83 units on a scale | Standard Deviation 27.21 |
| Brivaracetam | 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 | -0.24 units on a scale | Standard Deviation 25.84 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | -0.48 units on a scale | Standard Deviation 17.4 |
| Brivaracetam | 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 | 4.08 units on a scale | Standard Deviation 19.23 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 4.66 units on a scale | Standard Deviation 23.23 |
| Brivaracetam | 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 | 10.29 units on a scale | Standard Deviation 21.99 |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 3.04 units on a scale | Standard Deviation 12.58 |
| Brivaracetam | 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 | 4.22 units on a scale | Standard Deviation 13.73 |
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 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
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Evaluable subjects are subjects for whom the GES was completed by the investigator at last treatment period visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit | 4.79 units on a scale | Standard Deviation 1.14 |
| Brivaracetam | Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit | 5.00 units on a scale | Standard Deviation 1.22 |
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 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
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Evaluable subjects are subjects who completed the GES at last treatment period visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit | 4.73 units on a scale | Standard Deviation 1.37 |
| Brivaracetam | Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit | 5.07 units on a scale | Standard Deviation 1.36 |
Secondary
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.
Time frame: Baseline (Week 0) to end of Treatment Period (Week 16)
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | -18.93 percent change |
| Brivaracetam | Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | -26.92 percent change |
Secondary
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 frame: Baseline to 16-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 16-week Treatment Period | 54.3 percentage of participants |
| Brivaracetam | Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period | 47.9 percentage of participants |
Secondary
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.
Time frame: Baseline (Week 0) to the end of Treatment Period (Week 16)
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Responders | 16.7 percentage of participants |
| Placebo | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Non-Responders | 83.3 percentage of participants |
| Brivaracetam | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Responders | 30.3 percentage of participants |
| Brivaracetam | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Non-Responders | 69.7 percentage of participants |
Secondary
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)
Time frame: Baseline (Week 0) to the end of Treatment Period (Week 16)
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | Seizure-free | 0 percentage of participants |
| Placebo | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | No Seizure but non-completer | 0 percentage of participants |
| Placebo | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | Not Seizure free | 100.0 percentage of participants |
| Brivaracetam | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | Seizure-free | 1.5 percentage of participants |
| Brivaracetam | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | No Seizure but non-completer | 0 percentage of participants |
| Brivaracetam | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | Not Seizure free | 98.5 percentage of participants |
Secondary
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)
Time frame: Baseline (Week 0) to the end of Treatment Period (Week 16)
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period | 1.87 number of seizures per week |
| Brivaracetam | Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period | 1.74 number of seizures per week |
Secondary
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 frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Fifth Type I Seizure During the 16-week Treatment Period | 14 days |
| Brivaracetam | Time to Fifth Type I Seizure During the 16-week Treatment Period | 18 days |
Secondary
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 frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Type I Seizure During the 16-week Treatment Period | 3 days |
| Brivaracetam | Time to First Type I Seizure During the 16-week Treatment Period | 4 days |
Secondary
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.
Time frame: Baseline to 16-week Treatment Period
Population: Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Tenth Type I Seizure During Treatment Period | 36 days |
| Brivaracetam | Time to Tenth Type I Seizure During Treatment Period | 38 days |