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Clinical Trial Results:
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

Summary
EudraCT number	2019-004497-25
Trial protocol	DE CZ DK FI BE PL GB SK HU SE BG IT
Global end of trial date	15 Sep 2022

Results information
Results version number	v1(current)
This version publication date	21 Feb 2024
First version publication date	21 Feb 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

18898A

ISRCTN number

US NCT number

NCT04418765

WHO universal trial number (UTN)

Sponsor organisation name

H. Lundbeck A/S

Sponsor organisation address

Ottiliavej 9, Valby, Denmark, 2500

Public contact

LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com

Scientific contact

LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Sep 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Sep 2022

Was the trial ended prematurely?

Main objective of the trial

The main objective of the trial was to evaluate the efficacy of eptinezumab for the prevention of migraine in participants with unsuccessful prior preventive treatments.

Protection of trial subjects

This study was conducted in compliance with Good Clinical Practice and in accordance with the ethical principles described in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Jun 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 17

Country: Number of subjects enrolled

Bulgaria: 33

Country: Number of subjects enrolled

Czechia: 218

Country: Number of subjects enrolled

Germany: 21

Country: Number of subjects enrolled

Denmark: 12

Country: Number of subjects enrolled

Spain: 25

Country: Number of subjects enrolled

Finland: 13

Country: Number of subjects enrolled

France: 22

Country: Number of subjects enrolled

United Kingdom: 20

Country: Number of subjects enrolled

Georgia: 176

Country: Number of subjects enrolled

Hungary: 19

Country: Number of subjects enrolled

Italy: 5

Country: Number of subjects enrolled

Poland: 256

Country: Number of subjects enrolled

Russian Federation: 13

Country: Number of subjects enrolled

Slovakia: 34

Country: Number of subjects enrolled

Sweden: 2

Country: Number of subjects enrolled

United States: 6

Worldwide total number of subjects

892

EEA total number of subjects

677

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

867

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study included 2 periods: Placebo-controlled Period – 24-week double-blind treatment period with placebo or eptinezumab and Extension Period – 48-week dose-blinded period with eptinezumab after completion of the Placebo-controlled Period.

Screening details

Participants assigned to placebo in the Placebo-controlled Period were randomized 1:1 to treatment with either eptinezumab 100 milligrams (mg) or eptinezumab 300 mg. Participants assigned to eptinezumab 100 mg or 300 mg in the Placebo-controlled Period continued their treatment.

Period 1 title

Placebo-controlled Period (24 Weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Placebo was administered per schedule specified in the arm description.

Eptinezumab 100 mg

Arm description

Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).

Arm type

Experimental

Investigational medicinal product name

Eptinezumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Eptinezumab was administered per schedule specified in the arm description.

Eptinezumab 300 mg

Arm description

Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).

Arm type

Experimental

Investigational medicinal product name

Eptinezumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Eptinezumab was administered per schedule specified in the arm description.

Number of subjects in period 1	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Started	299	299	294
Received at least 1 dose of study drug	298	299	294
Completed	293	288	284
Not completed	6	11	10
Consent withdrawn by subject	1	5	2
Adverse event, non-fatal	1	1	6
Randomized but not treated	1	-	-
Other than specified	2	-	1
Lost to follow-up	-	1	-
Lack of efficacy	1	3	-
Protocol deviation	-	1	1

Period 2 title

Extension Period (48 Weeks)

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Eptinezumab 100 mg

Arm description

Arm type

Experimental

Investigational medicinal product name

Eptinezumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Eptinezumab was administered per schedule specified in the arm description.

Eptinezumab 300 mg

Arm description

Arm type

Experimental

Investigational medicinal product name

Eptinezumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Eptinezumab was administered per schedule specified in the arm description.

Number of subjects in period 2	Eptinezumab 100 mg	Eptinezumab 300 mg
Started	433	432
Received at least 1 dose of study drug	433	432
Completed	392	390
Not completed	41	42
Consent withdrawn by subject	21	14
Adverse event, non-fatal	2	9
Non-compliance with study drug	-	2
Other than specified	5	2
Lack of efficacy	13	13
Protocol deviation	-	2

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.

Reporting group title

Eptinezumab 100 mg

Reporting group description

Reporting group title

Eptinezumab 300 mg

Reporting group description

Reporting group values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg	Total
Number of subjects	299	299	294	892
Age categorical
Units: Subjects
Age Continuous
Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
Units: years
arithmetic mean (standard deviation)	43.8 ( 10.83 )	44.6 ( 10.76 )	43.1 ( 10.2 )	-
Sex: Female, Male
Units: participants
Female	264	277	261	802
Male	35	22	33	90
Monthly Migraine Days (MMDs)
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D as defined in the outcome measure 1. Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
Units: days/month
arithmetic mean (standard deviation)	13.9 ( 5.72 )	13.8 ( 5.58 )	13.7 ( 5.44 )	-
Monthly Headache Days (MHDs)
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D in outcome measure 1). Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
Units: days/month
arithmetic mean (standard deviation)	14.5 ( 5.79 )	14.5 ( 5.63 )	14.4 ( 5.45 )	-
Headache Impact Test (HIT-6) Score
The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). Here N = 288 (placebo), 281 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	66.2 ( 4.38 )	66.6 ( 4.7 )	66.5 ( 4.41 )	-
Percentage of Migraine Attacks With Severe Pain Intensity
A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D in outcome measure 1). Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
Units: percentage of migraine attacks
arithmetic mean (standard deviation)	40.4 ( 29.74 )	47.1 ( 29.82 )	43.9 ( 28.4 )	-
Percentage of Headache Episodes With Severe Pain Intensity
A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D in outcome measure 1). Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
Units: percentage of headache episodes
arithmetic mean (standard deviation)	38.5 ( 29.29 )	44.2 ( 28.56 )	41 ( 27.01 )	-
Acute Migraine Medication Days
Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 292 (Eptinezumab 300 mg).
Units: days
arithmetic mean (standard deviation)	11.2 ( 5.93 )	11.2 ( 5.47 )	11 ( 5.29 )	-
MMDs With Use of Acute Medication
Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
Units: days/month
arithmetic mean (standard deviation)	12.5 ( 5.62 )	12.7 ( 5.48 )	12.4 ( 5.38 )	-
Migraine-Specific Quality of Life (MSQ) Subscores - MSQ role function-restrictive
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. Here N = 288 (placebo), 276 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	35.1 ( 17.14 )	35.7 ( 17.33 )	35.7 ( 16.68 )	-
Migraine-Specific Quality of Life (MSQ) Subscores - MSQ role function-preventive
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. Here N = 288 (placebo), 276 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	50.5 ( 22.14 )	50.2 ( 21.39 )	51 ( 21.47 )	-
Migraine-Specific Quality of Life (MSQ) Subscores - MSQ emotional function
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. Here N = 288 (placebo), 276 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	48.4 ( 26.63 )	50.3 ( 24.7 )	48.6 ( 23.8 )	-
Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score
The EQ-5D-5L is a participant-reported assessment designed to measure the participant’s well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). Here N = 287 (placebo), 276 (Eptinezumab 100 mg), and 285 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	74 ( 20.36 )	75.9 ( 19.01 )	74.5 ( 20.72 )	-
WPAI Questionnaire Subscore (Absenteeism)
It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 218 (placebo), 196 (Eptinezumab 100 mg), and 209 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	12.8 ( 20.7 )	11.4 ( 19.4 )	12 ( 19.31 )	-
WPAI Questionnaire Subscores (Presenteeism)
It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 212 (placebo), 191 (Eptinezumab 100 mg), and 206 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	51.7 ( 24.22 )	50.8 ( 25.61 )	53.3 ( 24.01 )	-
WPAI Questionnaire Subscores (Work Productivity Loss)
It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 212 (placebo), 191 (Eptinezumab 100 mg), and 206 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	55.6 ( 24.7 )	53.7 ( 26.17 )	57 ( 24.1 )	-
WPAI Questionnaire Subscores (Activity Impairment)
It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 286 (placebo), 274 (Eptinezumab 100 mg), and 285 (Eptinezumab 300 mg).
Units: units on a scale
arithmetic mean (standard deviation)	58.7 ( 23.52 )	58.5 ( 23.47 )	59.1 ( 23.37 )	-

End points

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Reporting group title

Placebo

Reporting group description

Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.

Reporting group title

Eptinezumab 100 mg

Reporting group description

Reporting group title

Eptinezumab 300 mg

Reporting group description

Reporting group title

Eptinezumab 100 mg

Reporting group description

Reporting group title

Eptinezumab 300 mg

Reporting group description

Subject analysis set title

Placebo to Eptinezumab 100 mg

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.

Subject analysis set title

Placebo to Eptinezumab 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.

Subject analysis set title

Eptinezumab 100 mg to Eptinezumab 100 mg

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

Subject analysis set title

Eptinezumab 300 mg to Eptinezumab 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

Primary: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12

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End point title

Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12

End point description

A migraine day defined as any day participant reported a headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following criteria: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having a migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12.

End point type

Primary

End point timeframe

Baseline, Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: days/month
arithmetic mean (standard error)	-2.1 ( 0.38 )	-4.8 ( 0.37 )	-5.3 ( 0.37 )

Statistical Analysis 2

Statistical analysis description

Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.

Comparison groups

Placebo v Eptinezumab 100 mg

Number of subjects included in analysis

597

Analysis specification

Pre-specified

Analysis type

other ^[1]

P-value

< 0.0001 ^[2]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.36

Notes
[1] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[2] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 3 of testing order.

Statistical Analysis 1

Statistical analysis description

Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.

Comparison groups

Placebo v Eptinezumab 300 mg

Number of subjects included in analysis

591

Analysis specification

Pre-specified

Analysis type

other ^[3]

P-value

< 0.0001 ^[4]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-3.2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.9

upper limit

-2.5

Variability estimate

Standard error of the mean

Dispersion value

0.36

Notes
[3] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[4] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 1 of testing order.

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

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End point title

Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of participants
number (not applicable)	13.1	42.1	49.5

Statistical Analysis 2

Statistical analysis description

Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.

Comparison groups

Placebo v Eptinezumab 100 mg

Number of subjects included in analysis

597

Analysis specification

Pre-specified

Analysis type

other ^[5]

P-value

< 0.0001 ^[6]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

4.91

Confidence interval

level

95%

sides

2-sided

lower limit

3.29

upper limit

7.47

Notes
[5] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[6] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 4 of testing order.

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v Eptinezumab 300 mg

Number of subjects included in analysis

591

Analysis specification

Pre-specified

Analysis type

other ^[7]

P-value

< 0.0001 ^[8]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

6.58

Confidence interval

level

95%

sides

2-sided

lower limit

4.41

upper limit

10.01

Notes
[7] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[8] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 2 of testing order.

Secondary: Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24

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End point title

Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24

End point description

A migraine day defined as any day participant reported headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; with ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, with ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12. N= participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 13 - 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	295	287	286
Units: days/month
arithmetic mean (standard error)	-2.4 ( 0.39 )	-5.4 ( 0.39 )	-6.1 ( 0.39 )

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v Eptinezumab 100 mg

Number of subjects included in analysis

582

Analysis specification

Pre-specified

Analysis type

other ^[9]

P-value

< 0.0001 ^[10]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.8

upper limit

-2.2

Variability estimate

Standard error of the mean

Dispersion value

0.39

Notes
[9] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[10] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6a of testing order.

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v Eptinezumab 300 mg

Number of subjects included in analysis

581

Analysis specification

Pre-specified

Analysis type

other ^[11]

P-value

< 0.0001 ^[12]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-3.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.5

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

0.39

Notes
[11] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[12] - Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 5a of testing order.

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

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End point title

Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of participants
number (not applicable)	2.0	15.7	18.8

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v Eptinezumab 300 mg

Number of subjects included in analysis

591

Analysis specification

Pre-specified

Analysis type

other ^[13]

P-value

< 0.0001 ^[14]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

11.43

Confidence interval

level

95%

sides

2-sided

lower limit

5.22

upper limit

30.15

Notes
[13] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[14] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 5b of testing order.

Statistical Analysis 2

Statistical analysis description

Comparison groups

Placebo v Eptinezumab 100 mg

Number of subjects included in analysis

597

Analysis specification

Pre-specified

Analysis type

other ^[15]

P-value

< 0.0001 ^[16]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

9.19

Confidence interval

level

95%

sides

2-sided

lower limit

4.16

upper limit

24.35

Notes
[15] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[16] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6b of testing order.

Secondary: Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12

Top of page

End point title

Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12

End point description

The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	288	277	283
Units: units on a scale
arithmetic mean (standard error)	-3.1 ( 0.61 )	-6.9 ( 0.61 )	-8.5 ( 0.60 )

Statistical Analysis 2

Statistical analysis description

Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error. Testing continued only, if the previous comparison was statistically significant.

Comparison groups

Placebo v Eptinezumab 100 mg

Number of subjects included in analysis

565

Analysis specification

Pre-specified

Analysis type

other ^[17]

P-value

< 0.0001 ^[18]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-3.8

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

-2.5

Variability estimate

Standard error of the mean

Dispersion value

0.63

Notes
[17] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[18] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6c of testing order.

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo v Eptinezumab 300 mg

Number of subjects included in analysis

571

Analysis specification

Pre-specified

Analysis type

other ^[19]

P-value

< 0.0001 ^[20]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-5.4

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

-4.2

Variability estimate

Standard error of the mean

Dispersion value

0.63

Notes
[19] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
[20] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 5c of testing order.

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

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End point title

Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 13 - 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	295	287	286
Units: percentage of participants
number (not applicable)	23.7	52.3	59.1

No statistical analyses for this end point

Secondary: Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

Top of page

End point title

Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of participants
number (not applicable)	1.1	5.9	7.7

No statistical analyses for this end point

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

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End point title

Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 13 - 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	295	287	293
Units: percentage of participants
number (not applicable)	6.8	21.3	27.6

No statistical analyses for this end point

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

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End point title

Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

End point description

A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

End point type

Secondary

End point timeframe

Baseline to Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of participants
number (not applicable)	12.8	39.5	45.7

No statistical analyses for this end point

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

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End point title

Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of participants
number (not applicable)	2.3	15.1	16.4

No statistical analyses for this end point

Secondary: Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

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End point title

Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of participants
number (not applicable)	1.1	4.1	5.3

No statistical analyses for this end point

Secondary: Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12

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End point title

Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12

End point description

A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

End point type

Secondary

End point timeframe

Baseline, Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of migraine attacks
arithmetic mean (standard error)	-10.2 ( 1.91 )	-17.9 ( 1.87 )	-21.3 ( 1.87 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12

Top of page

End point title

Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: days/month
arithmetic mean (standard error)	-2.1 ( 0.38 )	-4.6 ( 0.37 )	-5.1 ( 0.37 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12

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End point title

Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12

End point description

Number of MMDs with acute medication usage was derived using the answer to “Did you take any medications to treat this headache?” in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as “Yes”. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

End point type

Secondary

End point timeframe

Baseline, Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: days/month
arithmetic mean (standard error)	-2.0 ( 0.36 )	-4.6 ( 0.36 )	-5.2 ( 0.36 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12

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End point title

Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12

End point description

A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

End point type

Secondary

End point timeframe

Baseline, Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of headache episodes
arithmetic mean (standard error)	-8.8 ( 1.85 )	-16.2 ( 1.81 )	-19.5 ( 1.81 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24

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End point title

Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24

End point description

In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 13- 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	294	287	285
Units: days/month
arithmetic mean (standard error)	-1.7 ( 0.36 )	-4.6 ( 0.36 )	-5.2 ( 0.36 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12

Top of page

End point title

Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	298	290
Units: days/month
arithmetic mean (standard error)	-1.6 ( 0.34 )	-4.1 ( 0.33 )	-4.6 ( 0.34 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24

Top of page

End point title

Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 13 - 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	295	287	286
Units: days/month
arithmetic mean (standard error)	-2.1 ( 0.39 )	-4.9 ( 0.39 )	-5.8 ( 0.38 )

No statistical analyses for this end point

Secondary: PGIC Score at Week 24

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End point title

PGIC Score at Week 24

End point description

The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	286	280	281
Units: units on a scale
arithmetic mean (standard error)	3.5 ( 0.09 )	2.5 ( 0.09 )	2.4 ( 0.09 )

No statistical analyses for this end point

Secondary: Patient Global Impression of Change (PGIC) Score at Week 12

Top of page

End point title

Patient Global Impression of Change (PGIC) Score at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	297	292	289
Units: units on a scale
arithmetic mean (standard error)	3.6 ( 0.09 )	2.6 ( 0.09 )	2.5 ( 0.09 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Migraine on the Day After First Dosing

Top of page

End point title

Percentage of Participants With Migraine on the Day After First Dosing

End point description

FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

End point type

Secondary

End point timeframe

Day 1

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	298	299	293
Units: percentage of participants
number (not applicable)	43.7	27.2	24.4

No statistical analyses for this end point

Secondary: Change From Baseline in the HIT-6 Score at Week 24

Top of page

End point title

Change From Baseline in the HIT-6 Score at Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	278	266	276
Units: units on a scale
arithmetic mean (standard error)	-3.9 ( 0.63 )	-8.9 ( 0.63 )	-9.9 ( 0.62 )

No statistical analyses for this end point

Secondary: Most Bothersome Symptom (MBS) Score at Week 12

Top of page

End point title

Most Bothersome Symptom (MBS) Score at Week 12

End point description

Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	293	289	287
Units: units on a scale
arithmetic mean (standard error)	3.7 ( 0.09 )	2.8 ( 0.09 )	2.7 ( 0.09 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12

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End point title

Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12

End point description

FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 1 - 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	37	38	35
Units: days/month
arithmetic mean (standard error)	-2.3 ( 1.12 )	-5.6 ( 1.07 )	-7.3 ( 1.18 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12

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End point title

Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12

End point description

The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	288	271	283
Units: units on a scale
arithmetic mean (standard error)
MSQ Role Function-Restrictive	13.7 ( 1.75 )	25.0 ( 1.75 )	28.7 ( 1.72 )
MSQ Role Function-Preventive	11.6 ( 1.63 )	22.7 ( 1.64 )	25.0 ( 1.61 )
MSQ Emotional Function	9.6 ( 1.83 )	20.6 ( 1.84 )	23.1 ( 1.80 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12

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End point title

Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12

End point description

The EQ-5D-5L is a participant-reported assessment designed to measure the participant’s well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	287	271	281
Units: units on a scale
arithmetic mean (standard error)	-3.1 ( 1.39 )	2.0 ( 1.40 )	4.4 ( 1.38 )

No statistical analyses for this end point

Secondary: Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24

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End point title

Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	278	259	275
Units: units on a scale
arithmetic mean (standard error)
MSQ Role Function-Restrictive	15.0 ( 1.76 )	30.1 ( 1.78 )	30.0 ( 1.73 )
MSQ Role Function-Preventive	13.1 ( 1.63 )	25.7 ( 1.65 )	26.3 ( 1.61 )
MSQ Emotional Function	9.9 ( 1.84 )	24.1 ( 1.86 )	24.1 ( 1.81 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24

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End point title

Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	276	258	273
Units: units on a scale
arithmetic mean (standard error)	-2.8 ( 1.38 )	2.0 ( 1.40 )	5.2 ( 1.37 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12

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End point title

Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12

End point description

WPAI Questionnaire contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. FAS: all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint. n = participants evaluable for specified categories.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	286	268	280
Units: units on a scale
arithmetic mean (standard error)
Absenteeism (n= 196,174,183)	-0.1 ( 1.49 )	-5.8 ( 1.53 )	-3.8 ( 1.50 )
Presenteeism (n= 188,169,179)	-9.9 ( 2.42 )	-19.0 ( 2.46 )	-23.3 ( 2.40 )
Work productivity loss (n= 188,169,179)	-9.7 ( 2.56 )	-19.5 ( 2.61 )	-24.0 ( 2.54 )
Activity impairment (n= 286,268,280)	-11.2 ( 2.07 )	-21.3 ( 2.07 )	-23.8 ( 2.05 )

No statistical analyses for this end point

Secondary: Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24

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End point title

Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	275	256	273
Units: units on a scale
arithmetic mean (standard error)
Absenteeism (n= 180,151,168)	-0.7 ( 1.46 )	-5.2 ( 1.53 )	-5.4 ( 1.47 )
Presenteeism (n= 173,145,166)	-7.5 ( 2.49 )	-22.2 ( 2.59 )	-19.3 ( 2.46 )
Work productivity loss (n= 173,145,166)	-7.2 ( 2.62 )	-22.6 ( 2.73 )	-20.2 ( 2.60 )
Activity impairment (n= 275,256,273)	-10.1 ( 2.07 )	-24.7 ( 2.09 )	-22.6 ( 2.04 )

No statistical analyses for this end point

Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score

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End point title

Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score

End point description

End point type

Secondary

End point timeframe

Baseline to Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	288	280	284
Units: percentage of participants
number (not applicable)	39.9	62.1	62.0

No statistical analyses for this end point

Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score

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End point title

Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score

End point description

End point type

Secondary

End point timeframe

Baseline to Week 24

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	288	280	285
Units: percentage of participants
number (not applicable)	46.2	72.1	71.6

No statistical analyses for this end point

Secondary: Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner

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End point title

Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner

End point description

Number of participants who visited to a family doctor/general practitioner has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	297	291	289
Units: participants
0 Visit	244	259	256
1 Visit	35	22	22
2 Visits	6	5	6
3 Visits	7	2	3
4 Visits	1	1	1
5 Visits	1	2	1
6 Visits	2	0	0
8 Visits	1	0	0

No statistical analyses for this end point

Secondary: HCRU: Visits to a Specialist

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End point title

HCRU: Visits to a Specialist

End point description

Number of participants who visited to a specialist has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	297	291	289
Units: participants
0 Visit	249	256	257
1 Visit	33	31	24
2 Visits	2	2	4
3 Visits	7	2	4
5 Visits	1	0	0
6 Visits	4	0	0
8 Visits	1	0	0

No statistical analyses for this end point

Secondary: HCRU: Number of Emergency Department Visits Due to Your Migraine

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End point title

HCRU: Number of Emergency Department Visits Due to Your Migraine

End point description

Number of participants who visited to emergency department due to your migraine has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	297	291	289
Units: participants
0 Visit	289	289	285
1 Visit	6	1	3
2 Visits	0	1	1
3 Visits	1	0	0
8 Visits	1	0	0

No statistical analyses for this end point

Secondary: HCRU: Number of Hospital Admissions Due to Migraine

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End point title

HCRU: Number of Hospital Admissions Due to Migraine

End point description

Number of participants who admitted in the hospital due to migraine has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	297	291	289
Units: participants
0 Visit	295	289	287
1 Visit	1	1	2
2 Visits	0	1	0
4 Visits	1	0	0

No statistical analyses for this end point

Secondary: HCRU: Total Number of Overnight Hospital Stays Due to Migraine

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End point title

HCRU: Total Number of Overnight Hospital Stays Due to Migraine

End point description

Number of participants who had total number of overnight hospital stays due to migraine has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	Eptinezumab 100 mg	Eptinezumab 300 mg
Number of subjects analysed	297	291	289
Units: participants
0 Visit	295	290	289
1 Visit	1	0	0
3 Visits	1	1	0

No statistical analyses for this end point

Secondary: Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

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End point title

Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

End point description

A migraine day was defined in endpoint #1. Full-analysis-long-term set (FAS_LT) included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'N' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72

End point values	Placebo to Eptinezumab 100 mg	Placebo to Eptinezumab 300 mg	Eptinezumab 100 mg to Eptinezumab 100 mg	Eptinezumab 300 mg to Eptinezumab 300 mg
Number of subjects analysed	144	146	282	282
Units: days/month
arithmetic mean (standard error)
Change at Weeks 25-36 (n=144,146,282,282)	-4.7 ( 0.49 )	-6.1 ( 0.49 )	-5.8 ( 0.39 )	-5.9 ( 0.39 )
Change at Weeks 37-48 (n=140,146,282,273)	-5.0 ( 0.50 )	-6.0 ( 0.50 )	-5.8 ( 0.40 )	-6.0 ( 0.40 )
Change at Weeks 49-60 (n=134,140,270,265)	-5.6 ( 0.51 )	-6.6 ( 0.51 )	-5.8 ( 0.41 )	-6.0 ( 0.41 )
Change at Weeks 61-72 (n=126,136,252,246)	-5.9 ( 0.51 )	-6.8 ( 0.51 )	-6.6 ( 0.41 )	-6.5 ( 0.41 )

No statistical analyses for this end point

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

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End point title

Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

End point description

A migraine day was defined in endpoint #1. FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'N' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72

End point values	Placebo to Eptinezumab 100 mg	Placebo to Eptinezumab 300 mg	Eptinezumab 100 mg to Eptinezumab 100 mg	Eptinezumab 300 mg to Eptinezumab 300 mg
Number of subjects analysed	144	146	282	282
Units: percentage of participants
number (not applicable)
Weeks 25-36 (n=144,146,282,282)	48.6	63.0	59.6	61.0
Weeks 37-48 (n=140,146,282,273)	49.3	60.3	60.6	61.9
Weeks 49-60 (n=134,140,270,265)	59.7	68.6	62.6	62.3
Weeks 61-72 (n=126,136,252,246)	63.5	69.9	68.3	65.9

No statistical analyses for this end point

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

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End point title

Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72

End point values	Placebo to Eptinezumab 100 mg	Placebo to Eptinezumab 300 mg	Eptinezumab 100 mg to Eptinezumab 100 mg	Eptinezumab 300 mg to Eptinezumab 300 mg
Number of subjects analysed	144	146	282	282
Units: percentage of participants
number (not applicable)
Weeks 25-36 (n=144,146,282,282)	19.4	28.1	25.9	31.2
Weeks 37-48 (n=140,146,282,273)	27.9	30.8	31.6	32.6
Weeks 49-60 (n=134,140,270,265)	32.1	33.6	29.3	38.9
Weeks 61-72 (n=126,136,252,246)	36.5	39.0	37.7	44.7

No statistical analyses for this end point

Secondary: Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72

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End point title

Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72

End point description

The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'N' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 36, 48, 60, and 72

End point values	Placebo to Eptinezumab 100 mg	Placebo to Eptinezumab 300 mg	Eptinezumab 100 mg to Eptinezumab 100 mg	Eptinezumab 300 mg to Eptinezumab 300 mg
Number of subjects analysed	138	139	265	272
Units: units on a scale
arithmetic mean (standard error)
Change at Week 36 (n=138,137,265,272)	-10.01 ( 0.69 )	-12.15 ( 0.73 )	-10.99 ( 0.57 )	-12.0 ( 0.56 )
Change at Week 48 (n=134,139,260,260)	-10.71 ( 0.77 )	-12.71 ( 0.75 )	-12.55 ( 0.59 )	-12.68 ( 0.60 )
Change at Week 60 (n=128,136,249,258)	-12.54 ( 0.80 )	-13.21 ( 0.71 )	-12.57 ( 0.56 )	-13.15 ( 0.59 )
Change at Week 72 (n=124,131,239,237)	-12.68 ( 0.87 )	-15.02 ( 0.78 )	-13.28 ( 0.63 )	-14.13 ( 0.63 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to Week 72

Adverse event reporting additional description

All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Placebo-controlled Period: Placebo

Reporting group description

Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.

Reporting group title

Placebo-controlled Period: Eptinezumab 300 mg

Reporting group description

Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.

Reporting group title

Placebo-controlled Period: Eptinezumab 100 mg

Reporting group description

Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.

Reporting group title

Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg

Reporting group description

Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

Reporting group title

Extension Period: Placebo to Eptinezumab 100 mg

Reporting group description

Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.

Reporting group title

Extension Period: Placebo to Eptinezumab 300 mg

Reporting group description

Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.

Reporting group title

Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg

Reporting group description

Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

Serious adverse events	Placebo-controlled Period: Placebo	Placebo-controlled Period: Eptinezumab 300 mg	Placebo-controlled Period: Eptinezumab 100 mg	Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg	Extension Period: Placebo to Eptinezumab 100 mg	Extension Period: Placebo to Eptinezumab 300 mg	Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 298 (1.01%)	7 / 294 (2.38%)	6 / 299 (2.01%)	9 / 284 (3.17%)	2 / 145 (1.38%)	7 / 148 (4.73%)	9 / 288 (3.13%)
number of deaths (all causes)	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	1 / 145 (0.69%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer in situ
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intraductal papilloma of breast
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Laryngeal neoplasm
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 298 (0.00%)	2 / 294 (0.68%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Bronchospasm
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nasal turbinate hypertrophy
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Suicidal ideation
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Road traffic accident
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Seizure
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychogenic seizure
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Conductive deafness
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Retinal detachment
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye pain
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	1 / 145 (0.69%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Lichen planus
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Bladder prolapse
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diastasis recti abdominis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
COVID-19
subjects affected / exposed	0 / 298 (0.00%)	2 / 294 (0.68%)	1 / 299 (0.33%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis intestinal perforated
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pilonidal disease
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Placebo-controlled Period: Placebo	Placebo-controlled Period: Eptinezumab 300 mg	Placebo-controlled Period: Eptinezumab 100 mg	Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg	Extension Period: Placebo to Eptinezumab 100 mg	Extension Period: Placebo to Eptinezumab 300 mg	Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	85 / 298 (28.52%)	90 / 294 (30.61%)	95 / 299 (31.77%)	118 / 284 (41.55%)	57 / 145 (39.31%)	62 / 148 (41.89%)	133 / 288 (46.18%)
Vascular disorders
Hypertension
subjects affected / exposed	3 / 298 (1.01%)	4 / 294 (1.36%)	4 / 299 (1.34%)	2 / 284 (0.70%)	3 / 145 (2.07%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	3	4	4	2	4	0	4
General disorders and administration site conditions
Fatigue
subjects affected / exposed	4 / 298 (1.34%)	6 / 294 (2.04%)	2 / 299 (0.67%)	2 / 284 (0.70%)	0 / 145 (0.00%)	1 / 148 (0.68%)	5 / 288 (1.74%)
occurrences all number	4	6	2	3	0	1	5
Pyrexia
subjects affected / exposed	4 / 298 (1.34%)	4 / 294 (1.36%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences all number	5	4	0	0	0	0	0
Asthenia
subjects affected / exposed	2 / 298 (0.67%)	3 / 294 (1.02%)	3 / 299 (1.00%)	1 / 284 (0.35%)	1 / 145 (0.69%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences all number	2	3	3	1	1	0	3
Immune system disorders
Immunisation reaction
subjects affected / exposed	2 / 298 (0.67%)	3 / 294 (1.02%)	0 / 299 (0.00%)	2 / 284 (0.70%)	0 / 145 (0.00%)	1 / 148 (0.68%)	2 / 288 (0.69%)
occurrences all number	3	4	0	3	0	1	2
Social circumstances
Menopause
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	1 / 145 (0.69%)	3 / 148 (2.03%)	1 / 288 (0.35%)
occurrences all number	1	0	1	0	1	3	1
Reproductive system and breast disorders
Menstruation irregular
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	1 / 148 (0.68%)	3 / 288 (1.04%)
occurrences all number	1	0	0	1	0	1	3
Menopausal symptoms
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	0	0	1	1	0	0	3
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	0 / 298 (0.00%)	3 / 294 (1.02%)	2 / 299 (0.67%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	0	3	2	0	0	0	3
Cough
subjects affected / exposed	2 / 298 (0.67%)	0 / 294 (0.00%)	2 / 299 (0.67%)	1 / 284 (0.35%)	0 / 145 (0.00%)	2 / 148 (1.35%)	2 / 288 (0.69%)
occurrences all number	2	0	3	1	0	2	5
Nasal congestion
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	3 / 284 (1.06%)	1 / 145 (0.69%)	0 / 148 (0.00%)	2 / 288 (0.69%)
occurrences all number	0	0	1	4	1	0	2
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 298 (0.00%)	3 / 294 (1.02%)	2 / 299 (0.67%)	2 / 284 (0.70%)	0 / 145 (0.00%)	1 / 148 (0.68%)	4 / 288 (1.39%)
occurrences all number	0	3	2	3	0	1	4
Depressive symptom
subjects affected / exposed	3 / 298 (1.01%)	1 / 294 (0.34%)	0 / 299 (0.00%)	0 / 284 (0.00%)	1 / 145 (0.69%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences all number	3	1	0	0	1	0	1
Anxiety
subjects affected / exposed	2 / 298 (0.67%)	1 / 294 (0.34%)	1 / 299 (0.33%)	2 / 284 (0.70%)	0 / 145 (0.00%)	1 / 148 (0.68%)	3 / 288 (1.04%)
occurrences all number	2	1	1	2	0	1	3
Depression
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	2 / 145 (1.38%)	0 / 148 (0.00%)	2 / 288 (0.69%)
occurrences all number	1	0	1	0	2	0	2
Investigations
Weight decreased
subjects affected / exposed	0 / 298 (0.00%)	2 / 294 (0.68%)	0 / 299 (0.00%)	2 / 284 (0.70%)	0 / 145 (0.00%)	2 / 148 (1.35%)	1 / 288 (0.35%)
occurrences all number	0	2	0	2	0	2	1
Blood pressure increased
subjects affected / exposed	3 / 298 (1.01%)	0 / 294 (0.00%)	2 / 299 (0.67%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences all number	4	0	2	1	0	0	1
Blood creatine phosphokinase increased
subjects affected / exposed	2 / 298 (0.67%)	1 / 294 (0.34%)	3 / 299 (1.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	1 / 148 (0.68%)	3 / 288 (1.04%)
occurrences all number	2	1	3	1	0	1	3
Weight increased
subjects affected / exposed	2 / 298 (0.67%)	1 / 294 (0.34%)	1 / 299 (0.33%)	2 / 284 (0.70%)	2 / 145 (1.38%)	2 / 148 (1.35%)	3 / 288 (1.04%)
occurrences all number	2	1	1	2	2	2	3
Blood cholesterol increased
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	0 / 145 (0.00%)	2 / 148 (1.35%)	0 / 288 (0.00%)
occurrences all number	0	0	0	1	0	2	0
Injury, poisoning and procedural complications
Post vaccination syndrome
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	4 / 299 (1.34%)	5 / 284 (1.76%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences all number	0	0	4	6	0	1	0
Procedural pain
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	2 / 148 (1.35%)	0 / 288 (0.00%)
occurrences all number	1	0	0	0	0	3	0
Ligament sprain
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	2 / 299 (0.67%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	1	0	2	1	0	0	3
Nervous system disorders
Dizziness
subjects affected / exposed	5 / 298 (1.68%)	5 / 294 (1.70%)	2 / 299 (0.67%)	4 / 284 (1.41%)	1 / 145 (0.69%)	1 / 148 (0.68%)	2 / 288 (0.69%)
occurrences all number	5	5	2	5	1	1	3
Migraine
subjects affected / exposed	3 / 298 (1.01%)	3 / 294 (1.02%)	1 / 299 (0.33%)	2 / 284 (0.70%)	0 / 145 (0.00%)	1 / 148 (0.68%)	7 / 288 (2.43%)
occurrences all number	3	5	1	4	0	1	7
Sciatica
subjects affected / exposed	1 / 298 (0.34%)	3 / 294 (1.02%)	1 / 299 (0.33%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	2 / 288 (0.69%)
occurrences all number	1	3	1	0	0	0	2
Somnolence
subjects affected / exposed	4 / 298 (1.34%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	0 / 145 (0.00%)	1 / 148 (0.68%)	0 / 288 (0.00%)
occurrences all number	4	0	2	0	0	1	0
Headache
subjects affected / exposed	3 / 298 (1.01%)	3 / 294 (1.02%)	3 / 299 (1.00%)	1 / 284 (0.35%)	2 / 145 (1.38%)	2 / 148 (1.35%)	3 / 288 (1.04%)
occurrences all number	4	3	4	1	3	3	3
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	1 / 145 (0.69%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	1	0	1	0	1	0	3
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	5 / 298 (1.68%)	5 / 294 (1.70%)	0 / 299 (0.00%)	2 / 284 (0.70%)	0 / 145 (0.00%)	2 / 148 (1.35%)	0 / 288 (0.00%)
occurrences all number	5	5	0	2	0	2	0
Constipation
subjects affected / exposed	3 / 298 (1.01%)	1 / 294 (0.34%)	3 / 299 (1.00%)	2 / 284 (0.70%)	1 / 145 (0.69%)	1 / 148 (0.68%)	3 / 288 (1.04%)
occurrences all number	3	2	3	2	1	2	3
Abdominal pain upper
subjects affected / exposed	2 / 298 (0.67%)	4 / 294 (1.36%)	5 / 299 (1.67%)	3 / 284 (1.06%)	1 / 145 (0.69%)	3 / 148 (2.03%)	4 / 288 (1.39%)
occurrences all number	3	5	5	4	1	4	5
Abdominal pain
subjects affected / exposed	2 / 298 (0.67%)	2 / 294 (0.68%)	4 / 299 (1.34%)	2 / 284 (0.70%)	0 / 145 (0.00%)	1 / 148 (0.68%)	3 / 288 (1.04%)
occurrences all number	2	2	4	2	0	1	3
Nausea
subjects affected / exposed	4 / 298 (1.34%)	5 / 294 (1.70%)	4 / 299 (1.34%)	3 / 284 (1.06%)	1 / 145 (0.69%)	5 / 148 (3.38%)	2 / 288 (0.69%)
occurrences all number	5	5	4	3	2	5	2
Haemorrhoids
subjects affected / exposed	2 / 298 (0.67%)	0 / 294 (0.00%)	0 / 299 (0.00%)	2 / 284 (0.70%)	2 / 145 (1.38%)	1 / 148 (0.68%)	2 / 288 (0.69%)
occurrences all number	3	0	0	2	2	1	2
Dyspepsia
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	1 / 299 (0.33%)	5 / 284 (1.76%)	0 / 145 (0.00%)	1 / 148 (0.68%)	1 / 288 (0.35%)
occurrences all number	0	1	1	6	0	1	1
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	4 / 299 (1.34%)	0 / 284 (0.00%)	1 / 145 (0.69%)	1 / 148 (0.68%)	1 / 288 (0.35%)
occurrences all number	0	0	4	0	1	1	1
Pruritus
subjects affected / exposed	0 / 298 (0.00%)	2 / 294 (0.68%)	2 / 299 (0.67%)	6 / 284 (2.11%)	1 / 145 (0.69%)	0 / 148 (0.00%)	2 / 288 (0.69%)
occurrences all number	0	2	2	6	1	0	2
Rash
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	3 / 284 (1.06%)	1 / 145 (0.69%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences all number	1	0	0	3	1	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 298 (0.00%)	4 / 294 (1.36%)	6 / 299 (2.01%)	6 / 284 (2.11%)	1 / 145 (0.69%)	2 / 148 (1.35%)	6 / 288 (2.08%)
occurrences all number	0	5	7	6	1	3	6
Back pain
subjects affected / exposed	4 / 298 (1.34%)	3 / 294 (1.02%)	6 / 299 (2.01%)	2 / 284 (0.70%)	1 / 145 (0.69%)	2 / 148 (1.35%)	8 / 288 (2.78%)
occurrences all number	4	3	6	2	1	2	8
Neck pain
subjects affected / exposed	1 / 298 (0.34%)	3 / 294 (1.02%)	1 / 299 (0.33%)	0 / 284 (0.00%)	1 / 145 (0.69%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences all number	1	3	1	0	1	0	1
Pain in extremity
subjects affected / exposed	3 / 298 (1.01%)	1 / 294 (0.34%)	3 / 299 (1.00%)	3 / 284 (1.06%)	0 / 145 (0.00%)	1 / 148 (0.68%)	2 / 288 (0.69%)
occurrences all number	3	1	3	3	0	1	2
Myalgia
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	2 / 299 (0.67%)	1 / 284 (0.35%)	0 / 145 (0.00%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	0	1	2	1	0	0	3
Osteoarthritis
subjects affected / exposed	0 / 298 (0.00%)	2 / 294 (0.68%)	0 / 299 (0.00%)	2 / 284 (0.70%)	2 / 145 (1.38%)	1 / 148 (0.68%)	4 / 288 (1.39%)
occurrences all number	0	2	0	2	2	1	4
Infections and infestations
Nasopharyngitis
subjects affected / exposed	3 / 298 (1.01%)	9 / 294 (3.06%)	5 / 299 (1.67%)	27 / 284 (9.51%)	7 / 145 (4.83%)	13 / 148 (8.78%)	19 / 288 (6.60%)
occurrences all number	3	11	7	38	8	15	25
COVID-19
subjects affected / exposed	16 / 298 (5.37%)	15 / 294 (5.10%)	19 / 299 (6.35%)	63 / 284 (22.18%)	25 / 145 (17.24%)	31 / 148 (20.95%)	63 / 288 (21.88%)
occurrences all number	16	15	19	63	26	33	69
Urinary tract infection
subjects affected / exposed	5 / 298 (1.68%)	5 / 294 (1.70%)	1 / 299 (0.33%)	4 / 284 (1.41%)	3 / 145 (2.07%)	4 / 148 (2.70%)	3 / 288 (1.04%)
occurrences all number	6	5	1	5	4	4	4
Upper respiratory tract infection
subjects affected / exposed	1 / 298 (0.34%)	2 / 294 (0.68%)	4 / 299 (1.34%)	8 / 284 (2.82%)	4 / 145 (2.76%)	6 / 148 (4.05%)	13 / 288 (4.51%)
occurrences all number	1	2	4	8	4	8	14
Sinusitis
subjects affected / exposed	3 / 298 (1.01%)	1 / 294 (0.34%)	0 / 299 (0.00%)	5 / 284 (1.76%)	2 / 145 (1.38%)	2 / 148 (1.35%)	4 / 288 (1.39%)
occurrences all number	3	1	0	5	2	2	4
Gastroenteritis
subjects affected / exposed	3 / 298 (1.01%)	2 / 294 (0.68%)	0 / 299 (0.00%)	5 / 284 (1.76%)	1 / 145 (0.69%)	1 / 148 (0.68%)	2 / 288 (0.69%)
occurrences all number	3	2	0	6	1	1	2
Bronchitis
subjects affected / exposed	1 / 298 (0.34%)	3 / 294 (1.02%)	0 / 299 (0.00%)	3 / 284 (1.06%)	1 / 145 (0.69%)	3 / 148 (2.03%)	4 / 288 (1.39%)
occurrences all number	1	3	0	3	1	3	4
Pharyngitis
subjects affected / exposed	1 / 298 (0.34%)	1 / 294 (0.34%)	1 / 299 (0.33%)	4 / 284 (1.41%)	0 / 145 (0.00%)	3 / 148 (2.03%)	3 / 288 (1.04%)
occurrences all number	1	1	1	5	0	3	3
Oral herpes
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	0 / 284 (0.00%)	2 / 145 (1.38%)	1 / 148 (0.68%)	1 / 288 (0.35%)
occurrences all number	0	0	1	0	2	1	1
Influenza
subjects affected / exposed	1 / 298 (0.34%)	0 / 294 (0.00%)	0 / 299 (0.00%)	1 / 284 (0.35%)	2 / 145 (1.38%)	1 / 148 (0.68%)	4 / 288 (1.39%)
occurrences all number	1	0	0	1	2	1	4
Herpes zoster
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	1 / 299 (0.33%)	0 / 284 (0.00%)	1 / 145 (0.69%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	0	1	1	0	1	0	3
Cystitis
subjects affected / exposed	1 / 298 (0.34%)	2 / 294 (0.68%)	0 / 299 (0.00%)	3 / 284 (1.06%)	0 / 145 (0.00%)	5 / 148 (3.38%)	1 / 288 (0.35%)
occurrences all number	1	2	0	3	0	5	1
Rhinitis
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	0 / 299 (0.00%)	3 / 284 (1.06%)	1 / 145 (0.69%)	0 / 148 (0.00%)	1 / 288 (0.35%)
occurrences all number	0	1	0	3	1	0	1
Tonsillitis
subjects affected / exposed	0 / 298 (0.00%)	2 / 294 (0.68%)	0 / 299 (0.00%)	4 / 284 (1.41%)	0 / 145 (0.00%)	0 / 148 (0.00%)	2 / 288 (0.69%)
occurrences all number	0	2	0	5	0	0	2
Viral upper respiratory tract infection
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	1 / 299 (0.33%)	4 / 284 (1.41%)	0 / 145 (0.00%)	0 / 148 (0.00%)	0 / 288 (0.00%)
occurrences all number	0	0	1	5	0	0	0
Metabolism and nutrition disorders
Hyperlipidaemia
subjects affected / exposed	0 / 298 (0.00%)	0 / 294 (0.00%)	3 / 299 (1.00%)	2 / 284 (0.70%)	1 / 145 (0.69%)	2 / 148 (1.35%)	0 / 288 (0.00%)
occurrences all number	0	0	3	2	1	2	0
Vitamin B12 deficiency
subjects affected / exposed	0 / 298 (0.00%)	1 / 294 (0.34%)	0 / 299 (0.00%)	0 / 284 (0.00%)	0 / 145 (0.00%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	0	1	0	0	0	0	3
Hypercholesterolaemia
subjects affected / exposed	1 / 298 (0.34%)	1 / 294 (0.34%)	2 / 299 (0.67%)	2 / 284 (0.70%)	2 / 145 (1.38%)	1 / 148 (0.68%)	4 / 288 (1.39%)
occurrences all number	1	1	2	2	2	1	4
Dyslipidaemia
subjects affected / exposed	2 / 298 (0.67%)	2 / 294 (0.68%)	1 / 299 (0.33%)	2 / 284 (0.70%)	0 / 145 (0.00%)	0 / 148 (0.00%)	3 / 288 (1.04%)
occurrences all number	2	2	1	2	0	0	3

More information

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Were there any global substantial amendments to the protocol? Yes

22 Jan 2021

It included following changes: - Added section describing how to manage reactions to investigational medicinal product; - Added withdrawal criteria for participants who have: • anaphylactic reactions or other severe and/or serious hypersensitivity reactions; • significant risk of suicide according to Columbia Suicide Severity Rating Scale (C-SSRS). - Made changes to the statistical methodology: • Primary analysis: MMRM replaced analysis of covariance (ANCOVA); • Key secondary responder endpoint analyses: logistic regression replaced the Cochran–Mantel–Haenszel (CMH) test; • Analysis of MMDs (Weeks 13-24): MMRM replaced ANCOVA • Added: that participants with a migraine on the day after the first dose and that 100% responder endpoints will be analysed using an extended CMH test.

30 Nov 2021

It included following changes: - Cancelled the planned interim analysis; - Clarified definitions for eligibility: migraine day, headache day, and eDiary compliant day. - Updated sections that described: • randomization stratified by MHDs and by country; • timing of exit interviews for participants who withdrew prior to Week 24; • definitions for calculating the number of episodic migraine (EM)/chronic migraine (CM) participants and low/high frequency EM participants for subgroup analyses; • unscheduled visits - Added that: • participants could attend up to two Screening Visits to complete all screening assessments; • vaccination against COVID-19 is allowed during the study; • following the database lock for the Placebo-controlled Period, Sponsor personnel involved in the development of the Clinical Study Report were unblinded to individual treatment codes.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12

Primary: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24

Secondary: Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12

Secondary: Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

Secondary: Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

Secondary: Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24

Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24

Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24

Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24

Secondary: PGIC Score at Week 24

Secondary: PGIC Score at Week 24

Secondary: Patient Global Impression of Change (PGIC) Score at Week 12

Secondary: Patient Global Impression of Change (PGIC) Score at Week 12

Secondary: Percentage of Participants With Migraine on the Day After First Dosing

Secondary: Percentage of Participants With Migraine on the Day After First Dosing

Secondary: Change From Baseline in the HIT-6 Score at Week 24

Secondary: Change From Baseline in the HIT-6 Score at Week 24

Secondary: Most Bothersome Symptom (MBS) Score at Week 12

Secondary: Most Bothersome Symptom (MBS) Score at Week 12

Secondary: Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12

Secondary: Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12

Secondary: Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12

Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12

Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12

Secondary: Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24

Secondary: Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24

Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24

Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24

Secondary: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12

Secondary: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12

Secondary: Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24

Secondary: Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24

Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score

Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score

Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score

Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score

Secondary: Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner

Secondary: Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner

Secondary: HCRU: Visits to a Specialist

Secondary: HCRU: Visits to a Specialist

Secondary: HCRU: Number of Emergency Department Visits Due to Your Migraine

Secondary: HCRU: Number of Emergency Department Visits Due to Your Migraine

Clinical Trial Results:
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments