CClinicalTrials.gg
Sign In
CompletedNCT00160667Updated Jan 31, 2019Results posted

A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)

A Phase 2 interventional study of Placebo and Brivaracetam in Neuralgia, Postherpetic, sponsored by UCB Pharma. Completed at 50 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2004, registered Sep 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.

02

Conditions studied

  • Neuralgia, Postherpetic

Keywords

  • Post-herpetic Neuralgia (PHN)
  • Brivaracetam
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 152 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria:

  • Male/female subject aged 18 years or older.
  • Pain present for at least 6 months after healing of the acute herpes zoster skin rash.
  • Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period.

Exclusion Criteria:

  • Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy.
  • Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation (TENS.
  • Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30 days and/or are not stabilized prior to screening and/or are not expected to be kept stable during the study.
  • Intake of more than two pain treatments at trial entry (screening visit) including Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or permitted opioid analgesics.
  • Subject being treated with Carbamazepine for any indication.
  • Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
  • Subject being treated in the four weeks prior to screening visit with 'strong' opioid analgesics.

Exclusion Criteria:

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
152 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Matching placebo tablets administered twice a day.

    Drug: Placebo

  • Experimental
    Brivaracetam 200 mg/day

    Brivaracetam 200 mg/day (100 mg administered twice a day).

    Drug: Brivaracetam

  • Experimental
    Brivaracetam 400 mg/day

    Brivaracetam 400 mg/day (200 mg administered twice a day).

    Drug: Brivaracetam

Interventions

  • DrugPlacebo

    Daily oral dose of two equal intakes.

  • DrugBrivaracetam

    Daily oral dose of two equal intakes.

    Also known as: Briviact

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, last week of the 4-week Treatment Period

Secondary outcomes

  1. 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.

    Time frame: Baseline, last week of the 4-week Treatment Period

  2. 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.

    Time frame: Baseline, each Evaluation visit (up to Week 4)

  3. 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.

    Time frame: Baseline, last assessment during the 4-week Treatment Period

  4. 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.

    Time frame: Baseline, each Evaluation visit (up to Week 4)

  5. 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.

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  6. 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.

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  7. 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.

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  8. 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.

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  9. 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.

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  10. 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).

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  11. 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).

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  12. 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.

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

  13. 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.

    Time frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

07

Results

Posted Jan 31, 2019

Participant flow

The study started to enroll patients in October 2004 and concluded in January 2006.

Participant flow — Overall Study
MilestonePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Started505151
Completed454845
Not completed536
Withdrew: Adverse event314
Withdrew: Withdrawal by subject201
Withdrew: Lack of efficacy010
Withdrew: Protocol violation010
Withdrew: Patient decision001

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline, last week of the 4-week Treatment Period
Reported as:
Mean · percentage of change
Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period
percentage of changePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period-26.16 ± 30.20-26.11 ± 33.73-27.36 ± 34.58
Statistical analysis
  • Placebo vs Brivaracetam 200 mg/Day · ANCOVA · p = =0.965 · Mean difference (final values): 0.29 · 95% CI -12.82 to 13.41Estimated value is the difference of Least Square Means.
  • Placebo vs Brivaracetam 400 mg/Day · ANCOVA · p = =0.825 · Mean difference (final values): 1.48 · 95% CI -11.69 to 14.65Estimated value is the difference of Least Square Means.
SecondaryResponder 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.

Time frame:
Baseline, last week of the 4-week Treatment Period
Reported as:
Number · percentage of participants
Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period
percentage of participantsPlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period33.337.340.0
SecondaryPercent 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.

Time frame:
Baseline, each Evaluation visit (up to Week 4)
Reported as:
Mean · percentage of change
Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score
percentage of changePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Week 1-10.3 ± 13.8-5.2 ± 27.0-8.5 ± 20.2
Week 2-20.8 ± 26.4-10.5 ± 25.6-18.7 ± 22.0
Week 3-24.3 ± 29.3-20.2 ± 36.6-25.5 ± 29.2
Week 4-27.5 ± 29.6-25.8 ± 37.2-29.1 ± 33.7
SecondaryPercent 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.

Time frame:
Baseline, last assessment during the 4-week Treatment Period
Reported as:
Mean · percentage of change
Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score
percentage of changePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score-42.00 ± 37.41-23.33 ± 51.34-30.17 ± 59.27
SecondaryPercent 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.

Time frame:
Baseline, each Evaluation visit (up to Week 4)
Reported as:
Mean · percentage of change
Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score
percentage of changePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Week 1-13.06 ± 23.83-6.96 ± 28.63-18.01 ± 45.27
Week 2-33.28 ± 35.27-5.69 ± 46.43-27.38 ± 49.76
Week 3-34.75 ± 38.22-12.86 ± 55.79-35.46 ± 55.88
Week 4-42.92 ± 36.37-22.05 ± 54.92-37.60 ± 55.77
SecondaryAbsolute 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.

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Mean · units on a scale
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)
units on a scalePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/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 ± 5.92-4.65 ± 6.80-4.62 ± 6.71
SecondaryAbsolute 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.

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Mean · units on a scale
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)
units on a scalePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/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 ± 5.10-3.79 ± 5.50-4.17 ± 5.05
SecondaryAbsolute 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.

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Mean · units on a scale
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)
units on a scalePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/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 ± 2.16-0.70 ± 2.08-0.75 ± 3.07
SecondaryAbsolute 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.

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Mean · units on a scale
Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ
units on a scalePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/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 ± 1.0-0.6 ± 1.3-0.9 ± 1.1
SecondaryAbsolute 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.

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Mean · units on a scale
Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ
units on a scalePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/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 ± 27.2-15.5 ± 25.2-17.9 ± 31.8
SecondaryPercentage 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).

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Number · percentage of participants
Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
percentage of participantsPlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Marked improvement14.99.823.4
Moderate improvement29.827.527.7
Slight improvement12.825.510.6
No change34.031.429.8
Slight worsening6.45.96.4
Moderate worsening2.102.1
Marked worsening000
SecondaryPercentage 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).

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Number · 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
percentage of participantsPlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Marked improvement10.29.817.6
Moderate improvement28.623.523.5
Slight improvement22.427.517.6
No change34.739.227.5
Slight worsening2.0013.7
Moderate worsening2.000
Marked worsening000
SecondaryPercent 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.

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Mean · percentage of change
Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient
percentage of changePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient-27.4 ± 34.8-12.9 ± 39.3-18.2 ± 70.6
SecondaryPercent 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.

Time frame:
Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Reported as:
Mean · percentage of change
Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator
percentage of changePlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator-5.39 ± 17.18-25.18 ± 32.106.88 ± 92.50

Adverse events

Collected over Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/50 (0%)0/50 (0%)8/50 (16%)
Brivaracetam 200 mg/Day0/51 (0%)0/51 (0%)19/51 (37.3%)
Brivaracetam 400 mg/Day0/51 (0%)1/51 (2%)18/51 (35.3%)
Most frequent serious events
Most frequent serious events
EventPlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
ThrombocytopeniaBlood and lymphatic system disorders0/500/511/51
Vascular purpuraSkin and subcutaneous tissue disorders0/500/511/51
Most frequent other events
Most frequent other events
EventPlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/Day
SomnolenceNervous system disorders2/508/518/51
VertigoEar and labyrinth disorders1/507/513/51
FatigueGeneral disorders2/503/516/51
DizzinessNervous system disorders4/505/515/51
NauseaGastrointestinal disorders1/501/514/51
HeadacheNervous system disorders1/504/512/51
AstheniaGeneral disorders1/503/511/51

Baseline characteristics

Baseline Characteristics refers to the Intention-to-treat (ITT) Set.

Age, Categorical
Age, Categorical(Participants)PlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/DayTotal Title
<=18 years0000
Between 18 and 65 years17222362
>=65 years33292890
Age, Continuous
Age, Continuous(years)PlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/DayTotal Title
Mean66.06 ± 10.8065.33 ± 10.9565.58 ± 10.2165.65 ± 10.59
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboBrivaracetam 200 mg/DayBrivaracetam 400 mg/DayTotal Title
Female29283087
Male21232165
08

Study locations

50 sites
  • Brussels, Belgium
  • Eeklo, Belgium
  • Genk, Belgium
  • Liege, Belgium
  • Lubbeek (Pellenberg), Belgium
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
  • Hradec Kralove, Czechia
  • Prague, Czechia
  • Svitavy, Czechia
  • Usti nad Labem, Czechia
  • Annecy, France
  • Clermont-Ferrand Cedex, France
  • Nice Cedex 1, France
  • Toulouse, France
  • Voiron, France
  • Bad Worishofen, Germany
  • Bochum, Germany
  • Essen, Germany
  • Kassel, Germany
  • Rodgau, Germany
  • Gdansk, Poland
  • Grudziadz, Poland
  • Katowice, Poland
  • Kielce, Poland
  • Krakow, Poland
  • Lublin, Poland
  • Olsztyn, Poland
  • Poznan, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
  • Zgierz, Poland
  • Belgarde, Serbia
  • Belgrade, Serbia
  • Kragujevac, Serbia
  • Bratislava, Slovakia
  • Dubnica nad Vahom, Slovakia
  • Kosice, Slovakia
  • Nitra, Slovakia
  • Cadiz, Spain
  • Granada, Spain
  • Hospitalet de Llobregat (Barcelona), Spain
  • Madrid, Spain
  • Sant Cugat Del Valles (Barcelona), Spain
  • Valencia, Spain
  • Bath, United Kingdom
  • Glasgow, United Kingdom
  • London, United Kingdom
  • Winchester, United Kingdom
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00160667
Lead sponsor
UCB Pharma
First posted
Sep 12, 2005
Start date
Oct 11, 2004
Primary completion
Jan 5, 2006
Completion
Jan 5, 2006
Results posted
Jan 31, 2019
Last update
Jan 31, 2019

Study contacts

UCB Cares
study director · +1 844 599 2273 (UCB)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neuralgia→

Other studies from this sponsor

UCB Pharma

Start the discussion