CClinicalTrials.gg
Sign In
CompletedNCT02614183EVOLVE-1Updated Jun 17, 2020Results posted

Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study

A Phase 3 interventional study of Galcanezumab and Placebo in Migraine, sponsored by Eli Lilly and Company. Completed at 95 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-17.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
862
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with episodic migraine.

02

Conditions studied

  • Migraine

Browse trials for

Keywords

  • prevention
  • prophylaxis
  • headache
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 862 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine Headache Days (MHD).

Exclusion criteria

Exclusion Criteria:

  • Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
  • Current use or prior exposure to Galcanezumab or another CGRP antibody.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab.
  • History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
862 participants (actual)

Study arms

  • Experimental
    Galcanezumab 120mg

    Galcanezumab given by subcutaneous (SC) injection at 120mg dose once a month for 6 months. Participants received a loading dose of 240mg (2 injections of 120mg each) was administered at visit 3 only.

    Drug: Galcanezumab

  • Experimental
    Galcanezumab 240mg

    Galcanezumab 240mg given by SC injection once a month for 6 months.

    Drug: Galcanezumab

  • Placebo comparator
    Placebo

    Placebo given by SC injection once a month for 6 months.

    Drug: Placebo

Interventions

  • DrugGalcanezumab

    Administered SC

    Also known as: LY2951742

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days

    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; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.

    Time frame: Baseline, Month 1 through Month 6

Secondary outcomes

  1. Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

    Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Mean 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, baseline.

    Time frame: Baseline, Month 1 through Month 6

  2. Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain

    MSQ v2.1 was developed to address physical \& emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 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 the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month \& baseline MHD category as fixed factors.

    Time frame: Baseline, Month 4 through Month 6

  3. Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache

    Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.

    Time frame: Baseline, Month 1 through Month 6

  4. Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating

    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. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.

    Time frame: Baseline, Month 4 through Month 6

  5. Overall Mean Change From Baseline in Headache Hours

    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 MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.

    Time frame: Baseline, Month 1 through Month 6

  6. Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score

    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 disability. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.

    Time frame: Baseline, Month 6

  7. Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab

    Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer \>= 1: 20.

    Time frame: Month 1 through Month 6

  8. Pharmacokinetics (PK): Serum Concentrations of Galcanezumab

    Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.

    Time frame: Month 6

  9. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

    Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).

    Time frame: Month 6

07

Results

Posted Nov 29, 2018

Participant flow

Double Blind Treatment Phase
Participant flow — Double Blind Treatment Phase
MilestonePlaceboGalcanezumab 120mgGalcanezumab 240mg
Started434214214
Received at least one dose of study drug433213212
Safety population432206220
Completed351177175
Not completed833739
Withdrew: Adverse event1097
Withdrew: Lack of efficacy1012
Withdrew: Lost to follow-up1895
Withdrew: Physician decision732
Withdrew: Pregnancy213
Withdrew: Protocol violation222
Withdrew: Withdrawal by subject331116
Withdrew: Did not receive study drug112
Post Treatment Follow-up Phase
Participant flow — Post Treatment Follow-up Phase
MilestonePlaceboGalcanezumab 120mgGalcanezumab 240mg
Started372185183
Safety population372183185
Completed354179171
Not completed18612
Withdrew: Lost to follow-up535
Withdrew: Physician decision512
Withdrew: Protocol violation100
Withdrew: Withdrawal by subject725

Outcome measures

PrimaryOverall Mean Change From Baseline in the Number of Monthly Migraine Headache Days

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; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.

Time frame:
Baseline, Month 1 through Month 6
Reported as:
Least squares mean · Days
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
DaysPlaceboGalcanezumab 120mgGalcanezumab 240mg
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days-2.81 ± 0.24-4.73 ± 0.29-4.57 ± 0.29
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -1.92 · 95% CI -2.48 to -1.37
  • Placebo vs Galcanezumab 240mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -1.76 · 95% CI -2.31 to -1.20
SecondaryMean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Mean 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, baseline.

Time frame:
Baseline, Month 1 through Month 6
Reported as:
Mean · percentage of participants
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
percentage of participantsPlaceboGalcanezumab 120mgGalcanezumab 240mg
≥50%38.6 ± 1.762.3 ± 2.460.9 ± 2.5
≥75%19.3 ± 1.438.8 ± 2.438.5 ± 2.4
100%6.2 ± 0.815.6 ± 1.614.6 ± 1.6
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Odds ratio (or): 2.63 · 95% CI 2.05 to 3.37
  • Placebo vs Galcanezumab 240mg · Odds ratio (or): 2.48 · 95% CI 1.94 to 3.18
  • Placebo vs Galcanezumab 120mg · Odds ratio (or): 2.65 · 95% CI 2.04 to 3.45
  • Placebo vs Galcanezumab 240mg · Odds ratio (or): 2.62 · 95% CI 2.01 to 3.41
  • Placebo vs Galcanezumab 120mg · Odds ratio (or): 2.80 · 95% CI 1.96 to 4.01
  • Placebo vs Galcanezumab 240mg · Odds ratio (or): 2.61 · 95% CI 1.81 to 3.75
SecondaryMean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain

MSQ v2.1 was developed to address physical \& emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 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 the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month \& baseline MHD category as fixed factors.

Time frame:
Baseline, Month 4 through Month 6
Reported as:
Least squares mean · units on a scale
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain
units on a scalePlaceboGalcanezumab 120mgGalcanezumab 240mg
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain24.69 ± 1.0732.43 ± 1.3132.09 ± 1.32
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): 7.74 · 95% CI 5.20 to 10.28
  • Placebo vs Galcanezumab 240mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): 7.40 · 95% CI 4.83 to 9.97
SecondaryOverall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.

Time frame:
Baseline, Month 1 through Month 6
Reported as:
Least squares mean · Days
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
DaysPlaceboGalcanezumab 120mgGalcanezumab 240mg
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache-2.15 ± 0.21-3.96 ± 0.25-3.76 ± 0.26
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -1.81 · 95% CI -2.28 to -1.33
  • Placebo vs Galcanezumab 240mg · Mixed Models Analysis · p = <.001 · Odds ratio (or): -1.61 · 95% CI -2.09 to -1.14
SecondaryMean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating

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. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.

Time frame:
Baseline, Month 4 through Month 6
Reported as:
Least squares mean · units on a scale
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating
units on a scalePlaceboGalcanezumab 120mgGalcanezumab 240mg
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating-1.27 ± 0.08-1.59 ± 0.10-1.55 ± 0.10
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -0.32 · 95% CI -0.52 to -0.12
  • Placebo vs Galcanezumab 240mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -0.28 · 95% CI -0.48 to -0.07
SecondaryOverall Mean Change From Baseline in Headache Hours

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 MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.

Time frame:
Baseline, Month 1 through Month 6
Reported as:
Least squares mean · Hours per Month
Overall Mean Change From Baseline in Headache Hours
Hours per MonthPlaceboGalcanezumab 120mgGalcanezumab 240mg
Overall Mean Change From Baseline in Headache Hours-15.67 ± 2.24-29.65 ± 2.70-29.31 ± 2.72
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -13.98 · 95% CI -18.99 to -8.97
  • Placebo vs Galcanezumab 240mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -13.64 · 95% CI -18.68 to -8.60
SecondaryMean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score

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 disability. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.

Time frame:
Baseline, Month 6
Reported as:
Least squares mean · units on a scale
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
units on a scalePlaceboGalcanezumab 120mgGalcanezumab 240mg
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score-14.87 ± 1.37-21.16 ± 1.65-20.06 ± 1.68
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -6.29 · 95% CI -9.45 to -3.13
  • Placebo vs Galcanezumab 240mg · Mixed Models Analysis · p = <.001 · Mean difference (final values): -5.19 · 95% CI -8.39 to -1.98
SecondaryPercentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab

Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer \>= 1: 20.

Time frame:
Month 1 through Month 6
Reported as:
Number · percentage of participants
Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab
percentage of participantsPlaceboGalcanezumab 120mgGalcanezumab 240mg
TE ADA+1.663.475.16
Neutralizing Antibodies1.423.475.16
Statistical analysis
  • Placebo vs Galcanezumab 120mg · Fisher Exact · p = <.160
  • Placebo vs Galcanezumab 240mg · Fisher Exact · p = .020
  • Placebo vs Galcanezumab 120mg · Fisher Exact · p = .131
  • Placebo vs Galcanezumab 240mg · Fisher Exact · p = .009
SecondaryPharmacokinetics (PK): Serum Concentrations of Galcanezumab

Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.

Time frame:
Month 6
Reported as:
Mean · Nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab
Nanogram per milliliter (ng/mL)Galcanezumab 120mgGalcanezumab 240mg
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab15400 ± 834029500 ± 12300
SecondaryPlasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).

Time frame:
Month 6
Reported as:
Mean · ng/mL
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
ng/mLPlaceboGalcanezumab 120mgGalcanezumab 240mg
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)0.888 ± 1.894.25 ± 1.795.13 ± 2.43

Adverse events

Collected over Up to 10 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo - Treatment Phase0/433 (0%)5/432 (1.2%)129/432 (29.9%)
Galcanezumab 120mg - Treatment Phase0/213 (0%)6/206 (2.9%)63/206 (30.6%)
Galcanezumab 240mg - Treatment Phase0/212 (0%)0/220 (0%)72/220 (32.7%)
Placebo - Post-Treatment Phase0/372 (0%)2/372 (0.5%)22/372 (5.9%)
Galcanezumab 120mg - Post-Treatment Phase0/185 (0%)4/183 (2.2%)12/183 (6.6%)
Galcanezumab 240mg - Post-Treatment Phase0/183 (0%)4/185 (2.2%)12/185 (6.5%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventPlacebo - Treatment PhaseGalcanezumab 120mg - Treatment PhaseGalcanezumab 240mg - Treatment PhasePlacebo - Post-Treatment PhaseGalcanezumab 120mg - Post-Treatment PhaseGalcanezumab 240mg - Post-Treatment Phase
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/3610/1750/1820/3111/1560/156
Abortion missedPregnancy, puerperium and perinatal conditions0/3610/1750/1820/3110/1561/156
Pre-eclampsiaPregnancy, puerperium and perinatal conditions0/3610/1750/1820/3111/1560/156
VomitingGastrointestinal disorders0/4320/2060/2200/3721/1830/185
Tonsil cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/4320/2060/2200/3721/1830/185
Cardiac failure congestiveCardiac disorders0/4320/2060/2200/3720/1831/185
CardiomyopathyCardiac disorders0/4320/2060/2200/3720/1831/185
Inner ear disorderEar and labyrinth disorders0/4320/2060/2200/3720/1831/185
Adjustment disorder with mixed anxiety and depressed moodPsychiatric disorders0/4320/2060/2200/3720/1831/185
Pancreatitis acuteGastrointestinal disorders0/4321/2060/2200/3720/1830/185
Most frequent other events
Most frequent other events
EventPlacebo - Treatment PhaseGalcanezumab 120mg - Treatment PhaseGalcanezumab 240mg - Treatment PhasePlacebo - Post-Treatment PhaseGalcanezumab 120mg - Post-Treatment PhaseGalcanezumab 240mg - Post-Treatment Phase
Injection site painGeneral disorders75/43233/20645/2200/3720/1830/185
Viral upper respiratory tract infectionInfections and infestations29/43219/2068/2203/3723/1837/185
Upper respiratory tract infectionInfections and infestations31/4329/20615/22012/3726/1835/185
Urinary tract infectionInfections and infestations15/4328/20613/2208/3723/1830/185
Injection site reactionGeneral disorders4/4327/20612/2200/3720/1830/185

Baseline characteristics

All randomized participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)PlaceboGalcanezumab 120mgGalcanezumab 240mgTotal
Mean41.33 ± 11.4040.93 ± 11.8739.07 ± 11.5240.67 ± 11.57
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboGalcanezumab 120mgGalcanezumab 240mgTotal
Female362181175718
Male713237140
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboGalcanezumab 120mgGalcanezumab 240mgTotal
Hispanic or Latino582737122
Not Hispanic or Latino359180171710
Unknown or Not Reported166426
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboGalcanezumab 120mgGalcanezumab 240mgTotal
American Indian or Alaska Native0033
Asian137424
Native Hawaiian or Other Pacific Islander1023
Black or African American42292394
White356169165690
More than one race2181544
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)PlaceboGalcanezumab 120mgGalcanezumab 240mgTotal
Canada44202185
Puerto Rico115420
United States378188187753
Migraine Headache Days (MHD) per month
Migraine Headache Days (MHD) per month(Days per Month)PlaceboGalcanezumab 120mgGalcanezumab 240mgTotal
Mean9.08 ± 2.979.21 ± 3.059.14 ± 2.919.13 ± 2.97
08

Study locations

95 sites
  • Territory Neurology & Research Institute
    Tucson, Arizona 85704, United States
  • Orange Grove Family Practice
    Tucson, Arizona 85741, United States
  • Arkansas Clinical Research
    Little Rock, Arkansas 72205, United States
  • Advanced Clinical Research
    Carmichael, California 95608, United States
  • Pharmacology Research Institute, Newport Beach
    Encino, California 91316, United States
  • Tooraj Joseph Raoof M.D., Inc.
    Encino, California 91436, United States
  • Fullerton Neurology and Headache Center
    Fullerton, California 92835, United States
  • Sun Valley Research Center
    Imperial, California 92251, United States
  • Irvine Clinical Research Center
    Irvine, California 92618, United States
  • Pharmacology Research Institute, Newport Beach
    Los Alamitos, California 90720, United States
  • Pharmacology Research Institute, Newport Beach
    Newport Beach, California 92660, United States
  • Desert Valley Research
    Rancho Mirage, California 92270, United States
  • Anderson Clinical Research
    Redlands, California 92374, United States
  • Artemis Institute for Clinical Research
    San Diego, California 92103, United States
  • Medical Center for Clinical Research
    San Diego, California 92108, United States
  • Alpine Clinical Research Center
    Boulder, Colorado 80301, United States
  • MCB Clinical Research Centers
    Colorado Springs, Colorado 80910, United States
  • Mile High Research Center
    Denver, Colorado 80218, United States
  • Colorado Neurological Institute
    Englewood, Colorado 80113, United States
  • Advanced Neurosciences Research, LLC
    Fort Collins, Colorado 80528, United States
  • Chase Medical Research, LLC
    Waterbury, Connecticut 06708, United States
  • Meridien Research
    Bradenton, Florida 34201, United States
  • Sarkis Clinical Trials
    Gainesville, Florida 32607, United States
  • Suncoast Clinical Research
    New Port Richey, Florida 34652, United States
  • Renstar Medical Research
    Ocala, Florida 34471, United States
  • Sensible Healthcare
    Ocoee, Florida 34761, United States
  • Psychiatric Inst of Florida-Clinical Neuroscience Solutions
    Orlando, Florida 32801, United States
  • Compass Research
    Oviedo, Florida 32765, United States
  • Accord Clinical Research, LLC
    Port Orange, Florida 32129, United States
  • Roskamp Institute
    Sarasota, Florida 34243, United States
  • Infinity Clinical Reserach . LLC
    Sunrise, Florida 33351, United States
  • Premiere Research Institute at Palm Beach Neurology
    West Palm Beach, Florida 33407, United States
  • Advanced Clinical Research LLC
    Meridian, Idaho 83642, United States
  • Healthcare Research Network - Blue Island
    Blue Island, Illinois 60406, United States
  • Community Clinical Research Center
    Anderson, Indiana 46011, United States
  • Investigative Clinical Research of Indiana, LLC
    Elwood, Indiana 46036, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • Deaconess Clinic Inc
    Newburgh, Indiana 47630, United States
  • Integrated Clinical Trial Services, Inc.
    West Des Moines, Iowa 50265, United States
  • Phoenix Medical Research, Inc
    Prairie Village, Kansas 66206, United States
  • Otri-Med Corporation
    Edgewood, Kentucky 41017, United States
  • L-Marc Research Center
    Louisville, Kentucky 40213, United States
  • PharmaSite Research Inc
    Baltimore, Maryland 21208, United States
  • Boston Clinical Trials Inc
    Boston, Massachusetts 02131, United States
  • Michigan Head, Pain and Neurological Institute
    Ann Arbor, Michigan 48104, United States
  • Clinical Research Institute
    Minneapolis, Minnesota 55402, United States
  • ClinVest
    Springfield, Missouri 65807, United States
  • Healthy Perspectives Innovative Mental Health Services, PL
    Nashua, New Hampshire 03060, United States
  • Albuquerque Clinical Trials
    Albuquerque, New Mexico 87102, United States
  • Dent Neurological Institute
    Amherst, New York 14226, United States
  • Central New York Clinical Research
    Manlius, New York 13104, United States
  • NYU Langone
    New York, New York 10016, United States
  • Fieve Clincial Services
    New York, New York 10168, United States
  • Rochester Clinical Research, Inc.
    Rochester, New York 14609, United States
  • Metrolina Neurological Associates, PA
    Charlotte, North Carolina 28210, United States
  • Headache Wellness Center
    Greensboro, North Carolina 27405, United States
  • Rapid Medical Research Inc
    Cleveland, Ohio 44122, United States
  • Medical College of Ohio at Toledo
    Toledo, Ohio 43614, United States
  • Healthcare Research Consultant
    Tulsa, Oklahoma 74135, United States
  • Summit Research Network Inc
    Portland, Oregon 97210, United States
  • Lehigh Center for Clinical Research
    Allentown, Pennsylvania 18104, United States
  • Preferred Primary Care Physicians
    Pittsburgh, Pennsylvania 15236, United States
  • Abington Neurological Associates
    Willow Grove, Pennsylvania 19090, United States
  • Omega Medical Research
    Warwick, Rhode Island 02886, United States
  • Clinical Trials of South Carolina
    Charleston, South Carolina 29406, United States
  • 8 Medical Park
    Columbia, South Carolina 29203, United States
  • ClinSearch
    Chattanooga, Tennessee 37421, United States
  • University of Tennessee Medical Center
    Knoxville, Tennessee 37920, United States
  • Clinical Research Associates
    Nashville, Tennessee 37203, United States
  • FutureSearch Trials
    Austin, Texas 78731, United States
  • Protenium Clinical Research
    Hurst, Texas 76054, United States
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
  • Radiant Research - San Antonio
    San Antonio, Texas 78229, United States
  • Advanced Clinical Research
    West Jordan, Utah 84088, United States
  • Charlottesville Medical Research
    Charlottesville, Virginia 22911, United States
  • Clinical Research Associates of Tidewater
    Norfolk, Virginia 23507, United States
  • National Clinical Research - Richmond
    Richmond, Virginia 23294, United States
  • Premier Clinical Research
    Spokane, Washington 99202, United States
  • Vancouver Clinic
    Vancouver, Washington 98664, United States
  • Clinical Investigation Specialists Inc
    Kenosha, Wisconsin 53142, United States
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Brampton, L6T 0G1, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Kelowna, V1Y 1Z9, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Mississauga, L4Y 2N8, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Montreal, H3A 2B4, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Ottawa, K2G 6E2, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Sherbrooke, J1H1Z1, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Toronto, M9W 4L6, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Vancouver, V6Z 2E8, Canada
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
    Waterloo, N2J 1C4, Canada
  • Office of Dr. Ruddy Guerra
    Manati, 00674, Puerto Rico
  • NuFrontiers Clinical Research LLC
    Rio Piedras, 00923, Puerto Rico
  • Clinical Research Puerto Rico, Inc.
    San Juan, 00909, Puerto Rico
  • GCM Medical Group PSC
    San Juan, 00909, Puerto Rico
  • Instituto de Neurologia Dra. Ivonne Fraga
    San Juan, 00918, Puerto Rico
  • Neuro GI Wellness Center
    San Juan, 00926, Puerto Rico
09

References and documents

Publications

  • Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25. PubMed 35076090 ↗
  • Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15. PubMed 34264500 ↗
  • Jedynak J, Eross E, Gendolla A, Rettiganti M, Stauffer VL. Shift from high-frequency to low-frequency episodic migraine in patients treated with Galcanezumab: results from two global randomized clinical trials. J Headache Pain. 2021 May 28;22(1):48. doi: 10.1186/s10194-021-01222-w. PubMed 34049484 ↗
  • Pozo-Rosich P, Samaan KH, Schwedt TJ, Nicholson RA, Rettiganti M, Pearlman EM. Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis. Adv Ther. 2021 Jun;38(6):3154-3165. doi: 10.1007/s12325-021-01708-8. Epub 2021 May 5. PubMed 33950375 ↗
  • Ament M, Day K, Stauffer VL, Skljarevski V, Rettiganti M, Pearlman E, Aurora SK. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021 Feb 6;22(1):6. doi: 10.1186/s10194-021-01215-9. Erratum In: J Headache Pain. 2021 Aug 26;22(1):100. doi: 10.1186/s10194-021-01307-6. PubMed 33549036 ↗
  • Kuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL. Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials. Adv Ther. 2021 Mar;38(3):1614-1626. doi: 10.1007/s12325-021-01632-x. Epub 2021 Feb 5. PubMed 33544305 ↗
  • Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3. PubMed 33143451 ↗
  • Ailani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020 Oct 17;21(1):123. doi: 10.1186/s10194-020-01190-7. PubMed 33069214 ↗
  • Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9. PubMed 32576229 ↗
  • Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7. Erratum In: BMC Neurol. 2020 Mar 13;20(1):90. doi: 10.1186/s12883-020-01675-7. PubMed 31952501 ↗
  • Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4. PubMed 31482569 ↗
  • Silberstein SD, Stauffer VL, Day KA, Lipsius S, Wilson MC. Galcanezumab in episodic migraine: subgroup analyses of efficacy by high versus low frequency of migraine headaches in phase 3 studies (EVOLVE-1 & EVOLVE-2). J Headache Pain. 2019 Jun 28;20(1):75. doi: 10.1186/s10194-019-1024-x. Erratum In: J Headache Pain. 2019 Dec 27;20(1):118. doi: 10.1186/s10194-019-1069-x. PubMed 31253091 ↗
  • Stauffer VL, Wang S, Voulgaropoulos M, Skljarevski V, Kovacik A, Aurora SK. Effect of Galcanezumab Following Treatment Cessation in Patients With Migraine: Results From 2 Randomized Phase 3 Trials. Headache. 2019 Jun;59(6):834-847. doi: 10.1111/head.13508. Epub 2019 Apr 3. PubMed 30942898 ↗
  • Forderreuther S, Zhang Q, Stauffer VL, Aurora SK, Lainez MJA. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018 Dec 29;19(1):121. doi: 10.1186/s10194-018-0951-2. PubMed 30594122 ↗
  • Nichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK. Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Headache. 2019 Feb;59(2):192-204. doi: 10.1111/head.13443. Epub 2018 Nov 21. PubMed 30462830 ↗
  • Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212. Erratum In: JAMA Neurol. 2019 Jul 1;76(7):872. doi: 10.1001/jamaneurol.2019.1177. PubMed 29813147 ↗

Study documents

  • Study protocol · Sep 23, 2015
  • Statistical analysis plan · Apr 25, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02614183
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 25, 2015
Start date
Nov 30, 2015
Primary completion
Mar 22, 2017
Completion
Aug 9, 2018
Results posted
Nov 29, 2018
Last update
Jun 17, 2020

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Migraine Disorders→

Other studies from this sponsor

Eli Lilly and Company

Start the discussion