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Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study (EVOLVE-2)

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: NCT02614196
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : January 7, 2019
Last Update Posted : June 17, 2020
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
Interventions Drug: Galcanezumab
Drug: Placebo
Enrollment 986
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg Placebo Maximum Extended Enrollment Cohort Galcanezumab 120mg Maximum Extended Enrollment Cohort Galcanezumab 240mg Maximum Extended Enrollment Cohort
Hide Arm/Group Description Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
Period Title: Double Blind Treatment Phase
Started 463 233 226 30 15 19
Received at Least One Dose of Study Drug 461 231 223 30 14 19
Completed 387 203 195 26 14 19
Not Completed 76 30 31 4 1 0
Reason Not Completed
Adverse Event             8             5             9             0             0             0
Lack of Efficacy             6             1             1             0             0             0
Lost to Follow-up             10             7             1             0             0             0
Physician Decision             4             0             2             0             0             0
Pregnancy             1             2             0             0             0             0
Protocol Violation             5             2             1             0             1             0
Terminated by sponsor             1             0             0             0             0             0
Withdrawal by Subject             39             11             14             4             0             0
Did not receive study drug             2             2             3             0             0             0
Period Title: Post Treatment Follow-up Phase
Started 410 [1] 213 [1] 207 [1] 25 [1] 15 [1] 19 [1]
Completed 390 208 199 24 13 19
Not Completed 20 5 8 1 2 0
Reason Not Completed
Lost to Follow-up             8             3             3             0             1             0
Pregnancy             2             0             0             0             0             0
Protocol Violation             0             1             0             0             1             0
Withdrawal by Subject             10             1             5             1             0             0
[1]
Participants who discontinued double blind phase had an option to enter post treatment phase
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg Placebo Maximum Extended Enrollment Cohort Galcanezumab 120mg Maximum Extended Enrollment Cohort Galcanezumab 240mg Maximum Extended Enrollment Cohort Total
Hide Arm/Group Description Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase. Total of all reporting groups
Overall Number of Baseline Participants 461 231 223 30 15 19 979
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug for non-ME2 arms & All randomized participants for ME2 arms.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 461 participants 231 participants 223 participants 30 participants 15 participants 19 participants 979 participants
42.33  (11.30) 40.91  (11.15) 41.91  (10.77) 45.37  (10.30) 39.40  (11.58) 42.58  (11.13) 41.95  (11.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 461 participants 231 participants 223 participants 30 participants 15 participants 19 participants 979 participants
Female 393 197 191 22 13 14 830
Male 68 34 32 8 2 5 149
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 461 participants 231 participants 223 participants 30 participants 15 participants 19 participants 979 participants
Hispanic or Latino 118 58 61 4 2 3 246
Not Hispanic or Latino 318 162 151 21 10 12 674
Unknown or Not Reported 25 11 11 5 3 4 59
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 461 participants 231 participants 223 participants 30 participants 15 participants 19 participants 979 participants
American Indian or Alaska Native 20 8 13 0 0 0 41
Asian 50 28 24 30 15 19 166
Native Hawaiian or Other Pacific Islander 0 0 2 0 0 0 2
Black or African American 36 11 16 0 0 0 63
White 325 166 152 0 0 0 643
More than one race 30 18 16 0 0 0 64
Unknown or Not Reported 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 461 participants 231 participants 223 participants 30 participants 15 participants 19 participants 979 participants
Argentina 22 12 10 0 0 0 44
South Korea 34 17 17 14 7 9 98
Netherlands 24 11 11 0 0 0 46
United States 224 112 110 0 0 0 446
Czechia 39 19 19 0 0 0 77
Taiwan 12 7 5 16 8 10 58
Mexico 36 18 17 0 0 0 71
United Kingdom 8 4 3 0 0 0 15
Israel 11 5 5 0 0 0 21
Germany 37 19 19 0 0 0 75
Spain 14 7 7 0 0 0 28
Migraine Headache Days (MHD) per month   [1] 
Mean (Standard Deviation)
Unit of measure:  Days per Month
Number Analyzed 461 participants 231 participants 223 participants 30 participants 15 participants 19 participants 979 participants
9.19  (2.99) 9.07  (2.87) 9.06  (2.92) 9.16  (2.98) 9.06  (2.86) 9.01  (2.90) 9.10  (2.93)
[1]
Measure Description: Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.
1.Primary Outcome
Title Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
Hide Description

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.

Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B):

A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia;

Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.

Time Frame Baseline, Month 1 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups

Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 450 226 220
Least Squares Mean (Standard Error)
Unit of Measure: Migraine Headache Days per Month
-2.28  (0.20) -4.29  (0.25) -4.18  (0.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.02
Confidence Interval (2-Sided) 95%
-2.55 to -1.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -1.90
Confidence Interval (2-Sided) 95%
-2.44 to -1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days
Hide Description

Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.

Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline.

Time Frame Baseline, Month 1 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 450 226 220
Mean (Standard Error)
Unit of Measure: percentage of participants
≥50% 36  (1.7) 59.3  (2.4) 56.5  (2.5)
≥75% 17.8  (1.3) 33.5  (2.3) 34.3  (2.3)
100% 5.7  (0.7) 11.5  (1.4) 13.8  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments Reduction from Baseline ≥50%
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.60
Confidence Interval (2-Sided) 95%
2.03 to 3.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments Reduction from Baseline ≥50%
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.31
Confidence Interval (2-Sided) 95%
1.81 to 2.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments Reduction from Baseline ≥75%
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.34
Confidence Interval (2-Sided) 95%
1.78 to 3.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments Reduction from Baseline ≥75%
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.42
Confidence Interval (2-Sided) 95%
1.84 to 3.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments Reduction from Baseline ≥100%
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.16
Confidence Interval (2-Sided) 95%
1.50 to 3.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments Reduction from Baseline ≥100%
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.67
Confidence Interval (2-Sided) 95%
1.87 to 3.81
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function Restrictive Domain
Hide Description

MSQ v2.1 was developed to address physical & emotional limitations of specific concern to individuals with migraine.

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 the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.

Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month & baseline MHD category as fixed factors.

Time Frame Baseline, Month 4 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo subcutaneously once a month for 6 months.
Participants received loading dose of 240mg galcanezumab followed by 120mg galcanezumab once a month for 5 months subcutaneously.
Participants received 240mg galcanezumab subcutaneously once a month for 6 months.
Overall Number of Participants Analyzed 443 226 219
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
19.65  (0.92) 28.47  (1.15) 27.04  (1.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 8.82
Confidence Interval (2-Sided) 95%
6.33 to 11.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 7.39
Confidence Interval (2-Sided) 95%
4.88 to 9.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.28
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
Hide Description

Migraine Headache Day (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 6 from MMRM model.LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.

Time Frame Baseline, Month 1 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline value.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 450 226 220
Least Squares Mean (Standard Error)
Unit of Measure: Days per Month
-1.85  (0.18) -3.67  (0.22) -3.63  (0.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -1.82
Confidence Interval (2-Sided) 95%
-2.29 to -1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -1.78
Confidence Interval (2-Sided) 95%
-2.25 to -1.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating
Hide Description The PGI-S scale is a participant-rated instrument that measures patients own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.
Time Frame Baseline, Month 4 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and post baseline value.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months subcutaneous injection.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 443 226 219
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.94  (0.07) -1.22  (0.08) -1.17  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.47 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.41 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Overall Mean Change From Baseline in Headache Hours
Hide Description Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.
Time Frame Baseline, Month 1 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Placebo Galcanezumab120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab followed by 120mg galcanezumab once a month for 5 months subcutaneously.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 450 226 220
Least Squares Mean (Standard Error)
Unit of Measure: Headache Hours per Month
-10.89  (1.92) -26.07  (2.41) -24.44  (2.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -15.19
Confidence Interval (2-Sided) 95%
-20.27 to -10.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -13.56
Confidence Interval (2-Sided) 95%
-18.67 to -8.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.60
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score
Hide 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.

LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.

Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Placebo Galcanezumab120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneous injection.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 409 216 215
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.02  (1.27) -21.17  (1.58) -20.24  (1.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -9.15
Confidence Interval (2-Sided) 95%
-12.61 to -5.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -8.22
Confidence Interval (2-Sided) 95%
-11.71 to -4.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.78
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab
Hide 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.
Time Frame Month 1 through Month 6
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Hide Analysis Population Description
All randomized participants who received at least one dose of study drug & had least one non-missing test result for ADA for each of the baseline period and the post-baseline period. As pre-specified in the analysis plan, outcome measures will not be reported for the ME2 arms/groups but only for the main global study arms/groups.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 443 222 214
Measure Type: Number
Unit of Measure: percentage of participants
0.45 8.56 5.14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments TE ADA Positive.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments TE ADA Positive
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Pharmacokinetics (PK): Serum Concentrations of Galcanezumab
Hide Description Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.
Time Frame Month 6
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Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had measurable serum concentrations.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneous injection.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 194 193
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
17400  (8820) 32200  (12600)
10.Secondary Outcome
Title Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Hide Description Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who had received at least one dose of study drug and had measurable plasma concentration.

As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection once a month for 6 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Number of Participants Analyzed 29 187 185
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.541  (1.11) 3.93  (1.83) 4.98  (1.60)
Time Frame Up to 10 Months
Adverse Event Reporting Description

There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 & 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment & equivalent ME2 arms for adverse event reporting.

Per protocol, AE analysis was planned per treatment regimen received.

 
Arm/Group Title Placebo - Treatment Phase Galcanezumab 120mg - Treatment Phase Galcanezumab 240mg - Treatment Phase Placebo - Post-treatment Phase Galcanezumab 120mg - Post-treatment Phase Galcanezumab 240mg - Post-treatment Phase Placebo - Treatment Phase ME2 Galcanezumab 120mg - Treatment Phase ME2 Galcanezumab 240mg - Treatment Phase ME2 Placebo - Post-treatment Phase ME2 Galcanezumab 120mg - Post-treatment Phase ME2 Galcanezumab 240mg - Post-treatment Phase ME2
Hide Arm/Group Description Participants received placebo subcutaneously once a month for 6 months. Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously. Participants received 240mg galcanezumab subcutaneously once a month for 6 months. Participants didn't receive any intervention. Participants didn't receive any intervention. Participants didn't receive any intervention. Participants received placebo subcutaneously once a month for 6 months. Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously. Participants received 240mg galcanezumab subcutaneously once a month for 6 months. Participants didn't receive any intervention. Participants didn't receive any intervention. Participants didn't receive any intervention.
All-Cause Mortality
Placebo - Treatment Phase Galcanezumab 120mg - Treatment Phase Galcanezumab 240mg - Treatment Phase Placebo - Post-treatment Phase Galcanezumab 120mg - Post-treatment Phase Galcanezumab 240mg - Post-treatment Phase Placebo - Treatment Phase ME2 Galcanezumab 120mg - Treatment Phase ME2 Galcanezumab 240mg - Treatment Phase ME2 Placebo - Post-treatment Phase ME2 Galcanezumab 120mg - Post-treatment Phase ME2 Galcanezumab 240mg - Post-treatment Phase ME2
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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/461 (0.00%)      0/226 (0.00%)      0/228 (0.00%)      0/410 (0.00%)      0/212 (0.00%)      0/208 (0.00%)      0/30 (0.00%)      0/14 (0.00%)      0/20 (0.00%)      0/25 (0.00%)      0/14 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
Placebo - Treatment Phase Galcanezumab 120mg - Treatment Phase Galcanezumab 240mg - Treatment Phase Placebo - Post-treatment Phase Galcanezumab 120mg - Post-treatment Phase Galcanezumab 240mg - Post-treatment Phase Placebo - Treatment Phase ME2 Galcanezumab 120mg - Treatment Phase ME2 Galcanezumab 240mg - Treatment Phase ME2 Placebo - Post-treatment Phase ME2 Galcanezumab 120mg - Post-treatment Phase ME2 Galcanezumab 240mg - Post-treatment Phase ME2
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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/461 (1.08%)      5/226 (2.21%)      7/228 (3.07%)      3/410 (0.73%)      1/212 (0.47%)      3/208 (1.44%)      1/30 (3.33%)      1/14 (7.14%)      0/20 (0.00%)      2/25 (8.00%)      0/14 (0.00%)      0/20 (0.00%)    
Cardiac disorders                         
Acute myocardial infarction  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Endocrine disorders                         
Goitre  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 1/410 (0.24%)  1 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders                         
Gastritis  1  0/461 (0.00%)  0 1/226 (0.44%)  1 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Haemorrhoids  1  1/461 (0.22%)  1 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Rectal polyp  1  0/461 (0.00%)  0 1/226 (0.44%)  1 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
General disorders                         
Pyrexia  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Hepatobiliary disorders                         
Cholecystitis acute  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 1/25 (4.00%)  1 0/14 (0.00%)  0 0/20 (0.00%)  0
Cholelithiasis  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Gallbladder polyp  1  1/461 (0.22%)  1 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations                         
Appendicitis  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 1/410 (0.24%)  1 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Influenza  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Pyelonephritis  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 1/410 (0.24%)  1 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Urosepsis  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 1/410 (0.24%)  1 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Injury, poisoning and procedural complications                         
Foot fracture  1  1/461 (0.22%)  1 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Meniscus injury  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Rib fracture  1  1/461 (0.22%)  1 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Road traffic accident  1  1/461 (0.22%)  1 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Arthralgia  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 1/30 (3.33%)  1 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Patellofemoral pain syndrome  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 1/208 (0.48%)  1 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
Adenocarcinoma of the cervix  1 [1]  0/393 (0.00%)  0 1/192 (0.52%)  1 0/196 (0.00%)  0 0/349 (0.00%)  0 0/179 (0.00%)  0 0/181 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 0/14 (0.00%)  0 0/18 (0.00%)  0 0/13 (0.00%)  0 0/14 (0.00%)  0
Uterine leiomyoma  1 [1]  0/393 (0.00%)  0 0/192 (0.00%)  0 0/196 (0.00%)  0 0/349 (0.00%)  0 1/179 (0.56%)  1 0/181 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 0/14 (0.00%)  0 0/18 (0.00%)  0 0/13 (0.00%)  0 0/14 (0.00%)  0
Nervous system disorders                         
Generalised tonic-clonic seizure  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Headache  1  0/461 (0.00%)  0 1/226 (0.44%)  1 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Migraine  1  1/461 (0.22%)  1 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 1/25 (4.00%)  1 0/14 (0.00%)  0 0/20 (0.00%)  0
Transient ischaemic attack  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders                         
Disorientation  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Panic attack  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 1/208 (0.48%)  1 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Post-traumatic stress disorder  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 1/208 (0.48%)  1 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Suicide attempt  1  1/461 (0.22%)  1 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Renal and urinary disorders                         
Bladder dysfunction  1  0/461 (0.00%)  0 1/226 (0.44%)  1 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Nasal septum deviation  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
[1]
All randomized female participants.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Treatment Phase Galcanezumab 120mg - Treatment Phase Galcanezumab 240mg - Treatment Phase Placebo - Post-treatment Phase Galcanezumab 120mg - Post-treatment Phase Galcanezumab 240mg - Post-treatment Phase Placebo - Treatment Phase ME2 Galcanezumab 120mg - Treatment Phase ME2 Galcanezumab 240mg - Treatment Phase ME2 Placebo - Post-treatment Phase ME2 Galcanezumab 120mg - Post-treatment Phase ME2 Galcanezumab 240mg - Post-treatment Phase ME2
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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   150/461 (32.54%)      78/226 (34.51%)      87/228 (38.16%)      40/410 (9.76%)      16/212 (7.55%)      13/208 (6.25%)      10/30 (33.33%)      9/14 (64.29%)      9/20 (45.00%)      3/25 (12.00%)      6/14 (42.86%)      0/20 (0.00%)    
Gastrointestinal disorders                         
Abdominal pain upper  1  3/461 (0.65%)  3 4/226 (1.77%)  5 3/228 (1.32%)  3 0/410 (0.00%)  0 0/212 (0.00%)  0 1/208 (0.48%)  2 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 1/25 (4.00%)  1 0/14 (0.00%)  0 0/20 (0.00%)  0
Nausea  1  15/461 (3.25%)  15 4/226 (1.77%)  4 3/228 (1.32%)  3 1/410 (0.24%)  1 0/212 (0.00%)  0 1/208 (0.48%)  1 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
Vomiting  1  4/461 (0.87%)  4 0/226 (0.00%)  0 2/228 (0.88%)  2 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
General disorders                         
Injection site pain  1  39/461 (8.46%)  142 21/226 (9.29%)  100 20/228 (8.77%)  61 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Injection site reaction  1  0/461 (0.00%)  0 7/226 (3.10%)  17 18/228 (7.89%)  25 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 3/20 (15.00%)  12 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations                         
Cystitis  1  5/461 (1.08%)  5 2/226 (0.88%)  2 2/228 (0.88%)  2 1/410 (0.24%)  1 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Hordeolum  1  2/461 (0.43%)  2 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Influenza  1  14/461 (3.04%)  16 3/226 (1.33%)  4 9/228 (3.95%)  9 5/410 (1.22%)  5 1/212 (0.47%)  1 1/208 (0.48%)  1 2/30 (6.67%)  2 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Nasopharyngitis  1  41/461 (8.89%)  49 19/226 (8.41%)  23 16/228 (7.02%)  21 18/410 (4.39%)  19 5/212 (2.36%)  5 4/208 (1.92%)  5 1/30 (3.33%)  1 2/14 (14.29%)  2 2/20 (10.00%)  3 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
Pharyngitis  1  1/461 (0.22%)  1 0/226 (0.00%)  0 1/228 (0.44%)  1 2/410 (0.49%)  2 1/212 (0.47%)  1 1/208 (0.48%)  1 2/30 (6.67%)  2 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Rhinitis  1  4/461 (0.87%)  4 2/226 (0.88%)  2 1/228 (0.44%)  2 0/410 (0.00%)  0 1/212 (0.47%)  1 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 1/25 (4.00%)  1 0/14 (0.00%)  0 0/20 (0.00%)  0
Upper respiratory tract infection  1  16/461 (3.47%)  19 13/226 (5.75%)  14 12/228 (5.26%)  12 3/410 (0.73%)  4 4/212 (1.89%)  5 2/208 (0.96%)  2 2/30 (6.67%)  2 3/14 (21.43%)  4 1/20 (5.00%)  1 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
Vaginal infection  1 [1]  0/393 (0.00%)  0 2/192 (1.04%)  2 1/196 (0.51%)  1 2/349 (0.57%)  2 0/179 (0.00%)  0 0/181 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 1/14 (7.14%)  1 0/18 (0.00%)  0 0/13 (0.00%)  0 0/14 (0.00%)  0
Vulvovaginitis  1 [1]  1/393 (0.25%)  1 0/192 (0.00%)  0 0/196 (0.00%)  0 0/349 (0.00%)  0 0/179 (0.00%)  0 0/181 (0.00%)  0 0/22 (0.00%)  0 0/13 (0.00%)  0 1/14 (7.14%)  1 0/18 (0.00%)  0 0/13 (0.00%)  0 0/14 (0.00%)  0
Injury, poisoning and procedural complications                         
Contusion  1  3/461 (0.65%)  3 1/226 (0.44%)  1 2/228 (0.88%)  2 0/410 (0.00%)  0 0/212 (0.00%)  0 1/208 (0.48%)  1 0/30 (0.00%)  0 0/14 (0.00%)  0 2/20 (10.00%)  2 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Muscle strain  1  1/461 (0.22%)  1 1/226 (0.44%)  1 1/228 (0.44%)  1 1/410 (0.24%)  1 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Arthralgia  1  5/461 (1.08%)  5 4/226 (1.77%)  4 3/228 (1.32%)  3 1/410 (0.24%)  1 2/212 (0.94%)  2 0/208 (0.00%)  0 2/30 (6.67%)  2 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
Arthritis  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 1/208 (0.48%)  1 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Back pain  1  20/461 (4.34%)  24 2/226 (0.88%)  2 5/228 (2.19%)  5 4/410 (0.98%)  4 2/212 (0.94%)  2 1/208 (0.48%)  1 1/30 (3.33%)  1 2/14 (14.29%)  3 0/20 (0.00%)  0 1/25 (4.00%)  1 1/14 (7.14%)  1 0/20 (0.00%)  0
Foot deformity  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
Intervertebral disc disorder  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
Skin papilloma  1  0/461 (0.00%)  0 0/226 (0.00%)  0 0/228 (0.00%)  0 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders                         
Carpal tunnel syndrome  1  0/461 (0.00%)  0 0/226 (0.00%)  0 1/228 (0.44%)  1 1/410 (0.24%)  1 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Dizziness  1  10/461 (2.17%)  12 8/226 (3.54%)  10 7/228 (3.07%)  7 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 0/25 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0
Hypoaesthesia  1  2/461 (0.43%)  2 0/226 (0.00%)  0 2/228 (0.88%)  2 0/410 (0.00%)  0 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 0/20 (0.00%)  0 1/25 (4.00%)  1 0/14 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders                         
Insomnia  1  8/461 (1.74%)  9 3/226 (1.33%)  3 0/228 (0.00%)  0 3/410 (0.73%)  3 0/212 (0.00%)  0 0/208 (0.00%)  0 0/30 (0.00%)  0 1/14 (7.14%)  1 1/20 (5.00%)  1 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
Reproductive system and breast disorders                         
Vaginal discharge  1 [1]  0/393 (0.00%)  0 0/192 (0.00%)  0 0/196 (0.00%)  0 0/349 (0.00%)  0 1/179 (0.56%)  1 0/181 (0.00%)  0 0/22 (0.00%)  0 1/13 (7.69%)  2 0/14 (0.00%)  0 0/18 (0.00%)  0 0/13 (0.00%)  0 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Cough  1  9/461 (1.95%)  9 4/226 (1.77%)  4 3/228 (1.32%)  3 2/410 (0.49%)  2 0/212 (0.00%)  0 1/208 (0.48%)  1 2/30 (6.67%)  3 0/14 (0.00%)  0 1/20 (5.00%)  1 0/25 (0.00%)  0 0/14 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
[1]
All randomized female participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
EMail: ClinicalTrials.gov@lilly.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614196    
Other Study ID Numbers: 15768
I5Q-MC-CGAH ( Other Identifier: Eli Lilly and Company )
2015-001882-17 ( EudraCT Number )
First Submitted: November 23, 2015
First Posted: November 25, 2015
Results First Submitted: August 23, 2018
Results First Posted: January 7, 2019
Last Update Posted: June 17, 2020