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Trial record 1 of 1 for:    NCT00368251
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Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults

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ClinicalTrials.gov Identifier: NCT00368251
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : April 13, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
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 Unverricht-Lundborg Disease
Interventions Other: Placebo
Drug: BRV 2.5 mg
Drug: BRV 25 mg
Drug: BRV 50 mg
Enrollment 56
Recruitment Details 72 subjects were screened, 56 subjects were randomized. Participant Flow refers to all subjects randomized who are identical with the Intent-To-Treat (ITT) Population, which consists of all randomized subjects who took at least one dose of study medication.
Pre-assignment Details  
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Hide Arm/Group Description Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Period Title: Overall Study
Started 18 20 18
Completed 17 20 17
Not Completed 1 0 1
Reason Not Completed
SAE, non-fatal             1             0             0
AE, non-serious non-fatal             0             0             1
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day Total Title
Hide Arm/Group Description Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period) [Not Specified]
Overall Number of Baseline Participants 18 20 18 56
Hide Baseline Analysis Population Description
The Baseline Analysis Population contains all randomized subjects who are identical with the Intent-To-Treat (ITT) population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 20 participants 18 participants 56 participants
<=18 years
0
   0.0%
1
   5.0%
1
   5.6%
2
   3.6%
Between 18 and 65 years
18
 100.0%
19
  95.0%
17
  94.4%
54
  96.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 20 participants 18 participants 56 participants
34.3  (9.2) 35.8  (10.9) 33.7  (11.4) 34.65  (10.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 20 participants 18 participants 56 participants
Female
12
  66.7%
11
  55.0%
9
  50.0%
32
  57.1%
Male
6
  33.3%
9
  45.0%
9
  50.0%
24
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 20 participants 18 participants 56 participants
Serbia 2 2 2 6
France 3 2 3 8
United States 2 3 4 9
Canada 4 3 2 9
Finland 3 4 2 9
Russian Federation 2 3 3 8
Israel 0 0 2 2
Tunisia 2 3 0 5
1.Primary Outcome
Title Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)
Hide Description The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time Frame From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Hide Arm/Group Description:
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Overall Number of Participants Analyzed 18 20 18
Median (Full Range)
Unit of Measure: Percent change
17.45
(-170.0 to 61.5)
-4.60
(-430.0 to 81.8)
12.34
(-58.3 to 96.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 150 mg/Day
Comments

The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day.

The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints.

The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.942
Comments All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.
Method stratified Wilcoxon Test
Comments Estimates and confidence intervals from Hodges-Lehmann (unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-26.12 to 24.96
Estimation Comments Difference versus Placebo was calculated.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 5 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.105
Comments Tested at the 5 % level - given the primary endpoint and the three UMRS related secondary endpoints comparing placebo versus Brivaracetam (BRV) 150 mg/day are significant at the 5 % level (hierarchical testing procedure).
Method stratified Wilcoxon Test
Comments Estimates and confidence intervals from Hodges-Lehmann (unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value -18.05
Confidence Interval (2-Sided) 95%
-39.31 to 4.86
Estimation Comments Difference versus Placebo.
2.Secondary Outcome
Title Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)
Hide Description The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time Frame Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Hide Arm/Group Description:
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Overall Number of Participants Analyzed 18 20 18
Median (Full Range)
Unit of Measure: Percent change
0.00
(-380.0 to 53.8)
0.00
(-380.0 to 60.0)
0.00
(-85.7 to 75.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 150 mg/Day
Comments If primary efficacy is proven for Brivaracetam (BRV) 150 mg/day, the following secondary endpoints will be tested for Placebo versus BRV 150 mg/day. The testing scheme will be hierarchical, thus statistical significance at 5 % on BRV 150 mg/day on a secondary endpoint is needed to continue testing BRV 150 mg/day at 5 % significance level for the next secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.672
Comments Tested at the 5 % level - given the Primary Outcome testing Placebo versus BRV 150 mg/day is significant at the 5 % level (hierarchical testing procedure).
Method stratified Wilcoxon Test
Comments Estimates and confidence intervals are obtained from Hodges-Lehmann(unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
-21.90 to 31.06
Estimation Comments Difference versus Placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 5 mg/Day
Comments

In case the three endpoints are significant for placebo versus Brivaracetam (BRV) 150 mg/day, the primary endpoint will be tested for Placebo versus BRV 5 mg/day. In case of significance, the three UMRS related secondary endpoints will be tested for Placebo versus BRV 5 mg/day, provided the previous is significant at 5 %. Secondary endpoints are tested in the following order:

  • Functional Disability
  • Stimulus Sensitivity
  • Myoclonus Patient Questionnaire
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.806
Comments Tested at the 5 % level - given the primary endpoint testing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).
Method stratified Wilcoxon Test
Comments Estimates and confidence intevals are obtained from Hodges-Lehmann (unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-33.33 to 18.75
Estimation Comments Difference versus Placebo.
3.Secondary Outcome
Title Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)
Hide Description The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time Frame Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Hide Arm/Group Description:
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Overall Number of Participants Analyzed 18 20 18
Median (Full Range)
Unit of Measure: Percent change
0.00
(-300.0 to 100.0)
43.44
(-300.0 to 100.0)
0.00
(-300.0 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.549
Comments Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).
Method stratified Willcoxon Test
Comments Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-25.00 to 100.00
Estimation Comments Difference versus Placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 5 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.654
Comments Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).
Method stratified Wilcoxon Test
Comments Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-50.00 to 66.67
Estimation Comments Difference versus Placebo.
4.Secondary Outcome
Title Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)
Hide Description The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.
Time Frame Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Hide Arm/Group Description:
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Overall Number of Participants Analyzed 17 20 18
Median (Full Range)
Unit of Measure: Percent change
-9.68
(-125.0 to 63.0)
0.00
(-95.0 to 55.6)
5.41
(-24.0 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.037
Comments Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).
Method stratified Wilcoxon Test
Comments Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value 14.29
Confidence Interval (2-Sided) 95%
-1.76 to 39.39
Estimation Comments Difference versus Placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 5 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.111
Comments Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).
Method stratified Wilcoxon Test
Comments Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).
Method of Estimation Estimation Parameter Hodges-Lehmann-estimator of difference
Estimated Value 10.00
Confidence Interval (2-Sided) 95%
-5.56 to 30.00
Estimation Comments Difference versus Placebo.
5.Secondary Outcome
Title Global Evaluation Score (Investigator) at the End of Treatment Period
Hide Description The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).
Time Frame End of Treatment Period (Week 14 or Early Discontinuation Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Hide Arm/Group Description:
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Overall Number of Participants Analyzed 18 20 18
Measure Type: Number
Unit of Measure: percentage of participants
Marked improvement 0 10.0 11.1
Moderate improvement 11.1 0 11.1
Slight improvement 33.3 30.0 33.3
No change 50.0 50.0 33.3
Slight worsening 0 10.0 5.6
Moderate worsening 0 0 5.6
Marked worsening 5.6 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 5 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.931
Comments The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.
Method Stratified Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 150 mg/Day
Comments P-value for pairwise comparison of each Brivaracetam dose versus Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.253
Comments The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.
Method Stratified Wilcoxon test
Comments [Not Specified]
Time Frame Adverse Events (AEs) were collected from Visit 1 (Week -2) until final Visit 10 (Week 18).
Adverse Event Reporting Description The Intent-To-Treat (ITT) population consists of all randomized subjects who took at least one dose of study medication.
 
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Hide Arm/Group Description Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
All-Cause Mortality
Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/18 (11.11%)      3/20 (15.00%)      2/18 (11.11%)    
General disorders       
Pyrexia * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Infections and infestations       
Appendicitis * 1  0/18 (0.00%)  0 2/20 (10.00%)  2 0/18 (0.00%)  0
Injury, poisoning and procedural complications       
Clavicle fracture * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders       
Convulsion * 1  1/18 (5.56%)  1 1/20 (5.00%)  1 0/18 (0.00%)  0
Grand mal convulsion * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Status epilepticus * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Myoclonic epilepsy * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Psychiatric disorders       
Attention-seeking behavior * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Brivaracetam 5 mg/Day Brivaracetam 150 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/18 (72.22%)      13/20 (65.00%)      15/18 (83.33%)    
Blood and lymphatic system disorders       
Granulocytopenia * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Lymphadenopathy * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Thrombocytopenia * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  2
Cardiac disorders       
Angina pectoris * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Electrocardiogram QT corrected interval prolonged * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Ear and labyrinth disorders       
Tinnitus * 1  1/18 (5.56%)  1 1/20 (5.00%)  1 0/18 (0.00%)  0
Middle ear inflammation * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Gastrointestinal disorders       
Nausea * 1  1/18 (5.56%)  1 2/20 (10.00%)  2 1/18 (5.56%)  1
Abdominal pain upper * 1  2/18 (11.11%)  2 2/20 (10.00%)  2 0/18 (0.00%)  0
Diarrhoea * 1  2/18 (11.11%)  3 1/20 (5.00%)  1 1/18 (5.56%)  1
Abdominal pain * 1  1/18 (5.56%)  3 0/20 (0.00%)  0 1/18 (5.56%)  1
Constipation * 1  2/18 (11.11%)  2 0/20 (0.00%)  0 1/18 (5.56%)  1
Gingival bleeding * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Toothache * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Gastrooesophageal reflux disease * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
General disorders       
Fatigue * 1  2/18 (11.11%)  2 1/20 (5.00%)  1 3/18 (16.67%)  6
Oedema peripheral * 1  1/18 (5.56%)  2 0/20 (0.00%)  0 0/18 (0.00%)  0
Pyrexia * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Hepatobiliary disorders       
Hepatomegaly * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations       
Nasopharyngitis * 1  3/18 (16.67%)  4 1/20 (5.00%)  1 1/18 (5.56%)  1
Respiratory tract infection viral * 1  0/18 (0.00%)  0 1/20 (5.00%)  1 1/18 (5.56%)  3
Gastrointestinal infection * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Vulvovaginal mycotic infection * 1  1/18 (5.56%)  1 1/20 (5.00%)  1 0/18 (0.00%)  0
Gastroenteritis * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Otitis externa * 1  2/18 (11.11%)  3 0/20 (0.00%)  0 0/18 (0.00%)  0
Pharyngitis * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Sinusitis * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Urinary tract infection * 1  2/18 (11.11%)  2 0/20 (0.00%)  0 0/18 (0.00%)  0
Injury, poisoning and procedural complications       
Excoriation * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Joint injury * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Limb injury * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Joint sprain * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Metabolism and nutrition disorders       
Weight decreased * 1  0/18 (0.00%)  0 1/20 (5.00%)  1 1/18 (5.56%)  1
Anorexia * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Increased appetite * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Weight increased * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle spasms * 1  1/18 (5.56%)  1 1/20 (5.00%)  1 1/18 (5.56%)  1
Arthralgia * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 1/18 (5.56%)  2
Arthritis * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Back pain * 1  1/18 (5.56%)  1 1/20 (5.00%)  1 0/18 (0.00%)  0
Pain in extremity * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  2
Shoulder pain * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders       
Myoclonus * 1  1/18 (5.56%)  2 4/20 (20.00%)  4 3/18 (16.67%)  4
Somnolence * 1  2/18 (11.11%)  2 3/20 (15.00%)  3 4/18 (22.22%)  7
Headache * 1  7/18 (38.89%)  8 3/20 (15.00%)  4 2/18 (11.11%)  2
Balance disorder * 1  0/18 (0.00%)  0 1/20 (5.00%)  1 2/18 (11.11%)  4
Dizziness * 1  2/18 (11.11%)  2 1/20 (5.00%)  1 1/18 (5.56%)  1
Grand mal convulsion * 1  0/18 (0.00%)  0 2/20 (10.00%)  2 0/18 (0.00%)  0
Hyporeflexia * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 2/18 (11.11%)  2
Complex partial seizures * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Coordination abnormal * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Dysarthria * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 1/18 (5.56%)  2
Migraine * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  3
Nystagmus * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Tremor * 1  3/18 (16.67%)  4 0/20 (0.00%)  0 1/18 (5.56%)  1
Convulsion * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Myoclonic epilepsy * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Sciatica * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Psychiatric disorders       
Aggression * 1  1/18 (5.56%)  1 2/20 (10.00%)  2 0/18 (0.00%)  0
Insomnia * 1  2/18 (11.11%)  2 2/20 (10.00%)  2 0/18 (0.00%)  0
Anxiety * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 1/18 (5.56%)  1
Depression * 1  1/18 (5.56%)  1 1/20 (5.00%)  1 0/18 (0.00%)  0
Bradyphrenia * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Depressed mood * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Disorientation * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Memory impairment * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Renal and urinary disorders       
Enuresis * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Pollakiuria * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Reproductive system and breast disorders       
Genital pruritus female * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Epistaxis * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Sinus congestion * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Upper respiratory tract congestion * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders       
Ecchymosis * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Ingrowing nail * 1  0/18 (0.00%)  0 0/20 (0.00%)  0 1/18 (5.56%)  1
Dry skin * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Night sweats * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Skin ulcer * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
Vascular disorders       
Haematoma * 1  1/18 (5.56%)  1 0/20 (0.00%)  0 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA9.0
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 Cares
Organization: UCB
Phone: +1877 822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00368251    
Other Study ID Numbers: N01236
2006-001536-46 ( EudraCT Number )
First Submitted: August 23, 2006
First Posted: August 24, 2006
Results First Submitted: March 14, 2016
Results First Posted: April 13, 2016
Last Update Posted: July 11, 2018