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A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

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: NCT02614287
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: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Intervention Drug: Galcanezumab
Enrollment 270
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase. Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.
Period Title: Open Label (OL) Treatment Phase
Started 135 135
Received at Least One Dose of Study Drug 135 135
Completed 97 113
Not Completed 38 22
Reason Not Completed
Adverse Event             7             6
Lack of Efficacy             13             5
Lost to Follow-up             7             4
Physician Decision             1             0
Withdrawal by Subject             10             7
Period Title: Post Treatment Follow-up Phase
Started 112 [1] 124 [1]
Completed 103 119
Not Completed 9 5
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             2             2
Withdrawal by Subject             6             3
[1]
Follow-up period was optional, few participants who completed OL period didn't enter follow-up.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg Total
Hide Arm/Group Description Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase & participants did not receive any intervention during post treatment follow-up phase. Participants received 240 mg galcanezumab once a month by subcutaneous injection during open label treatment phase & participants did not receive any intervention during post treatment follow-up phase. Total of all reporting groups
Overall Number of Baseline Participants 135 135 270
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 135 participants 270 participants
40.21  (11.68) 43.69  (10.99) 41.95  (11.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 135 participants 270 participants
Female 110 113 223
Male 25 22 47
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 128 participants 255 participants
Hispanic or Latino 12 20 32
Not Hispanic or Latino 115 108 223
Unknown or Not Reported 0 0 0
[1]
Measure Analysis Population Description: All randomized participants with ethnicity data.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 135 participants 270 participants
American Indian or Alaska Native 0 0 0
Asian 2 0 2
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 6 8 14
White 103 108 211
More than one race 23 19 42
Unknown or Not Reported 0 0 0
1.Primary Outcome
Title Percentage of Participants Who Discontinued Due to Adverse Event
Hide Description

Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section.

Time Frame Baseline through Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. There were 6 participants in the 120 mg group who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg group for AE analysis.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 129 141
Measure Type: Number
Unit of Measure: Percentage of Participants
4.65 4.96
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
Hide Description Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
Time Frame Baseline through Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Serum Concentrations of Galcanezumab
Hide Description Serum Concentrations of Galcanezumab.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with measurable serum concentrations at month 12.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 12 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 61 78
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
16500  (8370) 31600  (15900)
4.Secondary Outcome
Title Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Hide Description Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with measurable plasma concentration.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 87 103
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.74  (1.07) 3.85  (1.85)
5.Secondary Outcome
Title Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab
Hide Description

A Treatment Emergent Anti-drug Antibody (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA Present with titer >= 1: 20 (treatment-induced).

There were 6 participants in the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for safety analysis.

Time Frame Month 1 through Month 12
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 evaluable data for TE ADA.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 129 137
Measure Type: Number
Unit of Measure: Percentage of Participants
12.40 7.30
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments TE ADA Positive (TE ADA+)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .215
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD)
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 12 from MMRM model. Least squares mean (LSMean) was calculated using mixed model repeated measures (MMRM) model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time Frame Baseline, Month 1 through Month 12
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.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 132 135
Least Squares Mean (Standard Error)
Unit of Measure: Migraine Headache Days per Month
-5.61  (0.34) -6.47  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.76 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.46
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Overall Mean Change From Baseline in the Number of 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 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

Time Frame Baseline, Month 1 through Month 12
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.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 132 135
Least Squares Mean (Standard Error)
Unit of Measure: Headache Days per Month
-2.17  (0.30) -2.09  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .835
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.72 to 0.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.41
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days
Hide Description

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

Overall percentage of participants with a given response rate were estimated from the generalized linear mixed models (GLIMMIX) model.

Time Frame Baseline, Month 1 through Month 12
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.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 95 112
Measure Type: Number
Unit of Measure: percentage of Participants
65.6 73.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .063
Comments [Not Specified]
Method CPLRM
Comments CPLRM: Categorical pseudo likelihood-based repeated measures model
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.467
Confidence Interval (2-Sided) 95%
0.979 to 2.197
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches
Hide Description Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time Frame Baseline, Month 1 through Month 12
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 Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 132 135
Least Squares Mean (Standard Error)
Unit of Measure: Medication Used Days per Month
-5.09  (0.38) -5.05  (0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .937
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.96 to 1.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Overall Mean Patient Global Impression-Improvement (PGI-I) Score
Hide Description The Patient Global Impression of Improvement (PGI -I) scale is a participant-rated instrument that measures the participants own global impression of their symptom improvement. The participant was instructed as follows: "Mark the box that best describes your migraine headache condition since you started taking this medicine." Response options were on a 7-point scale in which a score of 1 indicates that the participant's condition is "very much better," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse." Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline PGI-S, and baseline PGI-S by month as fixed effects.
Time Frame Month 1 through Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had at least one post baseline value.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 130 135
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.18  (0.08) 1.99  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.40 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Overall Mean Change From Baseline on 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. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month.
Time Frame Baseline, Month 1 through Month 12
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 Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg of galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 124 130
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-33.58  (2.11) -32.67  (2.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .747
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
-4.65 to 6.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.82
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
Hide Description MSQv2.1 is a health status instrument,with a 4-week recall period, developed to address physical & emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings.It consists of 14 items addressing 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 total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.
Time Frame Baseline, Month 1 through Month 12
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.

Overall mean is derived from the average of months 1 to 12.LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg of galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 130 135
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total Score 28.27  (1.16) 30.25  (1.13)
Role Function-Restrictive Domain 31.55  (1.20) 33.40  (1.16)
Role Function-Preventive Domain 22.08  (1.11) 23.33  (1.08)
Emotional Function Domain 28.92  (1.35) 32.01  (1.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments Total Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 1.98
Confidence Interval (2-Sided) 95%
-1.07 to 5.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments Role Function-Restrictive Domain Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .247
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 1.85
Confidence Interval (2-Sided) 95%
-1.29 to 4.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments Role Function-Preventive Domain Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
-1.67 to 4.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Galcanezumab 120 mg, Galcanezumab 240 mg
Comments Emotional Function Domain Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 3.09
Confidence Interval (2-Sided) 95%
-0.46 to 6.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.80
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Hide Description The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment. Preference compares the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study".
Time Frame Baseline through Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had month 12 PSMQ-M measurement.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 90 112
Measure Type: Number
Unit of Measure: percentage of Participants
Satisfaction: Very satisfied 57.78 58.04
Satisfaction: Somewhat satisfied 18.89 15.18
Preference: Much prefer study medication 66.67 63.39
Preference: Prefer study medication 22.22 17.86
Side effects: Much less side effects 66.67 50.89
Side effects: Less side effects 14.44 30.36
14.Secondary Outcome
Title Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12
Hide Description The SQAAQ is a self-administered questionnaire that provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of study drug. Participants will respond to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree") shortly after the injection. If a caregiver administers the injection, the participants should be prepared to provide the caregiver's ratings of the questions.strongly agree & agree are considered as positive responses.
Time Frame Baseline through Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who switched from pre-filled syringe and received at least one dose of study drug by autoinjector.
Arm/Group Title Galcanezumab 120 mg Galcanezumab 240 mg
Hide Arm/Group Description:
Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 11 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Number of Participants Analyzed 84 95
Overall Number of Units Analyzed
Type of Units Analyzed: Number of participant visits
899 1032
Measure Type: Number
Unit of Measure: participants
Pre-filled Syringe : Easy to learn how to use Number Analyzed 646 Number of participant visits 751 Number of participant visits
611 688
Pre-filled Syringe : Easy to hold in hand Number Analyzed 646 Number of participant visits 751 Number of participant visits
589 660
Pre-filled Syringe : Easy to inject my dose Number Analyzed 645 Number of participant visits 751 Number of participant visits
580 659
Pre-filled Syringe : Easy to know dose is complete Number Analyzed 646 Number of participant visits 751 Number of participant visits
615 703
Pre-filled Syringe: Easy to store device in fridge Number Analyzed 625 Number of participant visits 726 Number of participant visits
536 630
Pre-filled Syringe : Easy to remove needle shield Number Analyzed 646 Number of participant visits 751 Number of participant visits
610 699
Pre-filled Syringe : Easy to pickup Number Analyzed 646 Number of participant visits 751 Number of participant visits
610 693
Pre-filled Syringe : overall, easy to use Number Analyzed 646 Number of participant visits 751 Number of participant visits
600 663
Pre-filled Syringe:Dvc is stable against skin Number Analyzed 646 Number of participant visits 744 Number of participant visits
590 652
Pre-filled Syringe:Confident in ability to use Number Analyzed 646 Number of participant visits 751 Number of participant visits
580 654
Pre-filled Syringe : Confident my dose is complete Number Analyzed 646 Number of participant visits 751 Number of participant visits
618 708
Autoinjector : Easy to learn how to use Number Analyzed 253 Number of participant visits 281 Number of participant visits
250 265
Autoinjector : Easy to hold in hand Number Analyzed 253 Number of participant visits 281 Number of participant visits
247 267
Autoinjector : Easy to inject my dose Number Analyzed 253 Number of participant visits 281 Number of participant visits
245 265
Autoinjector : Easy to know dose is complete Number Analyzed 253 Number of participant visits 281 Number of participant visits
241 261
Autoinjector : Easy store device in fridge Number Analyzed 247 Number of participant visits 278 Number of participant visits
230 256
Autoinjector : Easy to remove needle shield Number Analyzed 253 Number of participant visits 281 Number of participant visits
250 268
Autoinjector : Easy to pickup Number Analyzed 253 Number of participant visits 281 Number of participant visits
251 271
Autoinjector : Overall, easy to use Number Analyzed 253 Number of participant visits 281 Number of participant visits
251 262
Autoinjector : Dvc is stable against skin Number Analyzed 253 Number of participant visits 281 Number of participant visits
244 264
Autoinjector : Confident in ability to use Number Analyzed 253 Number of participant visits 281 Number of participant visits
247 260
Autoinjector : Confident my dose is complete Number Analyzed 253 Number of participant visits 281 Number of participant visits
244 263
Time Frame Up to 421 days
Adverse Event Reporting Description

All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis.

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

 
Arm/Group Title Galcanezumab 120 mg - Open Label Phase Galcanezumab 240 mg - Open Label Phase Galcanezumab 120 mg - Post-treatment Phase Galcanezumab 240 mg - Post-treatment Phase
Hide Arm/Group Description Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg Galcanezumab once a month by subcutaneous injection for 11 months. Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months. Participants did not receive any intervention. Participants did not receive any intervention.
All-Cause Mortality
Galcanezumab 120 mg - Open Label Phase Galcanezumab 240 mg - Open Label Phase Galcanezumab 120 mg - Post-treatment Phase Galcanezumab 240 mg - Post-treatment Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/129 (0.00%)      0/141 (0.00%)      0/112 (0.00%)      0/124 (0.00%)    
Hide Serious Adverse Events
Galcanezumab 120 mg - Open Label Phase Galcanezumab 240 mg - Open Label Phase Galcanezumab 120 mg - Post-treatment Phase Galcanezumab 240 mg - Post-treatment Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/129 (2.33%)      7/141 (4.96%)      3/112 (2.68%)      2/124 (1.61%)    
Gastrointestinal disorders         
Diverticulum intestinal  1  0/129 (0.00%)  0 1/141 (0.71%)  1 0/112 (0.00%)  0 0/124 (0.00%)  0
General disorders         
Non-cardiac chest pain  1  0/129 (0.00%)  0 1/141 (0.71%)  1 0/112 (0.00%)  0 0/124 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis  1  0/129 (0.00%)  0 1/141 (0.71%)  1 0/112 (0.00%)  0 0/124 (0.00%)  0
Infections and infestations         
Endocarditis  1  0/129 (0.00%)  0 0/141 (0.00%)  0 1/112 (0.89%)  1 0/124 (0.00%)  0
Infective aneurysm  1  0/129 (0.00%)  0 0/141 (0.00%)  0 1/112 (0.89%)  1 0/124 (0.00%)  0
Pneumonia  1  0/129 (0.00%)  0 1/141 (0.71%)  1 0/112 (0.00%)  0 0/124 (0.00%)  0
Injury, poisoning and procedural complications         
Subarachnoid haemorrhage  1  0/129 (0.00%)  0 0/141 (0.00%)  0 1/112 (0.89%)  1 0/124 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/129 (0.00%)  0 1/141 (0.71%)  1 0/112 (0.00%)  0 0/124 (0.00%)  0
Osteoarthritis  1  1/129 (0.78%)  1 0/141 (0.00%)  0 0/112 (0.00%)  0 0/124 (0.00%)  0
Pain in extremity  1  0/129 (0.00%)  0 1/141 (0.71%)  1 0/112 (0.00%)  0 0/124 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung neoplasm malignant  1  0/129 (0.00%)  0 0/141 (0.00%)  0 1/112 (0.89%)  1 0/124 (0.00%)  0
Malignant melanoma  1  0/129 (0.00%)  0 0/141 (0.00%)  0 0/112 (0.00%)  0 1/124 (0.81%)  1
Nervous system disorders         
Lumbar radiculopathy  1  1/129 (0.78%)  1 0/141 (0.00%)  0 0/112 (0.00%)  0 0/124 (0.00%)  0
Migraine  1  1/129 (0.78%)  1 0/141 (0.00%)  0 0/112 (0.00%)  0 0/124 (0.00%)  0
Pineal gland cyst  1  0/129 (0.00%)  0 0/141 (0.00%)  0 0/112 (0.00%)  0 1/124 (0.81%)  1
Reproductive system and breast disorders         
Haemorrhagic ovarian cyst  1 [1]  0/104 (0.00%)  0 0/119 (0.00%)  0 1/91 (1.10%)  1 0/106 (0.00%)  0
Surgical and medical procedures         
Uterine leiomyoma embolisation  1 [1]  0/104 (0.00%)  0 1/119 (0.84%)  1 0/91 (0.00%)  0 0/106 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
[1]
All randomized female participants. There were 6 female participants in the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Galcanezumab 120 mg - Open Label Phase Galcanezumab 240 mg - Open Label Phase Galcanezumab 120 mg - Post-treatment Phase Galcanezumab 240 mg - Post-treatment Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/129 (58.91%)      83/141 (58.87%)      6/112 (5.36%)      8/124 (6.45%)    
Gastrointestinal disorders         
Nausea  1  10/129 (7.75%)  11 9/141 (6.38%)  15 1/112 (0.89%)  1 0/124 (0.00%)  0
General disorders         
Injection site bruising  1  5/129 (3.88%)  5 8/141 (5.67%)  10 0/112 (0.00%)  0 0/124 (0.00%)  0
Injection site erythema  1  9/129 (6.98%)  20 9/141 (6.38%)  19 0/112 (0.00%)  0 0/124 (0.00%)  0
Injection site pain  1  22/129 (17.05%)  148 28/141 (19.86%)  272 0/112 (0.00%)  0 0/124 (0.00%)  0
Injection site reaction  1  15/129 (11.63%)  48 13/141 (9.22%)  32 0/112 (0.00%)  0 0/124 (0.00%)  0
Infections and infestations         
Influenza  1  8/129 (6.20%)  9 8/141 (5.67%)  8 1/112 (0.89%)  1 1/124 (0.81%)  1
Sinusitis  1  14/129 (10.85%)  16 13/141 (9.22%)  17 0/112 (0.00%)  0 0/124 (0.00%)  0
Upper respiratory tract infection  1  9/129 (6.98%)  10 21/141 (14.89%)  23 0/112 (0.00%)  0 1/124 (0.81%)  2
Viral upper respiratory tract infection  1  21/129 (16.28%)  27 16/141 (11.35%)  19 0/112 (0.00%)  0 2/124 (1.61%)  2
Investigations         
Weight increased  1  7/129 (5.43%)  7 4/141 (2.84%)  4 0/112 (0.00%)  0 0/124 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  8/129 (6.20%)  12 8/141 (5.67%)  10 1/112 (0.89%)  1 1/124 (0.81%)  1
Back pain  1  12/129 (9.30%)  15 15/141 (10.64%)  18 2/112 (1.79%)  2 3/124 (2.42%)  3
Myalgia  1  8/129 (6.20%)  9 3/141 (2.13%)  4 1/112 (0.89%)  1 0/124 (0.00%)  0
Nervous system disorders         
Dizziness  1  5/129 (3.88%)  7 9/141 (6.38%)  11 0/112 (0.00%)  0 0/124 (0.00%)  0
Reproductive system and breast disorders         
Prostatitis  1 [1]  0/25 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/18 (5.56%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
[1]
All randomized male 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
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614287    
Other Study ID Numbers: 15770
I5Q-MC-CGAJ ( Other Identifier: Eli Lilly and Company )
2015-001884-38 ( 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