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A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine (CONQUER)

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: NCT03559257
Recruitment Status : Completed
First Posted : June 18, 2018
Results First Posted : July 8, 2020
Last Update Posted : July 8, 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 463
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo/Galcanezumab 120mg Galcanezumab 120mg
Hide Arm/Group Description Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period. Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period.
Period Title: Double Blind Treatment Period
Started 230 233
Received at Least One Dose of Study Drug 230 232
Completed 226 225
Not Completed 4 8
Reason Not Completed
Withdrawal by Subject             2             1
Protocol Violation             1             4
Lack of Efficacy             1             1
Adverse Event             0             1
Screen Failure             0             1
Period Title: Open-label Treatment Period
Started 225 [1] 224 [2]
Completed 215 217
Not Completed 10 7
Reason Not Completed
Adverse Event             1             4
Lack of Efficacy             3             2
Withdrawal by Subject             3             0
Protocol Violation             2             0
Lost to Follow-up             1             0
Physician Decision             0             1
[1]
One participant who completed double blind period has withdrawn from the study.
[2]
One participant who completed double blind period had discontinued due to adverse event.
Arm/Group Title Placebo/Galcanezumab 120mg Galcanezumab 120mg Total
Hide Arm/Group Description Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period. Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period. Total of all reporting groups
Overall Number of Baseline Participants 230 232 462
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 230 participants 232 participants 462 participants
45.67  (12.33) 45.87  (11.34) 45.77  (11.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 462 participants
Female 202 195 397
Male 28 37 65
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 462 participants
Hispanic or Latino 16 15 31
Not Hispanic or Latino 174 172 346
Unknown or Not Reported 40 45 85
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 462 participants
American Indian or Alaska Native 1 0 1
Asian 35 37 72
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 2 3 5
White 182 183 365
More than one race 3 0 3
Unknown or Not Reported 7 8 15
Monthly Migraine Headache Days  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 230 participants 232 participants 462 participants
13.01  (5.73) 13.44  (6.08) 13.23  (5.91)
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.

Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.

Time Frame Baseline, Month 1 through Month 3
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.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 228 230
Least Squares Mean (Standard Error)
Unit of Measure: Days
-1.02  (0.32) -4.14  (0.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -3.12
Confidence Interval (2-Sided) 95%
-3.92 to -2.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.41
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine
Hide Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.

Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 132 137
Least Squares Mean (Standard Error)
Unit of Measure: Days
-0.31  (0.34) -2.88  (0.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.57
Confidence Interval (2-Sided) 95%
-3.41 to -1.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.43
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
Hide Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.

Time Frame Baseline, Month 1 through Month 3
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.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 228 230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
13.3
(10.2 to 17.3)
37.7
(32.9 to 42.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method pseudo likelihood-based repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.935
Confidence Interval (2-Sided) 95%
2.719 to 5.693
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
Hide Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.

Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 132 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
17.1
(12.7 to 22.7)
41.8
(35.7 to 48.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pseudo likelihood-based repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.481
Confidence Interval (2-Sided) 95%
2.252 to 5.381
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Hide Description MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),& are reverse-recoded (value 6 to 1) before 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.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.

LS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.

Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 222 223
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
10.68  (1.34) 23.21  (1.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 12.53
Confidence Interval (2-Sided) 95%
9.19 to 15.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.70
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants With Episodic Migraine
Hide Description MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),& are reverse-recoded (value 6 to 1) before 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.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized episodic migraine participants who received at least one dose of study drug and had a post baseline value at Month 3. LS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 127 135
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
11.88  (1.80) 23.39  (1.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 11.51
Confidence Interval (2-Sided) 95%
7.14 to 15.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.22
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days
Hide Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.

Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 132 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
3.7
(1.6 to 8.2)
18.4
(13.9 to 23.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Pseudo likelihood-based repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.878
Confidence Interval (2-Sided) 95%
2.374 to 14.554
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days
Hide Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.

Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 132 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.00
(0.00 to 0.00)
7.7
(4.7 to 12.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pseudo likelihood-based repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 999.999
Confidence Interval (2-Sided) 95%
548.706 to 999.999
Estimation Comments Estimated value and upper bound are >999.999
9.Secondary Outcome
Title Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days
Hide Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.

Time Frame Baseline, Month 1 through Month 3
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.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 228 230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
3.3
(1.7 to 6.3)
14.5
(10.9 to 19.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method pseudo likelihood-based repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.012
Confidence Interval (2-Sided) 95%
2.352 to 10.679
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days
Hide Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.

Time Frame Baseline, Month 1 through Month 3
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.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 228 230
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.000
(0.000 to 0.000)
4.9
(2.8 to 8.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pseudo likelihood-based repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 999.99
Confidence Interval (2-Sided) 95%
999.99 to 999.99
Estimation Comments Point estimate, upper limit and lower limit are >999.99
11.Secondary Outcome
Title Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use
Hide Description Overall mean is derived from the average of months 1 to 3 from Mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
Time Frame Baseline, Month 1 through Month 3
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.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 228 230
Least Squares Mean (Standard Error)
Unit of Measure: Days
-0.80  (0.31) -4.19  (0.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -3.40
Confidence Interval (2-Sided) 95%
-4.14 to -2.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Overall Mean Change From Baseline in the Number of Monthly Headache Days
Hide Description

Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache).

Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.

Time Frame Baseline, Month 1 through Month 3
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.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 228 230
Least Squares Mean (Standard Error)
Unit of Measure: Days
-1.05  (0.36) -4.18  (0.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -3.13
Confidence Interval (2-Sided) 95%
-3.96 to -2.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments [Not Specified]
13.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 missed 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. LS mean was calculated using analysis of covariance (ANCOVA) with last observation carried forward (LOCF), with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 225 228
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-3.295  (3.2834) -21.097  (3.3164)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4)
Hide Description MIBS-4 is a self-administered scale that measures the burden related to headache in the time between attacks. The instrument consists of 4 items that address disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty. The questionnaire specifically asks about the effect of the disease over the past 4 weeks on days without a headache attack. Response options include: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each responses associated numerical score are summed across all 4 items resulting in a total score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none, 1-2 mild, 3-4 moderate, and >5 severe. LS mean was calculated using MMRM model with fixed effects of treatment, pooled country, baseline migraine frequency category, month, treatment by month as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 222 223
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.78  (0.21) -1.83  (0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-1.58 to -0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI)
Hide Description The WPAI Questionnaire is a patient-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores are calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores are calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 225 227
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Activity Impairment Number Analyzed 225 participants 227 participants
-8.644  (1.9195) -20.713  (1.9537)
Absenteeism Number Analyzed 145 participants 148 participants
-2.900  (1.2436) -4.224  (1.2929)
Presenteeism Number Analyzed 141 participants 147 participants
-2.564  (2.3222) -12.504  (2.3705)
Work Impairment Number Analyzed 145 participants 148 participants
-3.457  (2.4098) -14.307  (2.5148)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments Activity Impairment.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments Absenteeism.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3880
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments Presenteeism.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments Work impairment.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
16.Secondary Outcome
Title Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S)
Hide Description The PGI-S is a patient-rated instrument that measures illness severity. For this study, the patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" The PGI-S includes a range of possible responses, from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 225 228
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.283  (0.0863) -0.664  (0.0873)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
17.Secondary Outcome
Title Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US)
Hide Description EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 225 227
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.002  (0.0079) 0.013  (0.0080)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1267
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
18.Secondary Outcome
Title Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK)
Hide Description EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the UK algorithm (-0.594 to 1). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 225 227
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.001  (0.0109) 0.017  (0.0110)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1630
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
19.Secondary Outcome
Title Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score
Hide Description EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. . The second part is assessed using a visual analog scale (VAS) on which the patient rates their perceived health state, ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase
Hide Arm/Group Description:
Participants received matching placebo every month for three months by SC injection.
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
Overall Number of Participants Analyzed 225 227
Least Squares Mean (Standard Error)
Unit of Measure: mm
-0.086  (1.2916) 3.376  (1.3080)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Double-Blind Treatment Phase, Galcanezumab 120mg - Double-Blind Treatment Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0277
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Up to 6 months
Adverse Event Reporting Description Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
 
Arm/Group Title Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase Placebo/Galcanezumab 120mg - Open-Label Treatment Phase Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment
Hide Arm/Group Description Participants received matching placebo every month for three months by SC injection. Participants received initial loading dose of 240 milligrams (mg) of Galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection. Participants received initial loading dose of 240mg Galcanezumab followed by 120mg every month for two months by SC injection. Participants received 120mg of Galcanezumab every month for three months by SC injection.
All-Cause Mortality
Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase Placebo/Galcanezumab 120mg - Open-Label Treatment Phase Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/230 (0.00%)      0/232 (0.00%)      0/225 (0.00%)      0/224 (0.00%)    
Hide Serious Adverse Events
Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase Placebo/Galcanezumab 120mg - Open-Label Treatment Phase Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/230 (0.87%)      2/232 (0.86%)      6/225 (2.67%)      3/224 (1.34%)    
Gastrointestinal disorders         
Haemorrhoids  1  0/230 (0.00%)  0 1/232 (0.43%)  1 0/225 (0.00%)  0 0/224 (0.00%)  0
Inguinal hernia  1  0/230 (0.00%)  0 0/232 (0.00%)  0 1/225 (0.44%)  1 0/224 (0.00%)  0
General disorders         
Asthenia  1  0/230 (0.00%)  0 0/232 (0.00%)  0 0/225 (0.00%)  0 1/224 (0.45%)  1
Pain  1  0/230 (0.00%)  0 0/232 (0.00%)  0 1/225 (0.44%)  1 0/224 (0.00%)  0
Infections and infestations         
Pneumonia  1  0/230 (0.00%)  0 0/232 (0.00%)  0 0/225 (0.00%)  0 1/224 (0.45%)  1
Tonsillitis  1  0/230 (0.00%)  0 1/232 (0.43%)  1 0/225 (0.00%)  0 0/224 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod bite  1  0/230 (0.00%)  0 0/232 (0.00%)  0 1/225 (0.44%)  1 0/224 (0.00%)  0
Injury  1  0/230 (0.00%)  0 0/232 (0.00%)  0 1/225 (0.44%)  1 0/224 (0.00%)  0
Lower limb fracture  1  1/230 (0.43%)  1 0/232 (0.00%)  0 0/225 (0.00%)  0 0/224 (0.00%)  0
Nervous system disorders         
Hemiplegia  1  0/230 (0.00%)  0 0/232 (0.00%)  0 1/225 (0.44%)  1 0/224 (0.00%)  0
Reproductive system and breast disorders         
Ovarian cyst ruptured  1  0/202 (0.00%)  0 0/195 (0.00%)  0 0/197 (0.00%)  0 1/187 (0.53%)  1
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  0/230 (0.00%)  0 0/232 (0.00%)  0 1/225 (0.44%)  1 0/224 (0.00%)  0
Vascular disorders         
Behcet's syndrome  1  1/230 (0.43%)  1 0/232 (0.00%)  0 0/225 (0.00%)  0 0/224 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase Placebo/Galcanezumab 120mg - Open-Label Treatment Phase Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/230 (13.48%)      21/232 (9.05%)      19/225 (8.44%)      13/224 (5.80%)    
General disorders         
Injection site pain  1  13/230 (5.65%)  30 5/232 (2.16%)  7 11/225 (4.89%)  19 5/224 (2.23%)  7
Infections and infestations         
Nasopharyngitis  1  21/230 (9.13%)  24 16/232 (6.90%)  17 11/225 (4.89%)  11 8/224 (3.57%)  9
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
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
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03559257    
Other Study ID Numbers: 16670
I5Q-MC-CGAW ( Other Identifier: Eli Lilly and Company )
2018-000600-42 ( EudraCT Number )
First Submitted: June 6, 2018
First Posted: June 18, 2018
Results First Submitted: June 19, 2020
Results First Posted: July 8, 2020
Last Update Posted: July 8, 2020