| Primary | Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period | Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain. A negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline. | Only subjects with valid data for average pain intensity score at Baseline and the last week of the 4-week Treatment Period are included in the analysis. | Posted | | Mean | Standard Deviation | percentage of change | | Baseline, last week of the 4-week Treatment Period | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-26.16± 30.20
- OG001-26.11± 33.73
- OG002-27.36± 34.58
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| | 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 |
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| | ANCOVA | | =0.965 | | Mean Difference (Final Values) | 0.29 | | | 2-Sided | 95 | -12.82 | 13.41 | | | Estimated value is the difference of Least Square Means. | | Superiority or Other | | | | | ANCOVA | |
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| Secondary | Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period | A responder is defined as a subject with a >= 30 % reduction in average pain intensity score at the Evaluation Week (last week of the Treatment Period) compared to the Baseline Period. | Only subjects with valid data for average pain intensity score at Baseline and the last week of the 4-week Treatment Period are included in the analysis. | Posted | | Number | | percentage of participants | | Baseline, last week of the 4-week Treatment Period | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score | Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain. A negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline. | Intention-To-Treat set included 50 subjects treated with Placebo, 51 subjects treated with brivaracetam (BRV) 200 mg/day, 51 subjects treated with BRV 400 mg/day. Only subjects with valid data for pain intensity score at the respective visit (week) are included in the analysis. Number of participants analyzed is given separately per visit (week). | Posted | | Mean | Standard Deviation | percentage of change | | Baseline, each Evaluation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score | Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'. A negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline. | Only subjects with valid data for Sleep Interference Score are included in the analysis. | Posted | | Mean | Standard Deviation | percentage of change | | Baseline, last assessment during the 4-week Treatment Period | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score | Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'. A negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline. | ITT set included 50 subjects treated with Placebo, 51 subjects treated with brivaracetam (BRV) 200 mg/day, 51 subjects treated with BRV 400 mg/day. Only subjects with valid data for Sleep Interference Score at the respective visit (week) are included in the analysis. Number of participants analyzed is given separately per visit (week). | Posted | | Mean | Standard Deviation | percentage of change | | Baseline, each Evaluation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Total Pain Score of the Short-Form McGill Pain Questionnaire (SF-MPQ) | The SF-MPQ has three components: the first one consists of 15 subscales (descriptors: 11 sensory, 4 affective) which are rated on an intensity scale with 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total subscales (descriptors). The SF-MPQ also includes a Present Pain Intensity (PPI) index and a visual analogue scale (VAS). Each of the 15 subscales is rated from 0=none to 3=severe pain. The Total Pain Score of the SF-MPQ is the sum of all 15 ratings and can hence vary from 0 (15*0=0: no pain) to 60 (15*4=60: severe pain). The mean change in total score is reported. | Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included. | Posted | | Mean | Standard Deviation | units on a scale | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching Placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day |
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| Secondary | Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Sensory Score of the Short-Form McGill Pain Questionnaire (SF-MPQ) | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sensory score ranges from 0 to 33. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean. A negative value in absolute change indicates an improvement. | Only subjects having values at randomization and at Evaluation (V5) / Early Discontinuation are included. | Posted | | Mean | Standard Deviation | units on a scale | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Affective Score of the Short-Form McGill Pain Questionnaire (SF-MPQ) | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The affective score ranges from 0 to 12. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean. A negative value in absolute change indicates an improvement. | Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included. | Posted | | Mean | Standard Deviation | units on a scale | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ | Present pain intensity (PPI) was rated by the subject. The score ranges from 0 (no pain) to 5 (excruciating). A negative value in absolute change indicates an improvement in PPI. | Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included. | Posted | | Mean | Standard Deviation | units on a scale | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ | Pain burden was rated by the subject using the visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). A negative value in absolute change indicates an improvement in pain burden. | Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included. | Posted | | Mean | Standard Deviation | units on a scale | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit | Patient´s global assessment of change in pain was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening). | Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis. | Posted | | Number | | percentage of participants | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit | Investigator´s global assessment of change was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening). | Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis. | Posted | | Number | | percentage of participants | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient | Brush-evoked allodynia intensity was assessed by the subject on an 11-point numerical rating scale, ranging from 0= no pain to 10= unbearable Pain. A negative value in percent change indicates an improvement in brush-evoked allodynia intensity. | Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis. | Posted | | Mean | Standard Deviation | percentage of change | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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| Secondary | Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator | Allodynia is pain due to a normally non-painful stimulus. The brush-evoked allodynia areas were assessed by the Investigator (location and contour of the allodynic regions drawn on a standard dermatomal map). Areas (mm²) of the allodynic regions drawn by the Investigator were afterwards computed by means of appropriate tools and calibrated templates. The larger the area in square centimeters the more allodynia. A negative value in percent change in the brush-evoked allodynia area indicates improvement. | Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis. | Posted | | Mean | Standard Deviation | percentage of change | | Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablets administered twice a day. | | OG001 | Brivaracetam 200 mg/Day | Brivaracetam 200 mg/day (100 mg administered twice a day). | | OG002 | Brivaracetam 400 mg/Day | Brivaracetam 400 mg/day (200 mg administered twice a day). |
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