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

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.

Serum Concentration of Galcanezumab at month 12 is reported.

Plasma Concentration of total CGRP at month 12 is reported.

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.

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.

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

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.

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

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.

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").

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.

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.

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".