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    Clinical Trial Results:
    A 15 WEEK, RANDOMIZED, DOUBLE BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, FLEXIBLE-DOSE, SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12-17 YEARS OLD) WITH FIBROMYALGIA

    Summary
    EudraCT number
    		 2010-019521-34
    Trial protocol
    		 CZ  
    Global end of trial date
    08 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    11 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A0081180
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01020474
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc
    Sponsor organisation address
    235 East 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    08 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of pregabalin (75-450 mg/day) compared with placebo in an adolescent fibromyalgia population.
    Protection of trial subjects
    The study was conducted in accordance with the protocol, legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (GCP) (International Conference on Harmonization [ICH] 1996), and the Declaration of Helsinki (World Medical Association 1996 and 2008). In addition, the study was conducted in accordance with applicable local regulatory requirements and laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 May 2010
    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
    Czech Republic: 4
    Country: Number of subjects enrolled
    India: 35
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United States: 67
    Worldwide total number of subjects
    107
    EEA total number of subjects
    4
    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)
    107
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 147 participants were screened, 107 participants were randomized to treatment. The 107 randomized participants were recruited in 4 countries at 23 study centers: United States (17 centers; 67 participants), India (4 centers; 35 participants), Czech Republic (1 center; 4 participants), and Taiwan (1 center; 1 participant).

    Pre-assignment
    Screening details
    		 This study consisted of 4 phases, screening (1 Week), dose optimization (3 Weeks), fixed dose (12 Weeks) and follow-up (1 Week).

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Participants were assigned a single subject identification number (SSID) which was obtained at the time of screening using the automated telerandomization system and retained throughout the study. Qualified participants were randomized in a 1:1 ratio to receive either pregabalin or placebo according to a computer-generated pseudorandom code using the method of random permuted blocks.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pregabalin
    Arm description
    		 Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lyrica
    Investigational medicinal product code
    PD-144,723
    Other name
    Pregabalin
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin was administered BID 75 mg/day to 450 mg/day for 15 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo capsules were administered twice daily.

    Number of subjects in period 1
    		Pregabalin Placebo
    Started
    54
    53
    Completed
    44
    36
    Not completed
    10
    17
         Consent withdrawn by subject
    5
    7
         Adverse event, non-fatal
    4
    4
         Other Reasons
    1
    1
         Insufficient Clinical Response
    -
    3
         Protocol Violation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.

    Reporting group values
    		 Pregabalin Placebo Total
    Number of subjects
    		 54 53 107
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 54 53 107
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.6 ( 1.2 ) 14.7 ( 1.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 48 44 92
        Male
    		 6 9 15

    End points

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    End points reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.

    Primary: Change from Baseline to Week 15 in mean pain diary score

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    End point title
    		 Change from Baseline to Week 15 in mean pain diary score
    End point description
    The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The participants rate their pain during the past 24 hours by choosing the appropriate number between 0 (“no pain”) and 10 (“worst possible pain”).
    End point type
    Primary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    54
    51
    Units: participants
        least squares mean (standard error)
    -1.6 ( 0.32 )
    -0.94 ( 0.31 )
    Statistical analysis title
    		 Mean pain diary score from Baseline to Week 15
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.121 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.51
         upper limit
    		 0.18
    Notes
    [1] - Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.

    Secondary: Change from Baseline to Week 15 in mean sleep quality diary score

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    End point title
    		 Change from Baseline to Week 15 in mean sleep quality diary score
    End point description
    Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    54
    50
    Units: units on a scale
        least squares mean (standard error)
    -1.13 ( 0.3 )
    -0.94 ( 0.31 )
    Statistical analysis title
    		 Mean sleep quality daily score in Week 15
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.655
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.63

    Secondary: Mean Change from Baseline to weekly mean pain score - daily pain numeric rating scale (NRS)

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    End point title
    		 Mean Change from Baseline to weekly mean pain score - daily pain numeric rating scale (NRS)
    End point description
    Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries are required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    54
    51
    Units: units on a scale
    least squares mean (standard error)
        Week 1 (N= 52, 49)
    -0.48 ( 0.25 )
    -0.41 ( 0.26 )
        Week 2 (N= 54, 47)
    -1.11 ( 0.25 )
    -0.48 ( 0.26 )
        Week 3 (N= 52, 44)
    -1.27 ( 0.25 )
    -0.45 ( 0.26 )
        Week 4 (N= 50, 46)
    -1.45 ( 0.25 )
    -0.55 ( 0.26 )
        Week 5 (N= 49, 44)
    -1.27 ( 0.25 )
    -0.59 ( 0.26 )
        Week 6 (N= 49, 44)
    -1.47 ( 0.25 )
    -0.51 ( 0.27 )
        Week 7 (N= 48, 42)
    -1.67 ( 0.25 )
    -0.77 ( 0.27 )
        Week 8 (N= 46, 44)
    -1.65 ( 0.25 )
    -0.59 ( 0.27 )
        Week 9 (N= 46, 42)
    -1.61 ( 0.26 )
    -0.66 ( 0.27 )
        Week 10 (N= 45, 40)
    -1.82 ( 0.26 )
    -0.85 ( 0.27 )
        Week 11 (N= 44, 38)
    -1.93 ( 0.26 )
    -1.07 ( 0.28 )
        Week 12 (N= 43, 34)
    -1.75 ( 0.26 )
    -0.78 ( 0.28 )
        Week 13 (N= 42, 33)
    -1.75 ( 0.27 )
    -1.01 ( 0.29 )
        Week 14 (N= 41, 34)
    -2.01 ( 0.27 )
    -1.11 ( 0.29 )
        Week 15 (N= 35, 33)
    -1.9 ( 0.28 )
    -1.16 ( 0.3 )
    Statistical analysis title
    		 Statistical analysis of Week 1.
    Comparison groups
    Placebo v Pregabalin
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.842
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 0.61
    Statistical analysis title
    		 Statistical analysis of Week 2.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.07
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.32
         upper limit
    		 0.05
    Statistical analysis title
    		 Statistical analysis of Week 3.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.019
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.51
         upper limit
    		 -0.14
    Statistical analysis title
    		 Statistical analysis of Week 4.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.011
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 -0.21
    Statistical analysis title
    		 Statistical analysis of Week 5.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.056
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.38
         upper limit
    		 0.02
    Statistical analysis title
    		 Statistical analysis of Week 6.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.008
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.66
         upper limit
    		 -0.26
    Statistical analysis title
    		 Statistical analysis of Week 7.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.013
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.19
    Statistical analysis title
    		 Statistical analysis of Week 8.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 -0.35
    Statistical analysis title
    		 Statistical analysis of Week 9.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.009
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 -0.24
    Statistical analysis title
    		 Statistical analysis of Week 10.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.008
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 -0.25
    Statistical analysis title
    		 Statistical analysis of Week 11.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.021
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 -0.13
    Statistical analysis title
    		 Statistical analysis of Week 12.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.01
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.71
         upper limit
    		 -0.23
    Statistical analysis title
    		 Statistical analysis of Week 13.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.051
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 0
    Statistical analysis title
    		 Statistical analysis of Week 14.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.02
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.66
         upper limit
    		 -0.14
    Statistical analysis title
    		 Statistical analysis of Week 15.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.06
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.51
         upper limit
    		 0.03

    Secondary: Mean change from Baseline to weekly mean sleep quality score (NRS)

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    End point title
    		 Mean change from Baseline to weekly mean sleep quality score (NRS)
    End point description
    Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    54
    51
    Units: units on a scale
    least squares mean (standard error)
        Week 1 (N= 52, 49)
    -0.52 ( 0.25 )
    -0.3 ( 0.26 )
        Week 2 (N= 54, 47)
    -0.84 ( 0.25 )
    -0.65 ( 0.26 )
        Week 3 (N= 52, 44)
    -0.89 ( 0.25 )
    -0.44 ( 0.26 )
        Week 4 (N= 50, 46)
    -1.03 ( 0.25 )
    -0.54 ( 0.26 )
        Week 5 (N= 49, 44)
    -0.99 ( 0.25 )
    -0.61 ( 0.27 )
        Week 6 (N= 49, 44)
    -1.18 ( 0.25 )
    -0.54 ( 0.27 )
        Week 7 (N= 48, 42)
    -1.3 ( 0.25 )
    -0.81 ( 0.27 )
        Week 8 (N= 46, 44)
    -1.43 ( 0.25 )
    -0.42 ( 0.27 )
        Week 9 (N= 46, 42)
    -1.38 ( 0.26 )
    -0.81 ( 0.27 )
        Week 10 (N= 45, 40)
    -1.43 ( 0.26 )
    -0.66 ( 0.27 )
        Week 11 (N= 44, 38)
    -1.39 ( 0.26 )
    -0.95 ( 0.28 )
        Week 12 (N= 43, 34)
    -1.38 ( 0.26 )
    -0.77 ( 0.28 )
        Week 13 (N= 42, 33)
    -1.34 ( 0.27 )
    -1 ( 0.29 )
        Week 14 (N= 41, 34)
    -1.36 ( 0.27 )
    -0.94 ( 0.29 )
        Week 15 (N= 35, 33)
    -1.25 ( 0.28 )
    -1.08 ( 0.3 )
    Statistical analysis title
    		 Statistical analysis of Week 1.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.54
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.47
    Statistical analysis title
    		 Statistical analysis of Week 2.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.593
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 0.5
    Statistical analysis title
    		 Statistical analysis of Week 3.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.206
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.13
         upper limit
    		 0.25
    Statistical analysis title
    		 Statistical analysis of Week 4.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.168
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 0.21
    Statistical analysis title
    		 Statistical analysis of Week 5.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.28
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.08
         upper limit
    		 0.32
    Statistical analysis title
    		 Statistical analysis of Week 6.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.075
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 0.06
    Statistical analysis title
    		 Statistical analysis of Week 7.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.168
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 0.21
    Statistical analysis title
    		 Statistical analysis of Week 8.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.006
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.73
         upper limit
    		 -0.3
    Statistical analysis title
    		 Statistical analysis of Week 9.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.12
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 0.15
    Statistical analysis title
    		 Statistical analysis of Week 10.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.037
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 -0.05
    Statistical analysis title
    		 Statistical analysis of Week 11.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.246
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.16
         upper limit
    		 0.3
    Statistical analysis title
    		 Statistical analysis of Week 12.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.105
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.36
         upper limit
    		 0.13
    Statistical analysis title
    		 Statistical analysis of Week 13.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.376
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.09
         upper limit
    		 0.41
    Statistical analysis title
    		 Statistical analysis of Week 14.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.285
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 0.35
    Statistical analysis title
    		 Statistical analysis of Week 15.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.663
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.61

    Secondary: Proportion of 30% pain responders in weekly mean pain score (NRS) at Week 15

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    End point title
    		 Proportion of 30% pain responders in weekly mean pain score (NRS) at Week 15
    End point description
    At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    54
    49
    Units: percentage of participants
        number (not applicable)
    42.6
    38.8
    Statistical analysis title
    		 Statistical analysis at Week 15
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.694
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 2.58

    Secondary: Proportion of 50% pain responders in weekly mean pain score (NRS) at Week 15

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    End point title
    		 Proportion of 50% pain responders in weekly mean pain score (NRS) at Week 15
    End point description
    At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    54
    49
    Units: percentage of participants
        number (not applicable)
    20.4
    10.2
    Statistical analysis title
    		 Statistical analysis at Week 15.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.162
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 7.02

    Secondary: Proportion of Patient Global Impression Change (PGIC) at Week 15

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    End point title
    		 Proportion of Patient Global Impression Change (PGIC) at Week 15
    End point description
    Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    49
    44
    Units: percentage of participants
    number (not applicable)
        Very much improved
    16.3
    2.3
        Much improved
    36.7
    27.3
        Minimally improved
    22.4
    27.3
        No change
    18.4
    38.6
        Minimally worse
    6.1
    2.3
        Much worse
    0
    2.3
        Very much worse
    0
    0
    Statistical analysis title
    		 Statistical analysis at Week 15.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.013 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.

    Secondary: Change from Baseline to Week 15 in mean pain numeric rating scale (1 week recall period)

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    End point title
    		 Change from Baseline to Week 15 in mean pain numeric rating scale (1 week recall period)
    End point description
    The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.
    End point type
    Secondary
    End point timeframe
    Week 15
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    54
    53
    Units: Units on a scale
        least squares mean (standard error)
    -1.64 ( 0.31 )
    -0.77 ( 0.3 )
    Statistical analysis title
    		 Statistical analysis for Week 15
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.037
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 -0.05

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
    Adverse event reporting additional description
    Participants are only counted once per treatment for each event.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.

    Serious adverse events
    		 Pregabalin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pregabalin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 54 (61.11%)
    27 / 53 (50.94%)
    Investigations
    Weight increased
         subjects affected / exposed
    9 / 54 (16.67%)
    0 / 53 (0.00%)
         occurrences all number
    10
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    5
    0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Dizziness
         subjects affected / exposed
    16 / 54 (29.63%)
    7 / 53 (13.21%)
         occurrences all number
    19
    7
    Headache
         subjects affected / exposed
    10 / 54 (18.52%)
    10 / 53 (18.87%)
         occurrences all number
    10
    18
    Migraine
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 53 (5.66%)
         occurrences all number
    3
    3
    Somnolence
         subjects affected / exposed
    5 / 54 (9.26%)
    2 / 53 (3.77%)
         occurrences all number
    6
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 54 (14.81%)
    4 / 53 (7.55%)
         occurrences all number
    12
    6
    Pyrexia
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 53 (5.66%)
         occurrences all number
    5
    3
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    Abdominal pain
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    Dry mouth
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    Nausea
         subjects affected / exposed
    12 / 54 (22.22%)
    5 / 53 (9.43%)
         occurrences all number
    14
    5
    Vomiting
         subjects affected / exposed
    3 / 54 (5.56%)
    4 / 53 (7.55%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 53 (7.55%)
         occurrences all number
    1
    4
    Nasal congestion
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    Oropharyngeal pain
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 53 (3.77%)
         occurrences all number
    4
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 53 (7.55%)
         occurrences all number
    1
    8
    Back pain
         subjects affected / exposed
    3 / 54 (5.56%)
    5 / 53 (9.43%)
         occurrences all number
    4
    6
    Neck pain
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    Pain in extremity
         subjects affected / exposed
    4 / 54 (7.41%)
    0 / 53 (0.00%)
         occurrences all number
    5
    0
    Infections and infestations
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    0
    4
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 54 (5.56%)
    4 / 53 (7.55%)
         occurrences all number
    3
    4
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    3
    1

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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