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    Clinical Trial Results:
    A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX9211 in the Treatment of Postherpetic Neuralgia (RELIEF-PHN1)

    Summary
    EudraCT number
    		 2020-004639-26
    Trial protocol
    		 CZ   PL  
    Global end of trial date
    28 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2024
    First version publication date
    06 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LX9211.1-202-PHN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04662281
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lexicon Pharmaceuticals, Inc.
    Sponsor organisation address
    2445 Technology Forest Blvd, The Woodlands, TX, United States, 77381-5261
    Public contact
    Vice President, Clinical Operations, Lexicon Pharmaceuticals, +1 281-863-3000, clinicaloperations@lexpharma.com
    Scientific contact
    Head of LX9211 Clinical Development, Lexicon Pharmaceuticals, +1 281-863-3000, clinicaloperations@lexpharma.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 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2022
    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 LX9211 in reducing pain related to postherpetic neuralgia (PHN).
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Dec 2020
    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
    Poland: 7
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    United States: 68
    Worldwide total number of subjects
    79
    EEA total number of subjects
    11
    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)
    35
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study at multiple investigative sites in Poland, Czechia, and the United States from 10 December 2020 to 28 December 2022.

    Pre-assignment
    Screening details
    		 Following a 2-week single blind Placebo Run-in period, a total of 79 subjects were randomised and treated in the study, with 41 subjects receiving a placebo and 38 subjects receiving LX9211.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LX9211-matching -placebo tablet was administered, orally as specified in the respective arm.

    Arm title
    		 LX9211
    Arm description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LX9211
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LX9211 tablet was administered, orally as specified in the respective arm.

    Number of subjects in period 1
    		Placebo LX9211
    Started
    41
    38
    Completed
    34
    21
    Not completed
    7
    17
         Subject Choice
    1
    2
         Reason Not Specified
    1
    2
         Adverse event
    4
    13
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.

    Reporting group title
    LX9211
    Reporting group description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.

    Reporting group values
    		 Placebo LX9211 Total
    Number of subjects
    		 41 38 79
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.6 ( 12.5 ) 65.4 ( 11.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 23 47
        Male
    		 17 15 32
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 12 11 23
        Not Hispanic or Latino
    		 29 27 56
    Race
    Units: Subjects
        Black or African American
    		 2 0 2
        White
    		 39 37 76
        Unknown or Not Reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.

    Reporting group title
    LX9211
    Reporting group description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.

    Primary: Change from Baseline (Week 2 of the Run-in period) in Average Daily Pain Score (ADPS)

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    End point title
    		 Change from Baseline (Week 2 of the Run-in period) in Average Daily Pain Score (ADPS)
    End point description
    ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 (no pain) to 10 (pain as bad as you can imagine). Higher ADPS scores indicated a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline (Week 2 of the Run-in period) to Week 6
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    36 [1]
    22 [2]
    Units: score on a scale
        least squares mean (standard error)
    -1.62 ( 0.360 )
    -2.42 ( 0.397 )
    Notes
    [1] - Number of subjects analysed signifies subjects who were evaluable for this endpoint.
    [2] - Number of subjects analysed signifies subjects who were evaluable for this endpoint.
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    The Mixed Model Repeated Measures (MMRM) model was used to assess the difference between LX9211 and placebo in the primary endpoint and it included fixed effects of treatment, week, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    LX9211 v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.82
         upper limit
    		 0.21

    Secondary: Change from Baseline in Pain Interfering With Sleep based on Question 9F of the ZBPI at Week 6

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    End point title
    		 Change from Baseline in Pain Interfering With Sleep based on Question 9F of the ZBPI at Week 6
    End point description
    Pain interfering with sleep is based on Question 9F of the ZBPI “Indicate the one number that describes how, in the past 24-hours shingles pain has interfered with your: Sleep; 0 = does not interfere to 10 = Completely interferes. Higher the number more the worsening of sleep due to pain interference. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    35 [3]
    22 [4]
    Units: score on a scale
        least squares mean (standard error)
    -1.43 ( 0.323 )
    -2.04 ( 0.364 )
    Notes
    [3] - Number of subjects analysed signifies subjects who were evaluable for this endpoint.
    [4] - Number of subjects analysed signifies subjects who were evaluable for this endpoint.
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.181
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.53
         upper limit
    		 0.29

    Secondary: Percentage of Subjects with ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6

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    End point title
    		 Percentage of Subjects with ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6
    End point description
    ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    41
    38
    Units: percentage of subjects
        number (not applicable)
    34.1
    42.1
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of Baseline severity score (moderate, severe) was used.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.504
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Percentage Difference
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.42
         upper limit
    		 29.34

    Secondary: Percentage of Subjects with ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6

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    End point title
    		 Percentage of Subjects with ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6
    End point description
    ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    41
    38
    Units: percentage of subjects
        number (not applicable)
    19.5
    23.7
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    CMH test stratified by the different levels of the randomisation stratification factors of Baseline severity score (moderate, severe) was used.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.671
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Percentage Difference
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.99
         upper limit
    		 22.33

    Secondary: Change from Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI

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    End point title
    		 Change from Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI
    End point description
    The ZBPI, a 9-item questionnaire assesses the severity of pain and its impact on functioning in subjects with PHN. The categories based on questions 9A-G of the ZBPI that were analyzed are general activity, mood, walking ability, normal work (includes both outside the home and housework) relations with other people, sleep, and enjoyment of life: 0 no interference - 10 complete interference. Higher ZBPI score indicates a worse outcome. The mITT population included all randomised subjects who had taken at least 1 dose of study drug. Here, ‘n’ signifies the number of subjects analysed at a given timepoint in this endpoint
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    41
    38
    Units: score on a scale
    least squares mean (standard error)
        General Activity, Change at Week 6 (n= 29, 26)
    -0.52 ( 0.392 )
    -1.75 ( 0.417 )
        Mood, Change at Week 6 (n= 29, 26)
    -1.52 ( 0.407 )
    -2.36 ( 0.435 )
        Walking Ability, Change at Week 6 (n= 29, 26)
    -0.28 ( 0.373 )
    -0.72 ( 0.391 )
        Normal Work, Change at Week 6 (n= 29, 26)
    -0.61 ( 0.383 )
    -1.28 ( 0.397 )
        Relations With Other People (n= 29, 26)
    -0.89 ( 0.381 )
    -1.27 ( 0.400 )
        Relations with Sleep, Change at Week 6 (n= 29, 26)
    -1.61 ( 0.370 )
    -1.66 ( 0.382 )
        Enjoyment of Life, Change at Week 6 (n= 29, 26)
    -1.13 ( 0.405 )
    -1.93 ( 0.435 )
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    General Activity: The change from baseline to Week 6 in general activity was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    LX9211 v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.024
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 -0.17
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Mood: The change from baseline to Week 6 in mood was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.138
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.95
         upper limit
    		 0.27
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Walking Ability: The change from baseline to Week 6 in walking ability was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.397
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 0.58
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Normal Work: The change from baseline to Week 6 in normal work was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.192
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 0.34
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Relations With Other People: The change from baseline to Week 6 in relation with other people was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.463
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.41
         upper limit
    		 0.65
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Sleep: The change from baseline to Week 6 in relations with sleep was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.908
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 0.93
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Enjoyment of Life: The change from baseline to Week 6 in enjoyment of life was analysed using the MMRM model. The MMRM model included fixed effects of treatment, week, treatment-by-week interaction, the randomisation stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.158
    Method
    		 MMRM
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 0.31

    Secondary: Percentage of Subjects Discontinuing Treatment due to Lack of Efficacy Defined as Increase in ADPS from Baseline of ≥30% Based on Question 5 of the ZBPI

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    End point title
    		 Percentage of Subjects Discontinuing Treatment due to Lack of Efficacy Defined as Increase in ADPS from Baseline of ≥30% Based on Question 5 of the ZBPI
    End point description
    ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [5] - Data for the outcome measure was not analysed due to change in planned analyses.
    [6] - Data for the outcome measure was not analysed due to change in planned analyses.
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (PGIC) at Week 6

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    End point title
    		 Patient Global Impression of Change (PGIC) at Week 6
    End point description
    PGIC is assessed on a 7-point rating scale where 1= very much improved to 7 = very much worse. Higher scores indicate worse outcomes. The mITT population included all randomised subjects who had taken at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    36 [7]
    27 [8]
    Units: score on a scale
        least squares mean (standard error)
    3.06 ( 0.222 )
    2.65 ( 0.265 )
    Notes
    [7] - Number of subjects analysed signifies subjects who were evaluable for this endpoint.
    [8] - Number of subjects analysed signifies subjects who were evaluable for this endpoint.
    Statistical analysis title
    		 Placebo Vs LX9211
    Statistical analysis description
    Analysis of variance (ANOVA) model was used with treatment and randomisation stratum of Baseline pain severity (moderate, severe) as independent variables.
    Comparison groups
    Placebo v LX9211
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.192
    Method
    		 ANOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 0.22

    Secondary: Time to Loss of Efficacy From Week 6 to Week 11 Among Subjects Achieving ≥30% Reduction in Pain Intensity in ADPS Based on Question 5 of the ZBPI.

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    End point title
    		 Time to Loss of Efficacy From Week 6 to Week 11 Among Subjects Achieving ≥30% Reduction in Pain Intensity in ADPS Based on Question 5 of the ZBPI.
    End point description
    ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
    End point type
    Secondary
    End point timeframe
    Week 6 to Week 11
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [9] - Data for the outcome measure was not analysed due to change in planned analyses.
    [10] - Data for the outcome measure was not analysed due to change in planned analyses.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
    End point description
    Adverse Events (AEs) are defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in subjects administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs reported after the first dose of double-blind study medication on study Day 1. The safety population included those subjects who took at least 1 dose of study drug during the Double-blind Treatment period.
    End point type
    Secondary
    End point timeframe
    From informed consent to the end of safety follow-up (up to 15 weeks)
    End point values
    		 Placebo LX9211
    Number of subjects analysed
    41
    38
    Units: subjects
        number (not applicable)
    13
    24
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to the end of safety follow-up (up to 15 weeks)
    Adverse event reporting additional description
    The data is reported for subjects in the Double-blind Treatment Period and Single-blind Placebo Safety Follow-up Treatment Period. The safety population included those subjects who took at least 1 dose of study drug during the Double-blind Treatment period. Adverse events reported occurred at a frequency >=5% in any treatment group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo (Double-blind Treatment Period)
    Reporting group description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.

    Reporting group title
    LX9211 (Double-blind Treatment Period)
    Reporting group description
    		 Following a 2-week Single-blind Placebo Run-in period, subjects received a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.

    Reporting group title
    Placebo (Single-blind Placebo Safety Follow-up Period)
    Reporting group description
    		 Following completion of the 6-week double-blind Treatment Period, all subjects entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of matching placebo to LX9211 tablet, orally.

    Reporting group title
    LX9211 (Single-blind Placebo Safety Follow-up Period)
    Reporting group description
    		 Following completion of the 6-week double-blind Treatment Period, all subjects entered the 5-week single-blind Placebo Safety Follow-up Period and received a daily dose of LX9211 tablet, orally.

    Serious adverse events
    		 Placebo (Double-blind Treatment Period) LX9211 (Double-blind Treatment Period) Placebo (Single-blind Placebo Safety Follow-up Period) LX9211 (Single-blind Placebo Safety Follow-up Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Double-blind Treatment Period) LX9211 (Double-blind Treatment Period) Placebo (Single-blind Placebo Safety Follow-up Period) LX9211 (Single-blind Placebo Safety Follow-up Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 41 (7.32%)
    21 / 38 (55.26%)
    2 / 38 (5.26%)
    1 / 31 (3.23%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 41 (4.88%)
    11 / 38 (28.95%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    2
    11
    0
    0
    Headache
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 38 (10.53%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Balance disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastrointestinal disorders
    Constipatiopn
         subjects affected / exposed
    0 / 41 (0.00%)
    4 / 38 (10.53%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Diarrhea
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 38 (7.89%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 38 (7.89%)
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences all number
    2
    3
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2020
    • EudraCT Number was provided as unique study reference for participating European Sites • Study Drug Administration: Run-in period Tables was removed as all patients during this time point were to be administered study placebo only • Futility assessment was not needed as interim efficacy analysis provided needed statistical data • Global protocol alignment with regard to patients being able to consume a light meal prior to study visits to ensure that patient’s weight was collected despite having had consumed food • Safety Physician contact information was updated as new person was performing this role • Appendix A: Clarification to table footer (i) to better outline which pregnancy test types (serum/urine) were collected during time points (Screening and Day 1 [Baseline]) • Appendix A: Clarification to table footer (k) performed to better outline the collection time points of Cp2hr, biomarker/target engagement, and cytokine and chemokine blood samples
    03 Mar 2021
    • To streamline brand and dose, only the acetaminophen provided by the Sponsor as a rescue medicine was to be used during the course of the study. It was noted that the use of personally acquired acetaminophen was prohibited. • To avoid confusion, the text in the protocol was globally aligned regarding the permitted time frame for brief use of opioid medication for the management of non-PHN acute pain prior to the Screening Visit. • Use of NSAIDs for the specific treatment of PHN pain was excluded. • The Sponsor was responsible for deciding if Verified Clinical Trials were established in specific countries. • The Safety Physician contact information was updated as new person performing this role.
    15 Oct 2021
    • Modified plans for interim analysis and their implications • The exclusion of patients with facial PHN were eligible for participation if trigeminal neuralgia was excluded as a cause • Changed the physical address of Lexicon Pharmaceuticals, Inc.

    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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