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A Study of Galcanezumab in Participants With Chronic Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438826
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : June 11, 2019
Last Update Posted : September 12, 2019
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 Chronic Cluster Headache
Interventions Drug: Galcanezumab 300 mg
Drug: Placebo
Enrollment 240
Recruitment Details  
Pre-assignment Details Results reported are for primary outcome, which is the double blind treatment phase up to Week 12; data beyond Week 12 will be reported after Study Completion final analysis up to month 19 results.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Period Title: Overall Study
Started 123 117
Received at Least 1 Dose of Study Drug 120 117
Completed 117 113
Not Completed 6 4
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             1             0
Withdrawal by Subject             1             1
Protocol Violation             1             2
Screen Failure             2             0
Arm/Group Title Placebo Galcanezumab 300 mg Total
Hide Arm/Group Description Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Total of all reporting groups
Overall Number of Baseline Participants 120 117 237
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 117 participants 237 participants
44.38  (10.81) 45.62  (11.03) 45.00  (10.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 117 participants 237 participants
Female 34 31 65
Male 86 86 172
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 117 participants 237 participants
Hispanic or Latino 15 18 33
Not Hispanic or Latino 87 81 168
Unknown or Not Reported 18 18 36
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 117 participants 237 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 1 2
White 101 99 200
More than one race 18 17 35
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Greece Number Analyzed 120 participants 117 participants 237 participants
0 1 1
Canada Number Analyzed 120 participants 117 participants 237 participants
4 4 8
Netherlands Number Analyzed 120 participants 117 participants 237 participants
5 5 10
Belgium Number Analyzed 120 participants 117 participants 237 participants
16 16 32
United States Number Analyzed 120 participants 117 participants 237 participants
15 18 33
Finland Number Analyzed 120 participants 117 participants 237 participants
2 2 4
Denmark Number Analyzed 120 participants 117 participants 237 participants
5 4 9
Italy Number Analyzed 120 participants 117 participants 237 participants
17 14 31
United Kingdom Number Analyzed 120 participants 117 participants 237 participants
8 8 16
France Number Analyzed 120 participants 117 participants 237 participants
20 20 40
Germany Number Analyzed 120 participants 117 participants 237 participants
22 20 42
Spain Number Analyzed 120 participants 117 participants 237 participants
6 5 11
Weekly Cluster Headache Attacks  
Mean (Standard Deviation)
Unit of measure:  Cluster headache attacks per week
Number Analyzed 120 participants 117 participants 237 participants
18.47  (10.66) 19.18  (9.82) 18.82  (10.24)
Lifetime Suicidal Ideation Prior to Screening   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 117 participants 237 participants
30 25 55
[1]
Measure Description: Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included = Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (No Plan); Active Suicidal Ideation with Some Intent to Act, without a Specific Plan; Active Suicidal Ideation with Intent to Act.
Lifetime Suicidal Behavior Prior to Screening   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 117 participants 236 participants
5 4 9
[1]
Measure Description: Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and completed suicide.
[2]
Measure Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had a baseline value for Lifetime Suicidal Behavior.
Verapamil Use at Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 117 participants 237 participants
63 55 118
1.Primary Outcome
Title Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency
Hide Description Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.
Time Frame Baseline, Week 1 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, and had baseline and at least one post baseline value.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 120 117
Least Squares Mean (Standard Error)
Unit of Measure: cluster headache attacks per week
-4.59  (0.79) -5.38  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments Cui, Hung, Wang (CHW) procedure applied
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-2.77 to 1.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Hide Description A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects.
Time Frame Baseline, Week 1 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 120 117
Mean (Standard Error)
Unit of Measure: percentage of participants
27.1  (3.5) 32.6  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments Cui, Hung, Wang (CHW) procedure applied
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.297
Confidence Interval (2-Sided) 95%
0.830 to 2.028
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Hide Description Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex, verapamil use and baseline value.
Time Frame Baseline, Week 3 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, had a baseline, and at least one post baseline value.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 120 117
Measure Type: Number
Unit of Measure: percentage of participants
17.50 16.24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.946
Comments Chui, Hung, Wang (CHW) procedure applied)
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks
Hide Description A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. .
Time Frame Baseline, Week 1 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 120 117
Mean (Standard Error)
Unit of Measure: percentage of participants
39.0  (3.9) 49.1  (4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.510
Confidence Interval (2-Sided) 95%
0.987 to 2.309
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Hide Description PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 4.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 92 88
Measure Type: Number
Unit of Measure: percentage of participants
19.4 21.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.141
Confidence Interval (2-Sided) 95%
0.563 to 2.314
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Hide Description PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 8.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 97 86
Measure Type: Number
Unit of Measure: percentage of participants
32.0 32.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.008
Confidence Interval (2-Sided) 95%
0.548 to 1.856
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Hide Description PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 12.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 95 95
Measure Type: Number
Unit of Measure: percentage of participants
35.6 30.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.437
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.788
Confidence Interval (2-Sided) 95%
0.431 to 1.440
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Time Frame Week 1 through Week 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 C-SSRS assessment.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Placebo administered by SQ injection every 30 Days for 12 weeks.
300 mg galcanezumab (LY2951742) administered by subcutaneous (SQ) injection every 30 days for 12 weeks.
Overall Number of Participants Analyzed 119 116
Measure Type: Number
Unit of Measure: percentage of participants
5.04 4.31
9.Secondary Outcome
Title Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Time Frame Week 1 through Week 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 C-SSRS assessment.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 119 116
Measure Type: Number
Unit of Measure: percentage of participants
0 0
10.Secondary Outcome
Title Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)
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 Baseline, Week 1 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 115 113
Measure Type: Number
Unit of Measure: percentage of participants
0 0.88
11.Secondary Outcome
Title Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Hide Description Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 2.
Arm/Group Title Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
30,600  (10,700)
12.Secondary Outcome
Title Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Hide Description Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 4.
Arm/Group Title Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
20,200  (6780)
13.Secondary Outcome
Title Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Hide Description Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 8.
Arm/Group Title Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 94
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
29,700  (11,500)
14.Secondary Outcome
Title Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Hide Description Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 12.
Arm/Group Title Galcanezumab 300 mg
Hide Arm/Group Description:
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
31,100  (11,900)
Time Frame Up to 12 weeks
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Placebo Galcanezumab 300 mg
Hide Arm/Group Description Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months
All-Cause Mortality
Placebo Galcanezumab 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)      0/117 (0.00%)    
Hide Serious Adverse Events
Placebo Galcanezumab 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/120 (2.50%)      2/117 (1.71%)    
Cardiac disorders     
Atrial fibrillation  1  0/120 (0.00%)  0 1/117 (0.85%)  1
Gastrointestinal disorders     
Constipation  1  0/120 (0.00%)  0 1/117 (0.85%)  1
Melaena  1  1/120 (0.83%)  1 0/117 (0.00%)  0
General disorders     
Non-cardiac chest pain  1  1/120 (0.83%)  1 0/117 (0.00%)  0
Psychiatric disorders     
Depression  1  1/120 (0.83%)  1 0/117 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Galcanezumab 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/120 (29.17%)      40/117 (34.19%)    
Gastrointestinal disorders     
Nausea  1  6/120 (5.00%)  8 6/117 (5.13%)  7
General disorders     
Fatigue  1  7/120 (5.83%)  9 5/117 (4.27%)  5
Injection site erythema  1  1/120 (0.83%)  1 8/117 (6.84%)  11
Injection site pain  1  11/120 (9.17%)  15 13/117 (11.11%)  31
Infections and infestations     
Nasopharyngitis  1  15/120 (12.50%)  16 12/117 (10.26%)  13
1
Term from vocabulary, MedDRA 20.1
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: NCT02438826    
Other Study ID Numbers: 15781
I5Q-MC-CGAM ( Other Identifier: Eli Lilly and Company )
2014-005429-11 ( EudraCT Number )
First Submitted: May 6, 2015
First Posted: May 8, 2015
Results First Submitted: April 2, 2019
Results First Posted: June 11, 2019
Last Update Posted: September 12, 2019