Trial Outcomes & Findings for A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia) (NCT NCT00160667)
NCT ID: NCT00160667
Last Updated: 2019-01-31
Results Overview
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.
COMPLETED
PHASE2
152 participants
Baseline, last week of the 4-week Treatment Period
2019-01-31
Participant Flow
The study started to enroll patients in October 2004 and concluded in January 2006.
Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Placebo
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
51
|
|
Overall Study
COMPLETED
|
45
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Patient decision
|
0
|
0
|
1
|
Baseline Characteristics
A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=51 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
Total Title
n=152 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Age, Continuous
|
66.06 years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
65.33 years
STANDARD_DEVIATION 10.95 • n=7 Participants
|
65.58 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
65.65 years
STANDARD_DEVIATION 10.59 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, last week of the 4-week Treatment PeriodPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=48 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=51 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period
|
-26.16 percentage of change
Standard Deviation 30.20
|
-26.11 percentage of change
Standard Deviation 33.73
|
-27.36 percentage of change
Standard Deviation 34.58
|
SECONDARY outcome
Timeframe: Baseline, last week of the 4-week Treatment PeriodPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=48 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=50 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period
|
33.3 percentage of participants
|
37.3 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, each Evaluation visit (up to Week 4)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=51 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score
Week 1
|
-10.3 percentage of change
Standard Deviation 13.8
|
-5.2 percentage of change
Standard Deviation 27.0
|
-8.5 percentage of change
Standard Deviation 20.2
|
|
Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score
Week 2
|
-20.8 percentage of change
Standard Deviation 26.4
|
-10.5 percentage of change
Standard Deviation 25.6
|
-18.7 percentage of change
Standard Deviation 22.0
|
|
Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score
Week 3
|
-24.3 percentage of change
Standard Deviation 29.3
|
-20.2 percentage of change
Standard Deviation 36.6
|
-25.5 percentage of change
Standard Deviation 29.2
|
|
Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score
Week 4
|
-27.5 percentage of change
Standard Deviation 29.6
|
-25.8 percentage of change
Standard Deviation 37.2
|
-29.1 percentage of change
Standard Deviation 33.7
|
SECONDARY outcome
Timeframe: Baseline, last assessment during the 4-week Treatment PeriodPopulation: Only subjects with valid data for Sleep Interference Score are included in the analysis.
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.
Outcome measures
| Measure |
Placebo
n=42 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=48 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=46 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score
|
-42.00 percentage of change
Standard Deviation 37.41
|
-23.33 percentage of change
Standard Deviation 51.34
|
-30.17 percentage of change
Standard Deviation 59.27
|
SECONDARY outcome
Timeframe: Baseline, each Evaluation visit (up to Week 4)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=51 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score
Week 1
|
-13.06 percentage of change
Standard Deviation 23.83
|
-6.96 percentage of change
Standard Deviation 28.63
|
-18.01 percentage of change
Standard Deviation 45.27
|
|
Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score
Week 2
|
-33.28 percentage of change
Standard Deviation 35.27
|
-5.69 percentage of change
Standard Deviation 46.43
|
-27.38 percentage of change
Standard Deviation 49.76
|
|
Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score
Week 3
|
-34.75 percentage of change
Standard Deviation 38.22
|
-12.86 percentage of change
Standard Deviation 55.79
|
-35.46 percentage of change
Standard Deviation 55.88
|
|
Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score
Week 4
|
-42.92 percentage of change
Standard Deviation 36.37
|
-22.05 percentage of change
Standard Deviation 54.92
|
-37.60 percentage of change
Standard Deviation 55.77
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=24 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=35 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
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)
|
-3.44 units on a scale
Standard Deviation 5.92
|
-4.65 units on a scale
Standard Deviation 6.80
|
-4.62 units on a scale
Standard Deviation 6.71
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects having values at randomization and at Evaluation (V5) / Early Discontinuation are included.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=24 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=35 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
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)
|
-2.42 units on a scale
Standard Deviation 5.10
|
-3.79 units on a scale
Standard Deviation 5.50
|
-4.17 units on a scale
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=23 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=36 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
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)
|
-1.04 units on a scale
Standard Deviation 2.16
|
-0.70 units on a scale
Standard Deviation 2.08
|
-0.75 units on a scale
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
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.
Outcome measures
| Measure |
Placebo
n=31 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=27 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=38 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ
|
-0.7 units on a scale
Standard Deviation 1.0
|
-0.6 units on a scale
Standard Deviation 1.3
|
-0.9 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
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.
Outcome measures
| Measure |
Placebo
n=33 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=27 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=38 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ
|
-13.1 units on a scale
Standard Deviation 27.2
|
-15.5 units on a scale
Standard Deviation 25.2
|
-17.9 units on a scale
Standard Deviation 31.8
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
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).
Outcome measures
| Measure |
Placebo
n=47 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=47 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Marked improvement
|
14.9 percentage of participants
|
9.8 percentage of participants
|
23.4 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Moderate improvement
|
29.8 percentage of participants
|
27.5 percentage of participants
|
27.7 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Slight improvement
|
12.8 percentage of participants
|
25.5 percentage of participants
|
10.6 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
No change
|
34.0 percentage of participants
|
31.4 percentage of participants
|
29.8 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Slight worsening
|
6.4 percentage of participants
|
5.9 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Moderate worsening
|
2.1 percentage of participants
|
0 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Marked worsening
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
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).
Outcome measures
| Measure |
Placebo
n=49 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=51 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
No change
|
34.7 percentage of participants
|
39.2 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Marked improvement
|
10.2 percentage of participants
|
9.8 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Moderate improvement
|
28.6 percentage of participants
|
23.5 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Slight improvement
|
22.4 percentage of participants
|
27.5 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Slight worsening
|
2.0 percentage of participants
|
0 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Moderate worsening
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Marked worsening
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
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.
Outcome measures
| Measure |
Placebo
n=28 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=37 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=28 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient
|
-27.4 percentage of change
Standard Deviation 34.8
|
-12.9 percentage of change
Standard Deviation 39.3
|
-18.2 percentage of change
Standard Deviation 70.6
|
SECONDARY outcome
Timeframe: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)Population: Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
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.
Outcome measures
| Measure |
Placebo
n=5 Participants
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=9 Participants
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=10 Participants
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator
|
-5.39 percentage of change
Standard Deviation 17.18
|
-25.18 percentage of change
Standard Deviation 32.10
|
6.88 percentage of change
Standard Deviation 92.50
|
Adverse Events
Placebo
Brivaracetam 200 mg/Day
Brivaracetam 400 mg/Day
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 participants at risk
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=51 participants at risk
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
2.0%
1/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Skin and subcutaneous tissue disorders
Vascular purpura
|
0.00%
0/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
2.0%
1/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
Matching placebo tablets administered twice a day.
|
Brivaracetam 200 mg/Day
n=51 participants at risk
Brivaracetam 200 mg/day (100 mg administered twice a day).
|
Brivaracetam 400 mg/Day
n=51 participants at risk
Brivaracetam 400 mg/day (200 mg administered twice a day).
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
13.7%
7/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
5.9%
3/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
2.0%
1/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
7.8%
4/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
General disorders
Asthenia
|
2.0%
1/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
5.9%
3/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
2.0%
1/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
General disorders
Fatigue
|
4.0%
2/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
5.9%
3/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
11.8%
6/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
9.8%
5/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
9.8%
5/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
7.8%
4/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
3.9%
2/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Nervous system disorders
Somnolence
|
4.0%
2/50 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
15.7%
8/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
15.7%
8/51 • Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60