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Trial record 1 of 1 for:    NCT00160667
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A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160667
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by:
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuralgia, Postherpetic
Interventions Drug: Placebo
Drug: Brivaracetam
Enrollment 152
Recruitment Details The study started to enroll patients in October 2004 and concluded in January 2006.
Pre-assignment Details Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description Matching placebo tablets administered twice a day. Brivaracetam 200 mg/day (100 mg administered twice a day). Brivaracetam 400 mg/day (200 mg administered twice a day).
Period Title: Overall Study
Started 50 51 51
Completed 45 48 45
Not Completed 5 3 6
Reason Not Completed
Adverse Event             3             1             4
Withdrawal by Subject             2             0             1
Lack of Efficacy             0             1             0
Protocol Violation             0             1             0
Patient decision             0             0             1
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day Total Title
Hide Arm/Group Description Matching placebo tablets administered twice a day. Brivaracetam 200 mg/day (100 mg administered twice a day). Brivaracetam 400 mg/day (200 mg administered twice a day). [Not Specified]
Overall Number of Baseline Participants 50 51 51 152
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the Intention-to-treat (ITT) Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 51 participants 152 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  34.0%
22
  43.1%
23
  45.1%
62
  40.8%
>=65 years
33
  66.0%
29
  56.9%
28
  54.9%
90
  59.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 51 participants 51 participants 152 participants
66.06  (10.80) 65.33  (10.95) 65.58  (10.21) 65.65  (10.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 51 participants 152 participants
Female
29
  58.0%
28
  54.9%
30
  58.8%
87
  57.2%
Male
21
  42.0%
23
  45.1%
21
  41.2%
65
  42.8%
1.Primary Outcome
Title Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 48 51 51
Mean (Standard Deviation)
Unit of Measure: percentage of change
-26.16  (30.20) -26.11  (33.73) -27.36  (34.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 200 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.965
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
-12.82 to 13.41
Estimation Comments Estimated value is the difference of Least Square Means.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 400 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.825
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
-11.69 to 14.65
Estimation Comments Estimated value is the difference of Least Square Means.
2.Secondary Outcome
Title Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 48 51 50
Measure Type: Number
Unit of Measure: percentage of participants
33.3 37.3 40.0
3.Secondary Outcome
Title Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 50 51 51
Mean (Standard Deviation)
Unit of Measure: percentage of change
Week 1 Number Analyzed 49 participants 51 participants 50 participants
-10.3  (13.8) -5.2  (27.0) -8.5  (20.2)
Week 2 Number Analyzed 46 participants 49 participants 48 participants
-20.8  (26.4) -10.5  (25.6) -18.7  (22.0)
Week 3 Number Analyzed 46 participants 49 participants 47 participants
-24.3  (29.3) -20.2  (36.6) -25.5  (29.2)
Week 4 Number Analyzed 46 participants 48 participants 47 participants
-27.5  (29.6) -25.8  (37.2) -29.1  (33.7)
4.Secondary Outcome
Title Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid data for Sleep Interference Score are included in the analysis.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 42 48 46
Mean (Standard Deviation)
Unit of Measure: percentage of change
-42.00  (37.41) -23.33  (51.34) -30.17  (59.27)
5.Secondary Outcome
Title Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 50 51 51
Mean (Standard Deviation)
Unit of Measure: percentage of change
Week 1 Number Analyzed 43 participants 48 participants 46 participants
-13.06  (23.83) -6.96  (28.63) -18.01  (45.27)
Week 2 Number Analyzed 40 participants 46 participants 44 participants
-33.28  (35.27) -5.69  (46.43) -27.38  (49.76)
Week 3 Number Analyzed 40 participants 46 participants 43 participants
-34.75  (38.22) -12.86  (55.79) -35.46  (55.88)
Week 4 Number Analyzed 40 participants 45 participants 43 participants
-42.92  (36.37) -22.05  (54.92) -37.60  (55.77)
6.Secondary Outcome
Title 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)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 31 24 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.44  (5.92) -4.65  (6.80) -4.62  (6.71)
7.Secondary Outcome
Title 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)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects having values at randomization and at Evaluation (V5) / Early Discontinuation are included.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 31 24 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.42  (5.10) -3.79  (5.50) -4.17  (5.05)
8.Secondary Outcome
Title 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)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 31 23 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.04  (2.16) -0.70  (2.08) -0.75  (3.07)
9.Secondary Outcome
Title Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 31 27 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (1.0) -0.6  (1.3) -0.9  (1.1)
10.Secondary Outcome
Title Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 33 27 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.1  (27.2) -15.5  (25.2) -17.9  (31.8)
11.Secondary Outcome
Title Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 47 51 47
Measure Type: Number
Unit of Measure: percentage of participants
Marked improvement 14.9 9.8 23.4
Moderate improvement 29.8 27.5 27.7
Slight improvement 12.8 25.5 10.6
No change 34.0 31.4 29.8
Slight worsening 6.4 5.9 6.4
Moderate worsening 2.1 0 2.1
Marked worsening 0 0 0
12.Secondary Outcome
Title Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 49 51 51
Measure Type: Number
Unit of Measure: percentage of participants
Marked improvement 10.2 9.8 17.6
Moderate improvement 28.6 23.5 23.5
Slight improvement 22.4 27.5 17.6
No change 34.7 39.2 27.5
Slight worsening 2.0 0 13.7
Moderate worsening 2.0 0 0
Marked worsening 0 0 0
13.Secondary Outcome
Title Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 28 37 28
Mean (Standard Deviation)
Unit of Measure: percentage of change
-27.4  (34.8) -12.9  (39.3) -18.2  (70.6)
14.Secondary Outcome
Title Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description:
Matching placebo tablets administered twice a day.
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam 400 mg/day (200 mg administered twice a day).
Overall Number of Participants Analyzed 5 9 10
Mean (Standard Deviation)
Unit of Measure: percentage of change
-5.39  (17.18) -25.18  (32.10) 6.88  (92.50)
Time Frame Adverse Events were collected from first intake of randomized study medication until Final Visit (Week 6)
Adverse Event Reporting Description Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
 
Arm/Group Title Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Hide Arm/Group Description Matching placebo tablets administered twice a day. Brivaracetam 200 mg/day (100 mg administered twice a day). Brivaracetam 400 mg/day (200 mg administered twice a day).
All-Cause Mortality
Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/51 (0.00%)   0/51 (0.00%) 
Hide Serious Adverse Events
Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/51 (0.00%)   1/51 (1.96%) 
Blood and lymphatic system disorders       
Thrombocytopenia * 1  0/50 (0.00%)  0/51 (0.00%)  1/51 (1.96%) 
Skin and subcutaneous tissue disorders       
Vascular purpura * 1  0/50 (0.00%)  0/51 (0.00%)  1/51 (1.96%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Brivaracetam 200 mg/Day Brivaracetam 400 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/50 (16.00%)   19/51 (37.25%)   18/51 (35.29%) 
Ear and labyrinth disorders       
Vertigo * 1  1/50 (2.00%)  7/51 (13.73%)  3/51 (5.88%) 
Gastrointestinal disorders       
Nausea * 1  1/50 (2.00%)  1/51 (1.96%)  4/51 (7.84%) 
General disorders       
Asthenia * 1  1/50 (2.00%)  3/51 (5.88%)  1/51 (1.96%) 
Fatigue * 1  2/50 (4.00%)  3/51 (5.88%)  6/51 (11.76%) 
Nervous system disorders       
Dizziness * 1  4/50 (8.00%)  5/51 (9.80%)  5/51 (9.80%) 
Headache * 1  1/50 (2.00%)  4/51 (7.84%)  2/51 (3.92%) 
Somnolence * 1  2/50 (4.00%)  8/51 (15.69%)  8/51 (15.69%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB
ClinicalTrials.gov Identifier: NCT00160667    
Other Study ID Numbers: N01162
2004-000975-32 ( EudraCT Number )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: October 26, 2017
Results First Posted: January 31, 2019
Last Update Posted: January 31, 2019