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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of a Single Treatment of AGN-214868 in Patients With Postherpetic Neuralgia

    Summary
    EudraCT number
    2012-002240-24
    Trial protocol
    DE   AT   PL  
    Global end of trial date
    30 Sep 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Nov 2016
    First version publication date
    10 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    214868-007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01678924
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan plc
    Sponsor organisation address
    2525 Dupont Drive, Irvine, United States, 92623-9534
    Public contact
    Therapeutic Area Head, Allergan plc, +1 714-246-4500, clinicaltrials@allergan.com
    Scientific contact
    Allergan Ltd. EU Regulatory Affairs, Allergan Ltd., +44 1628494 444, ml-eu_reg_affairs@allergan.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
    22 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety, tolerability, and efficacy of AGN-214868 compared with placebo in the treatment of postherpetic neuralgia (PHN).
    Protection of trial subjects
    This trial had investigator meetings at the outset to review all protocol procedures and investigator responsibilities under Good Clinical Practice (GCP). At the meeting, the conduct of the trial was explained and instructions were provided to ensure accuracy and consistency in data collection. This trial was conducted in conformance with GCP standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Jan 2013
    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: 75
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Germany: 141
    Country: Number of subjects enrolled
    United States: 57
    Worldwide total number of subjects
    280
    EEA total number of subjects
    223
    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)
    102
    From 65 to 84 years
    178
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 2 sequential dose cohort study. Patients in cohort 1 were randomized (1:2:2 ratio) to receive a two treatment sessions of AGN 214868 (total dose of either 32.5 or 65 µg) or placebo. Cohort 2 patients randomized (1:1 ratio) to receive a single treatment session

    Pre-assignment
    Screening details
    Patients had to be male or female, 18 to 80 years of age at screening with persistent Postherpetic Neuralgia (PHN) with pain present for ≥ 9 months (36 weeks) after the onset of a herpes zoster skin rash affecting the cervical, thoracic, lumbar, or sacral dermatomes.

    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
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AGN 214868 130µg
    Arm description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1
    Arm type
    Experimental

    Investigational medicinal product name
    AGN 214868
    Investigational medicinal product code
    Other name
    Senrebotase
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    65 injections of 2.0 micrograms/0.1ml into the area of pain on Day 1, for a total dose of 130 micrograms.

    Arm title
    AGN 214868 65µg
    Arm description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1
    Arm type
    Experimental

    Investigational medicinal product name
    AGN 214868
    Investigational medicinal product code
    Other name
    Senrebotase
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    65 injections of 1.0 micrograms/0.1ml into the area of pain on Day 1 for a total dose of 65 micrograms

    Arm title
    AGN 214868 32.5µg
    Arm description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1
    Arm type
    Experimental

    Investigational medicinal product name
    AGN 214868
    Investigational medicinal product code
    Other name
    Senrebotase
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    65 injections of 0.5 micrograms/0.1ml into the area of pain on Day 1 for a total dose of 32.5 micrograms

    Arm title
    Placebo
    Arm description
    Single treatment session; placebo given as 65 injections into the area of pain on Day 1
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    65 injections of placebo/0.1ml into the area of pain on Day 1.

    Number of subjects in period 1
    AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
    Started
    64
    63
    30
    123
    Completed
    54
    51
    28
    105
    Not completed
    10
    12
    2
    18
         Consent withdrawn by subject
    -
    3
    -
    2
         Adverse event, non-fatal
    1
    1
    -
    1
         Unable to attend scheduled visits
    -
    -
    -
    1
         Personal Reasons
    2
    2
    2
    7
         Lost to follow-up
    -
    4
    -
    2
         Lack of efficacy
    7
    2
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AGN 214868 130µg
    Reporting group description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1

    Reporting group title
    AGN 214868 65µg
    Reporting group description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1

    Reporting group title
    AGN 214868 32.5µg
    Reporting group description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1

    Reporting group title
    Placebo
    Reporting group description
    Single treatment session; placebo given as 65 injections into the area of pain on Day 1

    Reporting group values
    AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo Total
    Number of subjects
    64 63 30 123 280
    Age categorical
    Units: Subjects
        Adults (18 to less than 40 years)
    1 3 1 0 5
        Adults (40 to less than 65 years)
    20 19 12 46 97
        Adults (65 years and over)
    43 41 17 77 178
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    66.6 ± 10.47 65.3 ± 12.82 65 ± 11.99 67 ± 8.13 -
    Gender categorical
    Units: Subjects
        Male
    37 34 13 50 134
        Female
    27 29 17 73 146
    Race and Ethnicity
    Units: Subjects
        Caucasian
    56 52 26 112 246
        Black
    3 4 1 7 15
        Asian
    0 2 2 1 5
        Hispanic
    5 4 1 2 12
        Other
    0 1 0 1 2
    Weight
    Units: Kilograms
        arithmetic mean (standard deviation)
    84.9 ± 19.15 82.3 ± 17.67 80 ± 14.48 78.8 ± 17.83 -
    Height
    Units: Centimeters
        arithmetic mean (standard deviation)
    169.8 ± 10.22 167.7 ± 10.98 169.1 ± 8.91 166.4 ± 9.07 -

    End points

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    End points reporting groups
    Reporting group title
    AGN 214868 130µg
    Reporting group description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1

    Reporting group title
    AGN 214868 65µg
    Reporting group description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1

    Reporting group title
    AGN 214868 32.5µg
    Reporting group description
    Single treatment session; total dose given as 65 injections into the area of pain on Day 1

    Reporting group title
    Placebo
    Reporting group description
    Single treatment session; placebo given as 65 injections into the area of pain on Day 1

    Subject analysis set title
    Intent to Treat population - Cohort 1
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 postbaseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population

    Subject analysis set title
    Intent to Treat population - Cohort 2
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 postbaseline weekly average pain intensity score. Cohort 2 includes 125 patients from the mITT population

    Primary: Change from Baseline in Average Pain Intensity Score - Cohort 1

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    End point title
    Change from Baseline in Average Pain Intensity Score - Cohort 1 [1]
    End point description
    The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient’s eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = “no pain” and 10 = “pain as bad as you can imagine” Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    63
    30
    123
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 1
    -0.88 (-1.249 to -0.538)
    -1.02 (-1.38 to -0.587)
    -1.11 (-1.425 to -0.808)
        Week 2
    -1.33 (-1.746 to -0.968)
    -1.56 (-1.963 to -1.017)
    -1.57 (-1.97 to -1.174)
        Week 3
    -1.66 (-2.143 to -1.203)
    -1.93 (-2.426 to -1.227)
    -1.84 (-2.248 to -1.388)
        Week 4
    -1.78 (-2.277 to -1.31)
    -2.2 (-2.721 to -1.432)
    -1.98 (-2.423 to -1.482)
        Week 5
    -1.83 (-2.321 to -1.384)
    -2.19 (-2.675 to -1.379)
    -2.1 (-2.557 to -1.554)
        Week 6
    -1.97 (-2.442 to -1.495)
    -2.07 (-2.597 to -1.297)
    -2.34 (-2.755 to -1.697)
        Week 7
    -2 (-2.481 to -1.506)
    -2.08 (-2.572 to -1.328)
    -2.32 (-2.746 to -1.673)
        Week 8
    -2.11 (-2.591 to -1.618)
    -2.02 (-2.53 to -1.263)
    -2.4 (-2.825 to -1.745)
        Week 9
    -2.21 (-2.66 to -1.701)
    -2.15 (-2.682 to -1.352)
    -2.52 (-2.805 to -1.733)
        Week 10
    -2.28 (-2.679 to -1.674)
    -2.29 (-2.812 to -1.481)
    -2.48 (-2.743 to -1.634)
        Week 11
    -2.27 (-2.684 to -1.672)
    -2.46 (-2.996 to -1.57)
    -2.56 (-2.807 to -1.724)
        Week 12
    -2.2 (-2.626 to -1.6)
    -2.53 (-3.061 to -1.605)
    -2.65 (-2.886 to -1.783)
    Statistical analysis title
    65ug vs. 32.5ug - Week 1
    Comparison groups
    AGN 214868 65µg v AGN 214868 32.5µg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.633 [2]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    0.14
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.343
         upper limit
    0.623
    Notes
    [2] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.
    Statistical analysis title
    65ug vs. Placebo - Week 1
    Comparison groups
    AGN 214868 65µg v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.307 [3]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    0.23
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.144
         upper limit
    0.613
    Notes
    [3] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.
    Statistical analysis title
    32.5ug vs. Placebo - Week 1
    Comparison groups
    AGN 214868 32.5µg v Placebo
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.744 [4]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.384
         upper limit
    0.574
    Notes
    [4] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.
    Statistical analysis title
    65ug vs. 32.5ug - week 12
    Comparison groups
    AGN 214868 65µg v AGN 214868 32.5µg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.495 [5]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    0.33
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.473
         upper limit
    1.139
    Notes
    [5] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.
    Statistical analysis title
    65ug vs. Placebo - week 12
    Comparison groups
    AGN 214868 65µg v Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.25 [6]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    0.45
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.196
         upper limit
    1.101
    Notes
    [6] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.
    Statistical analysis title
    32.5ug vs. Placebo - week 12
    Comparison groups
    AGN 214868 32.5µg v Placebo
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.806 [7]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.684
         upper limit
    0.922
    Notes
    [7] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.

    Primary: Change From Baseline in Average Pain Intensity Score - Cohort 2

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    End point title
    Change From Baseline in Average Pain Intensity Score - Cohort 2 [8]
    End point description
    The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient’s eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = “no pain” and 10 = “pain as bad as you can imagine” Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    64
    61
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 1
    -0.78 (-1.093 to -0.451)
    -0.88 (-1.19 to -0.492)
        Week 2
    -1.12 (-1.508 to -0.701)
    -1.37 (-1.791 to -0.799)
        Week 3
    -1.45 (-1.788 to -0.952)
    -1.65 (-2.064 to -1.057)
        Week 4
    -1.62 (-1.934 to -1.072)
    -1.9 (-2.344 to -1.269)
        Week 5
    -1.88 (-2.202 to -1.301)
    -1.88 (-2.366 to -1.257)
        Week 6
    -2.04 (-2.226 to -1.305)
    -1.9 (-2.339 to -1.235)
        Week 7
    -2.14 (-2.345 to -1.352)
    -1.9 (-2.352 to -1.225)
        Week 8
    -2.29 (-2.405 to -1.404)
    -1.96 (-2.412 to -1.27)
        Week 9
    -2.35 (-2.493 to -1.497)
    -2 (-2.457 to -1.293)
        Week 10
    -2.44 (-2.584 to -1.557)
    -2.04 (-2.515 to -1.311)
        Week 11
    -2.49 (-2.647 to -1.581)
    -2.03 (-2.489 to -1.314)
        Week 12
    -2.49 (-2.659 to -1.632)
    -2.03 (-2.538 to -1.354)
    Statistical analysis title
    130ug vs. Placebo - Week 1
    Comparison groups
    AGN 214868 130µg v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.683 [9]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.293
         upper limit
    0.485
    Notes
    [9] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.
    Statistical analysis title
    130ug vs. Placebo - Week 12
    Comparison groups
    AGN 214868 130µg v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.271 [10]
    Method
    Type 3 sum of squares
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.47
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.166
         upper limit
    0.233
    Notes
    [10] - Obtained from analysis of covariance model including treatment as fixed effect, and baseline maximal area of spontaneous pain and corresponding baseline average pain intensity score as covariates, with the type 3 sum of squares.

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 [11]
    End point description
    The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 postbaseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
    End point type
    Secondary
    End point timeframe
    Baseline to Week 1
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    61
    30
    61
    Units: percentage of patients
        number (not applicable)
    18
    33.3
    21.3
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 [12]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 postbaseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    63
    30
    60
    Units: percentage of patients
        number (not applicable)
    27
    40
    36.7
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 [13]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 3
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    60
    30
    60
    Units: percentage of patients
        number (not applicable)
    35
    50
    50
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 [14]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    61
    30
    57
    Units: percentage of patients
        number (not applicable)
    40
    53.3
    52.6
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 [15]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 5
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    59
    30
    57
    Units: percentage of patients
        number (not applicable)
    40.7
    53.3
    52.6
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 [16]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    58
    30
    55
    Units: percentage of patients
        number (not applicable)
    41.4
    50
    54.5
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 [17]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 7
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    60
    30
    57
    Units: percentage of patients
        number (not applicable)
    43.3
    56.7
    50.9
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 [18]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    58
    30
    56
    Units: percentage of patients
        number (not applicable)
    43.1
    50
    55.4
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9 [19]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 9
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    55
    27
    52
    Units: percentage of patients
        number (not applicable)
    43.6
    51.9
    51.9
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10

    Close Top of page
    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10 [20]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 10
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    56
    28
    52
    Units: percentage of patients
        number (not applicable)
    46.4
    53.6
    55.8
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11

    Close Top of page
    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11 [21]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 11
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    53
    28
    52
    Units: percentage of patients
        number (not applicable)
    47.2
    53.6
    59.6
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12

    Close Top of page
    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12 [22]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    50
    27
    49
    Units: percentage of patients
        number (not applicable)
    48
    63
    63.3
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1 [23]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 1
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    63
    59
    Units: percentage of patients
        number (not applicable)
    14.3
    20.3
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2

    Close Top of page
    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2 [24]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    62
    58
    Units: percentage of patients
        number (not applicable)
    25.8
    27.6
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3 [25]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 3
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    59
    58
    Units: percentage of patients
        number (not applicable)
    30.5
    39.7
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4 [26]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    60
    58
    Units: percentage of patients
        number (not applicable)
    35
    43.1
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 [27]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 5
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    57
    57
    Units: Baseline to Week 5
        number (not applicable)
    42.1
    45.6
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6 [28]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    Notes
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    53
    57
    Units: percentage of patients
        number (not applicable)
    45.3
    45.6
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7 [29]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 7
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    50
    56
    Units: percentage of patients
        number (not applicable)
    50
    48.2
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8 [30]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    51
    55
    Units: percentage of patients
        number (not applicable)
    54.9
    49.1
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9 [31]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 9
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    51
    55
    Units: percentage of patients
        number (not applicable)
    58.8
    45.5
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10 [32]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 10
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    51
    55
    Units: percentage of patients
        number (not applicable)
    64.7
    47.3
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11 [33]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 11
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    50
    54
    Units: percentage of patients
        number (not applicable)
    64
    42.6
    No statistical analyses for this end point

    Secondary: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12

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    End point title
    Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 [34]
    End point description
    Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    44
    50
    Units: percentage of patients
        number (not applicable)
    61.4
    40
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2 [35]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    61
    27
    60
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -25.07 (-37.544 to -13.564)
    -34.07 (-60.871 to -4.114)
    -26.1 (-38.58 to -14.053)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4 [36]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    62
    29
    60
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -27.65 (-40.978 to -15.412)
    -25.96 (-49.316 to 0.309)
    -32.23 (-48.543 to -16.214)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8 [37]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    56
    28
    55
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -29.86 (-45.876 to -15.566)
    -37.18 (-64.825 to -1.989)
    -34.04 (-48.026 to -22.134)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12 [38]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    57
    29
    54
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -30.99 (-46.118 to -17.138)
    -31.4 (-61.185 to 3.853)
    -35.03 (-53.242 to -18.425)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2 [39]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    Notes
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    57
    57
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -9.86 (-38.087 to 18.02)
    -27.52 (-43.841 to -10.854)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4 [40]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    58
    59
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -22.23 (-48.893 to 3.903)
    -25.67 (-42.901 to -7.909)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8 [41]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    53
    57
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -42.92 (-65.58 to -23.08)
    -31.95 (-47.299 to -13.978)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12

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    End point title
    Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12 [42]
    End point description
    The assessment of maximal area of spontaneous pain was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of pain were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    54
    57
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -36.73 (-67.719 to -8.696)
    -32.6 (-49.823 to -12.574)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 1 - Week 2

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 1 - Week 2 [43]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    Notes
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    61
    27
    60
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -40.06 (-89.75 to -12.158)
    -14.42 (-34.431 to 23.824)
    -52.73 (-67.258 to -24.248)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 1 - Week 4

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 1 - Week 4 [44]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    62
    29
    60
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -54.12 (-118.867 to -19.566)
    -23.07 (-41.985 to 19.468)
    -58.14 (-70.452 to -26.048)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 1 - Week 8

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 1 - Week 8 [45]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    56
    28
    55
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -74.46 (-136.541 to -43.526)
    -50.47 (-75.433 to -4.124)
    -71.54 (-85.155 to -37.104)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 1 - Week 12

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 1 - Week 12 [46]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    57
    29
    54
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -67.71 (-130.695 to -35.611)
    -39.96 (-62.646 to 8.446)
    -70.46 (-92.167 to -29.97)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 2 - Week 2

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 2 - Week 2 [47]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    57
    57
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -36.66 (-59.461 to -0.328)
    -60.71 (-98.564 to -36.369)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 2 - Week 4

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 2 - Week 4 [48]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    58
    59
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -54.33 (-72.041 to -13.677)
    -69.39 (-116.234 to -45.112)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 2 - Week 8

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 2 - Week 8 [49]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    53
    57
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -78.78 (-99.958 to -43.748)
    -75.58 (-113.401 to -50.634)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Area of Allodynia - Cohort 2 - Week 12

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    End point title
    Change From Baseline in Area of Allodynia - Cohort 2 - Week 12 [50]
    End point description
    The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Areas of allodynia were quantified at a central reading center.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    54
    57
    Units: Square Centimeters (cm2)
        least squares mean (confidence interval 95%)
    -77.98 (-99.148 to -36.515)
    -79.99 (-129.775 to -49.428)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2 [51]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    48
    21
    50
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -17.4 (-25.67 to -10.68)
    -21.2 (-30.01 to -10.09)
    -15.3 (-22.76 to -7.32)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 [52]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    50
    25
    51
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -21.9 (-29.67 to -15.57)
    -20.5 (-28.34 to -11.34)
    -12.3 (-19.02 to -5.01)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8 [53]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    51
    22
    49
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -22.7 (-31.18 to -15.8)
    -24.8 (-34.73 to -14.45)
    -19.4 (-27.27 to -10.15)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 [54]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 65µg AGN 214868 32.5µg Placebo
    Number of subjects analysed
    51
    23
    46
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -19.2 (-27.51 to -12.14)
    -21.6 (-33.46 to -9.41)
    -21.5 (-28.99 to -12.79)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2 [55]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    53
    55
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -19 (-26.102 to -11.03)
    -16.2 (-23.4 to -9.691)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4 [56]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    52
    55
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -20.6 (-27.941 to -10.867)
    -20.5 (-29.487 to -13.64)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8 [57]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    48
    52
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -28.7 (-35.924 to -21.285)
    -19.7 (-27.721 to -11.895)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12

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    End point title
    Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12 [58]
    End point description
    Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No Statistical Analysis is reported for this outcome measure
    End point values
    AGN 214868 130µg Placebo
    Number of subjects analysed
    47
    51
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -26.9 (-37.75 to -16.548)
    -19.1 (-26.996 to -10.612)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Event reporting occurred over a 6 month period from May to October of 2015
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    AGN 214868 130µg
    Reporting group description
    Single treatment session of AGN-214868, total dose given as injections into the area of pain on Day 1

    Reporting group title
    AGN 214868 65µg
    Reporting group description
    Single treatment session of AGN-214868, total dose given as injections into the area of pain on Day 1

    Reporting group title
    AGN 214868 32.5µg
    Reporting group description
    Single treatment session of AGN-214868, total dose given as injections into the area of pain on Day 1

    Reporting group title
    Placebo
    Reporting group description
    Single treatment session of AGN-214868 placebo, given as injections into the area of pain on Day 1

    Serious adverse events
    AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 64 (3.13%)
    8 / 63 (12.70%)
    2 / 30 (6.67%)
    10 / 123 (8.13%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    1 / 30 (3.33%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 30 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 30 (3.33%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    1 / 30 (3.33%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fractured sacrum
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral injury
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 30 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Thalamic infarction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 30 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
    0 / 30 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    Joint crepitation
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
    0 / 30 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 63 (0.00%)
    0 / 30 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 64 (59.38%)
    39 / 63 (61.90%)
    20 / 30 (66.67%)
    70 / 123 (56.91%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 63 (3.17%)
    3 / 30 (10.00%)
    2 / 123 (1.63%)
         occurrences all number
    1
    2
    3
    2
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    6 / 64 (9.38%)
    1 / 63 (1.59%)
    0 / 30 (0.00%)
    6 / 123 (4.88%)
         occurrences all number
    6
    1
    0
    6
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 64 (6.25%)
    5 / 63 (7.94%)
    1 / 30 (3.33%)
    8 / 123 (6.50%)
         occurrences all number
    4
    5
    1
    8
    Nasopharyngitis
         subjects affected / exposed
    3 / 64 (4.69%)
    5 / 63 (7.94%)
    2 / 30 (6.67%)
    9 / 123 (7.32%)
         occurrences all number
    3
    5
    2
    9
    Urinary tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 63 (3.17%)
    2 / 30 (6.67%)
    7 / 123 (5.69%)
         occurrences all number
    1
    2
    2
    7

    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
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