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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Episodic Cluster Headache

    Summary
    EudraCT number
    		 2015-000149-22
    Trial protocol
    		 DE   GB   DK   BE   FI   ES   NL   GR  
    Global end of trial date
    04 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2019
    First version publication date
    30 Jun 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I5Q-MC-CGAL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02397473
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15780
    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
    04 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 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 efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headache.
    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
    22 May 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
    Greece: 3
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    United States: 34
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Italy: 20
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Spain: 13
    Worldwide total number of subjects
    106
    EEA total number of subjects
    70
    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)
    104
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects had screening/washout phase for minimum of 0 days to maximum of 12 months. Subjects who enter screening in an active cluster headache (CH) period & meet initial screening eligibility can move directly into baseline phase as long as they do not need to wash out of any excluded medications. Subjects who enter in remission remain in screening

    Pre-assignment
    Screening details
    		 until onset of their next CH period.Prospective baseline phase begins on the day that the Subject first records a CH attack in their electronic patient-reported outcome (ePRO) diary. Minimum duration is 10 days of daily ePRO diary recording prior to Visit 3, & the preferred maximum duration is 14 days of daily ePRO diary recording prior to visit 3.

    Period 1
    Period 1 title
    Treatment Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo once a month for 2 months by subcutaneous (SC) injection during treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered subcutaneously once a month for 2 months.

    Arm title
    		 Galcanezumab 300mg
    Arm description
    		 Participants received Galcanezumab 300mg once a month for two months by subcutaneous (SC) injection during treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab
    Investigational medicinal product code
    Other name
    LY2951742
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300mg Galcanezumab administered by subcutaneous injection once a month for 2 months.

    Number of subjects in period 1
    		Placebo Galcanezumab 300mg
    Started
    57
    49
    Received at least one dose of study drug
    57
    49
    Completed
    45
    45
    Not completed
    12
    4
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    2
         Lost to follow-up
    1
    -
         Lack of efficacy
    8
    1
    Period 2
    Period 2 title
    Post Treatment Follow-up Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    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 300mg
    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
    		Placebo Galcanezumab 300mg
    Started
    45
    45
    Completed
    47
    45
    Not completed
    3
    2
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    1
    -
         Lack of efficacy
    1
    1
         Protocol deviation
    1
    -
    Joined
    5
    2
         Discontinued treatment phase and joined
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once a month for 2 months by subcutaneous (SC) injection during treatment phase.

    Reporting group title
    Galcanezumab 300mg
    Reporting group description
    		 Participants received Galcanezumab 300mg once a month for two months by subcutaneous (SC) injection during treatment phase.

    Reporting group values
    		 Placebo Galcanezumab 300mg Total
    Number of subjects
    		 57 49 106
    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)
    		 45.40 ( 11.32 ) 47.49 ( 10.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 8 18
        Male
    		 47 41 88
    Lifetime suicidal ideation prior to screening
    Units: Subjects
        Lifetime suicidal ideation prior to screening
    		 5 9 14
        No Suicidal Ideation prior to screening
    		 52 40 92
    Lifetime suicidal behavior prior to screening
    Units: Subjects
        Lifetime suicidal behavior prior to screening
    		 0 1 1
        No suicidal behaviour prior to screening
    		 57 48 105
    Weekly Cluster Headache Attacks
    Units: Cluster Headache Attacks
        arithmetic mean (standard deviation)
    		 17.30 ( 10.05 ) 17.82 ( 10.12 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once a month for 2 months by subcutaneous (SC) injection during treatment phase.

    Reporting group title
    Galcanezumab 300mg
    Reporting group description
    		 Participants received Galcanezumab 300mg once a month for two months by subcutaneous (SC) injection during treatment phase.
    Reporting group title
    Placebo
    Reporting group description
    		 Participants did not receive any intervention during post treatment follow-up phase.

    Reporting group title
    Galcanezumab 300mg
    Reporting group description
    		 Participants did not receive any intervention during post treatment follow-up phase.

    Primary: Overall Mean Change from Baseline in Number of Weekly Cluster Headache Attacks

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    End point title
    		 Overall Mean Change from Baseline in Number of Weekly Cluster Headache Attacks
    End point description
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 3 from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects. Analysis Population Description (APD): All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
    End point type
    Primary
    End point timeframe
    Baseline, Week 1 through Week 3
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    57
    49
    Units: Cluster Headache Attacks per Week
        least squares mean (standard error)
    -5.22 ( 1.33 )
    -8.69 ( 1.42 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 300mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -3.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.72
         upper limit
    		 -0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.63

    Secondary: Percentage of Participants with 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks

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    End point title
    		 Percentage of Participants with 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
    End point description
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Percentage of participants with 50% or greater reduction from baseline at week 3 was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex and baseline value. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 3
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    57
    49
    Units: percentage of participants
        number (not applicable)
    52.63
    71.43
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Koch's nonparametric randomization-based ANCOVA.
    Comparison groups
    Galcanezumab 300mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.046
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks

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    End point title
    		 Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
    End point description
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 8 from MMRM analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week 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 measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 through Week 8
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    57
    49
    Units: Cluster Headache Attacks per Week
        least squares mean (standard error)
    -9.97 ( 0.95 )
    -10.80 ( 1.00 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 300mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.493
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.23
         upper limit
    		 1.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2

    Secondary: Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

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    End point title
    		 Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
    End point description
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects. APD:All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 4.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    49
    44
    Units: percentage of participants
        number (not applicable)
    46.4
    72.5
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 300mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.046
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.242
         upper limit
    		 7.469

    Secondary: Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

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    End point title
    		 Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
    End point description
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 8.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    40
    38
    Units: percentage of participants
        number (not applicable)
    66.1
    71.9
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 300mg v Placebo
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.575
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.312
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.502
         upper limit
    		 3.426

    Secondary: Percentage of Participants with 50% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks

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    End point title
    		 Percentage of Participants with 50% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks
    End point description
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures method with treatment, sex, week, treatment by week, and baseline 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 measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 through Week 8
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    57
    49
    Units: percentage of participants
        number (not applicable)
    70.4
    69.6
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 300mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.91
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.965
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.512
         upper limit
    		 1.819

    Secondary: Percentage of Participants with 30% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks

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    End point title
    		 Percentage of Participants with 30% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks
    End point description
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures with treatment, sex, week, treatment by week and baseline 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 measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 through Week 8
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    57
    49
    Units: percentage of participants
        number (not applicable)
    78.9
    77.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 300mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.841
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.929
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.449
         upper limit
    		 1.923

    Secondary: Pharmacokinetics (PK): Serum Concentration of Galcanezumab

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    End point title
    		 Pharmacokinetics (PK): Serum Concentration of Galcanezumab [1]
    End point description
    APD: All randomized participants who received at least one dose of study drug and had measurable PK samples.
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, Statistical analysis was not planned.
    End point values
    		 Galcanezumab 300mg
    Number of subjects analysed
    45
    Units: Nanogram per Milliliter (ng/mL)
        arithmetic mean (standard deviation)
    20200 ( 6880 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum Concentration of Galcanezumab

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    End point title
    		 Pharmacokinetics (PK): Serum Concentration of Galcanezumab [2]
    End point description
    APD: All randomized participants who received at least one dose of study drug and had measurable PK samples.
    End point type
    Secondary
    End point timeframe
    Week 8
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, Statistical analysis was not planned.
    End point values
    		 Galcanezumab 300mg
    Number of subjects analysed
    45
    Units: Nanogram per Milliliter (ng/mL)
        arithmetic mean (standard deviation)
    26400 ( 11200 )
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
    End point description
    Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject 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. APD: All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 8
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    53
    48
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
    End point description
    C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. APD:All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
    End point type
    Secondary
    End point timeframe
    Month 1 through Month 6
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    54
    49
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
    End point description
    C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. APD: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
    End point type
    Secondary
    End point timeframe
    Month 1 through Month 6
    End point values
    		 Placebo Galcanezumab 300mg
    Number of subjects analysed
    54
    49
    Units: percentage of participants
        number (not applicable)
    0
    0
    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
    I5Q-MC-CGAL
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo - Treatment Phase
    Reporting group description
    		 -

    Reporting group title
    Galcanezumab 300mg - Treatment Phase
    Reporting group description
    		 -

    Reporting group title
    Placebo - Post-treatment Phase
    Reporting group description
    		 -

    Reporting group title
    Galcanezumab 300mg - Post-treatment Phase
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo - Treatment Phase Galcanezumab 300mg - Treatment Phase Placebo - Post-treatment Phase Galcanezumab 300mg - Post-treatment Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 49 (0.00%)
    2 / 50 (4.00%)
    0 / 47 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    cluster headache
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
    0 / 47 (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
    Renal and urinary disorders
    nephrolithiasis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
    0 / 47 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo - Treatment Phase Galcanezumab 300mg - Treatment Phase Placebo - Post-treatment Phase Galcanezumab 300mg - Post-treatment Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 57 (7.02%)
    7 / 49 (14.29%)
    3 / 50 (6.00%)
    1 / 47 (2.13%)
    General disorders and administration site conditions
    injection site pain
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 49 (8.16%)
    0 / 50 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 49 (6.12%)
    3 / 50 (6.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    3
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2015
    Revised Inclusion Criteria 9 to allow oral triptans as an abortive medication to align with current clinical practice.
    10 Feb 2017
    Revised Exclusion Criterion 22e (Have any history of intracranial or carotid aneurysm, intracranial hemorrhage, or stroke.) and added Exclusion Criterion 23d (Patients with a history of an intracranial tumor or head trauma must be discussed and judged not to indicate a medical problem that would preclude study participation by Lilly Medical prior to enrollment.) because intracranial or carotid aneurysm, intracranial hemorrhage, and stroke are cardiovascular-related conditions, whereas intracranial tumor and significant head trauma are not cardiovascular related. Patients with either of the non-cardiovascular-related conditions mentioned here may be enrolled in the clinical trial if upon discussion with Lilly Medical it is judged not to indicate a medical problem that would preclude study participation. Revised exclusion criteria to allow patients who fail eligibility due to an elevation of ≥2X ULN for ALT, or ≥1.5X ULN TBL or ALP to be retested. Added a new rescreening allowance for Inclusion Criteria to allow patients who fail eligibility due to the occurrence of >8 cluster headache attacks per day to rescreen for the study during their current cluster headache period. Added a new rescreening allowance for Exclusion Criteria this change allows patients who fail eligibility due to a positive UDS to be rescreened during their current cluster headache period.
    18 Mar 2018
    Updated the primary endpoint to be the overall treatment effect across Weeks 1 to 3 in weekly cluster headache attack frequency rather than the treatment effect at a single time point (Week 3).

    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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