Migraine
Conditions
Keywords
prevention, prophylaxis, headache
Brief summary
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with episodic migraine.
Interventions
DRUGGalcanezumab
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days | 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; 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain | Baseline, Month 4 through Month 6 | 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. |
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache | Baseline, Month 1 through Month 6 | 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. |
| Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating | 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. 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. |
| Overall Mean Change From Baseline in Headache Hours | 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 MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category. |
| Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | Baseline, Month 1 through Month 6 | 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. |
| Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | Month 1 through Month 6 | 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. |
| Pharmacokinetics (PK): Serum Concentrations of Galcanezumab | Month 6 | Pharmacokinetics (PK): Serum Concentrations of Galcanezumab. |
| Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | Month 6 | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP). |
| Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | 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 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. |
Countries
Canada, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase. | 433 |
| Galcanezumab 120mg Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase. | 213 |
| Galcanezumab 240mg Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase. | 212 |
| Total | 858 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double Blind Treatment Phase | Adverse Event | 10 | 9 | 7 |
| Double Blind Treatment Phase | Did not receive study drug | 1 | 1 | 2 |
| Double Blind Treatment Phase | Lack of Efficacy | 10 | 1 | 2 |
| Double Blind Treatment Phase | Lost to Follow-up | 18 | 9 | 5 |
| Double Blind Treatment Phase | Physician Decision | 7 | 3 | 2 |
| Double Blind Treatment Phase | Pregnancy | 2 | 1 | 3 |
| Double Blind Treatment Phase | Protocol Violation | 2 | 2 | 2 |
| Double Blind Treatment Phase | Withdrawal by Subject | 33 | 11 | 16 |
| Post Treatment Follow-up Phase | Lost to Follow-up | 5 | 3 | 5 |
| Post Treatment Follow-up Phase | Physician Decision | 5 | 1 | 2 |
| Post Treatment Follow-up Phase | Protocol Violation | 1 | 0 | 0 |
| Post Treatment Follow-up Phase | Withdrawal by Subject | 7 | 2 | 5 |
Baseline characteristics
| Characteristic | Galcanezumab 120mg | Total | Placebo | Galcanezumab 240mg |
|---|---|---|---|---|
| Age, Continuous | 40.93 years STANDARD_DEVIATION 11.87 | 40.67 years STANDARD_DEVIATION 11.57 | 41.33 years STANDARD_DEVIATION 11.4 | 39.07 years STANDARD_DEVIATION 11.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 122 Participants | 58 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 180 Participants | 710 Participants | 359 Participants | 171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 26 Participants | 16 Participants | 4 Participants |
| Migraine Headache Days (MHD) per month | 9.21 Days per Month STANDARD_DEVIATION 3.05 | 9.13 Days per Month STANDARD_DEVIATION 2.97 | 9.08 Days per Month STANDARD_DEVIATION 2.97 | 9.14 Days per Month STANDARD_DEVIATION 2.91 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 24 Participants | 13 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 94 Participants | 42 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 44 Participants | 21 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 169 Participants | 690 Participants | 356 Participants | 165 Participants |
| Region of Enrollment Canada | 20 Participants | 85 Participants | 44 Participants | 21 Participants |
| Region of Enrollment Puerto Rico | 5 Participants | 20 Participants | 11 Participants | 4 Participants |
| Region of Enrollment United States | 188 Participants | 753 Participants | 378 Participants | 187 Participants |
| Sex: Female, Male Female | 181 Participants | 718 Participants | 362 Participants | 175 Participants |
| Sex: Female, Male Male | 32 Participants | 140 Participants | 71 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 433 | 0 / 213 | 0 / 212 | 0 / 372 | 0 / 185 | 0 / 183 |
| other Total, other adverse events | 129 / 432 | 63 / 206 | 72 / 220 | 22 / 372 | 12 / 183 | 12 / 185 |
| serious Total, serious adverse events | 5 / 432 | 6 / 206 | 0 / 220 | 2 / 372 | 4 / 183 | 4 / 185 |
Outcome results
Primary
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
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days | -2.81 Days | Standard Error 0.24 |
| Galcanezumab 120mg | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days | -4.73 Days | Standard Error 0.29 |
| Galcanezumab 240mg | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days | -4.57 Days | Standard Error 0.29 |
p-value: <0.00195% CI: [-2.48, -1.37]Mixed Models Analysis
p-value: <0.00195% CI: [-2.31, -1.2]Mixed Models Analysis
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain | 24.69 units on a scale | Standard Error 1.07 |
| Galcanezumab 120mg | Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain | 32.43 units on a scale | Standard Error 1.31 |
| Galcanezumab 240mg | Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain | 32.09 units on a scale | Standard Error 1.32 |
p-value: <0.00195% CI: [5.2, 10.28]Mixed Models Analysis
p-value: <0.00195% CI: [4.83, 9.97]Mixed Models Analysis
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating | -1.27 units on a scale | Standard Error 0.08 |
| Galcanezumab 120mg | Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating | -1.59 units on a scale | Standard Error 0.1 |
| Galcanezumab 240mg | Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating | -1.55 units on a scale | Standard Error 0.1 |
p-value: <0.00195% CI: [-0.52, -0.12]Mixed Models Analysis
p-value: <0.00195% CI: [-0.48, -0.07]Mixed Models Analysis
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -14.87 units on a scale | Standard Error 1.37 |
| Galcanezumab 120mg | Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -21.16 units on a scale | Standard Error 1.65 |
| Galcanezumab 240mg | Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -20.06 units on a scale | Standard Error 1.68 |
p-value: <0.00195% CI: [-9.45, -3.13]Mixed Models Analysis
p-value: <0.00195% CI: [-8.39, -1.98]Mixed Models Analysis
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | ≥75% | 19.3 percentage of participants | Standard Error 1.4 |
| Placebo | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | ≥50% | 38.6 percentage of participants | Standard Error 1.7 |
| Placebo | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | 100% | 6.2 percentage of participants | Standard Error 0.8 |
| Galcanezumab 120mg | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | ≥75% | 38.8 percentage of participants | Standard Error 2.4 |
| Galcanezumab 120mg | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | ≥50% | 62.3 percentage of participants | Standard Error 2.4 |
| Galcanezumab 120mg | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | 100% | 15.6 percentage of participants | Standard Error 1.6 |
| Galcanezumab 240mg | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | ≥50% | 60.9 percentage of participants | Standard Error 2.5 |
| Galcanezumab 240mg | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | 100% | 14.6 percentage of participants | Standard Error 1.6 |
| Galcanezumab 240mg | Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | ≥75% | 38.5 percentage of participants | Standard Error 2.4 |
Comparison: Reduction from Baseline ≥50%95% CI: [2.05, 3.37]
Comparison: Reduction from Baseline ≥50%95% CI: [1.94, 3.18]
Comparison: Reduction from Baseline ≥75%95% CI: [2.04, 3.45]
Comparison: Reduction from Baseline ≥75%95% CI: [2.01, 3.41]
Comparison: Reduction from Baseline = 100%95% CI: [1.96, 4.01]
Comparison: Reduction from Baseline = 100%95% CI: [1.81, 3.75]
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Overall Mean Change From Baseline in Headache Hours | -15.67 Hours per Month | Standard Error 2.24 |
| Galcanezumab 120mg | Overall Mean Change From Baseline in Headache Hours | -29.65 Hours per Month | Standard Error 2.7 |
| Galcanezumab 240mg | Overall Mean Change From Baseline in Headache Hours | -29.31 Hours per Month | Standard Error 2.72 |
p-value: <0.00195% CI: [-18.99, -8.97]Mixed Models Analysis
p-value: <0.00195% CI: [-18.68, -8.6]Mixed Models Analysis
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 Days | Standard Error 0.21 |
| Galcanezumab 120mg | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache | -3.96 Days | Standard Error 0.25 |
| Galcanezumab 240mg | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache | -3.76 Days | Standard Error 0.26 |
p-value: <0.00195% CI: [-2.28, -1.33]Mixed Models Analysis
p-value: <0.00195% CI: [-2.09, -1.14]Mixed Models Analysis
Secondary
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
Population: All randomized participants who received at least one dose of study drug and had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | TE ADA+ | 1.66 percentage of participants |
| Placebo | Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | Neutralizing Antibodies | 1.42 percentage of participants |
| Galcanezumab 120mg | Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | TE ADA+ | 3.47 percentage of participants |
| Galcanezumab 120mg | Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | Neutralizing Antibodies | 3.47 percentage of participants |
| Galcanezumab 240mg | Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | TE ADA+ | 5.16 percentage of participants |
| Galcanezumab 240mg | Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab | Neutralizing Antibodies | 5.16 percentage of participants |
Comparison: TE ADA Positive.p-value: <0.16Fisher Exact
Comparison: TE ADA Positive.p-value: 0.02Fisher Exact
Comparison: Neutralizing Antibodies.p-value: 0.131Fisher Exact
Comparison: Neutralizing Antibodies.p-value: 0.009Fisher Exact
Secondary
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.
Time frame: Month 6
Population: All randomized participants who received at least one dose of study drug and had measurable serum concentrations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Serum Concentrations of Galcanezumab | 15400 Nanogram per milliliter (ng/mL) | Standard Deviation 8340 |
| Galcanezumab 120mg | Pharmacokinetics (PK): Serum Concentrations of Galcanezumab | 29500 Nanogram per milliliter (ng/mL) | Standard Deviation 12300 |
Secondary
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Time frame: Month 6
Population: All randomized participants who had received at least one dose of study drug and had measurable plasma concentrations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | 0.888 ng/mL | Standard Deviation 1.89 |
| Galcanezumab 120mg | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | 4.25 ng/mL | Standard Deviation 1.79 |
| Galcanezumab 240mg | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | 5.13 ng/mL | Standard Deviation 2.43 |