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    Clinical Trial Results:
    Randomized, Double-Blind, Placebo-controlled, Parallel Group, Multi-center Trial of Pregabalin as Adjunctive Therapy in Pediatric and Adult Subjects With Primary Generalized Tonic-clonic Seizures (PGTC) - PROTOCOL A0081105

    Summary
    EudraCT number
    		 2010-023263-18
    Trial protocol
    		 CZ   GB   HU   LT   NL   SK   AT   BG   ES   PL   EE   GR   BE   HR   DK   PT   DE  
    Global end of trial date
    20 Feb 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A0081105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01747915
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superior efficacy of pregabalin compared to placebo for treatment of PGTC seizures as measured by the 28 day seizure rate.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 Subjects were required to be taking 1-3 antiepileptic drugs (AEDs) to participate.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belarus: 1
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 6
    Country: Number of subjects enrolled
    Bulgaria: 32
    Country: Number of subjects enrolled
    China: 6
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    India: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Montenegro: 1
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    Romania: 3
    Country: Number of subjects enrolled
    Russian Federation: 33
    Country: Number of subjects enrolled
    Serbia: 3
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Turkey: 2
    Country: Number of subjects enrolled
    Ukraine: 68
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    219
    EEA total number of subjects
    82
    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)
    36
    Adolescents (12-17 years)
    34
    Adults (18-64 years)
    149
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted at multiple sites in 21 countries in 219 subjects between 03 April 2013 and 20 February 2019.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day
    Arm description
    		 Subjects aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Subjects aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day, orally twice daily in equally divided doses for 12 weeks.

    Arm title
    		 Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day
    Arm description
    		 Subjects aged < 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Subjects aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day, orally twice daily in equally divided doses for 12 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg subjects; in the form of capsule or liquid oral solution for >=30 kg subjects). Subjects aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching pregabalin orally twice daily for 12 weeks.

    Number of subjects in period 1
    		Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day Placebo
    Started
    75
    72
    72
    Completed
    60
    61
    66
    Not completed
    15
    11
    6
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    4
    4
    1
         Adverse event, non-fatal
    8
    5
    2
         Pregnancy
    -
    -
    1
         Unspecified
    1
    1
    1
         Lost to follow-up
    1
    -
    -
         Protocol deviation
    1
    -
    -
         Lack of efficacy
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day
    Reporting group description
    		 Subjects aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Subjects aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

    Reporting group title
    Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day
    Reporting group description
    		 Subjects aged < 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Subjects aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg subjects; in the form of capsule or liquid oral solution for >=30 kg subjects). Subjects aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.

    Reporting group values
    		 Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day Placebo Total
    Number of subjects
    		 75 72 72 219
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 13 12 11 36
        Adolescents (12-17 years)
    		 14 11 9 34
        Adults (18-64 years)
    		 48 49 52 149
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.0 ± 13.3 25.4 ± 12.7 26.2 ± 13.2 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 42 39 40 121
        Male
    		 33 33 32 98
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 8 8 6 22
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 67 64 65 196
        More than one race
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day
    Reporting group description
    		 Subjects aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Subjects aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

    Reporting group title
    Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day
    Reporting group description
    		 Subjects aged < 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Subjects aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg subjects; in the form of capsule or liquid oral solution for >=30 kg subjects). Subjects aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.

    Primary: Log-transformed 28-day Seizure Rate for all Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase

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    End point title
    		 Log-transformed 28-day Seizure Rate for all Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
    End point description
    All PGTC seizures experienced during treatment phase were recorded by the subjects or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {–} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all subjects to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1). Intent to treat (ITT) population included all randomized subjects who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.
    End point type
    Primary
    End point timeframe
    Day 1 up to Week 12
    End point values
    		 Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day Placebo
    Number of subjects analysed
    75
    72
    72
    Units: Seizure per 28 days
        least squares mean (standard error)
    1.17 ± 0.097
    1.13 ± 0.095
    1.14 ± 0.098
    Statistical analysis title
    		 Pregabalin 5 mg/kg/day vs Placebo
    Statistical analysis description
    Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.
    Comparison groups
    Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8121
    Method
    		 ANCOVA
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.088
    Statistical analysis title
    		 Pregabalin 10 mg/kg/day Vs Placebo
    Statistical analysis description
    Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.
    Comparison groups
    Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8889
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.088

    Secondary: Percentage of Subjects With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase

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    End point title
    		 Percentage of Subjects With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase
    End point description
    Percentage of subjects with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {–} number of missing diary days in treatment phase])*28. ITT population included all randomized subjects who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 12
    End point values
    		 Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day Placebo
    Number of subjects analysed
    75
    72
    72
    Units: percentage of subjects
        number (not applicable)
    41.3
    38.9
    41.7
    Statistical analysis title
    		 Pregabalin 5 mg/kg/day Vs Placebo
    Comparison groups
    Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7973 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.095
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.548
         upper limit
    		 2.186
    Notes
    [1] - P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.
    Statistical analysis title
    		 Pregabalin 10 mg/kg/day Vs Placebo
    Comparison groups
    Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8474 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.934
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.465
         upper limit
    		 1.877
    Notes
    [2] - P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to end of study (Week 13)
    Adverse event reporting additional description
    Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as non-serious in another subject or 1 subject may have experienced both serious and non-serious event during study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day
    Reporting group description
    		 Subjects aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Subjects aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

    Reporting group title
    Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day
    Reporting group description
    		 Subjects aged < 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Subjects aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg subjects; in the form of capsule or liquid oral solution for >=30 kg subjects). Subjects aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.

    Serious adverse events
    		 Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 72 (2.78%)
    3 / 72 (4.17%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    Nervous system disorders
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 72 (2.78%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden unexplained death in epilepsy
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Pregabalin 5 mg/kg/day or 7 mg/kg/day or 300 mg/day Pregabalin 10 mg/kg/day or 14 mg/kg/day or 600 mg/day Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 75 (52.00%)
    41 / 72 (56.94%)
    36 / 72 (50.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombosis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 75 (6.67%)
    3 / 72 (4.17%)
    3 / 72 (4.17%)
         occurrences all number
    7
    3
    3
    Influenza like illness
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    2 / 72 (2.78%)
         occurrences all number
    1
    0
    2
    Sluggishness
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Therapeutic response unexpected
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Cervical polyp
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Menstruation irregular
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    1
    1
    0
    Anxiety disorder
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Apathy
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Bradyphrenia
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 72 (2.78%)
    0 / 72 (0.00%)
         occurrences all number
    0
    2
    0
    Confusional state
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Enuresis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Epileptic psychosis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Irritability
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    0
    Mood swings
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    1
    0
    1
    Soliloquy
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Suicidal ideation
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Thinking abnormal
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    2
    0
    Platelet count increased
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 75 (1.33%)
    7 / 72 (9.72%)
    0 / 72 (0.00%)
         occurrences all number
    1
    8
    0
    Lymphocyte morphology abnormal
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Contusion
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    1
    2
    0
    Face injury
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 72 (2.78%)
    3 / 72 (4.17%)
         occurrences all number
    1
    2
    3
    Foot fracture
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Head injury
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Joint dislocation
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Periorbital haematoma
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Skin injury
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Soft tissue injury
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth fracture
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    13 / 75 (17.33%)
    12 / 72 (16.67%)
    5 / 72 (6.94%)
         occurrences all number
    13
    14
    5
    Disturbance in attention
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    1
    Dysgraphia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Epilepsy
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Head titubation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    7 / 75 (9.33%)
    11 / 72 (15.28%)
    12 / 72 (16.67%)
         occurrences all number
    23
    16
    22
    Hypoaesthesia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Hypokinesia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Memory impairment
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Myoclonic epilepsy
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    1
    2
    0
    Nystagmus
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Petit mal epilepsy
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Sedation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Seizure
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    1
    1
    0
    Somnolence
         subjects affected / exposed
    5 / 75 (6.67%)
    11 / 72 (15.28%)
    7 / 72 (9.72%)
         occurrences all number
    6
    12
    8
    Tremor
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 72 (2.78%)
    1 / 72 (1.39%)
         occurrences all number
    0
    2
    1
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Vertigo
         subjects affected / exposed
    3 / 75 (4.00%)
    2 / 72 (2.78%)
    1 / 72 (1.39%)
         occurrences all number
    4
    2
    1
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    1
    Eye disorder
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Eye irritation
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Eye pain
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    1
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Dental caries
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    1 / 72 (1.39%)
         occurrences all number
    1
    1
    1
    Dry mouth
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 72 (2.78%)
    1 / 72 (1.39%)
         occurrences all number
    2
    2
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    1 / 72 (1.39%)
         occurrences all number
    0
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Leukocyturia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    3
    0
    0
    Metatarsalgia
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    1
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Back Pain
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Helicobacter infection
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 72 (2.78%)
    1 / 72 (1.39%)
         occurrences all number
    1
    2
    1
    Otitis media acute
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 72 (2.78%)
    4 / 72 (5.56%)
         occurrences all number
    4
    2
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    2
    0
    0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Viral rhinitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 72 (0.00%)
         occurrences all number
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 72 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 72 (1.39%)
         occurrences all number
    0
    0
    1
    Increased appetite
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    3 / 72 (4.17%)
         occurrences all number
    0
    1
    3

    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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