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    Clinical Trial Results:
    A PHASE 2, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, ADJUNCTIVE PLACEBO-CONTROLLED TRIAL WITH AN OPEN-LABEL EXTENSION TO EVALUATE THE EFFICACY AND SAFETY OF YKP3089 IN SUBJECTS WITH TREATMENT RESISTANT PARTIAL ONSET SEIZURES

    Summary
    EudraCT number
    		 2011-000901-37
    Trial protocol
    		 PL  
    Global end of trial date
    28 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2022
    First version publication date
    25 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    YKP3089C013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01397968
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SK Life Science, Inc
    Sponsor organisation address
    461 From Road, Paramus, New Jersey, United States, 07652
    Public contact
    Laurie Orlinski, SK Life Science, Inc, +1 201-421-3816, lorlinski@sklsi.com
    Scientific contact
    Marc Kamin, SK Life Science, Inc, +1 2014213830, mkamin@sklsi.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of YKP3089 when titrated from 50 to 200 milligram per day (mg/day) in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant antiepileptic drugs.
    Protection of trial subjects
    This study was conducted according to United States and international standards of Good Clinical Practice (Food and Drug Administration Title 21 Part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.
    Background therapy
    		 Subjects must have been taking 1-3 concomitant antiepileptic drugs, which they continued to take as prescribed, throughout the study. Subjects could not have any dose changes in their current antiepileptic drug therapy for at least 12 weeks prior to randomization, and doses were to remain stable throughout the double-blind treatment period.
    Evidence for comparator
    		 This was a placebo-controlled study and placebo was considered as the comparator.
    Actual start date of recruitment
    06 Jul 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 51
    Country: Number of subjects enrolled
    Korea, Republic of: 41
    Country: Number of subjects enrolled
    Poland: 44
    Country: Number of subjects enrolled
    United States: 86
    Worldwide total number of subjects
    222
    EEA total number of subjects
    44
    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)
    0
    Adults (18-64 years)
    222
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase 2 double-blind study with an open-label extension (OLE) was conducted in subjects with treatment resistant partial onset seizures at 40 investigational sites. Investigational sites in India did not participate in the OLE phase. A total of 222 subjects were randomized in a 1:1 ratio to YKP3089 or placebo in this study.

    Pre-assignment
    Screening details
    		 The study consisted of a baseline phase (8 weeks), a double-blind treatment period (6-week titration and 6-week maintenance phase), and an OLE phase. The OLE phase was designed without a pre-specified number of weeks. Subject disposition for the double-blind treatment period is based on Randomized Population.

    Period 1
    Period 1 title
    Double-Blind Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    During the double-blind period, the packaging and labeling of the clinical trial medication maintained the double-blind design of the trial. The treatment administered was not known to the subjects or the study personnel at the clinical site. Selected individuals from the Sponsor and/or designee and at the contract research organization (CRO) may have been unblinded to the study treatments on a need-to-know basis as described in the CRO’s Standard Operating Procedures on blinding and unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Double-Blind Treatment Period: YKP3089
    Arm description
    		 Subjects received YKP3089 50 mg orally once daily starting on Day 1 for the first 2 weeks. If well tolerated the dose was increased to 100 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 150 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 200 mg/day for the final 6-week maintenance phase. Subjects who reported side effects may, instead of increasing the dose, remained on the same dose (50 mg, 100 mg, or 150 mg) and not titrated until the following visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    YKP3089
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    YKP3089 capsules with dosages described above in Arm description were administrated orally once daily in the morning (with or without breakfast) from Day 1 to the end of double-blind treatment period.

    Arm title
    		 Double-Blind Treatment Period: Placebo
    Arm description
    		 Subjects received placebo (matching with YKP3089) orally once daily starting on Day 1 and throughout the 6-week titration phase and 6-week maintenance phase.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo (matching with YKP3089) capsules were administrated orally once daily in the morning (with or without breakfast) from Day 1 to the end of double-blind treatment period.

    Number of subjects in period 1
    		Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Started
    113
    109
    Completed
    102
    99
    Not completed
    11
    10
         Consent withdrawn by subject
    5
    4
         Adverse event, non-fatal
    4
    4
         Other
    -
    1
         Lost to follow-up
    2
    -
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Open-Label Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 OLE Phase: YKP3089
    Arm description
    		 Subjects who continued in the OLE phase received YKP3089 100 mg orally once daily starting on Day 1 of the OLE phase (Day 85 of study) and then increased by 50 mg/day increments every 2 weeks until reaching the maximum of 400 mg/day based on the same tolerability requirement used in the double-blind treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    YKP3089
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    YKP3089 capsules or tablets with dosages described above in Arm description were administrated orally once daily in the morning (with or without breakfast) from Day 1 to the end of OLE phase. The OLE phase could continue until development was stopped by the Sponsor, the product was approved for marketing or anytime at the discretion of the Sponsor. The OLE phase disposition is based on OLE Safety Evaluable Population, which is defined as all subjects treated in double-blind who continued into OLE phase and took at least 1 dose of open-label study medication.

    Number of subjects in period 2 [1]
    		OLE Phase: YKP3089
    Started
    149
    Completed
    37
    Not completed
    112
         Consent withdrawn by subject
    31
         Adverse event, non-fatal
    16
         Other
    12
         Lost to follow-up
    5
         Pregnancy
    1
         Entered Extended Access Program/Navigator
    47
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only subjects who completed the double-blind treatment period and still met inclusion/exclusion criteria except for seizure frequency were entered into the OLE phase. Please note, sites from India did not participate in the OLE phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-Blind Treatment Period: YKP3089
    Reporting group description
    		 Subjects received YKP3089 50 mg orally once daily starting on Day 1 for the first 2 weeks. If well tolerated the dose was increased to 100 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 150 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 200 mg/day for the final 6-week maintenance phase. Subjects who reported side effects may, instead of increasing the dose, remained on the same dose (50 mg, 100 mg, or 150 mg) and not titrated until the following visit.

    Reporting group title
    Double-Blind Treatment Period: Placebo
    Reporting group description
    		 Subjects received placebo (matching with YKP3089) orally once daily starting on Day 1 and throughout the 6-week titration phase and 6-week maintenance phase.

    Reporting group values
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo Total
    Number of subjects
    		 113 109 222
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.2 ± 11.27 37.5 ± 11.38 -
    Gender categorical
    Units: Subjects
        Female
    		 58 51 109
        Male
    		 55 58 113
    Race
    Units: Subjects
        White
    		 57 58 115
        Black or African American
    		 3 2 5
        Asian
    		 49 45 94
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Other
    		 1 2 3
        Unknown
    		 3 2 5
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 4 3 7
        Not Hispanic or Latino
    		 105 101 206
        Not Reported
    		 4 5 9

    End points

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    End points reporting groups
    Reporting group title
    Double-Blind Treatment Period: YKP3089
    Reporting group description
    		 Subjects received YKP3089 50 mg orally once daily starting on Day 1 for the first 2 weeks. If well tolerated the dose was increased to 100 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 150 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 200 mg/day for the final 6-week maintenance phase. Subjects who reported side effects may, instead of increasing the dose, remained on the same dose (50 mg, 100 mg, or 150 mg) and not titrated until the following visit.

    Reporting group title
    Double-Blind Treatment Period: Placebo
    Reporting group description
    		 Subjects received placebo (matching with YKP3089) orally once daily starting on Day 1 and throughout the 6-week titration phase and 6-week maintenance phase.
    Reporting group title
    OLE Phase: YKP3089
    Reporting group description
    		 Subjects who continued in the OLE phase received YKP3089 100 mg orally once daily starting on Day 1 of the OLE phase (Day 85 of study) and then increased by 50 mg/day increments every 2 weeks until reaching the maximum of 400 mg/day based on the same tolerability requirement used in the double-blind treatment period.

    Primary: Percent Change From Baseline in Seizure Frequency Per 28 Days During Double-Blind Treatment Period

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    End point title
    		 Percent Change From Baseline in Seizure Frequency Per 28 Days During Double-Blind Treatment Period
    End point description
    Percent change (reduction) was calculated as (baseline seizure frequency per 28 days – double-blind period seizure frequency per 28 days) / baseline seizure frequency per 28 days x 100. Baseline seizure frequency per 28 Days = number of seizures over baseline period (56 days prior to study Day 1) divided by the number of days in the interval multiplied by 28. The Intention-to-Treat (ITT) population included all randomized subjects who took at least 1 single dose of YKP3089 (or placebo) and had at least 1 efficacy evaluation. The analysis for the primary endpoint is based on ITT population.
    End point type
    Primary
    End point timeframe
    From Day 1 to the end of the double-blind treatment period (Week 12)
    End point values
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Number of subjects analysed
    113
    108
    Units: percent change
        median (full range (min-max))
    55.6 (-417.3 to 100.0)
    21.5 (-588.0 to 100.0)
    Statistical analysis title
    		 Percent Change from Baseline in Seizure Frequency
    Comparison groups
    Double-Blind Treatment Period: YKP3089 v Double-Blind Treatment Period: Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Wilcoxon rank-sum test
    Confidence interval
    Notes
    [1] - The p-value is based on a Wilcoxon rank-sum test assessing if the median percent change in seizure frequency for the treatment group is significantly different from the median percent change in seizure frequency for the placebo subjects.

    Secondary: Responder Rate (at Least 50% Reduction in Seizure Frequency) During Double-Blind Treatment Period

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    End point title
    		 Responder Rate (at Least 50% Reduction in Seizure Frequency) During Double-Blind Treatment Period
    End point description
    The main secondary endpoint was the responder rate (responder is defined as a subject with ≥ 50% reduction in seizure frequency during the double-blind treatment period). The ITT population included all randomized subjects who took at least 1 single does of YKP3089 (or placebo) and had at least 1 efficacy evaluation. The analysis for this secondary endpoint is based on ITT population.
    End point type
    Secondary
    End point timeframe
    From Day 1 to the end of the double-blind treatment period (Week 12)
    End point values
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Number of subjects analysed
    113
    108
    Units: percentage of responder subjects
        number (not applicable)
    50.4
    22.2
    Statistical analysis title
    		 Logistic Regression Analysis for Responder Rate
    Statistical analysis description
    The odds ratio, 95% confidence interval and p-value (YKP3089 versus placebo) are based on a logistic regression model with terms for treatment, country, and baseline seizure frequency (Wald chi-square).
    Comparison groups
    Double-Blind Treatment Period: YKP3089 v Double-Blind Treatment Period: Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.14
         upper limit
    		 7.24

    Secondary: Percent Change From Baseline in Seizure Frequency of Simple Partial Seizure With Motor Component (Type B) per 28 Days During Double-Blind Treatment Period

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    End point title
    		 Percent Change From Baseline in Seizure Frequency of Simple Partial Seizure With Motor Component (Type B) per 28 Days During Double-Blind Treatment Period
    End point description
    The 3 partial seizure types included simple partial seizure with motor component (Type B), complex partial seizures (Type C) and secondarily generalized tonic-clonic seizures (Type D). This secondary endpoint assessed the percent change for Type B seizure frequency. Percent change (reduction) was calculated as (baseline seizure frequency per 28 days – double-blind period seizure frequency per 28 days) / baseline seizure frequency per 28 days x 100. Baseline seizure frequency per 28 Days = number of seizures over baseline period (56 days prior to study Day 1) divided by the number of days in the interval multiplied by 28. The ITT population included all randomized subjects who took at least 1 single does of YKP3089 (or placebo) and had at least 1 efficacy evaluation. The analysis for this secondary endpoint is based on ITT population.
    End point type
    Secondary
    End point timeframe
    From Day 1 to the end of the double-blind treatment period (Week 12)
    End point values
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Number of subjects analysed
    30
    26
    Units: percent change
        median (full range (min-max))
    76.3 (-122.0 to 100.0)
    27.8 (-749.3 to 100.0)
    Statistical analysis title
    		 Percent Change from Baseline in Seizure Frequency
    Statistical analysis description
    Analysis was performed in Seizure Frequency (Type B).
    Comparison groups
    Double-Blind Treatment Period: YKP3089 v Double-Blind Treatment Period: Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0448 [2]
    Method
    		 Wilcoxon rank-sum test
    Confidence interval
    Notes
    [2] - The p-value is based on a Wilcoxon rank-sum test assessing if the median seizure frequency at post baseline for the treatment group is significantly different from the median seizure frequency for the placebo subjects.

    Secondary: Percent Change From Baseline in Seizure Frequency of Complex Partial Seizures (Type C) per 28 Days During Double-Blind Treatment Period

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    End point title
    		 Percent Change From Baseline in Seizure Frequency of Complex Partial Seizures (Type C) per 28 Days During Double-Blind Treatment Period
    End point description
    The 3 partial seizure types included simple partial seizure with motor component (Type B), complex partial seizures (Type C) and secondarily generalized tonic-clonic seizures (Type D). This secondary endpoint assessed the percent change for Type C seizure frequency. Percent change (reduction) was calculated as (baseline seizure frequency per 28 days – double-blind period seizure frequency per 28 days) / baseline seizure frequency per 28 days x 100. Baseline seizure frequency per 28 Days = number of seizures over baseline period (56 days prior to study Day 1) divided by the number of days in the interval multiplied by 28. The ITT population included all randomized subjects who took at least 1 single does of YKP3089 (or placebo) and had at least 1 efficacy evaluation. The analysis for this secondary endpoint is based on ITT population.
    End point type
    Secondary
    End point timeframe
    From Day 1 to the end of the double-blind treatment period (Week 12)
    End point values
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Number of subjects analysed
    87
    89
    Units: percent change
        median (full range (min-max))
    55.6 (-366.7 to 100.0)
    21.1 (-234.0 to 100.0)
    Statistical analysis title
    		 Percent Change from Baseline in Seizure Frequency
    Statistical analysis description
    Analysis was performed in Seizure Frequency (Type C).
    Comparison groups
    Double-Blind Treatment Period: YKP3089 v Double-Blind Treatment Period: Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0009 [3]
    Method
    		 Wilcoxon rank-sum test
    Confidence interval
    Notes
    [3] - The p-value is based on a Wilcoxon rank-sum test assessing if the median seizure frequency at post baseline for the treatment group is significantly different from the median seizure frequency for the placebo subjects.

    Secondary: Percent Change From Baseline in Seizure Frequency of Secondarily Generalized Tonic-Clonic Seizures (Type D) per 28 Days During Double-Blind Treatment Period

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    End point title
    		 Percent Change From Baseline in Seizure Frequency of Secondarily Generalized Tonic-Clonic Seizures (Type D) per 28 Days During Double-Blind Treatment Period
    End point description
    The 3 partial seizure types included simple partial seizure with motor component (Type B), complex partial seizures (Type C) and secondarily generalized tonic-clonic seizures (Type D). This secondary endpoint assessed the percent change for Type D seizure frequency. Percent change (reduction) was calculated as (baseline seizure frequency per 28 days – double-blind period seizure frequency per 28 days) / baseline seizure frequency per 28 days x 100. Baseline seizure frequency per 28 Days = number of seizures over baseline period (56 days prior to study Day 1) divided by the number of days in the interval multiplied by 28. The ITT population included all randomized subjects who took at least 1 single does of YKP3089 (or placebo) and had at least 1 efficacy evaluation. The analysis for this secondary endpoint is based on ITT population.
    End point type
    Secondary
    End point timeframe
    From Day 1 to the end of the double-blind treatment period (Week 12)
    End point values
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Number of subjects analysed
    38
    37
    Units: percent change
        median (full range (min-max))
    77.0 (-146.6 to 100.0)
    33.0 (-880.0 to 100.0)
    Statistical analysis title
    		 Percent Change from Baseline in Seizure Frequency
    Statistical analysis description
    Analysis was performed in Seizure Frequency (Type D).
    Comparison groups
    Double-Blind Treatment Period: YKP3089 v Double-Blind Treatment Period: Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0117 [4]
    Method
    		 Wilcoxon rank-sum test
    Confidence interval
    Notes
    [4] - The p-value is based on a Wilcoxon rank-sum test assessing if the median seizure frequency at post baseline for the treatment group is significantly different from the median seizure frequency for the placebo subjects.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) were reported during the double-blind treatment period.
    Adverse event reporting additional description
    Adverse events (AEs) that occur up to 7 days following the subject’s last dose of double-blind study drug are included as TEAEs. Double-blind safety evaluable population included all randomized subjects who took at least 1 dose of YKP3089 (or placebo). AEs are reporting in Safety evaluable population. Similar AEs data was observed during OLE phase.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Double-Blind Treatment Period: YKP3089
    Reporting group description
    		 Subjects received YKP3089 50 mg orally once daily starting on Day 1 for the first 2 weeks. If well tolerated the dose was increased to 100 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 150 mg/day for the next 2 weeks. If well tolerated the dose was then increased to 200 mg/day for the final 6-week maintenance phase. Subjects who reported side effects may, instead of increasing the dose, remained on the same dose (50 mg, 100 mg, or 150 mg) and not titrated until the following visit.

    Reporting group title
    Double-Blind Treatment Period: Placebo
    Reporting group description
    		 Subjects received placebo (matching with YKP3089) orally once daily starting on Day 1 and throughout the 6-week titration phase and 6-week maintenance phase.

    Serious adverse events
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 113 (1.77%)
    4 / 109 (3.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Arteriogram coronary normal
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 109 (1.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-Blind Treatment Period: YKP3089 Double-Blind Treatment Period: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 113 (74.34%)
    69 / 109 (63.30%)
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    9 / 113 (7.96%)
    1 / 109 (0.92%)
         occurrences all number
    11
    1
    Dizziness
         subjects affected / exposed
    25 / 113 (22.12%)
    18 / 109 (16.51%)
         occurrences all number
    49
    21
    Headache
         subjects affected / exposed
    14 / 113 (12.39%)
    14 / 109 (12.84%)
         occurrences all number
    19
    16
    Nystagmus
         subjects affected / exposed
    11 / 113 (9.73%)
    0 / 109 (0.00%)
         occurrences all number
    15
    0
    Somnolence
         subjects affected / exposed
    25 / 113 (22.12%)
    13 / 109 (11.93%)
         occurrences all number
    36
    15
    Tremor
         subjects affected / exposed
    7 / 113 (6.19%)
    3 / 109 (2.75%)
         occurrences all number
    24
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 113 (10.62%)
    7 / 109 (6.42%)
         occurrences all number
    15
    8
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 113 (5.31%)
    0 / 109 (0.00%)
         occurrences all number
    6
    0
    Diarrhea
         subjects affected / exposed
    6 / 113 (5.31%)
    0 / 109 (0.00%)
         occurrences all number
    9
    0
    Nausea
         subjects affected / exposed
    13 / 113 (11.50%)
    5 / 109 (4.59%)
         occurrences all number
    17
    5
    Vomiting
         subjects affected / exposed
    6 / 113 (5.31%)
    2 / 109 (1.83%)
         occurrences all number
    7
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 113 (0.88%)
    6 / 109 (5.50%)
         occurrences all number
    1
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 113 (6.19%)
    1 / 109 (0.92%)
         occurrences all number
    7
    1
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 113 (7.08%)
    5 / 109 (4.59%)
         occurrences all number
    9
    6
    Urinary tract infection
         subjects affected / exposed
    8 / 113 (7.08%)
    2 / 109 (1.83%)
         occurrences all number
    8
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2011
    To amend inclusion/exclusion criteria to allow subjects receiving carbamazepine into the study.
    01 Nov 2011
    To add an OLE to obtain long-term safety and tolerability data in subjects with treatment resistant partial onset seizures. To allow subjects under the care of guardians to participate in the study.
    28 Nov 2011
    To allow subjects with a body mass index up to 40 to participate in the study.
    10 Sep 2012
    To allow subjects to convert from double-blind to open-label treatment without a taper. Clarified exclusion criteria. To provide results of the second carbamazepine - YKP3089 interaction study.
    12 Nov 2012
    To allow subjects in the OLE to continue open-label treatment beyond 1 year and also to collect long term safety data for YKP3089.
    10 Apr 2013
    To add additional safety assessments for subjects with treatment-emergent rash.
    10 Oct 2013
    To provide the results of a multiple ascending dose study that targeted 400, 500 and 600 mg/day doses of YKP3089. To allow subjects in the OLE to increase the target dose up to 400 mg/day.
    11 Sep 2015
    To allow subjects in the OLE to take YKP3089 in tablet formulation.

    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
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