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    Clinical Trial Results:
    A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization

    Summary
    EudraCT number
    		 2014-003622-41
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Aug 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jul 2016
    First version publication date
    07 Feb 2015
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    For consistency reasons, revisions made on Clinicaltrials.gov due to NIH comments will also be performed on EudraCT.

    Trial information

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    Trial identification
    Sponsor protocol code
    EP0008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01710657
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 JAPIC: JapicCTI-121988
    Sponsors
    Sponsor organisation name
    UCB Pharma SA
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, B-1070
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173481515, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173481515, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of Lacosamide (LCM) administered concomitantly with 1 to 3 Antiepileptic Drugs (AEDs) in Japanese and Chinese subjects with or without additional vagus nerve stimulation (VNS) who currently have uncontrolled partial-onset seizures with or without secondary generalization.
    Protection of trial subjects
    The use of benzodiazepines, which have the indication for epilepsy for the control of uncountable seizures due to clustering, is restricted to rescue therapy where there is no alternative for 1-time rescue (ie, 3 doses over a 24-hour period) during the Titration Period and 1-time rescue during the Maintenance Period. Benzodiazepines are not allowed during the Baseline Period but may be used during the Transition or Taper Periods to control seizures at the discretion of the investigator.
    Background therapy
    		 Subject must be on a stable dose regimen of at least 1, but no more than 3 Antiepileptic Drugs (AEDs). Only oral administration and daily use are permitted.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    28 Sep 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 142
    Country: Number of subjects enrolled
    China: 405
    Worldwide total number of subjects
    547
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    35
    Adults (18-64 years)
    509
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 676 subjects with uncontrolled partial-onset seizures (of the 676 subjects, the number of Chinese subjects and Japanese subjects was planned to be 507 and 169, respectively) was planned to be screened and 540 subjects were planned to be enrolled in all regions of Japan and China.

    Pre-assignment
    Screening details
    		 Overall, 692 subjects were screened and 548 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 547 subjects were included in the Safety Set.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Lacosamide and matching placebo and their accompanying packaging were identical in appearance (size and color), so that neither the investigator nor the subject was able to tell whether the subject was receiving LCM or placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching Placebo for 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching oral Placebo tablets twice daily for 16 weeks.

    Arm title
    		 Lacosamide 200 mg / day
    Arm description
    		 Lacosamide Treatment with dosing of 200 mg / day for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lacosamide 50 mg
    Investigational medicinal product code
    SPM927
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to LCM 200 mg / day will receive LCM 100 mg / day for the first week and LCM 200 mg / day for the remaining 3 weeks of the Titration Period. Frequency: twice daily Duration: Subjects who complete the Titration Period will enter a 12-Week Maintenance Period. Subjects will be maintained on the dose achieved during the Titration Period.

    Investigational medicinal product name
    Lacosamide 100 mg
    Investigational medicinal product code
    SPM927
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet Dosage: Subjects randomized to LCM 200 mg / day will receive LCM 100 mg / day for the first week and LCM 200 mg / day for the remaining 3 weeks of the Titration Period. Frequency: twice daily Duration: Subjects who complete the Titration Period will enter a 12-Week Maintenance Period. Subjects will be maintained on the dose achieved during the Titration Period.

    Arm title
    		 Lacosamide 400 mg / day
    Arm description
    		 Lacosamide Treatment with dosing of 400 mg / day for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lacosamide 50 mg
    Investigational medicinal product code
    SPM927
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: Subjects randomized to LCM 400 mg / day will start at a dose of 100 mg / day during the first week of the Titration Period. The dose will then be increased by LCM 100 mg / day each week until the 400 mg / day dose is reached at the beginning of Week 4. Frequency: twice daily Duration: Subjects who complete the Titration Period will enter a 12-Week Maintenance Period. Subjects will be maintained on the dose achieved during the Titration Period.

    Investigational medicinal product name
    Lacosamide 100 mg
    Investigational medicinal product code
    SPM927
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: Subjects randomized to LCM 400 mg / day will start at a dose of 100 mg / day during the first week of the Titration Period. The dose will then be increased by LCM 100 mg / day each week until the 400 mg / day dose is reached at the beginning of Week 4. Frequency: twice daily Duration: Subjects who complete the Titration Period will enter a 12-Week Maintenance Period. Subjects will be maintained on the dose achieved during the Titration Period.

    Number of subjects in period 1
    		Placebo Lacosamide 200 mg / day Lacosamide 400 mg / day
    Started
    184
    183
    180
    Titration Period (4 Weeks)
    184
    183
    180
    Maintenance Period (12 Weeks)
    176
    175
    168
    Completed
    166
    171
    148
    Not completed
    18
    12
    32
         Consent withdrawn by subject
    -
    1
    2
         AE, non-serious non-fatal
    14
    7
    25
         Lost to follow-up
    2
    -
    1
         SAE, non-fatal
    -
    1
    3
         Protocol deviation
    2
    2
    -
         Lack of efficacy
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo for 16 weeks.

    Reporting group title
    Lacosamide 200 mg / day
    Reporting group description
    		 Lacosamide Treatment with dosing of 200 mg / day for 16 weeks.

    Reporting group title
    Lacosamide 400 mg / day
    Reporting group description
    		 Lacosamide Treatment with dosing of 400 mg / day for 16 weeks.

    Reporting group values
    		 Placebo Lacosamide 200 mg / day Lacosamide 400 mg / day Total
    Number of subjects
    		 184 183 180 547
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 12 11 12 35
        Adults (18-64 years)
    		 172 170 167 509
        From 65-84 years
    		 0 2 1 3
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.8 ( 12 ) 33.2 ( 12.2 ) 32.3 ( 11.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 82 89 76 247
        Male
    		 102 94 104 300
    Racial group
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 184 183 180 547
        African or African American
    		 0 0 0 0
        Native Hawaiian or other Pacific Islander
    		 0 0 0 0
        White
    		 0 0 0 0
        Other/Mixed
    		 0 0 0 0
    Racial Subgroup
    Units: Subjects
        Chinese
    		 136 136 133 405
        Japanese
    		 48 47 47 142

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo for 16 weeks.

    Reporting group title
    Lacosamide 200 mg / day
    Reporting group description
    		 Lacosamide Treatment with dosing of 200 mg / day for 16 weeks.

    Reporting group title
    Lacosamide 400 mg / day
    Reporting group description
    		 Lacosamide Treatment with dosing of 400 mg / day for 16 weeks.

    Subject analysis set title
    Full Analysis Set - Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.

    Subject analysis set title
    Full Analysis Set - Lacosamide 200 mg / day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.

    Subject analysis set title
    Full Analysis Set - Lacosamide 400 mg / day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.

    Primary: Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Maintenance Period

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    End point title
    		 Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Maintenance Period
    End point description
    Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.
    End point type
    Primary
    End point timeframe
    8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)
    End point values
    		 Full Analysis Set - Placebo Full Analysis Set - Lacosamide 200 mg / day Full Analysis Set - Lacosamide 400 mg / day
    Number of subjects analysed
    183
    182
    179
    Units: Seizure frequency
        median (full range (min-max))
    -1.22 (-93 to 39.8)
    -3.33 (-754.3 to 165.2)
    -4.5 (-97.5 to 28.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Full Analysis Set - Placebo v Full Analysis Set - Lacosamide 400 mg / day
    Number of subjects included in analysis
    362
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 % Reduction over Placebo
    Point estimate
    39.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.5
         upper limit
    		 47.6
    Notes
    [1] - To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group. If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group.
    [2] - Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Full Analysis Set - Placebo v Full Analysis Set - Lacosamide 200 mg / day
    Number of subjects included in analysis
    365
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 % Reduction over Placebo
    Point estimate
    29.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.7
         upper limit
    		 38.7
    Notes
    [3] - To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group. If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group.
    [4] - Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.

    Secondary: The proportion of individual patients who experience a 50 % or greater reduction in Partial-Onset Seizure frequency from Baseline to the Maintenance Period (50 % responder rate)

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    End point title
    		 The proportion of individual patients who experience a 50 % or greater reduction in Partial-Onset Seizure frequency from Baseline to the Maintenance Period (50 % responder rate)
    End point description
    End point type
    Secondary
    End point timeframe
    8-week Baseline Period (Visit1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
    End point values
    		 Full Analysis Set - Placebo Full Analysis Set - Lacosamide 200 mg / day Full Analysis Set - Lacosamide 400 mg / day
    Number of subjects analysed
    183
    182
    179
    Units: Participants
    36
    70
    88
    No statistical analyses for this end point

    Secondary: Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period

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    End point title
    		 Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
    End point description
    Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.
    End point type
    Secondary
    End point timeframe
    8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
    End point values
    		 Full Analysis Set - Placebo Full Analysis Set - Lacosamide 200 mg / day Full Analysis Set - Lacosamide 400 mg / day
    Number of subjects analysed
    183
    182
    179
    Units: percent
        median (full range (min-max))
    -10.1 (-97.6 to 233.5)
    -36.75 (-100 to 185.5)
    -48.78 (-100 to 346.4)
    No statistical analyses for this end point

    Secondary: Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Treatment Period (i.e., Titration + Maintenance Period)

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    End point title
    		 Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Treatment Period (i.e., Titration + Maintenance Period)
    End point description
    Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.
    End point type
    Secondary
    End point timeframe
    8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)
    End point values
    		 Full Analysis Set - Placebo Full Analysis Set - Lacosamide 200 mg / day Full Analysis Set - Lacosamide 400 mg / day
    Number of subjects analysed
    183
    182
    179
    Units: Seizure frequency
        median (full range (min-max))
    -1.1 (-102.4 to 102.5)
    -3.39 (-670 to 138.9)
    -4 (-92.4 to 34.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19).
    Adverse event reporting additional description
    Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo for 16 weeks.

    Reporting group title
    Lacosamide 400 mg / day
    Reporting group description
    		 Lacosamide Treatment with dosing of 400 mg / day for 16 weeks.

    Reporting group title
    Lacosamide 200 mg / day
    Reporting group description
    		 Lacosamide Treatment with dosing of 200 mg / day for 16 weeks.

    Serious adverse events
    		 Placebo Lacosamide 400 mg / day Lacosamide 200 mg / day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 184 (2.17%)
    9 / 180 (5.00%)
    2 / 183 (1.09%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 180 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Comminuted fracture
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    2 / 184 (1.09%)
    0 / 180 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 184 (0.54%)
    0 / 180 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Epileptic psychosis
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 184 (0.00%)
    0 / 180 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 184 (0.54%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 184 (0.00%)
    1 / 180 (0.56%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Lacosamide 400 mg / day Lacosamide 200 mg / day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 184 (41.85%)
    112 / 180 (62.22%)
    87 / 183 (47.54%)
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    2 / 184 (1.09%)
    10 / 180 (5.56%)
    8 / 183 (4.37%)
         occurrences all number
    2
    12
    14
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    24 / 184 (13.04%)
    63 / 180 (35.00%)
    33 / 183 (18.03%)
         occurrences all number
    32
    118
    57
    Somnolence
         subjects affected / exposed
    9 / 184 (4.89%)
    19 / 180 (10.56%)
    18 / 183 (9.84%)
         occurrences all number
    10
    21
    26
    Headache
         subjects affected / exposed
    11 / 184 (5.98%)
    19 / 180 (10.56%)
    16 / 183 (8.74%)
         occurrences all number
    21
    32
    18
    Eye disorders
    Diplopia
         subjects affected / exposed
    4 / 184 (2.17%)
    13 / 180 (7.22%)
    4 / 183 (2.19%)
         occurrences all number
    5
    15
    8
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    4 / 184 (2.17%)
    14 / 180 (7.78%)
    5 / 183 (2.73%)
         occurrences all number
    4
    18
    6
    Nausea
         subjects affected / exposed
    9 / 184 (4.89%)
    10 / 180 (5.56%)
    7 / 183 (3.83%)
         occurrences all number
    10
    11
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    24 / 184 (13.04%)
    29 / 180 (16.11%)
    28 / 183 (15.30%)
         occurrences all number
    41
    36
    40
    Upper respiratory tract infection
         subjects affected / exposed
    22 / 184 (11.96%)
    19 / 180 (10.56%)
    10 / 183 (5.46%)
         occurrences all number
    31
    28
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23859801
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