Adults 18 to 65, any sex, with Migraine Headache. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment PhasePrimary· 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 feat
Group
Value
95% CI
Placebo
-3.66
± 0.28
5mg Galcanezumab
-4.23
± 0.37
50mg Galcanezumab
-3.92
± 0.36
120mg Galcanezumab
-4.80
± 0.37
300mg Galcanezumab
-4.28
± 0.39
Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment PhaseSecondary· 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 avoida
Group
Value
95% CI
Placebo
-2.65
± 0.17
5mg Galcanezumab
-2.98
± 0.23
50mg Galcanezumab
-2.87
± 0.22
120mg Galcanezumab
-3.46
± 0.23
300mg Galcanezumab
-3.01
± 0.23
Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment PhaseSecondary· 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. Re
Group
Value
95% CI
Placebo
60.9
5mg Galcanezumab
75.4
50mg Galcanezumab
65.5
120mg Galcanezumab
76.5
300mg Galcanezumab
70.1
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 PhaseSecondary· 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 avoida
Group
Value
95% CI
Placebo
-2.51
± 0.23
5mg Galcanezumab
-3.27
± 0.32
50mg Galcanezumab
-2.58
± 0.31
120mg Galcanezumab
-3.59
± 0.31
300mg Galcanezumab
-3.15
± 0.32
Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment PhaseSecondary· 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.
Group
Value
95% CI
Placebo
-16.56
± 1.73
5mg Galcanezumab
-20.15
± 2.45
50mg Galcanezumab
-19.38
± 2.35
120mg Galcanezumab
-22.29
± 2.39
300mg Galcanezumab
-24.45
± 2.42
Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total ScoresSecondary· 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 f
Group
Value
95% CI
Placebo
21.08
± 1.82
5mg Galcanezumab
27.53
± 2.53
50mg Galcanezumab
25.35
± 2.46
120mg Galcanezumab
30.23
± 2.58
300mg Galcanezumab
27.49
± 2.51
Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) ScoresSecondary· 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.
Group
Value
95% CI
Placebo
-7.26
± 0.79
5mg Galcanezumab
-9.26
± 1.09
50mg Galcanezumab
-8.46
± 1.06
120mg Galcanezumab
-9.95
± 1.12
300mg Galcanezumab
-8.27
± 1.09
Serum Concentration of GalcanezumabSecondary· 12 Weeks
Blood serum concentrations of galcanezumab.
Group
Value
95% CI
5mg Galcanezumab
840
± 602
50mg Galcanezumab
4650
± 2430
120mg Galcanezumab
13200
± 7060
300mg Galcanezumab
32100
± 19100
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)Secondary· 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).
Group
Value
95% CI
Placebo
0.1810
± 0.1030
5mg Galcanezumab
0.4750
± 0.3940
50mg Galcanezumab
1.5700
± 0.7010
120mg Galcanezumab
2.8000
± 1.2200
300mg Galcanezumab
3.8300
± 1.3100
Percentage of Participants Developing Anti-drug Antibodies to GalcanezumabSecondary· 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.
Group
Value
95% CI
Placebo
2.2
5mg Galcanezumab
7.7
50mg Galcanezumab
4.6
120mg Galcanezumab
2.9
300mg Galcanezumab
3.1
Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) ScoresSecondary· 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.
Suicidal Ideation
Group
Value
95% CI
Placebo
0
5mg Galcanezumab
0
50mg Galcanezumab
0
120mg Galcanezumab
0
300mg Galcanezumab
1.52
Suicidal Behavior
Group
Value
95% CI
Placebo
0
5mg Galcanezumab
0
50mg Galcanezumab
0
120mg Galcanezumab
0
300mg Galcanezumab
0
Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment PhaseSecondary· 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
Group
Value
95% CI
Placebo
-2.47
± 0.22
5mg Galcanezumab
-2.81
± 0.32
50mg Galcanezumab
-2.57
± 0.30
120mg Galcanezumab
-3.11
± 0.31
300mg Galcanezumab
-3.37
± 0.31
Adverse events — posted to ClinicalTrials.gov
Time frame: Up To 24 Weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 23 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02163993.