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A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163993
Recruitment Status : Completed
First Posted : June 16, 2014
Results First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Headache
Interventions Drug: Galcanezumab
Drug: Placebo
Enrollment 414
Recruitment Details Treatment period (0 to 12 weeks), Post-treatment period (12 to 24 weeks)
Pre-assignment Details  
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description Placebo given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period. 5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Period Title: Treatment Period
Started 138 68 68 71 69
Received at Least 1 Dose of Study Drug 137 68 68 70 67
Completed 126 59 66 62 62
Not Completed 12 9 2 9 7
Reason Not Completed
Adverse Event             0             1             0             0             1
Lost to Follow-up             2             3             1             3             1
Physician Decision             1             0             0             0             0
Protocol Violation             2             1             0             1             2
Withdrawal by Subject             6             4             1             4             1
Not treated             1             0             0             1             2
Period Title: Post-treatment Period
Started 125 [1] 61 [2] 66 63 [2] 65 [2]
Completed 121 55 62 61 62
Not Completed 4 6 4 2 3
Reason Not Completed
Adverse Event             0             0             1             0             0
Lost to Follow-up             2             2             3             1             0
Protocol Violation             0             0             0             0             1
Withdrawal by Subject             2             4             0             1             2
[1]
One participant discontinued after Treatment Period. Did not enter into Post-treatment Period.
[2]
Participants who discontinued or completed the Treatment Period entered the Post-treatment period.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab Total
Hide Arm/Group Description Placebo given as SQ injections once every 28 days during a 12 week treatment period. 5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period. 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. Total of all reporting groups
Overall Number of Baseline Participants 137 68 68 70 67 410
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 68 participants 68 participants 70 participants 67 participants 410 participants
39.54  (12.10) 41.40  (11.15) 39.63  (12.42) 40.57  (10.92) 40.79  (13.20) 40.24  (11.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 68 participants 68 participants 70 participants 67 participants 410 participants
Female 109 55 61 59 56 340
Male 28 13 7 11 11 70
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 68 participants 68 participants 70 participants 67 participants 410 participants
Hispanic or Latino 20 14 11 8 14 67
Not Hispanic or Latino 117 54 57 62 53 343
Unknown or Not Reported 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 68 participants 68 participants 70 participants 67 participants 410 participants
American Indian or Alaska Native 2 0 0 0 0 2
Asian 6 1 0 3 1 11
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0
Black or African American 14 16 9 23 13 75
White 106 49 57 43 52 307
More than one race 9 2 2 1 1 15
Unknown or Not Reported 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 137 participants 68 participants 68 participants 70 participants 67 participants 410 participants
137 68 68 70 67 410
Number of migraine headache days   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 137 participants 68 participants 68 participants 70 participants 67 participants 410 participants
6.64  (2.73) 6.68  (2.73) 6.41  (2.66) 6.95  (2.56) 6.73  (2.48) 6.68  (2.64)
[1]
Measure Description: Migraine Headache Day: A calendar day on which a migraine headache occurred.
Number of probable and migraine headache days   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 137 participants 68 participants 68 participants 70 participants 67 participants 410 participants
8.04  (3.08) 8.55  (3.23) 8.33  (3.21) 8.69  (3.46) 8.01  (2.79) 8.28  (3.15)
[1]
Measure Description: Probable Migraine Headache Day: A calendar day on which a probable migraine headache occurred.
1.Primary Outcome
Title Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Hide Description The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 134 65 68 69 66
Mean (Standard Deviation)
Unit of Measure: Days
-3.66  (0.28) -4.23  (0.37) -3.92  (0.36) -4.80  (0.37) -4.28  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 5mg Galcanezumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Bayesian Dose Response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.40 to 0.24
Parameter Dispersion
Type: Standard Deviation
Value: 0.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 50mg Galcanezumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Bayesian Dose Response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-1.06 to 0.56
Parameter Dispersion
Type: Standard Deviation
Value: 0.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 120mg Galcanezumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Bayesian Dose Response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -1.14
Confidence Interval (2-Sided) 95%
-2.02 to -0.29
Parameter Dispersion
Type: Standard Deviation
Value: 0.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 300mg Galcanezumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Bayesian Dose Response Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.50 to 0.27
Parameter Dispersion
Type: Standard Deviation
Value: 0.45
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase
Hide Description A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) mean was calculated using mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 134 65 68 69 66
Least Squares Mean (Standard Error)
Unit of Measure: Migraine attacks
-2.65  (0.17) -2.98  (0.23) -2.87  (0.22) -3.46  (0.23) -3.01  (0.23)
3.Secondary Outcome
Title Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Hide Description The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 134 65 68 69 66
Measure Type: Number
Unit of Measure: Percentage of participants
60.9 75.4 65.5 76.5 70.1
4.Secondary Outcome
Title Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase
Hide Description A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 134 65 68 69 66
Least Squares Mean (Standard Error)
Unit of Measure: Days
-2.51  (0.23) -3.27  (0.32) -2.58  (0.31) -3.59  (0.31) -3.15  (0.32)
5.Secondary Outcome
Title Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase
Hide Description Number of headache hours calculated as the total number of headache hours in a 28-day period on which a headache occurred. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 134 65 68 69 66
Least Squares Mean (Standard Error)
Unit of Measure: Hours
-16.56  (1.73) -20.15  (2.45) -19.38  (2.35) -22.29  (2.39) -24.45  (2.42)
6.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores
Hide Description MSQL consists of 14 questions across 3 dimensions (role function-restrictive, role function-preventive, and emotional function). All question values range from 1 to 6. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recorded before item scores were calculated. Then, dimension scores were calculated as the sum of the recorded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = [(dimension score-7)*100]/35, for the preventive function = [(dimension score-4)*100]/20, and for the emotional function = [(dimension score-3)*100]/15. A lower score indicated a poorer quality of life associated with that domain. LS means was determined by Analysis of covariance (ANCOVA) with treatment, pooled investigative site and baseline.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 133 63 67 63 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
21.08  (1.82) 27.53  (2.53) 25.35  (2.46) 30.23  (2.58) 27.49  (2.51)
7.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores
Hide Description The HIT-6 consists of 6 questions to measure the impact of headaches on the participants ability to function on the job, at school, at home and in social situations. A score to each question will be assigned as follows: never - 6, rarely - 8, sometimes - 10, very often - 11, and always - 13. The composite score is calculated as the sum of the scores for all 6 questions, the total score ranges between 36 and 78 with higher total scores reflecting more severe impact of headaches. LS means was determined by ANCOVA with treatment, pooled investigative site and baseline.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 133 63 67 63 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.26  (0.79) -9.26  (1.09) -8.46  (1.06) -9.95  (1.12) -8.27  (1.09)
8.Secondary Outcome
Title Serum Concentration of Galcanezumab
Hide Description Blood serum concentrations of galcanezumab.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for serum concentration of galcanezumab.
Arm/Group Title 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 59 66 62 63
Mean (Standard Deviation)
Unit of Measure: nanomoles per litre (nmol/L)
840  (602) 4650  (2430) 13200  (7060) 32100  (19100)
9.Secondary Outcome
Title Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Hide Description CGRP has been shown to be involved in the pathophysiology of migraine through dilation of cerebral and dural blood vessels, release of inflammatory mediators, and transmission of nociceptive (pain) information from intracranial blood vessels to the nervous system (Villalón and Olesen 2009). In migraineurs, serum concentrations of CGRP are significantly elevated during migraine attacks (Goadsby et al. 1990; Goadsby and Edvinsson 1993).
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for CGRP plasma concentration.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 14 55 63 61 63
Mean (Standard Deviation)
Unit of Measure: nanomoles per litre (nmol/L)
0.1810  (0.1030) 0.4750  (0.3940) 1.5700  (0.7010) 2.8000  (1.2200) 3.8300  (1.3100)
10.Secondary Outcome
Title Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab
Hide Description The percent of participants with treatment emergent Anti-drug Antibodies (ADA) were assessed at week 1 to 12. A participant was considered to have treatment-emergent Galcanezumab ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as any of the following: A negative baseline ADA result and a subsequent positive post-baseline ADA result with a titer >=20; or a positive ADA results and a subsequent positive post-baseline ADA results with a 4-fold or greater increase in titer from the baseline measurement.
Time Frame Baseline through 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline ADA measures.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 136 65 66 68 65
Measure Type: Number
Unit of Measure: Percentage of participants
2.2 7.7 4.6 2.9 3.1
11.Secondary Outcome
Title Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Hide Description The 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.
Time Frame Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and with non-missing baseline and postbaseline C-SSRS assessment.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 136 66 67 68 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Suicidal Ideation 0 0 0 0 1.52
Suicidal Behavior 0 0 0 0 0
12.Secondary Outcome
Title Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Hide Description Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-3 beta definition. It is defined as headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 134 65 68 69 66
Least Squares Mean (Standard Error)
Unit of Measure: Days
-2.47  (0.22) -2.81  (0.32) -2.57  (0.30) -3.11  (0.31) -3.37  (0.31)
13.Secondary Outcome
Title Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Hide Description Number of calendar days on which headache lasts ≥4 hrs it includes migraines, PM & non-migraines. MH is headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea &/or vomiting, or photophobia & phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. Severity was measured via interactive voice response system questionnaire "What was the worst headache pain? For mild press 1. For moderate 2. For severe press 3". LSmean was calculated using MMRM with treatment, pooled investigative site, period, treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title Placebo 5mg Galcanezumab 50mg Galcanezumab 120mg Galcanezumab 300mg Galcanezumab
Hide Arm/Group Description:
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Overall Number of Participants Analyzed 134 65 68 69 66
Least Squares Mean (Standard Error)
Unit of Measure: Days
-2.33  (0.20) -2.49  (0.28) -2.33  (0.27) -2.88  (0.28) -3.13  (0.28)
Time Frame Up To 24 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Treatment Phase 5mg Galcanezumab-Treatment Phase 50mg Galcanezumab-Treatment Phase 120mg Galcanezumab-Treatment Phase 300mg Galcanezumab-Treatment Phase Placebo - Post-Treatment Phase 5mg Galcanezumab-Post-Treatment Phase 50mg Galcanezumab-Post-Treatment Phase 120mg Galcanezumab-Post-Treatment Phase 300mg Galcanezumab-Post-Treatment Phase
Hide Arm/Group Description Placebo given as SQ injections once every 28 days during a 12 week treatment period. 5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. Placebo given as SQ injections once every 28 days during a 12 week treatment period. 5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
All-Cause Mortality
Placebo - Treatment Phase 5mg Galcanezumab-Treatment Phase 50mg Galcanezumab-Treatment Phase 120mg Galcanezumab-Treatment Phase 300mg Galcanezumab-Treatment Phase Placebo - Post-Treatment Phase 5mg Galcanezumab-Post-Treatment Phase 50mg Galcanezumab-Post-Treatment Phase 120mg Galcanezumab-Post-Treatment Phase 300mg Galcanezumab-Post-Treatment Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo - Treatment Phase 5mg Galcanezumab-Treatment Phase 50mg Galcanezumab-Treatment Phase 120mg Galcanezumab-Treatment Phase 300mg Galcanezumab-Treatment Phase Placebo - Post-Treatment Phase 5mg Galcanezumab-Post-Treatment Phase 50mg Galcanezumab-Post-Treatment Phase 120mg Galcanezumab-Post-Treatment Phase 300mg Galcanezumab-Post-Treatment Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/137 (0.00%)      0/68 (0.00%)      0/68 (0.00%)      1/70 (1.43%)      1/67 (1.49%)      0/125 (0.00%)      1/61 (1.64%)      0/66 (0.00%)      0/63 (0.00%)      1/65 (1.54%)    
Congenital, familial and genetic disorders                     
Ankyloglossia Congenital  1 [1]  0/137 (0.00%)  0 0/68 (0.00%)  0 0/68 (0.00%)  0 0/70 (0.00%)  0 1/67 (1.49%)  1 0/125 (0.00%)  0 0/61 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 0/65 (0.00%)  0
Gastrointestinal disorders                     
Crohn's disease  1  0/137 (0.00%)  0 0/68 (0.00%)  0 0/68 (0.00%)  0 0/70 (0.00%)  0 0/67 (0.00%)  0 0/125 (0.00%)  0 1/61 (1.64%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/65 (0.00%)  0
Infections and infestations                     
Appendicitis  1  0/137 (0.00%)  0 0/68 (0.00%)  0 0/68 (0.00%)  0 1/70 (1.43%)  1 0/67 (0.00%)  0 0/125 (0.00%)  0 0/61 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 0/65 (0.00%)  0
Psychiatric disorders                     
Suicidal Ideation  1  0/137 (0.00%)  0 0/68 (0.00%)  0 0/68 (0.00%)  0 0/70 (0.00%)  0 0/67 (0.00%)  0 0/125 (0.00%)  0 0/61 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 1/65 (1.54%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
[1]
Following database lock, an additional SAE, ankyloglossia congenital, in a male infant of a paternal pregnancy case, was reported in the Lilly Safety System database (the father was treated with the 300-mg dose of galcanezumab).
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Treatment Phase 5mg Galcanezumab-Treatment Phase 50mg Galcanezumab-Treatment Phase 120mg Galcanezumab-Treatment Phase 300mg Galcanezumab-Treatment Phase Placebo - Post-Treatment Phase 5mg Galcanezumab-Post-Treatment Phase 50mg Galcanezumab-Post-Treatment Phase 120mg Galcanezumab-Post-Treatment Phase 300mg Galcanezumab-Post-Treatment Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/137 (16.79%)      20/68 (29.41%)      18/68 (26.47%)      23/70 (32.86%)      19/67 (28.36%)      6/125 (4.80%)      2/61 (3.28%)      2/66 (3.03%)      2/63 (3.17%)      3/65 (4.62%)    
Gastrointestinal disorders                     
Nausea  1  4/137 (2.92%)  4 1/68 (1.47%)  2 2/68 (2.94%)  2 0/70 (0.00%)  0 4/67 (5.97%)  5 0/125 (0.00%)  0 1/61 (1.64%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/65 (0.00%)  0
General disorders                     
Injection site pain  1  4/137 (2.92%)  6 7/68 (10.29%)  11 6/68 (8.82%)  15 10/70 (14.29%)  13 9/67 (13.43%)  18 0/125 (0.00%)  0 0/61 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 0/65 (0.00%)  0
Infections and infestations                     
Nasopharyngitis  1  3/137 (2.19%)  3 8/68 (11.76%)  8 3/68 (4.41%)  3 6/70 (8.57%)  6 2/67 (2.99%)  2 1/125 (0.80%)  1 1/61 (1.64%)  1 1/66 (1.52%)  1 0/63 (0.00%)  0 0/65 (0.00%)  0
Upper respiratory tract infection  1  12/137 (8.76%)  15 7/68 (10.29%)  7 8/68 (11.76%)  8 8/70 (11.43%)  8 4/67 (5.97%)  4 4/125 (3.20%)  4 0/61 (0.00%)  0 1/66 (1.52%)  1 2/63 (3.17%)  2 2/65 (3.08%)  3
Reproductive system and breast disorders                     
Dysmenorrhoea  1  0/137 (0.00%)  0 1/68 (1.47%)  4 4/68 (5.88%)  4 0/70 (0.00%)  0 2/67 (2.99%)  2 1/125 (0.80%)  1 0/61 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 1/65 (1.54%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02163993    
Other Study ID Numbers: 15414
I5Q-MC-CGAB ( Other Identifier: Eli Lilly and Company )
First Submitted: June 12, 2014
First Posted: June 16, 2014
Results First Submitted: October 8, 2018
Results First Posted: November 23, 2018
Last Update Posted: November 23, 2018