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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02163993
• Collaborator: (none)
• Enrollment: 414
• Locations: 40
• Arms: 5
• Actual Duration (Months): 43.2
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.

Condition or Disease	Intervention/Treatment	Phase
Migraine Headache	Drug: Galcanezumab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 414 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients With Episodic Migraine
• Actual Study Start Date: Jul 7, 2014
• Actual Primary Completion Date: Aug 19, 2015
• Actual Study Completion Date: Feb 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5mg Galcanezumab 5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	Drug: Galcanezumab; Administered SQ; Other Names: LY2951742
Experimental: 50mg Galcanezumab 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	Drug: Galcanezumab; Administered SQ; Other Names: LY2951742
Experimental: 120mg Galcanezumab 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	Drug: Galcanezumab; Administered SQ; Other Names: LY2951742
Experimental: 300mg Galcanezumab 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	Drug: Galcanezumab; Administered SQ; Other Names: LY2951742
Placebo Comparator: Placebo Placebo given as SQ injections once every 28 days during a 12 week treatment period.	Drug: Placebo; Administered SQ

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [Baseline, 12 Weeks]

   The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.

Secondary Outcome Measures

1. Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase [Baseline, 12 Weeks]

   A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) mean was calculated using mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.

2. Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [Week 12]

   The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.

3. Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase [Baseline, 12 Weeks]

   A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.

4. Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase [Baseline, 12 Weeks]

   Number of headache hours calculated as the total number of headache hours in a 28-day period on which a headache occurred. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.

5. Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores [Baseline, 12 Weeks]

   MSQL consists of 14 questions across 3 dimensions (role function-restrictive, role function-preventive, and emotional function). All question values range from 1 to 6. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recorded before item scores were calculated. Then, dimension scores were calculated as the sum of the recorded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = [(dimension score-7)*100]/35, for the preventive function = [(dimension score-4)*100]/20, and for the emotional function = [(dimension score-3)*100]/15. A lower score indicated a poorer quality of life associated with that domain. LS means was determined by Analysis of covariance (ANCOVA) with treatment, pooled investigative site and baseline.

6. Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores [Baseline, 12 Weeks]

   The HIT-6 consists of 6 questions to measure the impact of headaches on the participants ability to function on the job, at school, at home and in social situations. A score to each question will be assigned as follows: never - 6, rarely - 8, sometimes - 10, very often - 11, and always - 13. The composite score is calculated as the sum of the scores for all 6 questions, the total score ranges between 36 and 78 with higher total scores reflecting more severe impact of headaches. LS means was determined by ANCOVA with treatment, pooled investigative site and baseline.

7. Serum Concentration of Galcanezumab [12 Weeks]

   Blood serum concentrations of galcanezumab.

8. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [12 Weeks]

   CGRP has been shown to be involved in the pathophysiology of migraine through dilation of cerebral and dural blood vessels, release of inflammatory mediators, and transmission of nociceptive (pain) information from intracranial blood vessels to the nervous system (Villalón and Olesen 2009). In migraineurs, serum concentrations of CGRP are significantly elevated during migraine attacks (Goadsby et al. 1990; Goadsby and Edvinsson 1993).

9. Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab [Baseline through 12 Weeks]

   The percent of participants with treatment emergent Anti-drug Antibodies (ADA) were assessed at week 1 to 12. A participant was considered to have treatment-emergent Galcanezumab ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as any of the following: A negative baseline ADA result and a subsequent positive post-baseline ADA result with a titer >=20; or a positive ADA results and a subsequent positive post-baseline ADA results with a 4-fold or greater increase in titer from the baseline measurement.

10. Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores [Baseline through Week 12]

    The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.

11. Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [Baseline, 12 Weeks]

    Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-3 beta definition. It is defined as headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.

12. Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [Baseline, 12 Weeks]

    Number of calendar days on which headache lasts ≥4 hrs it includes migraines, PM & non-migraines. MH is headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea &/or vomiting, or photophobia & phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. Severity was measured via interactive voice response system questionnaire "What was the worst headache pain? For mild press 1. For moderate 2. For severe press 3". LSmean was calculated using MMRM with treatment, pooled investigative site, period, treatment-by-period interaction, baseline and baseline-by-period interaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants with a history of migraine of at least 1 year prior to enrollment.

• Migraine onset prior to age 50.

Exclusion Criteria:

• Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.

• Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).

• History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.

• Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.

• Failure to respond to more than two adequately dosed effective migraine prevention treatments.

• Evidence of significant active psychiatric disease, in the opinion of the investigator.

• Women who are pregnant or nursing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Advantage	Gilbert	Arizona	United States	85234
2	21st Century Neurology	Phoenix	Arizona	United States	85004
3	Arizona Research Center	Phoenix	Arizona	United States	85023
4	Pharmacology Research Institute, Long Beach	Encino	California	United States	91316
5	Collaborative Neuroscience Network - CNS	Long Beach	California	United States	90806
6	Pharmacology Research Institute, Long Beach	Los Alamitos	California	United States	90720
7	Pharmacology Research Institute, Long Beach	Newport Beach	California	United States	92660
8	Desert Valley Research	Rancho Mirage	California	United States	92270
9	Artemis Institute for Clinical Research	San Diego	California	United States	92013
10	Medical Center for Clinical Research	San Diego	California	United States	92108
11	San Francisco Clinical Research Center	San Francisco	California	United States	94109
12	California Medical Clinic for Headache	Santa Monica	California	United States	90404
13	Alpine Clinical Research Center	Boulder	Colorado	United States	80304
14	New England Institute for Clinical Research	Stamford	Connecticut	United States	06905
15	Avail Clinical Research LLC	DeLand	Florida	United States	32720
16	Florida Clinical Research Center LLC	Maitland	Florida	United States	32751
17	Renstar Medical Research	Ocala	Florida	United States	34471
18	Psychiatric Inst of Florida-Clinical Neuroscience Solutions	Orlando	Florida	United States	32801
19	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida	United States	33407
20	Otri-Med Corporation	Edgewood	Kentucky	United States	41017
21	PharmaSite Research Inc	Baltimore	Maryland	United States	21208
22	Boston Clinical Trials Inc	Boston	Massachusetts	United States	02131
23	Michigan Head, Pain and Neurological Institute	Ann Arbor	Michigan	United States	48104
24	Westside Family Medical Center	Kalamazoo	Michigan	United States	49009
25	Mercy Health Research	Saint Louis	Missouri	United States	63141
26	ClinVest	Springfield	Missouri	United States	68507
27	Albuquerque Clinical Trials	Albuquerque	New Mexico	United States	87102
28	Island Neuro Associates,PC	Plainview	New York	United States	11803
29	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
30	PharmQuest	Greensboro	North Carolina	United States	27408
31	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
32	Summit Research Network Inc	Portland	Oregon	United States	97210
33	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
34	Coastal Carolina Research Center, Inc.	Mount Pleasant	South Carolina	United States	29464
35	CNS Health Care	Memphis	Tennessee	United States	38119
36	FutureSearch Trials	Austin	Texas	United States	78731
37	DermResearch	Austin	Texas	United States	78759
38	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
39	North Seattle Womens Group	Seattle	Washington	United States	98105
40	Dean Foundation for Health Research and Education	Middleton	Wisconsin	United States	53562

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02163993
• Other Study ID Numbers: 15414; I5Q-MC-CGAB
• First Posted: Jun 16, 2014
• Last Update Posted: Nov 23, 2018
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Migraine Disorders; Headache

Study Results

Participant Flow

Recruitment Details	Treatment period (0 to 12 weeks), Post-treatment period (12 to 24 weeks)

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Period Title: Treatment Period
STARTED	138	68	68	71	69
Received at Least 1 Dose of Study Drug	137	68	68	70	67
COMPLETED	126	59	66	62	62
NOT COMPLETED	12	9	2	9	7
Period Title: Treatment Period
STARTED	125	61	66	63	65
COMPLETED	121	55	62	61	62
NOT COMPLETED	4	6	4	2	3

Baseline Characteristics

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab	Total
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	Total of all reporting groups
Overall Participants	137	68	68	70	67	410
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.54 (12.10)	41.40 (11.15)	39.63 (12.42)	40.57 (10.92)	40.79 (13.20)	40.24 (11.96)
Sex: Female, Male (Count of Participants)
Female	109 79.6%	55 80.9%	61 89.7%	59 84.3%	56 83.6%	340 82.9%
Male	28 20.4%	13 19.1%	7 10.3%	11 15.7%	11 16.4%	70 17.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	20 14.6%	14 20.6%	11 16.2%	8 11.4%	14 20.9%	67 16.3%
Not Hispanic or Latino	117 85.4%	54 79.4%	57 83.8%	62 88.6%	53 79.1%	343 83.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.5%	0 0%	0 0%	0 0%	0 0%	2 0.5%
Asian	6 4.4%	1 1.5%	0 0%	3 4.3%	1 1.5%	11 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	14 10.2%	16 23.5%	9 13.2%	23 32.9%	13 19.4%	75 18.3%
White	106 77.4%	49 72.1%	57 83.8%	43 61.4%	52 77.6%	307 74.9%
More than one race	9 6.6%	2 2.9%	2 2.9%	1 1.4%	1 1.5%	15 3.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	137 100%	68 100%	68 100%	70 100%	67 100%	410 100%
Number of migraine headache days (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	6.64 (2.73)	6.68 (2.73)	6.41 (2.66)	6.95 (2.56)	6.73 (2.48)	6.68 (2.64)
Number of probable and migraine headache days (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	8.04 (3.08)	8.55 (3.23)	8.33 (3.21)	8.69 (3.46)	8.01 (2.79)	8.28 (3.15)

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Description	The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	134	65	68	69	66
Mean (Standard Deviation) [Days]	-3.66 (0.28)	-4.23 (0.37)	-3.92 (0.36)	-4.80 (0.37)	-4.28 (0.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, 5mg Galcanezumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -1.40 to 0.24
	Parameter Dispersion	Type: Standard Deviation; Value: 0.42
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, 50mg Galcanezumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -1.06 to 0.56
	Parameter Dispersion	Type: Standard Deviation; Value: 0.41
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, 120mg Galcanezumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-1.14
	Confidence Interval	(2-Sided) 95%; -2.02 to -0.29
	Parameter Dispersion	Type: Standard Deviation; Value: 0.44
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, 300mg Galcanezumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Posterior Mean Difference
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -1.50 to 0.27
	Parameter Dispersion	Type: Standard Deviation; Value: 0.45
	Estimation Comments

2. Secondary Outcome

Title	Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase
Description	A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) mean was calculated using mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	134	65	68	69	66
Least Squares Mean (Standard Error) [Migraine attacks]	-2.65 (0.17)	-2.98 (0.23)	-2.87 (0.22)	-3.46 (0.23)	-3.01 (0.23)

3. Secondary Outcome

Title	Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Description	The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	134	65	68	69	66
Number [Percentage of participants]	60.9 44.5%	75.4 110.9%	65.5 96.3%	76.5 109.3%	70.1 104.6%

4. Secondary Outcome

Title	Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase
Description	A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	134	65	68	69	66
Least Squares Mean (Standard Error) [Days]	-2.51 (0.23)	-3.27 (0.32)	-2.58 (0.31)	-3.59 (0.31)	-3.15 (0.32)

5. Secondary Outcome

Title	Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase
Description	Number of headache hours calculated as the total number of headache hours in a 28-day period on which a headache occurred. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	134	65	68	69	66
Least Squares Mean (Standard Error) [Hours]	-16.56 (1.73)	-20.15 (2.45)	-19.38 (2.35)	-22.29 (2.39)	-24.45 (2.42)

6. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores
Description	MSQL consists of 14 questions across 3 dimensions (role function-restrictive, role function-preventive, and emotional function). All question values range from 1 to 6. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recorded before item scores were calculated. Then, dimension scores were calculated as the sum of the recorded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = [(dimension score-7)*100]/35, for the preventive function = [(dimension score-4)*100]/20, and for the emotional function = [(dimension score-3)*100]/15. A lower score indicated a poorer quality of life associated with that domain. LS means was determined by Analysis of covariance (ANCOVA) with treatment, pooled investigative site and baseline.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	133	63	67	63	64
Least Squares Mean (Standard Error) [units on a scale]	21.08 (1.82)	27.53 (2.53)	25.35 (2.46)	30.23 (2.58)	27.49 (2.51)

7. Secondary Outcome

Title	Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores
Description	The HIT-6 consists of 6 questions to measure the impact of headaches on the participants ability to function on the job, at school, at home and in social situations. A score to each question will be assigned as follows: never - 6, rarely - 8, sometimes - 10, very often - 11, and always - 13. The composite score is calculated as the sum of the scores for all 6 questions, the total score ranges between 36 and 78 with higher total scores reflecting more severe impact of headaches. LS means was determined by ANCOVA with treatment, pooled investigative site and baseline.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	133	63	67	63	64
Least Squares Mean (Standard Error) [units on a scale]	-7.26 (0.79)	-9.26 (1.09)	-8.46 (1.06)	-9.95 (1.12)	-8.27 (1.09)

8. Secondary Outcome

Title	Serum Concentration of Galcanezumab
Description	Blood serum concentrations of galcanezumab.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for serum concentration of galcanezumab.

Arm/Group Title	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	59	66	62	63
Mean (Standard Deviation) [nanomoles per litre (nmol/L)]	840 (602)	4650 (2430)	13200 (7060)	32100 (19100)

9. Secondary Outcome

Title	Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Description	CGRP has been shown to be involved in the pathophysiology of migraine through dilation of cerebral and dural blood vessels, release of inflammatory mediators, and transmission of nociceptive (pain) information from intracranial blood vessels to the nervous system (Villalón and Olesen 2009). In migraineurs, serum concentrations of CGRP are significantly elevated during migraine attacks (Goadsby et al. 1990; Goadsby and Edvinsson 1993).
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for CGRP plasma concentration.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	14	55	63	61	63
Mean (Standard Deviation) [nanomoles per litre (nmol/L)]	0.1810 (0.1030)	0.4750 (0.3940)	1.5700 (0.7010)	2.8000 (1.2200)	3.8300 (1.3100)

10. Secondary Outcome

Title	Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab
Description	The percent of participants with treatment emergent Anti-drug Antibodies (ADA) were assessed at week 1 to 12. A participant was considered to have treatment-emergent Galcanezumab ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as any of the following: A negative baseline ADA result and a subsequent positive post-baseline ADA result with a titer >=20; or a positive ADA results and a subsequent positive post-baseline ADA results with a 4-fold or greater increase in titer from the baseline measurement.
Time Frame	Baseline through 12 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline ADA measures.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	136	65	66	68	65
Number [Percentage of participants]	2.2 1.6%	7.7 11.3%	4.6 6.8%	2.9 4.1%	3.1 4.6%

11. Secondary Outcome

Title	Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Description	The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and with non-missing baseline and postbaseline C-SSRS assessment.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	136	66	67	68	66
Suicidal Ideation	0 0%	0 0%	0 0%	0 0%	1.52 2.3%
Suicidal Behavior	0 0%	0 0%	0 0%	0 0%	0 0%

12. Secondary Outcome

Title	Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Description	Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-3 beta definition. It is defined as headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	134	65	68	69	66
Least Squares Mean (Standard Error) [Days]	-2.47 (0.22)	-2.81 (0.32)	-2.57 (0.30)	-3.11 (0.31)	-3.37 (0.31)

13. Secondary Outcome

Title	Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
Description	Number of calendar days on which headache lasts ≥4 hrs it includes migraines, PM & non-migraines. MH is headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-3 beta definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea &/or vomiting, or photophobia & phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. Severity was measured via interactive voice response system questionnaire "What was the worst headache pain? For mild press 1. For moderate 2. For severe press 3". LSmean was calculated using MMRM with treatment, pooled investigative site, period, treatment-by-period interaction, baseline and baseline-by-period interaction.
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.

Arm/Group Title	Placebo	5mg Galcanezumab	50mg Galcanezumab	120mg Galcanezumab	300mg Galcanezumab
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.	5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.	50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.	300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
Measure Participants	134	65	68	69	66
Least Squares Mean (Standard Error) [Days]	-2.33 (0.20)	-2.49 (0.28)	-2.33 (0.27)	-2.88 (0.28)	-3.13 (0.28)

Adverse Events

Time Frame	Up To 24 Weeks
Arm/Group Title	Placebo - Treatment Phase		5mg Galcanezumab-Treatment Phase		50mg Galcanezumab-Treatment Phase		120mg Galcanezumab-Treatment Phase		300mg Galcanezumab-Treatment Phase		Placebo - Post-Treatment Phase		5mg Galcanezumab-Post-Treatment Phase		50mg Galcanezumab-Post-Treatment Phase		120mg Galcanezumab-Post-Treatment Phase		300mg Galcanezumab-Post-Treatment Phase
Arm/Group Description	Placebo given as SQ injections once every 28 days during a 12 week treatment period.		5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.		50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.		120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.		300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.		Placebo given as SQ injections once every 28 days during a 12 week treatment period.		5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.		50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.		120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.		300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
All Cause Mortality
	Placebo - Treatment Phase		5mg Galcanezumab-Treatment Phase		50mg Galcanezumab-Treatment Phase		120mg Galcanezumab-Treatment Phase		300mg Galcanezumab-Treatment Phase		Placebo - Post-Treatment Phase		5mg Galcanezumab-Post-Treatment Phase		50mg Galcanezumab-Post-Treatment Phase		120mg Galcanezumab-Post-Treatment Phase		300mg Galcanezumab-Post-Treatment Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo - Treatment Phase		5mg Galcanezumab-Treatment Phase		50mg Galcanezumab-Treatment Phase		120mg Galcanezumab-Treatment Phase		300mg Galcanezumab-Treatment Phase		Placebo - Post-Treatment Phase		5mg Galcanezumab-Post-Treatment Phase		50mg Galcanezumab-Post-Treatment Phase		120mg Galcanezumab-Post-Treatment Phase		300mg Galcanezumab-Post-Treatment Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/137 (0%)		0/68 (0%)		0/68 (0%)		1/70 (1.4%)		1/67 (1.5%)		0/125 (0%)		1/61 (1.6%)		0/66 (0%)		0/63 (0%)		1/65 (1.5%)
Congenital, familial and genetic disorders
Ankyloglossia Congenital	0/137 (0%)	0	0/68 (0%)	0	0/68 (0%)	0	0/70 (0%)	0	1/67 (1.5%)	1	0/125 (0%)	0	0/61 (0%)	0	0/66 (0%)	0	0/63 (0%)	0	0/65 (0%)	0
Gastrointestinal disorders
Crohn's disease	0/137 (0%)	0	0/68 (0%)	0	0/68 (0%)	0	0/70 (0%)	0	0/67 (0%)	0	0/125 (0%)	0	1/61 (1.6%)	1	0/66 (0%)	0	0/63 (0%)	0	0/65 (0%)	0
Infections and infestations
Appendicitis	0/137 (0%)	0	0/68 (0%)	0	0/68 (0%)	0	1/70 (1.4%)	1	0/67 (0%)	0	0/125 (0%)	0	0/61 (0%)	0	0/66 (0%)	0	0/63 (0%)	0	0/65 (0%)	0
Psychiatric disorders
Suicidal Ideation	0/137 (0%)	0	0/68 (0%)	0	0/68 (0%)	0	0/70 (0%)	0	0/67 (0%)	0	0/125 (0%)	0	0/61 (0%)	0	0/66 (0%)	0	0/63 (0%)	0	1/65 (1.5%)	1
Other (Not Including Serious) Adverse Events
	Placebo - Treatment Phase		5mg Galcanezumab-Treatment Phase		50mg Galcanezumab-Treatment Phase		120mg Galcanezumab-Treatment Phase		300mg Galcanezumab-Treatment Phase		Placebo - Post-Treatment Phase		5mg Galcanezumab-Post-Treatment Phase		50mg Galcanezumab-Post-Treatment Phase		120mg Galcanezumab-Post-Treatment Phase		300mg Galcanezumab-Post-Treatment Phase
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/137 (16.8%)		20/68 (29.4%)		18/68 (26.5%)		23/70 (32.9%)		19/67 (28.4%)		6/125 (4.8%)		2/61 (3.3%)		2/66 (3%)		2/63 (3.2%)		3/65 (4.6%)
Gastrointestinal disorders
Nausea	4/137 (2.9%)	4	1/68 (1.5%)	2	2/68 (2.9%)	2	0/70 (0%)	0	4/67 (6%)	5	0/125 (0%)	0	1/61 (1.6%)	1	0/66 (0%)	0	0/63 (0%)	0	0/65 (0%)	0
General disorders
Injection site pain	4/137 (2.9%)	6	7/68 (10.3%)	11	6/68 (8.8%)	15	10/70 (14.3%)	13	9/67 (13.4%)	18	0/125 (0%)	0	0/61 (0%)	0	0/66 (0%)	0	0/63 (0%)	0	0/65 (0%)	0
Infections and infestations
Nasopharyngitis	3/137 (2.2%)	3	8/68 (11.8%)	8	3/68 (4.4%)	3	6/70 (8.6%)	6	2/67 (3%)	2	1/125 (0.8%)	1	1/61 (1.6%)	1	1/66 (1.5%)	1	0/63 (0%)	0	0/65 (0%)	0
Upper respiratory tract infection	12/137 (8.8%)	15	7/68 (10.3%)	7	8/68 (11.8%)	8	8/70 (11.4%)	8	4/67 (6%)	4	4/125 (3.2%)	4	0/61 (0%)	0	1/66 (1.5%)	1	2/63 (3.2%)	2	2/65 (3.1%)	3
Reproductive system and breast disorders
Dysmenorrhoea	0/137 (0%)	0	1/68 (1.5%)	4	4/68 (5.9%)	4	0/70 (0%)	0	2/67 (3%)	2	1/125 (0.8%)	1	0/61 (0%)	0	0/66 (0%)	0	0/63 (0%)	0	1/65 (1.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.