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An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

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: NCT01506882
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : October 13, 2014
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy
Partial Onset Seizures
Intervention Drug: Levetiracetam (LEV)
Enrollment 71
Recruitment Details This multicenter study started to enroll subjects in December 2011 in order to end up with 27 centers with enrolled subjects in Japan.
Pre-assignment Details Participant Flow refers to the Randomized Set (RS). RS consists of all subjects who were randomized to the study groups.
Arm/Group Title Levetiracetam 1000 mg/Day to 2000 mg/Day Group Levetiracetam 3000 mg/Day Group
Hide Arm/Group Description
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
  • Frequency: Twice daily
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
  • Frequency: Twice daily
Period Title: Overall Study
Started 61 10
Completed 39 3
Not Completed 22 7
Reason Not Completed
Lack of Efficacy             4             3
Lost to Follow-up             1             0
Withdrawal by Subject             9             3
SAE, non-fatal             2             0
AE, non-serious non-fatal             3             1
SAE,non-fatal+AE,non-serious non-fatal             1             0
Other Reason             2             0
Arm/Group Title Levetiracetam 1000 mg/Day to 2000 mg/Day Group Levetiracetam 3000 mg/Day Group Total Title
Hide Arm/Group Description
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
  • Frequency: Twice daily
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
  • Frequency: Twice daily
[Not Specified]
Overall Number of Baseline Participants 61 10 71
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set (SS). SS consists of all subjects in the Enrolled Set, who received at least 1 dose of the Investigational Medicinal Product (IMP).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 10 participants 71 participants
<=18 years
10
  16.4%
1
  10.0%
11
  15.5%
Between 18 and 65 years
45
  73.8%
8
  80.0%
53
  74.6%
>=65 years
6
   9.8%
1
  10.0%
7
   9.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 10 participants 71 participants
36.5  (18.0) 37.0  (18.6) 36.5  (17.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 10 participants 71 participants
Female
34
  55.7%
4
  40.0%
38
  53.5%
Male
27
  44.3%
6
  60.0%
33
  46.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 61 participants 10 participants 71 participants
61 10 71
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 61 participants 10 participants 71 participants
58.98  (12.30) 62.58  (15.11) 59.48  (12.67)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 61 participants 10 participants 71 participants
161.96  (8.77) 166.07  (10.21) 162.54  (9.02)
1.Primary Outcome
Title Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Hide Description

A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:

  • A documented seizure during 6 consecutive months of the Evaluation Analysis Period
  • Subject discontinued the study prematurely during the Evaluation Analysis Period
  • Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Time Frame From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Hide Outcome Measure Data
Hide Analysis Population Description
Data for the primary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Arm/Group Title Levetiracetam 1000 mg/Day to 2000 mg/Day Group
Hide Arm/Group Description:
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.8
(60.9 to 84.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levetiracetam 1000 mg/Day to 2000 mg/Day Group
Comments

The primary efficacy variable was to be calculated as the proportion p=n/N of subjects (n) staying seizure free for 6 months out of the total number of subjects (N). For this proportion p, an exact 2-sided 95% confidence interval (CI) was computed based on the F distribution.

The hypothesis H0: p=0.4 was to be formally rejected in favor of H1: p>0.4, if the lower confidence limit for p was greater than 0.4.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent
Estimated Value 73.8
Confidence Interval (2-Sided) 95%
60.9 to 84.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Hide Description Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.
Time Frame From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Arm/Group Title Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)
Hide Arm/Group Description:

FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.

  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59.0
(45.7 to 71.4)
3.Secondary Outcome
Title Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Hide Description

A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:

  • A documented seizure during 6 consecutive months of the Evaluation Analysis Period
  • Subject discontinued the study prematurely during the Evaluation Analysis Period
  • Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Time Frame From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.
Arm/Group Title Levetiracetam 3000 mg/Day Group
Hide Arm/Group Description:
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.2
(2.8 to 60.0)
4.Secondary Outcome
Title Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Hide Description Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.
Time Frame From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.
Arm/Group Title Full Analysis Set (LEV 3000 mg/Day Group)
Hide Arm/Group Description:

FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.

  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.1
(0.3 to 48.2)
5.Secondary Outcome
Title Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Hide Description

Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.

The Median time to first seizure will be estimated from the Kaplan-Meier curve.

Time Frame During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Arm/Group Title Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)
Hide Arm/Group Description:

FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.

  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(359 to NA)
[1]
values not estimable due to small number of events
6.Secondary Outcome
Title Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Hide Description Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Time Frame During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.
Arm/Group Title Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)
Hide Arm/Group Description:

FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.

  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
values not estimable due to small number of events
7.Secondary Outcome
Title Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Hide Description

Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.

The Median time to first seizure will be estimated from the Kaplan-Meier curve.

Time Frame During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.
Arm/Group Title Full Analysis Set (LEV 3000 mg/Day Group)
Hide Arm/Group Description:

FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.

  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: days
106 [1] 
(9 to NA)
[1]
value not estimable due to small number of events
8.Secondary Outcome
Title Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Hide Description Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Time Frame During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.
Arm/Group Title Levetiracetam 3000 mg/Day Group
Hide Arm/Group Description:
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
  • Frequency: Twice daily
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: days
91
(21 to 197)
Time Frame Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit.
Adverse Event Reporting Description Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
 
Arm/Group Title Levetiracetam 1000 mg/Day to 2000 mg/Day Group Levetiracetam 3000 mg/Day Group
Hide Arm/Group Description
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.
  • Frequency: Twice daily
  • Formulation: Tablet
  • Strength: LEV 250 mg, LEV 500 mg
  • Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.
  • Frequency: Twice daily
All-Cause Mortality
Levetiracetam 1000 mg/Day to 2000 mg/Day Group Levetiracetam 3000 mg/Day Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam 1000 mg/Day to 2000 mg/Day Group Levetiracetam 3000 mg/Day Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/61 (13.11%)      2/10 (20.00%)    
General disorders     
Irritability * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Immune system disorders     
Anaphylactic reaction * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Infections and infestations     
Cystitis * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Kaposi's varicelliform eruption * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Pyelonephritis * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Nervous system disorders     
Status epilepticus * 1  3/61 (4.92%)  3 0/10 (0.00%)  0
Postictal state * 1  2/61 (3.28%)  2 0/10 (0.00%)  0
Convulsion * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Epilepsy * 1  0/61 (0.00%)  0 1/10 (10.00%)  2
Syncope * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Psychiatric disorders     
Agitation * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Alcohol withdrawal syndrome * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Postictal psychosis * 1  1/61 (1.64%)  1 0/10 (0.00%)  0
Suicide attempt * 1  1/61 (1.64%)  2 0/10 (0.00%)  0
Surgical and medical procedures     
Meniscus removal * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levetiracetam 1000 mg/Day to 2000 mg/Day Group Levetiracetam 3000 mg/Day Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/61 (95.08%)      10/10 (100.00%)    
Ear and labyrinth disorders     
Vertigo * 1  0/61 (0.00%)  0 1/10 (10.00%)  2
Gastrointestinal disorders     
Diarrhoea * 1  8/61 (13.11%)  18 2/10 (20.00%)  2
Nausea * 1  6/61 (9.84%)  14 1/10 (10.00%)  1
Dental caries * 1  6/61 (9.84%)  7 0/10 (0.00%)  0
Abdominal discomfort * 1  4/61 (6.56%)  4 1/10 (10.00%)  1
Abdominal pain upper * 1  4/61 (6.56%)  17 0/10 (0.00%)  0
Gastritis * 1  4/61 (6.56%)  4 0/10 (0.00%)  0
Vomiting * 1  4/61 (6.56%)  5 0/10 (0.00%)  0
Gastrooesophageal reflux disease * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Constipation * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Lip ulceration * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Malaise * 1  12/61 (19.67%)  13 0/10 (0.00%)  0
Pyrexia * 1  5/61 (8.20%)  6 1/10 (10.00%)  2
Infections and infestations     
Nasopharyngitis * 1  47/61 (77.05%)  155 4/10 (40.00%)  7
Influenza * 1  7/61 (11.48%)  8 0/10 (0.00%)  0
Cystitis * 1  4/61 (6.56%)  5 0/10 (0.00%)  0
Gastroenteritis * 1  3/61 (4.92%)  3 1/10 (10.00%)  1
Gingivitis * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Rhinitis * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Injury, poisoning and procedural complications     
Contusion * 1  5/61 (8.20%)  6 0/10 (0.00%)  0
Head injury * 1  1/61 (1.64%)  1 2/10 (20.00%)  2
Ligament sprain * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Arthropod sting * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Mouth injury * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Procedural pain * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Investigations     
Weight increased * 1  2/61 (3.28%)  2 2/10 (20.00%)  2
Gamma-glutamyltransferase increased * 1  2/61 (3.28%)  2 1/10 (10.00%)  1
Urine ketone body present * 1  2/61 (3.28%)  2 1/10 (10.00%)  1
Blood urine present * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Neutrophil count increased * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  6/61 (9.84%)  7 0/10 (0.00%)  0
Musculoskeletal pain * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Nervous system disorders     
Somnolence * 1  25/61 (40.98%)  32 2/10 (20.00%)  2
Headache * 1  10/61 (16.39%)  14 1/10 (10.00%)  1
Dizziness * 1  8/61 (13.11%)  9 1/10 (10.00%)  1
Dizziness postural * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Amnestic disorder * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders     
Depression * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Attention deficit/hyperactivity disorder * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Renal and urinary disorders     
Ketonuria * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Reproductive system and breast disorders     
Dysmenorrhoea * 1  5/61 (8.20%)  8 0/10 (0.00%)  0
Acquired phimosis * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  5/61 (8.20%)  6 0/10 (0.00%)  0
Rhinitis allergic * 1  1/61 (1.64%)  1 1/10 (10.00%)  3
Upper respiratory tract inflammation * 1  1/61 (1.64%)  1 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
Eczema * 1  1/61 (1.64%)  1 1/10 (10.00%)  2
Dry skin * 1  0/61 (0.00%)  0 1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.0
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 Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01506882     History of Changes
Other Study ID Numbers: N01375
2014-004377-16 ( EudraCT Number )
First Submitted: January 5, 2012
First Posted: January 10, 2012
Results First Submitted: October 7, 2014
Results First Posted: October 13, 2014
Last Update Posted: December 31, 2015