NCT02959177 is a Phase 2 clinical trial of Galcanezumab in Migraine, sponsored by Eli Lilly and Company.

Who is sponsoring NCT02959177?

NCT02959177 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT02959177?

Interventions in NCT02959177: Galcanezumab, Placebo.

Is NCT02959177 still recruiting?

NCT02959177 is currently completed. Last updated 27 April 2021.

Are results published for NCT02959177?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-04-27 · How we verify

NCT02959177

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine

Completed Phase 2 Results posted Last updated 27 April 2021

What this trial tests

Phase 2 trial testing Galcanezumab in Migraine in 459 participants. Completed in 18 January 2019.

Timeline

9 November 2016

Primary endpoint
18 January 2019

18 January 2019

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	459
Start date	9 November 2016
Primary completion	18 January 2019
Estimated completion	18 January 2019
Sites	47 locations across Japan

Drugs / interventions tested

Galcanezumab (GALCANEZUMAB) — full drug profile →
Placebo

Conditions studied

Migraine — all drugs for Migraine →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Migraine. 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.

Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) Primary · Baseline, Month 1 through Month 6

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; The overall mean is derived from the average of

Group	Value	95% CI
120 mg Galcanezumab	-3.60	-4.25 – -2.96
240 mg Galcanezumab	-3.36	-4.01 – -2.71
Placebo	-0.59	-1.05 – -0.14

Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days Secondary · Baseline, Month 1 through Month 6

Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.

Group	Value	95% CI
120 mg Galcanezumab	49.8	± 3.4
240 mg Galcanezumab	48.2	± 3.5
Placebo	20.3	± 2.0

Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days Secondary · Baseline, Month 1 through Month 6

Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 75% responder in a particular month is any participant who has a ≥75% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.

Group	Value	95% CI
120 mg Galcanezumab	25.5	± 2.8
240 mg Galcanezumab	25.0	± 2.8
Placebo	9.6	± 1.3

Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days Secondary · Baseline, Month 1 through Month 6

Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 100% responder in a particular month is any participant who has a 100% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.

Group	Value	95% CI
120 mg Galcanezumab	9.0	± 1.5
240 mg Galcanezumab	8.1	± 1.5
Placebo	2.8	± 0.6

Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire Secondary · Baseline, Month 4 through Month 6

MSQ version 2.1 is a health status instrument 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 sc

Group	Value	95% CI
120 mg Galcanezumab	17.13	15.10 – 19.15
240 mg Galcanezumab	15.91	13.89 – 17.93
Placebo	10.12	8.70 – 11.55

Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use Secondary · Baseline, Month 1 through Month 6

Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication. The overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.

Group	Value	95% CI
120 mg Galcanezumab	-3.02	-3.60 – -2.43
240 mg Galcanezumab	-2.81	-3.40 – -2.23
Placebo	-0.12	-0.53 – 0.30

Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score Secondary · Baseline, Month 4 through Month 6

The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. Least square mean (LSM) was calculated using an MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.

Group	Value	95% CI
120 mg Galcanezumab	-0.25	-0.40 – -0.10
240 mg Galcanezumab	-0.41	-0.56 – -0.25
Placebo	-0.15	-0.26 – -0.04

Overall Mean Change From Baseline in Headache Hours Secondary · Baseline, Month 1 through Month 6

Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using the MMRM model with treatment, month, treatment by month, baseline, baseline by month and baseline MHD category.

Group	Value	95% CI
120 mg Galcanezumab	-14.56	-18.10 – -11.01
240 mg Galcanezumab	-16.46	-20.02 – -12.90
Placebo	-2.73	-5.25 – -0.22

Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score Secondary · Baseline, Month 6

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

Group	Value	95% CI
120 mg Galcanezumab	-7.06	-9.67 – -4.44
240 mg Galcanezumab	-5.13	-7.69 – -2.58
Placebo	-2.16	-3.96 – -0.36

Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) Secondary · Month 6

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"

Satisfaction: Very satisfied

Group	Value	95% CI
120 mg Galcanezumab	35.58
240 mg Galcanezumab	44.14
Placebo	7.56

Satisfaction: Somewhat satisfied

Group	Value	95% CI
120 mg Galcanezumab	26.92
240 mg Galcanezumab	23.42
Placebo	27.11

Side effects: Much less side effects

Group	Value	95% CI
120 mg Galcanezumab	35.58
240 mg Galcanezumab	28.83
Placebo	24.89

Side effects: Less side effects

Group	Value	95% CI
120 mg Galcanezumab	22.12
240 mg Galcanezumab	33.33
Placebo	25.78

Preference: Prefer study medication

Group	Value	95% CI
120 mg Galcanezumab	40.38
240 mg Galcanezumab	34.23
Placebo	28.00

Preference: Much Prefer study medication

Group	Value	95% CI
120 mg Galcanezumab	22.12
240 mg Galcanezumab	27.03
Placebo	3.11

Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) Secondary · Month 1 through Month 6

C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thoughts occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation (SI): 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 inten

Wish to be dead

Group	Value	95% CI
120 mg Galcanezumab	1
240 mg Galcanezumab	0
Placebo	0

Non-specific active suicidal thoughts

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Active SI with no intent

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Active SI with some intent

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Active SI with specific plan and intent

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) Secondary · Month 1 through Month 6

C -SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as 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 is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

Preparatory acts or behavior

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Aborted attempt

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Non-fatal suicide attempt

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Completed suicide

Group	Value	95% CI
120 mg Galcanezumab	0
240 mg Galcanezumab	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Phase Placebo

Serious: 0/230 (0%)

Deaths: 0/230

Treatment Phase 120 mg Galcanezumab

Serious: 3/115 (3%)

Deaths: 0/115

Treatment Phase 240 mg Galcanezumab

Serious: 1/114 (1%)

Deaths: 0/114

Follow-up Phase Placebo

Serious: 1/100 (1%)

Deaths: 0/100

Follow-up 120 mg Galcanezumab

Serious: 0/52 (0%)

Deaths: 0/52

Follow-up Phase 240 mg Galcanezumab

Serious: 0/52 (0%)

Deaths: 0/52

Serious adverse events (5 terms)

Reaction	System	Treatment Phase Placebo	Treatment Phase 120 mg Gal…	Treatment Phase 240 mg Gal…	Follow-up Phase Placebo	Follow-up 120 mg Galcanezu…	Follow-up Phase 240 mg Gal…
Sudden hearing loss	Ear and labyrinth disorders	—	—	—	—	—	—
Tooth impacted	Gastrointestinal disorders	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Meniscus injury	Injury, poisoning and procedural complications	—	—	—	—	—	—
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—

Other adverse events (248 terms — click to expand)

Reaction	System	Treatment Phase Placebo	Treatment Phase 120 mg Gal…	Treatment Phase 240 mg Gal…	Follow-up Phase Placebo	Follow-up 120 mg Galcanezu…	Follow-up Phase 240 mg Gal…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Injection site induration	General disorders	—	—	—	—	—	—
Injection site inflammation	General disorders	—	—	—	—	—	—
Injection site rash	General disorders	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Migraine without aura	Nervous system disorders	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Sudden hearing loss	Ear and labyrinth disorders	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Sudden hearing loss, Tooth impacted, Pneumonia, Meniscus injury, Nasal septum deviation.

Data from ClinicalTrials.gov NCT02959177 adverse events section.

Sponsor's own description

The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis.
Wang X, Chen Y, Song J, You C. · · 2021 · cited 35× · PMID 33867991 · DOI 10.3389/fphar.2021.649143
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale.
Cohen F, Yuan H, Silberstein SD. · · 2022 · cited 28× · PMID 35476215 · DOI 10.1007/s40259-022-00530-0
The Arrival of Anti-CGRP Monoclonal Antibodies in Migraine.
Cohen F, Yuan H, DePoy EMG, Silberstein SD. · · 2022 · cited 28× · PMID 35426060 · DOI 10.1007/s13311-022-01230-x
Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Score Improvement in Japanese Patients with Episodic Migraine by Galcanezumab Treatment: Japan Phase 2 Study.
Shibata M, Nakamura T, Ozeki A, Ueda K, et al · · 2020 · cited 12× · PMID 33408512 · DOI 10.2147/jpr.s287781
Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine.
Igarashi H, Shibata M, Ozeki A, Day KA, et al · · 2021 · cited 9× · PMID 34815708 · DOI 10.2147/jpr.s326905
Galcanezumab Effects on Migraine Severity and Symptoms in Japanese Patients with Episodic Migraine: Secondary Analysis of a Phase 2 Randomized Trial.
Igarashi H, Shibata M, Ozeki A, Matsumura T. · · 2023 · cited 7× · PMID 36266558 · DOI 10.1007/s40120-022-00410-3
Once-monthly galcanezumab for the prevention of migraine in adults: an evidence-based descriptive review and potential place in therapy.
Lupi C, Guerzoni S, Negro A, Benemei S. · · 2019 · cited 7× · PMID 31043785 · DOI 10.2147/tcrm.s159690
Increased infection risk in patients on preventive CGRP-targeting therapies- a meta-analysis and clinical effect assessment.
Straburzyński M, Kopyt D, Marschollek K, Błaszczyk B, et al · · 2025 · cited 5× · PMID 40281424 · DOI 10.1186/s10194-025-02040-0

Verify or expand the search:

Other trials of Galcanezumab

Trials testing the same drug.

NCT07323927 — Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease · EARLY_PHASE1 · recruiting
NCT05492695 — Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study · Phase 4 · terminated
NCT05281770 — Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study · unknown
NCT05284019 — Real World Effectiveness of Eptinezumab in Participants With Migraine · Phase 4 · terminated
NCT05127486 — A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine · Phase 4 · completed

Other recruiting trials for Migraine

Currently open trials in the same condition.

NCT07419607 — MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducat · NA · recruiting
NCT07487701 — Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study · NA · active not recruiting
NCT07343427 — Impact of GON PRF on Central Sensitization in Migraine Patients · NA · active not recruiting
NCT07336056 — Nerivio Efficacy Under High-Frequency Use · Phase 4 · active not recruiting
NCT07385755 — Desvenlafaxine for Preventive Treatment of Frequent Migraines · NA · active not recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02959177 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 27 April 2021

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/NCT02959177.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing