Migraine
Conditions
Keywords
prevention, prophylaxis, headache
Brief summary
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.
Interventions
DRUGGalcanezumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN. * Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Exclusion criteria
* For Chronic Migraine participants: * 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 other antibodies of calcitonin gene-related peptide (CGRP) or its receptor. * Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product. * 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. * Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) | Month 12: Predose | Plasma Concentration of total CGRP at month 12 is reported. |
| Percentage of Participants Developing Anti-Drug Antibodies (ADA) | 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. |
| Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) | 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 Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative. |
| Mean Change From Baseline in the Number of Headache Days (HDs) | 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). |
| Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days | 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. |
| Pharmacokinetics (PK): Serum Concentration of Galcanezumab | Month 12: Predose | Serum Concentration of Galcanezumab at month 12 is reported. |
| 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 | 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. |
| Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score | 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). |
| Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | 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 disability. |
| Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | 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), & 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 scores indicating a better health status & a positive change in scores reflecting functional improvement. |
| Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Month 12 | 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 (5 categories). Preference compared 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 (5 categories). The side effects responses range from significantly less side effects to significantly more side effects (5 categories). Positive responses for each item were defined as follows: Satisfaction: Very Satisfied or Somewhat Satisfied; Preference: Much Prefer Study Medication or Prefer Study Medication; Side Effects: Much-Less Side Effects or Less Side Effects. |
| Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache | Baseline, Month 12 | Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication. |
Countries
Japan
Participant flow
Recruitment details
Episodic migraine (EM) participants rolled over from parental Study I5Q-JE-CGAN (CGAN - NCT02959177)), and chronic migraine (CM) participants were newly enrolled in this CGAP study.
Participants by arm
| Arm | Count |
|---|---|
| 120mg/120mg Galcanezumab - EM 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. | 58 |
| 240mg/240mg Galcanezumab - EM 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. | 62 |
| Placebo/ 120mg Galcanezumab - EM 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. | 62 |
| Placebo/ 240mg Galcanezumab - EM 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. | 64 |
| 120mg Galcanezumab - CM 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. | 32 |
| 240mg Galcanezumab - CM 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. | 33 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Open Label | Adverse Event | 5 | 7 | 3 | 4 |
| Open Label | Physician Decision | 0 | 0 | 1 | 0 |
| Open Label | Pregnancy | 0 | 1 | 0 | 0 |
| Open Label | Protocol Violation | 0 | 0 | 0 | 2 |
| Open Label | Withdrawal by Subject | 2 | 8 | 0 | 0 |
| Post Treatment Follow Up | Adverse Event | 1 | 1 | 0 | 0 |
| Post Treatment Follow Up | Withdrawal by Subject | 2 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 120mg/120mg Galcanezumab - EM | Total | 240mg Galcanezumab - CM | 120mg Galcanezumab - CM | Placebo/ 240mg Galcanezumab - EM | Placebo/ 120mg Galcanezumab - EM | 240mg/240mg Galcanezumab - EM |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.95 years STANDARD_DEVIATION 10.04 | 44.71 years STANDARD_DEVIATION 9.98 | 43.70 years STANDARD_DEVIATION 11.53 | 41.88 years STANDARD_DEVIATION 9.4 | 45.08 years STANDARD_DEVIATION 8.88 | 45.35 years STANDARD_DEVIATION 10.69 | 45.47 years STANDARD_DEVIATION 9.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 311 Participants | 33 Participants | 32 Participants | 64 Participants | 62 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 58 Participants | 311 Participants | 33 Participants | 32 Participants | 64 Participants | 62 Participants | 62 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 58 Participants | 311 Participants | 33 Participants | 32 Participants | 64 Participants | 62 Participants | 62 Participants |
| Sex: Female, Male Female | 48 Participants | 268 Participants | 27 Participants | 32 Participants | 58 Participants | 51 Participants | 52 Participants |
| Sex: Female, Male Male | 10 Participants | 43 Participants | 6 Participants | 0 Participants | 6 Participants | 11 Participants | 10 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 62 | 0 / 62 | 0 / 64 | 0 / 32 | 0 / 33 | 0 / 117 | 0 / 120 | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 54 / 58 | 56 / 62 | 54 / 62 | 61 / 64 | 31 / 32 | 29 / 33 | 40 / 117 | 37 / 120 | 10 / 32 | 13 / 32 |
| serious Total, serious adverse events | 2 / 58 | 0 / 62 | 2 / 62 | 2 / 64 | 1 / 32 | 2 / 33 | 2 / 117 | 1 / 120 | 1 / 32 | 1 / 32 |
Outcome results
Primary
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Time frame: Up To 16 Months
Population: All participants who were randomized and received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any SAE | 2 participants |
| 120mg/120mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 54 participants |
| 240mg/240mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any SAE | 0 participants |
| 240mg/240mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 56 participants |
| Placebo/ 120mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 54 participants |
| Placebo/ 120mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any SAE | 2 participants |
| Placebo/ 240mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any SAE | 2 participants |
| Placebo/ 240mg Galcanezumab - EM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 61 participants |
| 120mg Galcanezumab - CM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any SAE | 1 participants |
| 120mg Galcanezumab - CM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 31 participants |
| 240mg Galcanezumab - CM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any SAE | 2 participants |
| 240mg Galcanezumab - CM | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 29 participants |
Secondary
Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
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).
Time frame: Baseline, Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score | -0.29 score on a scale | Standard Deviation 0.76 |
| 240mg/240mg Galcanezumab - EM | Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score | -0.04 score on a scale | Standard Deviation 0.76 |
| Placebo/ 120mg Galcanezumab - EM | Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score | -0.02 score on a scale | Standard Deviation 0.66 |
| Placebo/ 240mg Galcanezumab - EM | Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score | 0.11 score on a scale | Standard Deviation 0.77 |
| 120mg Galcanezumab - CM | Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score | -0.07 score on a scale | Standard Deviation 1.59 |
| 240mg Galcanezumab - CM | Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score | -0.81 score on a scale | Standard Deviation 1.14 |
Secondary
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.
Time frame: Baseline, Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -0.38 score on a scale | Standard Deviation 8.99 |
| 240mg/240mg Galcanezumab - EM | Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -0.42 score on a scale | Standard Deviation 15.94 |
| Placebo/ 120mg Galcanezumab - EM | Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -8.67 score on a scale | Standard Deviation 17.39 |
| Placebo/ 240mg Galcanezumab - EM | Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -4.60 score on a scale | Standard Deviation 12.77 |
| 120mg Galcanezumab - CM | Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -20.71 score on a scale | Standard Deviation 32.66 |
| 240mg Galcanezumab - CM | Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score | -15.48 score on a scale | Standard Deviation 32.26 |
Secondary
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
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), & 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 scores indicating a better health status & a positive change in scores reflecting functional improvement.
Time frame: Baseline, Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Total Score | 1.02 score on a scale | Standard Deviation 8.68 |
| 120mg/120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Restrictive Domain | 1.68 score on a scale | Standard Deviation 9.77 |
| 120mg/120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Preventive Domain | 0.09 score on a scale | Standard Deviation 9.7 |
| 120mg/120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Emotional Function Domain | 0.71 score on a scale | Standard Deviation 10.54 |
| 240mg/240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Preventive Domain | 0.75 score on a scale | Standard Deviation 13.17 |
| 240mg/240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Restrictive Domain | 0.22 score on a scale | Standard Deviation 13.75 |
| 240mg/240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Total Score | 0.38 score on a scale | Standard Deviation 11.97 |
| 240mg/240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Emotional Function Domain | 0.25 score on a scale | Standard Deviation 11.47 |
| Placebo/ 120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Emotional Function Domain | 5.06 score on a scale | Standard Deviation 11.47 |
| Placebo/ 120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Preventive Domain | 7.16 score on a scale | Standard Deviation 10.18 |
| Placebo/ 120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Restrictive Domain | 8.77 score on a scale | Standard Deviation 12.74 |
| Placebo/ 120mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Total Score | 7.51 score on a scale | Standard Deviation 10.58 |
| Placebo/ 240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Total Score | 4.56 score on a scale | Standard Deviation 11.22 |
| Placebo/ 240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Emotional Function Domain | 4.68 score on a scale | Standard Deviation 12.34 |
| Placebo/ 240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Restrictive Domain | 4.96 score on a scale | Standard Deviation 12.6 |
| Placebo/ 240mg Galcanezumab - EM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Preventive Domain | 3.77 score on a scale | Standard Deviation 12.86 |
| 120mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Preventive Domain | 15.89 score on a scale | Standard Deviation 13.68 |
| 120mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Emotional Function Domain | 15.71 score on a scale | Standard Deviation 13.96 |
| 120mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Restrictive Domain | 22.65 score on a scale | Standard Deviation 15.08 |
| 120mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Total Score | 19.23 score on a scale | Standard Deviation 12.57 |
| 240mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Restrictive Domain | 22.96 score on a scale | Standard Deviation 17.69 |
| 240mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Role Function-Preventive Domain | 13.52 score on a scale | Standard Deviation 16.63 |
| 240mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Emotional Function Domain | 13.83 score on a scale | Standard Deviation 17.82 |
| 240mg Galcanezumab - CM | Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 | Total Score | 18.31 score on a scale | Standard Deviation 15.67 |
Secondary
Mean Change From Baseline in the Number of Headache Days (HDs)
A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).
Time frame: Baseline, Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Mean Change From Baseline in the Number of Headache Days (HDs) | -2.37 Headache days (HDs) | Standard Deviation 3.62 |
| 240mg/240mg Galcanezumab - EM | Mean Change From Baseline in the Number of Headache Days (HDs) | -1.75 Headache days (HDs) | Standard Deviation 4.57 |
| Placebo/ 120mg Galcanezumab - EM | Mean Change From Baseline in the Number of Headache Days (HDs) | -5.04 Headache days (HDs) | Standard Deviation 4.71 |
| Placebo/ 240mg Galcanezumab - EM | Mean Change From Baseline in the Number of Headache Days (HDs) | -4.00 Headache days (HDs) | Standard Deviation 5.14 |
| 120mg Galcanezumab - CM | Mean Change From Baseline in the Number of Headache Days (HDs) | -9.30 Headache days (HDs) | Standard Deviation 6.83 |
| 240mg Galcanezumab - CM | Mean Change From Baseline in the Number of Headache Days (HDs) | -9.42 Headache days (HDs) | Standard Deviation 8.37 |
Secondary
Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)
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 Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative.
Time frame: Baseline, Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) | -1.82 MHDs | Standard Deviation 2.96 |
| 240mg/240mg Galcanezumab - EM | Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) | -1.49 MHDs | Standard Deviation 4.11 |
| Placebo/ 120mg Galcanezumab - EM | Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) | -4.29 MHDs | Standard Deviation 4.07 |
| Placebo/ 240mg Galcanezumab - EM | Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) | -3.23 MHDs | Standard Deviation 5.81 |
| 120mg Galcanezumab - CM | Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) | -9.44 MHDs | Standard Deviation 6.16 |
| 240mg Galcanezumab - CM | Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) | -8.97 MHDs | Standard Deviation 8.06 |
Secondary
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
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.
Time frame: Baseline, Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | 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 | -1.62 MHDs and HDs with medication use | Standard Deviation 3.21 |
| 240mg/240mg Galcanezumab - EM | 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 | -1.17 MHDs and HDs with medication use | Standard Deviation 3.89 |
| Placebo/ 120mg Galcanezumab - EM | 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 | -4.47 MHDs and HDs with medication use | Standard Deviation 4.81 |
| Placebo/ 240mg Galcanezumab - EM | 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 | -3.43 MHDs and HDs with medication use | Standard Deviation 5.53 |
| 120mg Galcanezumab - CM | 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 | -8.21 MHDs and HDs with medication use | Standard Deviation 6.84 |
| 240mg Galcanezumab - CM | 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 | -7.48 MHDs and HDs with medication use | Standard Deviation 8.21 |
Secondary
Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache
Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.
Time frame: Baseline, Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache | -1.40 MHDs with medication use | Standard Deviation 2.54 |
| 240mg/240mg Galcanezumab - EM | Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache | -1.00 MHDs with medication use | Standard Deviation 3.59 |
| Placebo/ 120mg Galcanezumab - EM | Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache | -3.87 MHDs with medication use | Standard Deviation 3.84 |
| Placebo/ 240mg Galcanezumab - EM | Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache | -3.01 MHDs with medication use | Standard Deviation 5.76 |
| 120mg Galcanezumab - CM | Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache | -8.36 MHDs with medication use | Standard Deviation 6.29 |
| 240mg Galcanezumab - CM | Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache | -7.43 MHDs with medication use | Standard Deviation 7.89 |
Secondary
Percentage of Participants Developing Anti-Drug Antibodies (ADA)
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.
Time frame: Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose
Population: All participants who were randomized and received at least 1 dose of the study drug and had evaluable immunogenicity data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 120mg/120mg Galcanezumab - EM | Percentage of Participants Developing Anti-Drug Antibodies (ADA) | 12.07 percentage of participants |
| 240mg/240mg Galcanezumab - EM | Percentage of Participants Developing Anti-Drug Antibodies (ADA) | 9.68 percentage of participants |
| Placebo/ 120mg Galcanezumab - EM | Percentage of Participants Developing Anti-Drug Antibodies (ADA) | 16.13 percentage of participants |
| Placebo/ 240mg Galcanezumab - EM | Percentage of Participants Developing Anti-Drug Antibodies (ADA) | 10.94 percentage of participants |
| 120mg Galcanezumab - CM | Percentage of Participants Developing Anti-Drug Antibodies (ADA) | 12.50 percentage of participants |
| 240mg Galcanezumab - CM | Percentage of Participants Developing Anti-Drug Antibodies (ADA) | 18.18 percentage of participants |
Secondary
Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days
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.
Time frame: Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 120mg/120mg Galcanezumab - EM | Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days | 48.9 Percentage of participants |
| 240mg/240mg Galcanezumab - EM | Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days | 45.7 Percentage of participants |
| Placebo/ 120mg Galcanezumab - EM | Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days | 52.7 Percentage of participants |
| Placebo/ 240mg Galcanezumab - EM | Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days | 46.4 Percentage of participants |
| 120mg Galcanezumab - CM | Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days | 35.7 Percentage of participants |
| 240mg Galcanezumab - CM | Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days | 51.9 Percentage of participants |
Secondary
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
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 (5 categories). Preference compared 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 (5 categories). The side effects responses range from significantly less side effects to significantly more side effects (5 categories). Positive responses for each item were defined as follows: Satisfaction: Very Satisfied or Somewhat Satisfied; Preference: Much Prefer Study Medication or Prefer Study Medication; Side Effects: Much-Less Side Effects or Less Side Effects.
Time frame: Month 12
Population: All participants who were randomized and received at least 1 dose of the study drug and had month 12 PSMQ-M measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for preference | 76.8 Percentage of participants |
| 120mg/120mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for satisfaction | 80.4 Percentage of participants |
| 120mg/120mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for side effect | 78.6 Percentage of participants |
| 240mg/240mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for preference | 73.6 Percentage of participants |
| 240mg/240mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for satisfaction | 73.6 Percentage of participants |
| 240mg/240mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for side effect | 69.8 Percentage of participants |
| Placebo/ 120mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for preference | 75.9 Percentage of participants |
| Placebo/ 120mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for satisfaction | 72.4 Percentage of participants |
| Placebo/ 120mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for side effect | 72.4 Percentage of participants |
| Placebo/ 240mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for preference | 75.4 Percentage of participants |
| Placebo/ 240mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for satisfaction | 73.7 Percentage of participants |
| Placebo/ 240mg Galcanezumab - EM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for side effect | 71.9 Percentage of participants |
| 120mg Galcanezumab - CM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for preference | 85.7 Percentage of participants |
| 120mg Galcanezumab - CM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for satisfaction | 82.1 Percentage of participants |
| 120mg Galcanezumab - CM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for side effect | 82.1 Percentage of participants |
| 240mg Galcanezumab - CM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for satisfaction | 74.1 Percentage of participants |
| 240mg Galcanezumab - CM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for side effect | 81.5 Percentage of participants |
| 240mg Galcanezumab - CM | Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) | Responder for preference | 81.5 Percentage of participants |
Secondary
Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of total CGRP at month 12 is reported.
Time frame: Month 12: Predose
Population: All participants who were randomized and received at least 1 dose of the study drug and had measurable CGRP concentrations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) | 4.51 ng/mL | Standard Deviation 1.26 |
| 240mg/240mg Galcanezumab - EM | Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) | 5.87 ng/mL | Standard Deviation 1.45 |
| Placebo/ 120mg Galcanezumab - EM | Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) | 4.69 ng/mL | Standard Deviation 1.45 |
| Placebo/ 240mg Galcanezumab - EM | Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) | 5.59 ng/mL | Standard Deviation 1.45 |
| 120mg Galcanezumab - CM | Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) | 4.37 ng/mL | Standard Deviation 1.4 |
| 240mg Galcanezumab - CM | Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) | 5.19 ng/mL | Standard Deviation 1.52 |
Secondary
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Serum Concentration of Galcanezumab at month 12 is reported.
Time frame: Month 12: Predose
Population: All participants who were randomized and received at least 1 dose of the study drug and had evaluable galcanezumab PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 120mg/120mg Galcanezumab - EM | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | 21100 nanogram/milliliter (ng/mL) | Standard Deviation 6120 |
| 240mg/240mg Galcanezumab - EM | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | 46000 nanogram/milliliter (ng/mL) | Standard Deviation 15300 |
| Placebo/ 120mg Galcanezumab - EM | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | 21000 nanogram/milliliter (ng/mL) | Standard Deviation 7290 |
| Placebo/ 240mg Galcanezumab - EM | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | 42200 nanogram/milliliter (ng/mL) | Standard Deviation 12400 |
| 120mg Galcanezumab - CM | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | 20100 nanogram/milliliter (ng/mL) | Standard Deviation 8550 |
| 240mg Galcanezumab - CM | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | 39600 nanogram/milliliter (ng/mL) | Standard Deviation 13600 |