Trial Outcomes & Findings for A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura (NCT NCT02614287)

Last Updated: 2020-06-17

Results Overview

Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

270 participants

Primary outcome timeframe

Baseline through Month 12

Results posted on

2020-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Galcanezumab 120 mg Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.	Galcanezumab 240 mg Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.
Open Label (OL) Treatment Phase STARTED	135	135
Open Label (OL) Treatment Phase Received at Least One Dose of Study Drug	135	135
Open Label (OL) Treatment Phase COMPLETED	97	113
Open Label (OL) Treatment Phase NOT COMPLETED	38	22
Post Treatment Follow-up Phase STARTED	112	124
Post Treatment Follow-up Phase COMPLETED	103	119
Post Treatment Follow-up Phase NOT COMPLETED	9	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Galcanezumab 120 mg Participants received a loading dose of 240 milligram (mg) galcanezumab at first dosing visit followed by120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.	Galcanezumab 240 mg Participants received 240 mg of galcanezumab once a month by subcutaneous injection during open label treatment phase. Participants did not receive any intervention during post treatment follow-up phase.
Open Label (OL) Treatment Phase Adverse Event	7	6
Open Label (OL) Treatment Phase Lack of Efficacy	13	5
Open Label (OL) Treatment Phase Lost to Follow-up	7	4
Open Label (OL) Treatment Phase Physician Decision	1	0
Open Label (OL) Treatment Phase Withdrawal by Subject	10	7
Post Treatment Follow-up Phase Adverse Event	1	0
Post Treatment Follow-up Phase Lost to Follow-up	2	2
Post Treatment Follow-up Phase Withdrawal by Subject	6	3

Baseline Characteristics

All randomized participants with ethnicity data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Galcanezumab 120 mg n=135 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection during open label treatment phase \& participants did not receive any intervention during post treatment follow-up phase.	Galcanezumab 240 mg n=135 Participants Participants received 240 mg galcanezumab once a month by subcutaneous injection during open label treatment phase \& participants did not receive any intervention during post treatment follow-up phase.	Total n=270 Participants Total of all reporting groups
Age, Continuous	40.21 years STANDARD_DEVIATION 11.68 • n=135 Participants	43.69 years STANDARD_DEVIATION 10.99 • n=135 Participants	41.95 years STANDARD_DEVIATION 11.45 • n=270 Participants
Sex: Female, Male Female	110 Participants n=135 Participants	113 Participants n=135 Participants	223 Participants n=270 Participants
Sex: Female, Male Male	25 Participants n=135 Participants	22 Participants n=135 Participants	47 Participants n=270 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=127 Participants • All randomized participants with ethnicity data.	20 Participants n=128 Participants • All randomized participants with ethnicity data.	32 Participants n=255 Participants • All randomized participants with ethnicity data.
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=127 Participants • All randomized participants with ethnicity data.	108 Participants n=128 Participants • All randomized participants with ethnicity data.	223 Participants n=255 Participants • All randomized participants with ethnicity data.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=127 Participants • All randomized participants with ethnicity data.	0 Participants n=128 Participants • All randomized participants with ethnicity data.	0 Participants n=255 Participants • All randomized participants with ethnicity data.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=135 Participants	0 Participants n=135 Participants	0 Participants n=270 Participants
Race (NIH/OMB) Asian	2 Participants n=135 Participants	0 Participants n=135 Participants	2 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=135 Participants	0 Participants n=135 Participants	1 Participants n=270 Participants
Race (NIH/OMB) Black or African American	6 Participants n=135 Participants	8 Participants n=135 Participants	14 Participants n=270 Participants
Race (NIH/OMB) White	103 Participants n=135 Participants	108 Participants n=135 Participants	211 Participants n=270 Participants
Race (NIH/OMB) More than one race	23 Participants n=135 Participants	19 Participants n=135 Participants	42 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=135 Participants	0 Participants n=135 Participants	0 Participants n=270 Participants

PRIMARY outcome

Timeframe: Baseline through Month 12

Population: All randomized participants who received at least one dose of study drug. There were 6 participants in the 120 mg group who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg group for AE analysis.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=129 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=141 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Percentage of Participants Who Discontinued Due to Adverse Event	4.65 Percentage of Participants	4.96 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline through Month 12

Population: Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 12

Population: All randomized participants with measurable serum concentrations at month 12.

Serum Concentrations of Galcanezumab.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=61 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=78 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Serum Concentrations of Galcanezumab	16500 Nanogram per milliliter (ng/mL) Standard Deviation 8370	31600 Nanogram per milliliter (ng/mL) Standard Deviation 15900

SECONDARY outcome

Timeframe: Month 12

Population: All randomized participants with measurable plasma concentration.

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=87 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=103 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)	2.74 ng/mL Standard Deviation 1.07	3.85 ng/mL Standard Deviation 1.85

SECONDARY outcome

Timeframe: Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline evaluable data for TE ADA.

A Treatment Emergent Anti-drug Antibody (TE ADA) evaluable participant is considered to be TE ADA+ if the participant 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 (treatment-induced). There were 6 participants in the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for safety analysis.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=129 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=137 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab	12.40 Percentage of Participants	7.30 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline value.

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 12 from MMRM model. Least squares mean (LSMean) was calculated using mixed model repeated measures (MMRM) model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=132 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=135 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD)	-5.61 Migraine Headache Days per Month Standard Error 0.34	-6.47 Migraine Headache Days per Month Standard Error 0.33

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline Value.

Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=132 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=135 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Mean Change From Baseline in the Number of Headache Days	-2.17 Headache Days per Month Standard Error 0.30	-2.09 Headache Days per Month Standard Error 0.30

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline value.

Migraine Headache Day: A calendar day on which a migraine headache or probable migraine headache occurred. Overall percentage of participants with a given response rate were estimated from the generalized linear mixed models (GLIMMIX) model.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=95 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=112 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days	65.6 percentage of Participants	73.7 percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=132 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=135 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches	-5.09 Medication Used Days per Month Standard Error 0.38	-5.05 Medication Used Days per Month Standard Error 0.37

SECONDARY outcome

Timeframe: Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had at least one post baseline value.

The Patient Global Impression of Improvement (PGI -I) scale is a participant-rated instrument that measures the participants own global impression of their symptom improvement. The participant was instructed as follows: "Mark the box that best describes your migraine headache condition since you started taking this medicine." Response options were on a 7-point scale in which a score of 1 indicates that the participant's condition is "very much better," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse." Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline PGI-S, and baseline PGI-S by month as fixed effects.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=130 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=135 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Mean Patient Global Impression-Improvement (PGI-I) Score	2.18 units on a scale Standard Error 0.08	1.99 units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.

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. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=124 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=130 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score	-33.58 units on a scale Standard Error 2.11	-32.67 units on a scale Standard Error 2.04

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 12

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. Overall mean is derived from the average of months 1 to 12.LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.

MSQv2.1 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.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=130 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=135 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Emotional Function Domain	28.92 units on a scale Standard Error 1.35	32.01 units on a scale Standard Error 1.31
Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Total Score	28.27 units on a scale Standard Error 1.16	30.25 units on a scale Standard Error 1.13
Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function-Restrictive Domain	31.55 units on a scale Standard Error 1.20	33.40 units on a scale Standard Error 1.16
Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function-Preventive Domain	22.08 units on a scale Standard Error 1.11	23.33 units on a scale Standard Error 1.08

SECONDARY outcome

Timeframe: Baseline through Month 12

Population: All randomized participants who received at least one dose of study drug and had month 12 PSMQ-M measurement.

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. Preference compares 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".

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=90 Participants Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=112 Participants Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) Preference: Much prefer study medication	66.67 percentage of Participants	63.39 percentage of Participants
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) Satisfaction: Very satisfied	57.78 percentage of Participants	58.04 percentage of Participants
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) Satisfaction: Somewhat satisfied	18.89 percentage of Participants	15.18 percentage of Participants
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) Preference: Prefer study medication	22.22 percentage of Participants	17.86 percentage of Participants
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) Side effects: Much less side effects	66.67 percentage of Participants	50.89 percentage of Participants
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) Side effects: Less side effects	14.44 percentage of Participants	30.36 percentage of Participants

SECONDARY outcome

Timeframe: Baseline through Month 12

Population: All randomized participants who switched from pre-filled syringe and received at least one dose of study drug by autoinjector.

The SQAAQ is a self-administered questionnaire that provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of study drug. Participants will respond to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree") shortly after the injection. If a caregiver administers the injection, the participants should be prepared to provide the caregiver's ratings of the questions.strongly agree \& agree are considered as positive responses.

Outcome measures

Outcome measures
Measure	Galcanezumab 120 mg n=899 Number of participant visits Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection 11 months.	Galcanezumab 240 mg n=1032 Number of participant visits Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : Easy to pickup	610 participants	693 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : overall, easy to use	600 participants	663 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : Confident my dose is complete	618 participants	708 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Easy to remove needle shield	250 participants	268 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : Easy to learn how to use	611 participants	688 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : Easy to hold in hand	589 participants	660 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : Easy to inject my dose	580 participants	659 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : Easy to know dose is complete	615 participants	703 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe: Easy to store device in fridge	536 participants	630 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe : Easy to remove needle shield	610 participants	699 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe:Dvc is stable against skin	590 participants	652 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Pre-filled Syringe:Confident in ability to use	580 participants	654 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Easy to learn how to use	250 participants	265 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Easy to hold in hand	247 participants	267 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Easy to inject my dose	245 participants	265 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Easy to know dose is complete	241 participants	261 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Easy store device in fridge	230 participants	256 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Easy to pickup	251 participants	271 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Overall, easy to use	251 participants	262 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Dvc is stable against skin	244 participants	264 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Confident in ability to use	247 participants	260 participants
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 Autoinjector : Confident my dose is complete	244 participants	263 participants

Adverse Events

Galcanezumab 120 mg - Open Label Phase

Serious events: 3 serious events

Other events: 76 other events

Deaths: 0 deaths

Galcanezumab 240 mg - Open Label Phase

Serious events: 7 serious events

Other events: 83 other events

Deaths: 0 deaths

Galcanezumab 120 mg - Post-treatment Phase

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Galcanezumab 240 mg - Post-treatment Phase

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Galcanezumab 120 mg - Open Label Phase n=129 participants at risk Participants received a loading dose of 240 mg galcanezumab at first dosing visit followed by 120 mg Galcanezumab once a month by subcutaneous injection for 11 months.	Galcanezumab 240 mg - Open Label Phase n=141 participants at risk Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 12 months.	Galcanezumab 120 mg - Post-treatment Phase n=112 participants at risk Participants did not receive any intervention.	Galcanezumab 240 mg - Post-treatment Phase n=124 participants at risk Participants did not receive any intervention.
Gastrointestinal disorders Nausea	7.8% 10/129 • Number of events 11 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	6.4% 9/141 • Number of events 15 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.89% 1/112 • Number of events 1 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
General disorders Injection site bruising	3.9% 5/129 • Number of events 5 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	5.7% 8/141 • Number of events 10 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
General disorders Injection site erythema	7.0% 9/129 • Number of events 20 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	6.4% 9/141 • Number of events 19 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
General disorders Injection site pain	17.1% 22/129 • Number of events 148 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	19.9% 28/141 • Number of events 272 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
General disorders Injection site reaction	11.6% 15/129 • Number of events 48 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	9.2% 13/141 • Number of events 32 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Influenza	6.2% 8/129 • Number of events 9 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	5.7% 8/141 • Number of events 8 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.89% 1/112 • Number of events 1 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.81% 1/124 • Number of events 1 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Sinusitis	10.9% 14/129 • Number of events 16 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	9.2% 13/141 • Number of events 17 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Upper respiratory tract infection	7.0% 9/129 • Number of events 10 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	14.9% 21/141 • Number of events 23 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.81% 1/124 • Number of events 2 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Viral upper respiratory tract infection	16.3% 21/129 • Number of events 27 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	11.3% 16/141 • Number of events 19 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	1.6% 2/124 • Number of events 2 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Investigations Weight increased	5.4% 7/129 • Number of events 7 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	2.8% 4/141 • Number of events 4 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 8/129 • Number of events 12 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	5.7% 8/141 • Number of events 10 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.89% 1/112 • Number of events 1 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.81% 1/124 • Number of events 1 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Back pain	9.3% 12/129 • Number of events 15 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	10.6% 15/141 • Number of events 18 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	1.8% 2/112 • Number of events 2 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	2.4% 3/124 • Number of events 3 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 8/129 • Number of events 9 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	2.1% 3/141 • Number of events 4 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.89% 1/112 • Number of events 1 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Dizziness	3.9% 5/129 • Number of events 7 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	6.4% 9/141 • Number of events 11 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/112 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/124 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.
Reproductive system and breast disorders Prostatitis	0.00% 0/25 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/22 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/21 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.	5.6% 1/18 • Number of events 1 • Up to 421 days All randomized participants. There were 6 participants in the 120 mg open label arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis. Per protocol, AE analysis was planned per treatment regimen received.