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    Clinical Trial Results:
    A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients with Migraine

    Summary
    EudraCT number
    		 2015-001884-38
    Trial protocol
    		 HU   BE   FR  
    Global end of trial date
    14 Aug 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    I5Q-MC-CGAJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02614287
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15770
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    14 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.
    Protection of trial subjects
    “This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.”
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2015
    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
    Belgium: 37
    Country: Number of subjects enrolled
    Canada: 25
    Country: Number of subjects enrolled
    Hungary: 47
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    United States: 133
    Worldwide total number of subjects
    270
    EEA total number of subjects
    112
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    270
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 At first visit subjects had undergone full clinical assessment, including a comprehensive medical evaluation documenting medical history, and a physical and neurological examination.

    Period 1
    Period 1 title
    Open label (OL) treatment phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Galcanezumab 120 mg
    Arm description
    		 Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe, Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection.

    Arm title
    		 Galcanezumab 240 mg
    Arm description
    		 Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector, Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 240 milligram (mg) galcanezumab once a month by subcutaneous injection.

    Number of subjects in period 1
    		Galcanezumab 120 mg Galcanezumab 240 mg
    Started
    135
    135
    Received at least one dose of study drug
    135
    135
    Completed
    97
    113
    Not completed
    38
    22
         Physician decision
    1
    -
         Consent withdrawn by subject
    10
    7
         Adverse event, non-fatal
    7
    6
         Lost to follow-up
    7
    4
         Lack of efficacy
    13
    5
    Period 2
    Period 2 title
    Post Treatment Follow-up Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Galcanezumab 120 mg
    Arm description
    		 Participants did not receive any intervention during post treatment follow-up phase.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Galcanezumab 240 mg
    Arm description
    		 Participants did not receive any intervention during post treatment follow-up phase.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Galcanezumab 120 mg Galcanezumab 240 mg
    Started
    97
    113
    Completed
    103
    119
    Not completed
    9
    5
         Consent withdrawn by subject
    6
    3
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    2
    2
    Joined
    15
    11
         Open Label Discontinued Subjects
    15
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Galcanezumab 120 mg
    Reporting group description
    		 Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase.

    Reporting group title
    Galcanezumab 240 mg
    Reporting group description
    		 Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase.

    Reporting group values
    		 Galcanezumab 120 mg Galcanezumab 240 mg Total
    Number of subjects
    		 135 135 270
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.21 ( 11.68 ) 43.69 ( 10.99 ) -
    Gender categorical
    Units: Subjects
        Female
    		 110 113 223
        Male
    		 25 22 47
    Sex: Female, Male
    Units: Subjects
        Female
    		 110 113 223
        Male
    		 25 22 47
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 12 20 32
        Not Hispanic or Latino
    		 115 108 223
        Unknown or Not Reported
    		 8 7 15
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 0 2
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 6 8 14
        White
    		 103 108 211
        More than one race
    		 23 19 42
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Galcanezumab 120 mg
    Reporting group description
    		 Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase.

    Reporting group title
    Galcanezumab 240 mg
    Reporting group description
    		 Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase.
    Reporting group title
    Galcanezumab 120 mg
    Reporting group description
    		 Participants did not receive any intervention during post treatment follow-up phase.

    Reporting group title
    Galcanezumab 240 mg
    Reporting group description
    		 Participants did not receive any intervention during post treatment follow-up phase.

    Primary: Percentage of Participants who Discontinued due to Adverse Event

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    End point title
    		 Percentage of Participants who Discontinued due to Adverse Event
    End point description
    Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section. Analysis Population Description (APD): All randomized participants who received at least one dose of study drug. There were 6 participants in the 120 mg group who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg group for AE analysis.
    End point type
    Primary
    End point timeframe
    Baseline through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    129
    135 [1]
    Units: Percentage of Participants
        number (not applicable)
    4.65
    4.96
    Notes
    [1] - N=141; 6 subjects in 120mg who received initial dose of 240mg & discontinued were moved to 240mg.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
    End point description
    Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab. Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    Baseline through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: NA
    Notes
    [2] - Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.
    [3] - Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Galcanezumab

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    End point title
    		 Serum Concentrations of Galcanezumab
    End point description
    Serum Concentrations of Galcanezumab. APD: All randomized participants with measurable serum concentrations at month 12.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    61
    78
    Units: Nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    16500 ( 8370 )
    31600 ( 15900 )
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

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    End point title
    		 Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
    End point description
    Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) APD: All randomized participants with measurable plasma concentration.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    87
    103
    Units: ng/mL
        arithmetic mean (standard deviation)
    2.74 ( 1.07 )
    3.85 ( 1.85 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab

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    End point title
    		 Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab
    End point description
    A Treatment Emergent Anti-drug Antibody (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA Present with titer >= 1: 20 (treatment-induced). There were 6 participants in the 120 mg group Open Label who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg group for safety analysis. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline evaluable data for TE ADA.
    End point type
    Secondary
    End point timeframe
    Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    129
    135 [4]
    Units: Percentage of Participants
        number (not applicable)
    12.40
    7.30
    Notes
    [4] - N=137; 6 subjects in 120mg who received initial dose of 240mg & discontinued were moved to 240mg.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Neutralizing Antibodies
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.215
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    TE ADA Positive (TE ADA+)
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.215
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Overall Mean Change from Baseline in the Number of Migraine Headache Days (MHD)

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    End point title
    		 Overall Mean Change from Baseline in the Number of Migraine Headache Days (MHD)
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 12 from MMRM model. Least squares mean (LSMean) was calculated using mixed model repeated measures (MMRM) model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    132
    135
    Units: Migraine Headache Days per Month
        least squares mean (standard error)
    -5.61 ( 0.34 )
    -6.47 ( 0.33 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.76
         upper limit
    		 0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.46

    Secondary: Overall Mean Change from Baseline in the Number of Headache Days

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    End point title
    		 Overall Mean Change from Baseline in the Number of Headache Days
    End point description
    Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline Value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    132
    135
    Units: Headache Days per Month
        least squares mean (standard error)
    -2.17 ( 0.30 )
    -2.09 ( 0.30 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.835
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 0.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.41

    Secondary: Percentage of Participants with Overall Reduction from Baseline ≥50% in Monthly Migraine Headache Days

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    End point title
    		 Percentage of Participants with Overall Reduction from Baseline ≥50% in Monthly Migraine Headache Days
    End point description
    Migraine Headache Day: A calendar day on which a migraine headache or probable migraine headache occurred. The overall percentage of patients with a given response rate were estimated from the GLIMMIX model. APD: All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    132
    135
    Units: percentage of Participants
        number (not applicable)
    65.6
    73.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.063
    Method
    		 CPLRM
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.467
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.979
         upper limit
    		 2.197

    Secondary: Overall Mean Change from Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches

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    End point title
    		 Overall Mean Change from Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches
    End point description
    Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    132
    135
    Units: Medication Used Days per Month
        least squares mean (standard error)
    -5.09 ( 0.38 )
    -5.05 ( 0.37 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.937
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 1.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51

    Secondary: Overall Mean Patient Global Impression-Improvement (PGI-I) Score

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    End point title
    		 Overall Mean Patient Global Impression-Improvement (PGI-I) Score
    End point description
    The Patient Global Impression of Improvement (PGI -I) scale is a participant-rated instrument that measures the participants own global impression of their symptom improvement. The participant was instructed as follows: “Mark the box that best describes your migraine headache condition since you started taking this medicine.” Response options were on a 7-point scale in which a score of 1 indicates that the participant's condition is "very much better," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse." Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline PGI-S, and baseline PGI-S by month as fixed effects.
    End point type
    Secondary
    End point timeframe
    Month 1 through Month 12 APD: All randomized participants who received at least one dose of study drug and had at least one post baseline value.
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    130
    135
    Units: units on a scale
        least squares mean (standard error)
    2.18 ( 0.08 )
    1.99 ( 0.08 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Secondary: Overall Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score

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    End point title
    		 Overall Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
    End point description
    The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    124
    130
    Units: units on a scale
        least squares mean (standard error)
    -33.58 ( 2.11 )
    -32.67 ( 2.04 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.747
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.65
         upper limit
    		 6.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.82

    Secondary: Overall Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1

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    End point title
    		 Overall Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1
    End point description
    MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical & emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all the items in that domain. After total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & positive change in scores reflecting functional improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 12 APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    130
    135
    Units: units on a scale
    least squares mean (standard error)
        Total Score
    28.27 ( 1.16 )
    30.25 ( 1.13 )
        Role Function-Restrictive Domain
    31.55 ( 1.20 )
    33.40 ( 1.16 )
        Role Function-Preventive Domain
    22.08 ( 1.11 )
    23.33 ( 1.08 )
        Emotional Function Domain
    28.92 ( 1.35 )
    32.01 ( 1.31 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Total Score
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.203
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 5.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.55
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Role Function-Restrictive Domain Score
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.247
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 4.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.59
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Role Function-Preventive Domain Score
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.399
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 4.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.49
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Emotional Function Domain Score
    Comparison groups
    Galcanezumab 120 mg v Galcanezumab 240 mg
    Number of subjects included in analysis
    265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.88
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    3.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 6.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8

    Secondary: Percentage of participant Visits with positive responses on Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M)

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    End point title
    		 Percentage of participant Visits with positive responses on Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M)
    End point description
    The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from “very unsatisfied” to “very satisfied” with the current treatment. Preference compares the current study medication to previous medications, with responses from “much rather prefer my previous medication” to “much rather prefer the medication administered to me during the study". APD: All randomized participants who received at least one dose of study drug and had month 12 PSMQ-M measurement.
    End point type
    Secondary
    End point timeframe
    Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    131
    133
    Units: percentage of Participants
    number (not applicable)
        Satisfaction: Very satisfied
    57.78
    58.04
        Satisfaction: Somewhat satisfied
    18.89
    15.18
        Preference: Much prefer study medication
    66.67
    63.39
        Preference: Prefer study medication
    22.22
    17.86
        Side effects: Much less side effects
    66.67
    50.89
        Side effects: Less side effects
    14.44
    30.36
    No statistical analyses for this end point

    Secondary: Number of Participants with Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12

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    End point title
    		 Number of Participants with Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12
    End point description
    The SQAAQ is a self-administered questionnaire that provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of study drug. Participants will respond to questionnaire items using a 7-point Likert scale (from “Strongly Disagree” to “Strongly Agree”) shortly after the injection. If a caregiver administers the injection, the participants should be prepared to provide the caregiver’s ratings of the questions.strongly agree & agree are considered as positive responses. APD: All randomized participants who switched from pre-filled syringe and received at least one dose of study drug by autoinjector.
    End point type
    Secondary
    End point timeframe
    Month 1 through Month 12
    End point values
    		 Galcanezumab 120 mg Galcanezumab 240 mg
    Number of subjects analysed
    84
    95
    Units: Number of participant visits
    number (not applicable)
        Pre-filled Syringe : Easy to learn how to use
    611
    688
        Pre-filled Syringe : Easy to hold in hand
    589
    660
        Pre-filled Syringe : Easy to inject my dose
    580
    659
        Pre-filled Syringe : Easy to know dose is complete
    615
    703
        Pre-filled Syringe: Easy to store device in fridge
    536
    630
        Pre-filled Syringe : Easy to remove needle shield
    610
    699
        Pre-filled Syringe : Easy to pickup
    610
    693
        Pre-filled Syringe : overall, easy to use
    600
    663
        Pre-filled Syringe:Dvc is stable against skin
    590
    652
        Pre-filled Syringe:Confident in ability to use
    580
    654
        Pre-filled Syringe : Confident my dose is complete
    618
    708
        Autoinjector : Easy to learn how to use
    250
    265
        Autoinjector : Easy to hold in hand
    247
    267
        Autoinjector : Easy to inject my dose
    245
    265
        Autoinjector : Easy to know dose is complete
    241
    261
        Autoinjector : Easy store device in fridge
    230
    256
        Autoinjector : Easy to remove needle shield
    250
    268
        Autoinjector : Easy to pickup
    251
    271
        Autoinjector : Overall, easy to use
    251
    262
        Autoinjector : Dvc is stable against skin
    244
    264
        Autoinjector : Confident in ability to use
    247
    260
        Autoinjector : Confident my dose is complete
    244
    263
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    All randomized participants. There were 6 participants in the 120 mg group Open Label who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg group for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Galcanezumab 120mg - Open-Label Phase
    Reporting group description
    		 -

    Reporting group title
    Galcanezumab 240mg - Open-Label Phase
    Reporting group description
    		 -

    Reporting group title
    Galcanezumab 120mg - Post-treatment Phase
    Reporting group description
    		 -

    Reporting group title
    Galcanezumab 240mg - Post-treatment Phase
    Reporting group description
    		 -

    Serious adverse events
    		 Galcanezumab 120mg - Open-Label Phase Galcanezumab 240mg - Open-Label Phase Galcanezumab 120mg - Post-treatment Phase Galcanezumab 240mg - Post-treatment Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 129 (2.33%)
    7 / 141 (4.96%)
    3 / 112 (2.68%)
    2 / 124 (1.61%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    lung neoplasm malignant
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 141 (0.00%)
    1 / 112 (0.89%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant melanoma
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 141 (0.00%)
    0 / 112 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 141 (0.00%)
    1 / 112 (0.89%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    uterine leiomyoma embolisation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed [1]
    0 / 104 (0.00%)
    1 / 119 (0.84%)
    0 / 91 (0.00%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    lumbar radiculopathy
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 141 (0.00%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    migraine
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 141 (0.00%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pineal gland cyst
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 141 (0.00%)
    0 / 112 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    non-cardiac chest pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 141 (0.71%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    diverticulum intestinal
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 141 (0.71%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    haemorrhagic ovarian cyst
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed [2]
    0 / 104 (0.00%)
    0 / 119 (0.00%)
    1 / 91 (1.10%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 141 (0.71%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 141 (0.71%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 141 (0.00%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain in extremity
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 141 (0.71%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    endocarditis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 141 (0.00%)
    1 / 112 (0.89%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infective aneurysm
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 141 (0.00%)
    1 / 112 (0.89%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 141 (0.71%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender based adverse event, analyzed in female subjects.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender based adverse event, analyzed in female subjects.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Galcanezumab 120mg - Open-Label Phase Galcanezumab 240mg - Open-Label Phase Galcanezumab 120mg - Post-treatment Phase Galcanezumab 240mg - Post-treatment Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 129 (58.91%)
    83 / 141 (58.87%)
    6 / 112 (5.36%)
    8 / 124 (6.45%)
    Investigations
    weight increased
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 129 (5.43%)
    4 / 141 (2.84%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    7
    4
    0
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    5 / 129 (3.88%)
    9 / 141 (6.38%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    7
    11
    0
    0
    General disorders and administration site conditions
    injection site bruising
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    5 / 129 (3.88%)
    8 / 141 (5.67%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    5
    10
    0
    0
    injection site erythema
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    9 / 129 (6.98%)
    9 / 141 (6.38%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    20
    19
    0
    0
    injection site pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    22 / 129 (17.05%)
    28 / 141 (19.86%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    148
    272
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    15 / 129 (11.63%)
    13 / 141 (9.22%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    48
    32
    0
    0
    Gastrointestinal disorders
    nausea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    10 / 129 (7.75%)
    9 / 141 (6.38%)
    1 / 112 (0.89%)
    0 / 124 (0.00%)
         occurrences all number
    11
    15
    1
    0
    Reproductive system and breast disorders
    prostatitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed [3]
    0 / 25 (0.00%)
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 129 (6.20%)
    8 / 141 (5.67%)
    1 / 112 (0.89%)
    1 / 124 (0.81%)
         occurrences all number
    12
    10
    1
    1
    back pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    12 / 129 (9.30%)
    15 / 141 (10.64%)
    2 / 112 (1.79%)
    3 / 124 (2.42%)
         occurrences all number
    15
    18
    2
    3
    myalgia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 129 (6.20%)
    3 / 141 (2.13%)
    1 / 112 (0.89%)
    0 / 124 (0.00%)
         occurrences all number
    9
    4
    1
    0
    Infections and infestations
    influenza
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 129 (6.20%)
    8 / 141 (5.67%)
    1 / 112 (0.89%)
    1 / 124 (0.81%)
         occurrences all number
    9
    8
    1
    1
    sinusitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    14 / 129 (10.85%)
    13 / 141 (9.22%)
    0 / 112 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    16
    17
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    9 / 129 (6.98%)
    21 / 141 (14.89%)
    0 / 112 (0.00%)
    1 / 124 (0.81%)
         occurrences all number
    10
    23
    0
    2
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    21 / 129 (16.28%)
    16 / 141 (11.35%)
    0 / 112 (0.00%)
    2 / 124 (1.61%)
         occurrences all number
    27
    19
    0
    2
    Notes
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender based adverse event, analyzed in male subjects.

    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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