NCT02959190 is a Phase 3 clinical trial of Galcanezumab in Migraine, sponsored by Eli Lilly and Company.

Who is sponsoring NCT02959190?

NCT02959190 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT02959190?

Interventions in NCT02959190: Galcanezumab.

Is NCT02959190 still recruiting?

NCT02959190 is currently completed. Last updated 29 September 2020.

Are results published for NCT02959190?

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

Last reviewed 2020-09-29 · How we verify

NCT02959190

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 Migraine

Completed Phase 3 Results posted Last updated 29 September 2020

What this trial tests

Phase 3 trial testing Galcanezumab in Migraine in 311 participants. Completed in 10 August 2019.

Timeline

7 February 2017

Primary endpoint
10 August 2019

10 August 2019

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	311
Start date	7 February 2017
Primary completion	10 August 2019
Estimated completion	10 August 2019
Sites	44 locations across Japan

Drugs / interventions tested

Galcanezumab (GALCANEZUMAB) — full drug profile →

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.

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · Up To 16 Months

A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.

Any TEAE

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	54
240mg/240mg Galcanezumab - EM	56
Placebo/ 120mg Galcanezumab - EM	54
Placebo/ 240mg Galcanezumab - EM	61
120mg Galcanezumab - CM	31
240mg Galcanezumab - CM	29

Any SAE

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	2
240mg/240mg Galcanezumab - EM	0
Placebo/ 120mg Galcanezumab - EM	2
Placebo/ 240mg Galcanezumab - EM	2
120mg Galcanezumab - CM	1
240mg Galcanezumab - CM	2

Pharmacokinetics (PK): Serum Concentration of Galcanezumab Secondary · Month 12: Predose

Serum Concentration of Galcanezumab at month 12 is reported.

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	21100	± 6120
240mg/240mg Galcanezumab - EM	46000	± 15300
Placebo/ 120mg Galcanezumab - EM	21000	± 7290
Placebo/ 240mg Galcanezumab - EM	42200	± 12400
120mg Galcanezumab - CM	20100	± 8550
240mg Galcanezumab - CM	39600	± 13600

Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) Secondary · Month 12: Predose

Plasma Concentration of total CGRP at month 12 is reported.

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	4.51	± 1.26
240mg/240mg Galcanezumab - EM	5.87	± 1.45
Placebo/ 120mg Galcanezumab - EM	4.69	± 1.45
Placebo/ 240mg Galcanezumab - EM	5.59	± 1.45
120mg Galcanezumab - CM	4.37	± 1.40
240mg Galcanezumab - CM	5.19	± 1.52

Percentage of Participants Developing Anti-Drug Antibodies (ADA) Secondary · Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose

Treatment emergent ADA will be defined as any of the following: A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA. A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	12.07
240mg/240mg Galcanezumab - EM	9.68
Placebo/ 120mg Galcanezumab - EM	16.13
Placebo/ 240mg Galcanezumab - EM	10.94
120mg Galcanezumab - CM	12.50
240mg Galcanezumab - CM	18.18

Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) Secondary · Baseline, Month 12

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache (EM Participants): 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. Migraine Headache (CM Particip

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	-1.82	± 2.96
240mg/240mg Galcanezumab - EM	-1.49	± 4.11
Placebo/ 120mg Galcanezumab - EM	-4.29	± 4.07
Placebo/ 240mg Galcanezumab - EM	-3.23	± 5.81
120mg Galcanezumab - CM	-9.44	± 6.16
240mg Galcanezumab - CM	-8.97	± 8.06

Mean Change From Baseline in the Number of Headache Days (HDs) Secondary · Baseline, Month 12

A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	-2.37	± 3.62
240mg/240mg Galcanezumab - EM	-1.75	± 4.57
Placebo/ 120mg Galcanezumab - EM	-5.04	± 4.71
Placebo/ 240mg Galcanezumab - EM	-4.00	± 5.14
120mg Galcanezumab - CM	-9.30	± 6.83
240mg Galcanezumab - CM	-9.42	± 8.37

Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days Secondary · Month 12

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.

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	48.9
240mg/240mg Galcanezumab - EM	45.7
Placebo/ 120mg Galcanezumab - EM	52.7
Placebo/ 240mg Galcanezumab - EM	46.4
120mg Galcanezumab - CM	35.7
240mg Galcanezumab - CM	51.9

Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache Secondary · Baseline, Month 12

Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	-1.40	± 2.54
240mg/240mg Galcanezumab - EM	-1.00	± 3.59
Placebo/ 120mg Galcanezumab - EM	-3.87	± 3.84
Placebo/ 240mg Galcanezumab - EM	-3.01	± 5.76
120mg Galcanezumab - CM	-8.36	± 6.29
240mg Galcanezumab - CM	-7.43	± 7.89

Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache Secondary · Baseline, Month 12

Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache: Calendar days on which headache, migraine or probable migraine occurs, requiring acute medication.

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	-1.62	± 3.21
240mg/240mg Galcanezumab - EM	-1.17	± 3.89
Placebo/ 120mg Galcanezumab - EM	-4.47	± 4.81
Placebo/ 240mg Galcanezumab - EM	-3.43	± 5.53
120mg Galcanezumab - CM	-8.21	± 6.84
240mg Galcanezumab - CM	-7.48	± 8.21

Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score Secondary · Baseline, Month 12

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").

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	-0.29	± 0.76
240mg/240mg Galcanezumab - EM	-0.04	± 0.76
Placebo/ 120mg Galcanezumab - EM	-0.02	± 0.66
Placebo/ 240mg Galcanezumab - EM	0.11	± 0.77
120mg Galcanezumab - CM	-0.07	± 1.59
240mg Galcanezumab - CM	-0.81	± 1.14

Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score Secondary · Baseline, Month 12

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
120mg/120mg Galcanezumab - EM	-0.38	± 8.99
240mg/240mg Galcanezumab - EM	-0.42	± 15.94
Placebo/ 120mg Galcanezumab - EM	-8.67	± 17.39
Placebo/ 240mg Galcanezumab - EM	-4.60	± 12.77
120mg Galcanezumab - CM	-20.71	± 32.66
240mg Galcanezumab - CM	-15.48	± 32.26

Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Secondary · Baseline, Month 12

MSQ version 2.1 is a health status instrument,with a 4-week recall period,developed to address physical \& emotional limitations of specific concern to individuals with migraine.Addressing the impact of migraine on work or daily activities,relationships with family \& friends,leisure time,productivity,concentration, energy,tiredness \& feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);\&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6)

Total Score

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	1.02	± 8.68
240mg/240mg Galcanezumab - EM	0.38	± 11.97
Placebo/ 120mg Galcanezumab - EM	7.51	± 10.58
Placebo/ 240mg Galcanezumab - EM	4.56	± 11.22
120mg Galcanezumab - CM	19.23	± 12.57
240mg Galcanezumab - CM	18.31	± 15.67

Role Function-Restrictive Domain

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	1.68	± 9.77
240mg/240mg Galcanezumab - EM	0.22	± 13.75
Placebo/ 120mg Galcanezumab - EM	8.77	± 12.74
Placebo/ 240mg Galcanezumab - EM	4.96	± 12.60
120mg Galcanezumab - CM	22.65	± 15.08
240mg Galcanezumab - CM	22.96	± 17.69

Role Function-Preventive Domain

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	0.09	± 9.70
240mg/240mg Galcanezumab - EM	0.75	± 13.17
Placebo/ 120mg Galcanezumab - EM	7.16	± 10.18
Placebo/ 240mg Galcanezumab - EM	3.77	± 12.86
120mg Galcanezumab - CM	15.89	± 13.68
240mg Galcanezumab - CM	13.52	± 16.63

Emotional Function Domain

Group	Value	95% CI
120mg/120mg Galcanezumab - EM	0.71	± 10.54
240mg/240mg Galcanezumab - EM	0.25	± 11.47
Placebo/ 120mg Galcanezumab - EM	5.06	± 11.47
Placebo/ 240mg Galcanezumab - EM	4.68	± 12.34
120mg Galcanezumab - CM	15.71	± 13.96
240mg Galcanezumab - CM	13.83	± 17.82

Adverse events — posted to ClinicalTrials.gov

Time frame: Up To 16 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM

Serious: 2/58 (3%)

Deaths: 0/58

240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM

Serious: 0/62 (0%)

Deaths: 0/62

Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM

Serious: 2/62 (3%)

Deaths: 0/62

Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM

Serious: 2/64 (3%)

Deaths: 0/64

120mg Galcanezumab - Open-Label Treatment Phase-CM

Serious: 1/32 (3%)

Deaths: 0/32

240mg Galcanezumab - Open-Label Treatment Phase-CM

Serious: 2/33 (6%)

Deaths: 0/33

120mg Galcanezumab - Post-Treatment Phase - EM

Serious: 2/117 (2%)

Deaths: 0/117

240mg Galcanezumab - Post-Treatment Phase - EM

Serious: 1/120 (1%)

Deaths: 0/120

120mg Galcanezumab - Post-Treatment Phase - CM

Serious: 1/32 (3%)

Deaths: 0/32

240mg Galcanezumab - Post-Treatment Phase - CM

Serious: 1/32 (3%)

Deaths: 0/32

Serious adverse events (10 terms)

Reaction	System	120mg/120mg Galcanezumab -…	240mg/240mg Galcanezumab -…	Placebo/ 120mg Galcanezuma…	Placebo/ 240mg Galcanezuma…	120mg Galcanezumab - Open-…	240mg Galcanezumab - Open-…	120mg Galcanezumab - Post-…	240mg Galcanezumab - Post-…	120mg Galcanezumab - Post-…	240mg Galcanezumab - Post-…
Stress cardiomyopathy	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Cholangitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pelvic inflammatory disease	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Ligament rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Fracture malunion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Uterine polyp	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (315 terms — click to expand)

Reaction	System	120mg/120mg Galcanezumab -…	240mg/240mg Galcanezumab -…	Placebo/ 120mg Galcanezuma…	Placebo/ 240mg Galcanezuma…	120mg Galcanezumab - Open-…	240mg Galcanezumab - Open-…	120mg Galcanezumab - Post-…	240mg Galcanezumab - Post-…	120mg Galcanezumab - Post-…	240mg Galcanezumab - Post-…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Injection site induration	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Gingivitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Injection site rash	General disorders	—	—	—	—	—	—	—	—	—	—
Wound	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Deafness neurosensory	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Vertigo positional	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Asthenopia	Eye disorders	—	—	—	—	—	—	—	—	—	—
Blepharitis	Eye disorders	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site mass	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site warmth	General disorders	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Stress cardiomyopathy, Cholangitis acute, Appendicitis, Pelvic inflammatory disease, Pneumonia, Ligament rupture, Fracture malunion, Intervertebral disc protrusion.

Data from ClinicalTrials.gov NCT02959190 adverse events section.

Sponsor's own description

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.

Publications & conference data

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

A long-term open-label safety study of galcanezumab in Japanese patients with migraine.
Hirata K, Takeshima T, Sakai F, Tatsuoka Y, et al · · 2021 · cited 14× · PMID 33393835 · DOI 10.1080/14740338.2021.1866536
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
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
Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study.
Takeshima T, Doi H, Ooba S, Tanji Y, et al · · 2024 · cited 2× · PMID 38581615 · DOI 10.1007/s40120-024-00602-z
Decoding the long-term safety of anti-CGRP (receptor) mAbs: a meta-analysis and systematic review.
Hoehne CL, Overeem LH, Sanchez-Del-Rio M, Deligianni C, et al · · 2026 · cited 1× · PMID 41484941 · DOI 10.1186/s10194-025-02256-0

Verify or expand the search:

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Currently open trials in the same condition.

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Other Eli Lilly and Company trials

Trials by the same sponsor.

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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 NCT02959190 (US National Library of Medicine, public domain)
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: 29 September 2020

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/NCT02959190.

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

NCT02959190

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Galcanezumab

Other recruiting trials for Migraine

Other Eli Lilly and Company trials

Verify against primary sources