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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

    Summary
    EudraCT number
    2015-004775-78
    Trial protocol
    LV   GB   CZ   SK   AT   ES   NL   BE   FR   RO   BG   LT   IT  
    Global end of trial date
    06 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Aug 2019
    First version publication date
    22 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1014802-203
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02935608
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Biogen
    Sponsor organisation address
    250 Binney Street, Cambridge, United States, 02142
    Public contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
    Scientific contact
    Biogen Study Medical Director, Biogen, clinicaltrials@biogen.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
    06 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with pain from lumbosacral radiculopathy (PLSR).
    Protection of trial subjects
    Written informed consent was obtained from each subject or subject’s legally authorized representative (e.g., parent or legal guardian), as applicable, prior to evaluations performed for eligibility. Subjects or the subject’s legally authorized representative were given adequate time to review the information in the informed consent/assent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Oct 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 108
    Country: Number of subjects enrolled
    Slovakia: 70
    Country: Number of subjects enrolled
    Czech Republic: 69
    Country: Number of subjects enrolled
    Serbia: 51
    Country: Number of subjects enrolled
    Georgia: 50
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Romania: 16
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Latvia: 13
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    424
    EEA total number of subjects
    323
    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)
    360
    From 65 to 84 years
    64
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted from 31 October 2016 to 06 Aug 2018 in Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Georgia, Italy, Latvia, Netherlands, Romania, Serbia, Slovakia, Spain, United Kingdom.

    Pre-assignment
    Screening details
    A total of 502 subjects were enrolled in the study and 425 were randomised. Of which, 424 subjects received study treatment and 383 subjects completed the study.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    All subjects received placebo tablets (matched to BIIB074) orally twice daily (BID), in placebo run-in period (14 days). Subjects randomized to placebo in the double-blind (DB) blind period received placebo tablets (matched to BIIB074) orally BID for up to 12 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to BIIB074 tablets taken orally BID for up to 12 weeks during the DB period.

    Arm title
    BIIB074 200 milligram (mg) BID
    Arm description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 200mg tablets orally BID for up to 12 weeks during the DB period.
    Arm type
    Experimental

    Investigational medicinal product name
    BIIB074
    Investigational medicinal product code
    Other name
    Vixotrigine
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BIIB074 200mg tablets orally BID for up to 12 weeks during the DB period.

    Arm title
    BIIB074 350 mg BID
    Arm description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 350mg tablets orally BID for up to 12 weeks during the DB period.
    Arm type
    Experimental

    Investigational medicinal product name
    BIIB074
    Investigational medicinal product code
    Other name
    Vixotrigine
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BIIB074 350mg tablets orally BID for up to 12 weeks during the DB period.

    Number of subjects in period 1
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Started
    142
    140
    142
    Completed
    127
    129
    127
    Not completed
    15
    11
    15
         Other
    4
    -
    1
         Adverse event
    1
    4
    3
         Investigator decision
    -
    -
    1
         Lost to follow-up
    -
    1
    -
         Consent withdrawn
    10
    6
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally twice daily (BID), in placebo run-in period (14 days). Subjects randomized to placebo in the double-blind (DB) blind period received placebo tablets (matched to BIIB074) orally BID for up to 12 weeks.

    Reporting group title
    BIIB074 200 milligram (mg) BID
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 200mg tablets orally BID for up to 12 weeks during the DB period.

    Reporting group title
    BIIB074 350 mg BID
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 350mg tablets orally BID for up to 12 weeks during the DB period.

    Reporting group values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID Total
    Number of subjects
    142 140 142 424
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    53.1 ( 11.16 ) 52.1 ( 10.65 ) 52.8 ( 9.58 ) -
    Gender Categorical
    Units: Subjects
        Female
    86 92 92 270
        Male
    56 48 50 154

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally twice daily (BID), in placebo run-in period (14 days). Subjects randomized to placebo in the double-blind (DB) blind period received placebo tablets (matched to BIIB074) orally BID for up to 12 weeks.

    Reporting group title
    BIIB074 200 milligram (mg) BID
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 200mg tablets orally BID for up to 12 weeks during the DB period.

    Reporting group title
    BIIB074 350 mg BID
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 350mg tablets orally BID for up to 12 weeks during the DB period.

    Primary: Change from Baseline to Double-Blind (DB) Week 12 in Weekly Average of Daily Neuropathic Pain Score

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    End point title
    Change from Baseline to Double-Blind (DB) Week 12 in Weekly Average of Daily Neuropathic Pain Score
    End point description
    The subjects rated their average neuropathic pain score scores over 24 hours using the 11-point pain intensity numerical rating scale (PI-NRS) where 0= No pain and 10= Pain as bad as you can imagine. A negative change from Baseline indicates an improvement. The primary analysis is based on the intent-to-treat (ITT) population which includes all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Primary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    139 [1]
    142
    Units: score on a scale
        least squares mean (standard error)
    -1.75 ( 0.181 )
    -1.50 ( 0.177 )
    -1.81 ( 0.176 )
    Notes
    [1] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.314
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.24
         upper limit
    0.74
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.797
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.55
         upper limit
    0.43

    Secondary: Percentage of Subjects with 50% Neuropathic Pain Reduction Response at DB Week 12

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    End point title
    Percentage of Subjects with 50% Neuropathic Pain Reduction Response at DB Week 12
    End point description
    Daily neuropathic pain score is used to capture the subject's average neuropathic pain scores and low back pain scores over 24 hours on 11-point pain intensity numerical rating scale (PI-NRS). Each item is rated on a scale where 0= No pain and 10= Pain as bad as you can imagine. The percentage of subjects with 50% pain reduction from baseline are tallied. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: percentage of subjects
        number (not applicable)
    22.5
    20.0
    20.4
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on logistic regression adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.525
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.46
         upper limit
    1.48
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on logistic regression adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.669
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    1.56

    Secondary: Percentage of Subjects with 30% Neuropathic Pain Reduction Response at DB Week 12

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    End point title
    Percentage of Subjects with 30% Neuropathic Pain Reduction Response at DB Week 12
    End point description
    Daily neuropathic pain score is used to capture the subject's average neuropathic pain scores and low back pain scores over 24 hours on 11-point pain intensity numerical rating scale (PI-NRS). Each item is rated on a scale where 0= No pain and 10= Pain as bad as you can imagine. The percentage of subjects with 30% pain reduction from baseline are tallied. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: percentage of subjects
        number (not applicable)
    40.1
    34.3
    33.8
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on logistic regression adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.248
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    1.23
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on logistic regression adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.277
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.47
         upper limit
    1.24

    Secondary: Change from Baseline in Weekly Average of the Daily Neuropathic Pain Score at Each Visit

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    End point title
    Change from Baseline in Weekly Average of the Daily Neuropathic Pain Score at Each Visit
    End point description
    Daily neuropathic pain score is used to capture the subject's average neuropathic pain scores and low back pain scores over 24 hours on 11-point pain intensity numerical rating scale (PI-NRS). Each item is rated on a scale where 0= No pain and 10= Pain as bad as you can imagine. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 1, DB Week 2, DB Week 3, DB Week 4, DB Week 5, DB Week 6, DB Week 7, DB Week 8, DB Week 9, DB Week 10, DB Week 11
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    139 [2]
    142
    Units: score on a scale
    least squares mean (standard error)
        Change at DB Week 1
    -0.30 ( 0.082 )
    -0.36 ( 0.083 )
    -0.42 ( 0.082 )
        Change at DB Week 2
    -0.48 ( 0.098 )
    -0.59 ( 0.099 )
    -0.64 ( 0.098 )
        Change at DB Week 3
    -0.77 ( 0.117 )
    -0.77 ( 0.117 )
    -0.93 ( 0.117 )
        Change at DB Week 4
    -0.97 ( 0.125 )
    -0.88 ( 0.125 )
    -1.09 ( 0.125 )
        Change at DB Week 5
    -1.16 ( 0.136 )
    -1.03 ( 0.136 )
    -1.40 ( 0.135 )
        Change at DB Week 6
    -1.25 ( 0.144 )
    -1.05 ( 0.144 )
    -1.53 ( 0.143 )
        Change at DB Week 7
    -1.42 ( 0.152 )
    -1.08 ( 0.151 )
    -1.59 ( 0.150 )
        Change at DB Week 8
    -1.50 ( 0.157 )
    -1.19 ( 0.157 )
    -1.69 ( 0.155 )
        Change at DB Week 9
    -1.64 ( 0.165 )
    -1.34 ( 0.162 )
    -1.75 ( 0.161 )
        Change at DB Week 10
    -1.62 ( 0.170 )
    -1.39 ( 0.166 )
    -1.78 ( 0.165 )
        Change at DB Week 11
    -1.66 ( 0.176 )
    -1.41 ( 0.172 )
    -1.77 ( 0.171 )
    Notes
    [2] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    DB Week 1: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 1: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.28
         upper limit
    0.18
    Statistical analysis title
    DB Week 1: Placebo v 350 mg BID
    Statistical analysis description
    DB Week 1: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.34
         upper limit
    0.11
    Statistical analysis title
    DB Week 2: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 2: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.38
         upper limit
    0.16
    Statistical analysis title
    DB Week 2: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 2: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.43
         upper limit
    0.11
    Statistical analysis title
    DB Week 3: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 3: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.33
         upper limit
    0.32
    Statistical analysis title
    DB Week 3: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 3: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.49
         upper limit
    0.16
    Statistical analysis title
    DB Week 4: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 4: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.26
         upper limit
    0.43
    Statistical analysis title
    DB Week 4: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 4: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.47
         upper limit
    0.22
    Statistical analysis title
    DB Week 5: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 5: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.25
         upper limit
    0.5
    Statistical analysis title
    DB Week 5: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 5: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.62
         upper limit
    0.13
    Statistical analysis title
    DB Week 6: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 6: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region(Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    0.6
    Statistical analysis title
    DB Week 6: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 6: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.68
         upper limit
    0.12
    Statistical analysis title
    DB Week 7: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 7: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region(Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.08
         upper limit
    0.76
    Statistical analysis title
    DB Week 7: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 7: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.58
         upper limit
    0.25
    Statistical analysis title
    DB Week 8: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 8: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.74
    Statistical analysis title
    DB Week 8: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 8: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.62
         upper limit
    0.24
    Statistical analysis title
    DB Week 9: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 9: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.14
         upper limit
    0.76
    Statistical analysis title
    DB Week 9: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 9: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.56
         upper limit
    0.34
    Statistical analysis title
    DB Week 10: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 10: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.22
         upper limit
    0.7
    Statistical analysis title
    DB Week 10: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 10: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.61
         upper limit
    0.31
    Statistical analysis title
    DB Week 11: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    DB Week 11: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.22
         upper limit
    0.72
    Statistical analysis title
    DB Week 11: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    DB Week 11: ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Least squares mean difference
    Point estimate
    -0.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.59
         upper limit
    0.37

    Secondary: Change from Baseline to DB Week 12 in Weekly Average of Daily Low Back Pain Score

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    End point title
    Change from Baseline to DB Week 12 in Weekly Average of Daily Low Back Pain Score
    End point description
    The subjects rated their average low back pain score scores over 24 hours using the 11-point pain intensity numerical rating scale (PI-NRS) where 0= No pain and 10= Pain as bad as you can imagine. A negative change from Baseline indicates an improvement. The analysis is based on the ITT population which includes all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    139 [3]
    142
    Units: score on a scale
        least squares mean (standard error)
    -0.94 ( 0.164 )
    -0.74 ( 0.162 )
    -1.03 ( 0.163 )
    Notes
    [3] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.695
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.55
         upper limit
    0.36
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.403
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.26
         upper limit
    0.65

    Secondary: Number of Subjects with Patient Global Impression of Change (PGIC) Responder at DB Week 12

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    End point title
    Number of Subjects with Patient Global Impression of Change (PGIC) Responder at DB Week 12
    End point description
    PGIC is a 7-point scale depicting a subject's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse). The data represented the number of subjects who had answered 'very much improved' or 'much improved' on the PGIC questionnaire. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: subjects
        number (not applicable)
    35
    30
    35
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on logistic regression adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.997
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.58
         upper limit
    1.72
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on logistic regression adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.434
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    1.41

    Secondary: Change from Baseline on the Oswestry Disability Index up to DB Week 12

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    End point title
    Change from Baseline on the Oswestry Disability Index up to DB Week 12
    End point description
    Disability at the day measured by Oswestry Disability index (ODI). Each of the ten items in the ODI has six statements from which subjects are requested to select one. This allows scoring from 0-5 for each item, where 0 represents no pain and 5 worst pain. A maximum score of 50 is possible. A negative change indicates no disability. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    135 [4]
    136 [5]
    135 [6]
    Units: score on a scale
        least squares mean (standard error)
    -6.85 ( 1.039 )
    -6.31 ( 1.020 )
    -6.24 ( 1.030 )
    Notes
    [4] - Number of subjects analysed is number of subjects with data available for analysis.
    [5] - Number of subjects analysed is number of subjects with data available for analysis.
    [6] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.711
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    3.38
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.68
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.26
         upper limit
    3.47

    Secondary: Change from Baseline in the Weekly Average of the Daily Sleep Interference Score up to DB Week 12

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    End point title
    Change from Baseline in the Weekly Average of the Daily Sleep Interference Score up to DB Week 12
    End point description
    Daily sleep interference score is assessed using electronic diaries using an 11-point numeric rating scale (NRS) ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). The sleep interference NRS is a tool sleep numerical rating scale how leg pain interfered with their sleep quality. A negative change indicates minimal or no interference in sleep. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    141 [7]
    138 [8]
    141 [9]
    Units: score on a scale
        least squares mean (standard error)
    -1.46 ( 0.173 )
    -1.27 ( 0.174 )
    -1.55 ( 0.176 )
    Notes
    [7] - Number of subjects analysed is number of subjects with data available for analysis.
    [8] - Number of subjects analysed is number of subjects with data available for analysis.
    [9] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.458
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    0.66
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.716
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.57
         upper limit
    0.39

    Secondary: Change from Baseline in the Brief Pain Inventory (BPI) –Interference index up to DB Week 12

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    End point title
    Change from Baseline in the Brief Pain Inventory (BPI) –Interference index up to DB Week 12
    End point description
    BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each activity is rated on a scale of 0 (does not interfere) to 10 (completely interferes). The BPI - Interference index was calculated as the mean of the seven interference scores. If more than 3 of the 7 scores are missing, then the BPI – Interference Index will be set to missing. A negative score indicates no interference. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    140 [10]
    137 [11]
    135 [12]
    Units: score on a scale
        least squares mean (standard error)
    -1.25 ( 0.147 )
    -1.19 ( 0.145 )
    -1.37 ( 0.145 )
    Notes
    [10] - Number of subjects analysed is number of subjects with data available for analysis.
    [11] - Number of subjects analysed is number of subjects with data available for analysis.
    [12] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.767
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.34
         upper limit
    0.46
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.545
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.53
         upper limit
    0.28

    Secondary: Change from Baseline in the BPI – Pain index to DB Week 12

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    End point title
    Change from Baseline in the BPI – Pain index to DB Week 12
    End point description
    BPI items 3-6 ask subjects to assess their pain at its “worst”, “least”, “average” and “right now”, respectively. Each item is rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The BPI – Pain Index is calculated as the mean of the scores from items 3-6, and is set to missing if any of items 3-6 are missing. A negative change indicates no pain. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    140 [13]
    137 [14]
    135 [15]
    Units: score on a scale
        least squares mean (standard error)
    -1.40 ( 0.146 )
    -1.43 ( 0.147 )
    -1.58 ( 0.148 )
    Notes
    [13] - Number of subjects analysed is number of subjects with data available for analysis.
    [14] - Number of subjects analysed is number of subjects with data available for analysis.
    [15] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.889
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.43
         upper limit
    0.37
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.399
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.58
         upper limit
    0.23

    Secondary: Change from Baseline on the EuroQoL 5-Dimension 5-Level (EQ- 5D-5L) Questionnaire Health Index to DB Week 12

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    End point title
    Change from Baseline on the EuroQoL 5-Dimension 5-Level (EQ- 5D-5L) Questionnaire Health Index to DB Week 12
    End point description
    The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate subject preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health on a visual analogue scale from 0 to 100 where 0 represents the “best health you can imagine” and 100 represents the “worst health you can imagine”. A positive change indicates worst health. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    135 [16]
    136 [17]
    135 [18]
    Units: score on a scale
        least squares mean (standard error)
    0.06 ( 0.009 )
    0.05 ( 0.010 )
    0.06 ( 0.010 )
    Notes
    [16] - Number of subjects analysed is number of subjects with data available for analysis.
    [17] - Number of subjects analysed is number of subjects with data available for analysis.
    [18] - Number of subjects analysed is number of subjects with data available for analysis.
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.542
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.03
         upper limit
    0.02
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.741
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.02
         upper limit
    0.03

    Secondary: Change from Baseline to DB Week 12 in the Short Form 36 (SF-36) Questionnaire

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    End point title
    Change from Baseline to DB Week 12 in the Short Form 36 (SF-36) Questionnaire
    End point description
    36-Item Short Form Health Survey (SF-36) Version 2 is a general health-related quality of life survey, with a 1-week recall period. It is composed of 36 items. These items are grouped into 8 scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, physical component score (PCS) and mental component score. All of the scales are scored 1-100, with higher scores indicating better health. The ITT population included all randomised subjects who took at least one dose of randomised study treatment. Here, "n" signifies the number of subjects with data available for analysis at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2), DB Week 12
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: score on a scale
    least squares mean (standard error)
        Physical Functioning (n=133,135,134)
    8.68 ( 1.472 )
    8.08 ( 1.459 )
    7.16 ( 1.468 )
        Role Physical (n=132,135,134)
    8.23 ( 1.536 )
    6.70 ( 1.521 )
    6.92 ( 1.522 )
        Bodily Pain (n=132,135,134)
    9.56 ( 1.355 )
    8.95 ( 1.341 )
    10.66 ( 1.345 )
        General Health (n=133,135,134)
    4.44 ( 1.209 )
    2.13 ( 1.200 )
    4.71 ( 1.203 )
        Vitality (n=132,135,134)
    5.52 ( 1.204 )
    5.34 ( 1.189 )
    5.19 ( 1.194 )
        Social Functioning (n=132,135,134)
    6.09 ( 1.670 )
    4.90 ( 1.652 )
    4.54 ( 1.656 )
        Role Emotional (n=132,135,134)
    6.43 ( 1.692 )
    4.48 ( 1.674 )
    2.78 ( 1.675 )
        Mental Health (n=132,135,134)
    4.53 ( 1.120 )
    3.28 ( 1.111 )
    4.02 ( 1.111 )
        Physical Component Score (n=132,135,134)
    3.43 ( 0.553 )
    3.09 ( 0.547 )
    3.51 ( 0.549 )
        Mental Component Score (n=132,135,134)
    2.17 ( 0.649 )
    1.59 ( 0.643 )
    1.30 ( 0.643 )
    Statistical analysis title
    Physical Functioning: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.772
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.67
         upper limit
    3.47
    Statistical analysis title
    Physical Functioning: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.463
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.62
         upper limit
    2.56
    Statistical analysis title
    Role Physical: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.482
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.79
         upper limit
    2.74
    Statistical analysis title
    Role Physical: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.546
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.56
         upper limit
    2.94
    Statistical analysis title
    Bodily Pain: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.749
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.36
         upper limit
    3.14
    Statistical analysis title
    Bodily Pain: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.562
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    1.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.64
         upper limit
    4.86
    Statistical analysis title
    General Health: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.177
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -2.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.66
         upper limit
    1.05
    Statistical analysis title
    General Health: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.874
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.08
         upper limit
    3.62
    Statistical analysis title
    Vitality: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.916
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.51
         upper limit
    3.15
    Statistical analysis title
    Vitality: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.847
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.66
         upper limit
    3.01
    Statistical analysis title
    Social Functioning: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.613
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.81
         upper limit
    3.43
    Statistical analysis title
    Social Functioning: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.51
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.17
         upper limit
    3.07
    Statistical analysis title
    Role Emotional: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.415
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.64
         upper limit
    2.74
    Statistical analysis title
    Role Emotional: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.126
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -3.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.33
         upper limit
    1.03
    Statistical analysis title
    Mental Health: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.429
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.37
         upper limit
    1.86
    Statistical analysis title
    Mental Health: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.747
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.61
         upper limit
    2.59
    Statistical analysis title
    PCS: Placebo v BIIB074 200 mg BID
    Statistical analysis description
    ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline SF-36 parameter.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.656
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -0.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.88
         upper limit
    1.18
    Statistical analysis title
    PCS: Placebo v BIIB074 350 mg BID
    Statistical analysis description
    ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline SF-36 parameter.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.924
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.46
         upper limit
    1.61
    Statistical analysis title
    Mental Component Score:Placebo v BIIB074 200mg BID
    Statistical analysis description
    ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline SF-36 parameter.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.527
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -0.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.38
         upper limit
    1.22
    Statistical analysis title
    Mental Component Score:Placebo v BIIB074 350mg BID
    Statistical analysis description
    ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs ongoing at randomization (yes/no), region (Eastern/Western Europe) and baseline SF-36 parameter.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.341
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -0.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.66
         upper limit
    0.92

    Secondary: Amount of Rescue Medication Used

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    End point title
    Amount of Rescue Medication Used
    End point description
    The amount of rescue medication used per day during the double-blind (DB) period will be calculated as the total dosage recorded divided by the total number of days with a recorded rescue medication use (including the days with a record of 0 tablet) during the DB period. The ITT population included all randomised subjects who took at least one dose of randomised study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2) up to Day 125
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: dosage/day
        least squares mean (standard error)
    377.37 ( 49.055 )
    447.54 ( 49.405 )
    356.33 ( 49.052 )
    Statistical analysis title
    Placebo v BIIB074 200 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 200 milligram (mg) BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.314
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    70.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -66.7
         upper limit
    207.04
    Statistical analysis title
    Placebo v BIIB074 350 mg BID
    Statistical analysis description
    Analysis was based on ANCOVA model adjusted for treatment, prior back surgery (yes/no), NSAIDs use at randomization (yes/no), region (Eastern/Western Europe) and baseline neuropathic pain score.
    Comparison groups
    Placebo v BIIB074 350 mg BID
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.762
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -21.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -157.42
         upper limit
    115.32

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in subjects who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious. The safety population included all subjects who were randomised and received at least 1 dose of study treatment in the double-blind period.
    End point type
    Secondary
    End point timeframe
    AEs: Baseline (Week 2) up to Day 125; SAEs: Screening up to Day 125
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: subjects
    number (not applicable)
        AEs
    36
    34
    40
        SAEs
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Relevant Abnormalities in Vital Signs

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    End point title
    Number of Subjects With Clinically Relevant Abnormalities in Vital Signs
    End point description
    Abnormal vital signs were determined by the following criteria: temperature >38°C and an increase from pre-dose of at least 1°C; pulse >100 beat per minute (bpm) and an increase from baseline of more than 20 bpm, or <50 bpm and a decrease from baseline of more than 20 bpm; systolic blood pressure >160 mmHg and an increase from baseline of more than 40 mmHg, or <90 mmHg and a decrease from baseline of more than 30 mmHg; diastolic blood pressure >100 mmHg and an increase from pre-dose of more than 30 mmHg, or <45 mmHg and a decrease from pre-dose of more than 20 mmHg; respiration rate >25 breaths per minute, or <10 breaths per minute. The safety population included all subjects who were randomised and received at least 1 dose of study treatment in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 125
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: subjects
    number (not applicable)
        Temperature
    0
    0
    0
        Pulse
    0
    1
    1
        Systolic blood pressure
    0
    0
    0
        Diastolic blood pressure
    0
    0
    0
        Respiration Rate
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormal Significant 12-Lead Electrocardiogram (ECG) Values

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    End point title
    Number of Subjects with Abnormal Significant 12-Lead Electrocardiogram (ECG) Values
    End point description
    The safety population included all subjects who were randomised and received at least 1 dose of study treatment in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2) up to Day 125
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: subjects
        number (not applicable)
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Laboratory Test Abnormalities

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    End point title
    Number of Subjects with Clinically Significant Laboratory Test Abnormalities
    End point description
    The safety population included all subjects who were randomised and received at least 1 dose of study treatment in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 2) up to Day 125
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    140
    142
    Units: subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score

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    End point title
    Percentage of Subjects with Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score
    End point description
    The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. C-SSRS data are collected at each clinic visit. Suicidal ideation events include: (1) Wish to be dead, (2) Nonspecific active thoughts, (3) Active ideation: method, but no intent or plan, (4) Active ideation: method and intent, but no plan; (5) Active ideation: method, intent, and plan. Suicidal behaviour events include (6) actual attempt, (7) Interrupted attempt, (8) Aborted attempt, (9) Preparatory acts or behavior, (10) Suicide behavior, and (11) Suicide. All suicide-related events based on C-SSRS data will be listed only for subjects with YES response to any question. Here, SI/B = Suicidal ideation or behavior and b/w = between. The safety population included all subjects who were randomised and received at least 1 dose of study treatment in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Screening (=<28 days before Day 1) up to Day 125
    End point values
    Placebo BIIB074 200 milligram (mg) BID BIIB074 350 mg BID
    Number of subjects analysed
    142
    139 [19]
    139 [20]
    Units: percentage of subjects
    number (not applicable)
        Screening: SI/B
    2.8
    0.7
    2.2
        B/w screening&first randomized dose:SI/B
    1.4
    0
    0.7
        Randomization visit: SI/B
    2.1
    0
    0.7
        During the DB period: SI/B
    2.1
    0
    0.7
        Follow-up: SI/B
    0
    0
    0
    Notes
    [19] - Number of subjects analysed is number of subjects with data available for analysis.
    [20] - Number of subjects analysed is number of subjects with data available for analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 (Week 2) up to through the follow-up visit (Day 129)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    All subjects received placebo matched to BIIB074 tablets twice daily (BID), in placebo run-in period (14 days) and orally on Day 1 (Week 0); Day 15 (Week 2); Day 29 (Week 4); Day 43 (Week 6); and Day 71 (Week 10).

    Reporting group title
    BIIB074 350 mg
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 350mg tablets orally BID for up to 12 weeks.

    Reporting group title
    BIIB074 200 mg
    Reporting group description
    All subjects received placebo tablets (matched to BIIB074) orally BID in placebo run-in period (14 days). Subjects received BIIB074 200mg tablets orally BID for up to 12 weeks.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse event occurred in the 5% threshold in any of the reporting arms.
    Serious adverse events
    Placebo BIIB074 350 mg BIIB074 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 142 (0.70%)
    2 / 140 (1.43%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 142 (0.70%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    1 / 140 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 142 (0.00%)
    0 / 140 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo BIIB074 350 mg BIIB074 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 142 (0.00%)
    0 / 140 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2016
    • Clarification was added to clinic procedures and laboratory tests for safety assessments, eligibility criteria, prohibited medications, and treatment compliance, and to the timing of interim sample size re-estimation. • Information on serotonin syndrome was added, as requested by the Food and Drug Administration (FDA).
    28 Jul 2016
    • The maximum dose of paracetamol/acetaminophen in prolonged therapy was reduced from 3 g/day to 2.5 g/day and a restriction to the duration of prolonged therapy to no more than 5 out of 7 consecutive days was added; an associated exclusion and withdrawal criteria were also added. • The number of contraceptives to be used for highly effective contraception was reduced from 2 to 1 (thereafter stated as “effective contraception”). • Changes to the withdrawal criteria and inclusion and exclusion criteria were made to consolidate the protocol across different countries. • Changes were made to ensure any event of seizure was considered medically significant and, hence, reported as an SAE.
    05 May 2017
    • The nonclinical safety information included under “Profile of Previous Experience” was updated. • Alcohol and drug screen, study treatment administration, and drug accountability were added as assessments to the Unscheduled Visit. • The exclusion criteria were updated to exclude concomitant use of medications that are P-glycoprotein substrates with a narrow therapeutic index, prohibit the concomitant use of all cytochrome P450 3A4 and uridine 5'-diphosphoglucuronosyltransferase inducers and inhibitors, and allow the enrollment of individuals already receiving disability payments for PLSR. • Instructions were added for managing subjects who experienced a suspected treatment-induced rash. • An unblinded administrative interim analysis was added to enable planning of the Phase 3 program for PLSR.
    23 May 2017
    • A clarification was provided that the pregnancy of a female partner would not impact the study status of a male subject either at Screening or during his participation in the study. • The eligibility criteria were updated to clarify the definition of a positive test result for Hepatitis B at Screening.

    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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