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

• 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: UCB Japan Co. Ltd.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Levetiracetam 1000 mg/Day to 2000 mg/Day Group	Levetiracetam 3000 mg/Day Group	Total Title
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
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)

Outcome Measures

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--		--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB
• Phone: +1 877 822 9493

• Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
• ClinicalTrials.gov Identifier: NCT01506882
• 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