| 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 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) | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Median | Inter-Quartile Range | seizures per week | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG002 | Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects) | Brivaracetam 20 mg/day, 10 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG003 | Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects) | Brivaracetam 50 mg/day, 25 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
| | Units | Counts |
|---|
| Participants | - OG00096
- OG00196
- OG00299
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002.15(1.43 to 4.15)
- OG0011.80(0.99 to 5.59)
- OG0021.96(1.05 to 5.45)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals. | ANCOVA | Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration. | =0.025 | | % reduction over Placebo | 12.8 | | | 2-Sided | 95 | 1.7 | 22.6 | | | The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate. | |
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| Secondary | Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period | The responder rate was presented as the number 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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Number | | participants | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| Secondary | All Seizure Frequency (Type I+II+III) Per Week Over the 12-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) | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Median | Inter-Quartile Range | seizures per week | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| Secondary | Percent Change From Baseline to the 12-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). The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Median | Inter-Quartile Range | Percent change in POS frequency | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| Secondary | Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Number | | percentage of participants | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | |
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| 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 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) | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Number | | percentage of participants | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| Secondary | Time to First Type I Seizure During the 12-week Treatment Period | The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Median | 95% Confidence Interval | days | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| Secondary | Time to Fifth Type I Seizure During the 12-week Treatment Period | The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Median | 95% Confidence Interval | days | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| Secondary | Time to Tenth Type I Seizure During the 12-week Treatment Period | The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Median | 95% Confidence Interval | days | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) | Brivaracetam 5 mg/day, 2.5 mg administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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 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 seven multi-items 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 social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | |
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| 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 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 seven multi-items 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 social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | |
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| 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 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 seven multi-items 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 social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. 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. A negative value in change from Baseline shows an improvement in HADS from Baseline. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) |
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| 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. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. 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. A negative value in change from Baseline shows an improvement in HADS from Baseline. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) |
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| Secondary | Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit | 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?' | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Number | | percentage of participants | | Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) |
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| 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.' | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Number | | percentage of participants | | Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | | OG001 | Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects) |
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| 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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline to 12-week Treatment Period | | | | ID | Title | Description |
|---|
| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline to 12-week Treatment Period | | | | ID | Title | Description |
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| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline to 12-week Treatment Period | | | | ID | Title | Description |
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| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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| 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. | The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline to 12-week Treatment Period | | | | ID | Title | Description |
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| OG000 | Modified Intention-to-Treat (Placebo Treated Subjects) | Matching Placebo tablets administered twice a day. The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy. |
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