Trial Outcomes & Findings for A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache (NCT NCT05452239)

Results Overview

A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

608 participants

Primary outcome timeframe

Baseline, Weeks 1 - 4

Results posted on

2026-01-29

Participant Flow

The study consisted of a 12-week placebo-controlled Period followed by a 12-week open-label Period.

Participant milestones

Participant milestones
Measure	Eptinezumab Participants received an intravenous (IV) infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period and at Week 12 during the open-label period.	Placebo Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period and an IV infusion of eptinezumab at Week 12 during the open-label period.
Placebo-controlled Period STARTED	305	303
Placebo-controlled Period Received at Least 1 Dose of Study Drug	303	301
Placebo-controlled Period Full Analysis Set (FAS)	302	300
Placebo-controlled Period COMPLETED	301	295
Placebo-controlled Period NOT COMPLETED	4	8
Open-label Period STARTED	300	293
Open-label Period Received at Least 1 Dose of Study Drug	300	293
Open-label Period COMPLETED	294	290
Open-label Period NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Eptinezumab Participants received an intravenous (IV) infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period and at Week 12 during the open-label period.	Placebo Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period and an IV infusion of eptinezumab at Week 12 during the open-label period.
Placebo-controlled Period Withdrawal by Subject	0	4
Placebo-controlled Period Lost to Follow-up	1	0
Placebo-controlled Period Failure to comply with trial procedures	0	1
Placebo-controlled Period Randomized but not treated	2	2
Placebo-controlled Period Other than specified	1	1
Open-label Period Withdrawal by Subject	2	1
Open-label Period Lost to Follow-up	3	0
Open-label Period Other than specified	1	2

Baseline Characteristics

Full Analysis Set (FAS) included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. Here, MMDs at Baseline are reported.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eptinezumab n=303 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period and at Week 12 during the open-label period.	Placebo n=301 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period and an IV infusion of eptinezumab at Week 12 during the open-label period.	Total n=604 Participants Total of all reporting groups
Age, Continuous	45.7 years STANDARD_DEVIATION 11.95 • n=303 Participants	45.2 years STANDARD_DEVIATION 12.03 • n=301 Participants	45.5 years STANDARD_DEVIATION 11.98 • n=604 Participants
Sex: Female, Male Female	264 Participants n=303 Participants	253 Participants n=301 Participants	517 Participants n=604 Participants
Sex: Female, Male Male	39 Participants n=303 Participants	48 Participants n=301 Participants	87 Participants n=604 Participants
Race/Ethnicity, Customized Race · White	151 Participants n=303 Participants	147 Participants n=301 Participants	298 Participants n=604 Participants
Race/Ethnicity, Customized Race · Black	3 Participants n=303 Participants	4 Participants n=301 Participants	7 Participants n=604 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=303 Participants	1 Participants n=301 Participants	2 Participants n=604 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=303 Participants	4 Participants n=301 Participants	6 Participants n=604 Participants
Race/Ethnicity, Customized Race · Not Collected/Unknown	146 Participants n=303 Participants	145 Participants n=301 Participants	291 Participants n=604 Participants
Monthly Migraine Days (MMDs)	21.0 days/month STANDARD_DEVIATION 4.26 • n=302 Participants • Full Analysis Set (FAS) included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. Here, MMDs at Baseline are reported.	20.9 days/month STANDARD_DEVIATION 4.28 • n=300 Participants • Full Analysis Set (FAS) included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. Here, MMDs at Baseline are reported.	20.9 days/month STANDARD_DEVIATION 4.27 • n=602 Participants • Full Analysis Set (FAS) included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. Here, MMDs at Baseline are reported.

PRIMARY outcome

Timeframe: Baseline, Weeks 1 - 4

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=300 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=299 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4	-6.85 days/month Standard Error 0.518	-3.66 days/month Standard Error 0.519

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.

A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in MMDs at Weeks 1 to 12	-7.44 days/month Standard Error 0.508	-4.50 days/month Standard Error 0.508

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 4 and Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-4	-6.54 days/month Standard Error 0.502	-3.40 days/month Standard Error 0.502
Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-12	-7.38 days/month Standard Error 0.497	-4.45 days/month Standard Error 0.497

SECONDARY outcome

Timeframe: Weeks 1 - 4 and Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis. MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH) Weeks 1-4	37.8 percentage of participants	18.1 percentage of participants
Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH) Weeks 1-12	27.2 percentage of participants	12.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 2

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.

Daily Pain assessment data were collected in the headache electronic diary (eDiary) via the question "What was the worst pain intensity of this headache today?". The pain intensity assessment was collected on a 3-point scale: Mild (score = 1), Moderate (score = 2), and Severe (score = 3). For each day, the Daily Pain assessment score was derived by averaging the worst pain intensity over all headaches of that day. For days on which no headaches took place during the relevant period, the Daily Pain score was given as a score of 0. The average Daily Pain score was calculated using the Daily Pain assessments collected during Weeks 1-2.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 1 to 2	-0.58 units on a scale Standard Error 0.048	-0.27 units on a scale Standard Error 0.048

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 4 and Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Acute migraine medication included those medications classified as opioid, barbiturates, ergotamine, triptan, non-opioid analgesic, and combination of analgesic ingredients.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-4	-11.32 days/month Standard Error 0.508	-7.69 days/month Standard Error 0.509
Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-12	-11.18 days/month Standard Error 0.490	-7.83 days/month Standard Error 0.490

SECONDARY outcome

Timeframe: Baseline, Weeks 13-16, 17-20, and 21-24

Population: All-Participants-Treated-Open-Label Set (APTS-OL) included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=293 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=285 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 Change at Weeks 13-16	-10.23 days/month Standard Deviation 7.167	-10.08 days/month Standard Deviation 7.136
Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 Change at Weeks 17-20	-10.29 days/month Standard Deviation 7.093	-10.29 days/month Standard Deviation 7.301
Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 Change at Weeks 21-24	-9.24 days/month Standard Deviation 7.220	-9.30 days/month Standard Deviation 7.602

SECONDARY outcome

Timeframe: Baseline, at Weeks 13-16, 17-20, and 21-24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=293 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=285 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 Change at Weeks 13-16	-10.31 days/month Standard Deviation 7.113	-9.99 days/month Standard Deviation 7.082
Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 Change at Weeks 17-20	-10.46 days/month Standard Deviation 6.941	-10.34 days/month Standard Deviation 7.253
Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 Change at Weeks 21-24	-9.46 days/month Standard Deviation 7.206	-9.47 days/month Standard Deviation 7.382

SECONDARY outcome

Timeframe: Weeks 13 - 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis. MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=296 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=291 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM Nor MOH at Weeks 13 to 24	38.9 percentage of participants	40.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 13-16, 17-20, and 21-24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Number analyzed' = participants evaluable at specified timepoint.

Daily Pain assessment data were collected in the headache eDiary via the question "What was the worst pain intensity of this headache today?". The pain intensity assessment was collected on a 3-point scale: Mild (score = 1), Moderate (score = 2), and Severe (score = 3). For each day, the Daily Pain assessment score was derived by averaging the worst pain intensity over all headaches of that day. For days on which no headaches took place during the relevant period, the Daily Pain score was given as a score of 0. The average Daily Pain score was calculated using the Daily Pain assessments collected during Weeks 13-16, 17-20, and 21-24.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=300 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=293 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 Change at Weeks 13-16	-0.90 units on a scale Standard Deviation 0.628	-0.90 units on a scale Standard Deviation 0.602
Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 Change at Weeks 17-20	-0.88 units on a scale Standard Deviation 0.641	-0.89 units on a scale Standard Deviation 0.630
Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 Change at Weeks 21-24	-0.84 units on a scale Standard Deviation 0.638	-0.81 units on a scale Standard Deviation 0.667

SECONDARY outcome

Timeframe: Baseline, Weeks 13-16, 17-20, and 21-24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Acute migraine medication included paracetamol, triptans, ergotamine, combination of non-opioid analgesics, individual non-opioid analgesics, and nonsteroidal anti-inflammatory drugs (NSAIDs). Barbiturates and/or opioid analgesics were allowed when considered medically indicated providing its use does not exceed 4 days per month.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=289 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=282 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 21-24	-10.96 days/month Standard Deviation 6.693	-10.44 days/month Standard Deviation 7.338
Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 13-16	-12.08 days/month Standard Deviation 6.738	-11.67 days/month Standard Deviation 6.470
Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 17-20	-11.82 days/month Standard Deviation 6.690	-11.39 days/month Standard Deviation 7.080

SECONDARY outcome

Timeframe: Weeks 1 - 4 and Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-4	55.0 percentage of participants	32.4 percentage of participants
Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-12	44.4 percentage of participants	23.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1 - 4 and Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-4	52.2 percentage of participants	31.9 percentage of participants
Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-12	40.1 percentage of participants	24.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.

A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in MMDs With Use of Acute Headache Medication at Weeks 1 to 12	-10.32 days/month Standard Error 0.481	-7.16 days/month Standard Error 0.481

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 1 to 12	-8.35 days/month Standard Error 0.411	-5.49 days/month Standard Error 0.409

SECONDARY outcome

Timeframe: Baseline, Weeks 13-16, 17-20, and 21-24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=289 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=282 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 13-16	-8.70 days/month Standard Deviation 6.736	-8.79 days/month Standard Deviation 6.781
Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 17-20	-8.24 days/month Standard Deviation 6.540	-8.31 days/month Standard Deviation 6.982
Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 21-24	-7.43 days/month Standard Deviation 6.505	-7.56 days/month Standard Deviation 6.700

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=294 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=295 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or Non-steroidal Anti-inflammatory Drug (NSAID) Medication Use at Weeks 1 to 12	-5.94 days/month Standard Error 0.402	-4.80 days/month Standard Error 0.402

SECONDARY outcome

Timeframe: Baseline, Weeks 13-16, 17-20, and 21-24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=289 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=282 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 13-16	-6.55 days/month Standard Deviation 7.205	-6.66 days/month Standard Deviation 7.108
Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 17-20	-6.65 days/month Standard Deviation 7.193	-6.62 days/month Standard Deviation 7.316
Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 Change at Weeks 21-24	-6.18 days/month Standard Deviation 7.018	-6.44 days/month Standard Deviation 7.468

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=294 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=295 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Monthly Days With Combination Non-opioid Analgesics Medication Use at Weeks 1 to 12	-1.24 days/month Standard Error 0.202	-1.12 days/month Standard Error 0.201

SECONDARY outcome

Timeframe: Day 1

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Number of Participants With Migraine on the Day After Dosing	162 Participants	203 Participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 4 and 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-4	36.7 percentage of participants	13.7 percentage of participants
Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-12	40.4 percentage of participants	18.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 4 and 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-4	13.0 percentage of participants	4.3 percentage of participants
Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-12	12.9 percentage of participants	5.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 4 and 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-4	33.0 percentage of participants	11.0 percentage of participants
Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-12	35.8 percentage of participants	15.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 4 and 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.

A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=302 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=300 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-4	9.3 percentage of participants	3.3 percentage of participants
Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 Weeks 1-12	10.9 percentage of participants	5.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 4 and 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

A migraine that fulfilled the criteria for a migraine, was referred to as a migraine attack.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=299 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=297 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-4	-10.30 percentage of migraine attacks Standard Error 1.912	-1.60 percentage of migraine attacks Standard Error 1.916
Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-12	-5.21 percentage of migraine attacks Standard Error 1.859	-1.60 percentage of migraine attacks Standard Error 1.860

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 4 and 1 - 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

A non-migraine headache that lasted ≥30 minutes or a migraine headache, was referred to as a headache episode.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=300 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=297 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-4	-11.78 percentage of headache episodes Standard Error 1.867	-3.36 percentage of headache episodes Standard Error 1.872
Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 Change at Weeks 1-12	-6.99 percentage of headache episodes Standard Error 1.822	-2.79 percentage of headache episodes Standard Error 1.825

SECONDARY outcome

Timeframe: Weeks 4 and 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

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.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=284 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12 Week 12	2.64 units on a scale Standard Error 0.101	3.54 units on a scale Standard Error 0.101
Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12 Week 4	2.62 units on a scale Standard Error 0.100	3.63 units on a scale Standard Error 0.100

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=283 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=277 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: PGIC Score at Week 24	2.3 units on a scale Standard Deviation 1.18	2.3 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=283 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Most Bothersome Symptom (MBS) Score at Week 12	2.87 units on a scale Standard Error 0.106	3.59 units on a scale Standard Error 0.107

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=283 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=277 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: MBS Score at Week 24	2.6 units on a scale Standard Deviation 1.22	2.6 units on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

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).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=279 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=274 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12 Change at Week 4	-6.5 units on a scale Standard Error 7.25	-2.6 units on a scale Standard Error 5.30
Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12 Change at Week 12	-7.4 units on a scale Standard Error 8.60	-3.9 units on a scale Standard Error 6.42

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

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).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=274 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=265 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in HIT-6 Total Score at Week 24	-8.1 units on a scale Standard Deviation 8.21	-7.6 units on a scale Standard Deviation 7.74

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

The mMIDAS is a self-administered questionnaire that contains 7 questions about the headache a participant had in the previous month. The first 5 questions assess the impact of migraine on 3 domains of daily activity: 2 questions for paid work or schoolwork, 2 questions for household work, and 1 question for family, social and leisure activities. The 2 questions for each of the first two groups assess, respectively, the number of days off due to headache, and the number of days in which the productivity was reduced by half or more. mMIDAS total score was derived from the sum of the answers on the first 5 questions. Total score ranged from 0 (little/no disability) to 20 (severe disability) with higher scores indicating more severe disability.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=276 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=271 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12 Change at Week 4	-14.73 units on a scale Standard Error 1.475	-6.62 units on a scale Standard Error 1.476
Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12 Change at Week 12	-13.83 units on a scale Standard Error 1.494	-8.76 units on a scale Standard Error 1.496

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

The mMIDAS is a self-administered questionnaire that contains 7 questions about the headache a participant had in the previous month. The first 5 questions assess the impact of migraine on 3 domains of daily activity: 2 questions for paid work or schoolwork, 2 questions for household work, and 1 question for family, social and leisure activities. The 2 questions for each of the first two groups assess, respectively, the number of days off due to headache, and the number of days in which the productivity was reduced by half or more. mMIDAS total score was derived from the sum of the answers on the first 5 questions. Total score ranged from 0 (little/no disability) to 20 (severe disability) with higher scores indicating more severe disability.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=270 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=263 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in mMIDAS Total Score at Week 24	-17.3 units on a scale Standard Deviation 20.71	-15.2 units on a scale Standard Deviation 19.69

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

The MSQ v2.1 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.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=276 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=267 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 Change at Week 4: Role function- restrictive	24.04 units on a scale Standard Error 1.898	10.15 units on a scale Standard Error 1.902
Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 Change at Week 12: Role function- restrictive	22.55 units on a scale Standard Error 1.873	11.79 units on a scale Standard Error 1.877
Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 Change at Week 4: Role function- preventive	18.58 units on a scale Standard Error 1.862	7.88 units on a scale Standard Error 1.864
Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 Change at Week 12: Role function- preventive	17.96 units on a scale Standard Error 1.834	10.16 units on a scale Standard Error 1.836
Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 Change at Week 4: Emotional function	23.82 units on a scale Standard Error 2.143	10.11 units on a scale Standard Error 2.145
Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 Change at Week 12: Emotional function	22.06 units on a scale Standard Error 2.188	11.67 units on a scale Standard Error 2.193

SECONDARY outcome

Timeframe: Baseline, Weeks 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

The MSQ v2.1 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.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=270 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=257 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 Role function- restrictive	26.38 units on a scale Standard Error 23.302	26.33 units on a scale Standard Error 24.159
Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 Role function- preventive	20.6 units on a scale Standard Error 23.61	20.7 units on a scale Standard Error 22.85
Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 Emotional function	26.86 units on a scale Standard Error 27.806	26.54 units on a scale Standard Error 28.385

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

The EQ-5D-5L VAS measures participant's self-rated health-related quality of life on a VAS. The VAS score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=276 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=264 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12 Change at Week 4	5.09 units on a scale Standard Error 1.561	0.49 units on a scale Standard Error 1.574
Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12 Change at Week 12	7.43 units on a scale Standard Error 1.526	2.23 units on a scale Standard Error 1.540

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

The EQ-5D-5L VAS measures participant's self-rated health-related quality of life on a VAS. The VAS score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=268 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=256 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in EQ-5D-5L VAS Score at Week 24	5.9 units on a scale Standard Deviation 22.69	3.9 units on a scale Standard Deviation 22.10

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.

The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It 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, that is, worse outcomes.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=276 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=263 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Activity impairment	-18.87 units on a scale Standard Error 2.065	-10.42 units on a scale Standard Error 2.079
Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Absenteeism	-4.73 units on a scale Standard Error 2.342	-1.18 units on a scale Standard Error 2.324
Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Presenteeism	-19.10 units on a scale Standard Error 2.602	-10.12 units on a scale Standard Error 2.544
Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Work productivity loss	-19.88 units on a scale Standard Error 2.790	-9.04 units on a scale Standard Error 2.727

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.

The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It 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, that is, worse outcomes.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=268 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=256 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Absenteeism	-9.22 units on a scale Standard Deviation 27.236	-4.75 units on a scale Standard Deviation 25.007
Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Presenteeism	-18.8 units on a scale Standard Deviation 28.41	-22.7 units on a scale Standard Deviation 27.58
Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Work productivity loss	-20.54 units on a scale Standard Deviation 29.162	-24.18 units on a scale Standard Deviation 29.102
Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Activity impairment	-19.6 units on a scale Standard Deviation 28.14	-21.0 units on a scale Standard Deviation 28.73

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.

The HADS is a participant-rated scale designed to assess psychological distress in non-psychiatric participants. The HADS consists of 2 sub-scales: depression and anxiety. Each sub-scale contains 7 items, and each item was rated from 0 (absent) to 3 (maximum severity). The total score of each sub-scale ranged from 0 (absent) to 21 (maximum severity). Higher scores indicated higher severity.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=276 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=264 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 Change at Week 4: Total Depression Score	-1.59 units on a scale Standard Error 0.294	-0.61 units on a scale Standard Error 0.296
Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 Change at Week 12: Total Depression Score	-1.82 units on a scale Standard Error 0.300	-0.64 units on a scale Standard Error 0.302
Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 Change at Week 4: Total Anxiety Score	-1.32 units on a scale Standard Error 0.262	-0.49 units on a scale Standard Error 0.263
Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 Change at Week 12: Total Anxiety Score	-1.37 units on a scale Standard Error 0.257	-0.40 units on a scale Standard Error 0.257

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants analyzed for this outcome measure.

The HADS is a participant-rated scale designed to assess psychological distress in non-psychiatric participants. The HADS consists of 2 sub-scales: depression and anxiety. Each sub-scale contains 7 items, and each item was rated from 0 (absent) to 3 (maximum severity). The total score of each sub-scale ranged from 0 (absent) to 21 (maximum severity). Higher scores indicated higher severity.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=269 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=256 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24 Total Depression Score	-2.1 units on a scale Standard Deviation 3.78	-1.3 units on a scale Standard Deviation 3.88
Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24 Total Anxiety Score	-2.0 units on a scale Standard Deviation 3.36	-1.1 units on a scale Standard Deviation 3.54

SECONDARY outcome

Timeframe: Weeks 4 and 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.

TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=281 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 Week 4: Effectiveness Score	58.21 units on a scale Standard Error 2.228	39.01 units on a scale Standard Error 2.236
Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 Week 12: Effectiveness Score	57.95 units on a scale Standard Error 2.264	40.89 units on a scale Standard Error 2.278
Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 Week 4: Convenience Score	69.60 units on a scale Standard Error 1.736	63.62 units on a scale Standard Error 1.743
Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 Week 12: Convenience Score	69.42 units on a scale Standard Error 1.786	63.12 units on a scale Standard Error 1.797
Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 Week 4: Overall Satisfaction Score	59.56 units on a scale Standard Error 2.094	43.57 units on a scale Standard Error 2.099
Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 Week 12: Overall Satisfaction Score	62.54 units on a scale Standard Error 2.136	46.98 units on a scale Standard Error 2.146

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants analyzed for this outcome measure.

TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=281 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=276 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: TSQM-9 Score at Week 24 Overall Satisfaction Score	64.23 units on a scale Standard Deviation 29.401	63.51 units on a scale Standard Deviation 27.603
Open-label Period: TSQM-9 Score at Week 24 Effectiveness Score	63.23 units on a scale Standard Deviation 28.684	62.50 units on a scale Standard Deviation 27.896
Open-label Period: TSQM-9 Score at Week 24 Convenience Score	66.23 units on a scale Standard Deviation 21.451	66.02 units on a scale Standard Deviation 23.017

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Number of participants who visited to a family doctor/general practitioner during the past 4 weeks has been reported at Baseline and Week 12.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=281 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 15 Visits	0 Participants	1 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 6 Visits	1 Participants	0 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 10 Visits	0 Participants	0 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 15 Visits	0 Participants	0 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 0 Visit	242 Participants	217 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 1 Visit	29 Participants	41 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 2 Visits	7 Participants	15 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 3 Visits	5 Participants	4 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 4 Visits	4 Participants	2 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Week 12 · 5 Visits	0 Participants	2 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 6 Visits	1 Participants	0 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 10 Visits	1 Participants	0 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 0 Visit	213 Participants	198 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 1 Visit	44 Participants	42 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 2 Visits	10 Participants	17 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 3 Visits	11 Participants	4 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 4 Visits	2 Participants	3 Participants
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 Baseline · 5 Visits	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Number of participants who visited a specialist during the past 4 weeks has been reported at Baseline and Week 12.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=281 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 0 Visit	180 Participants	156 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 1 Visit	71 Participants	83 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 2 Visits	21 Participants	18 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 3 Visits	6 Participants	5 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 4 Visits	3 Participants	2 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 5 Visits	1 Participants	2 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 6 Visits	1 Participants	0 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Baseline · 12 Visits	0 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 0 Visit	245 Participants	224 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 1 Visit	30 Participants	43 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 2 Visits	7 Participants	8 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 3 Visits	1 Participants	5 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 4 Visits	4 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 5 Visits	1 Participants	0 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 6 Visits	0 Participants	0 Participants
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 Week 12 · 12 Visits	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Number of participants who visited to the emergency department due to migraine during the past 4 weeks has been reported at Baseline and Week 12.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=281 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Baseline · 0 Visit	275 Participants	256 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Baseline · 1 Visit	7 Participants	7 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Baseline · 2 Visits	1 Participants	3 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Baseline · 9 Visits	0 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Week 12 · 0 Visit	281 Participants	268 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Week 12 · 1 Visit	5 Participants	10 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Week 12 · 2 Visits	2 Participants	3 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 Week 12 · 9 Visits	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Number of participants who were admitted to the hospital during the past 4 weeks due to migraine has been reported at Baseline and Week 12.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=281 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Baseline · 0 Admission	279 Participants	258 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Baseline · 1 Admission	3 Participants	7 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Baseline · 2 Admissions	1 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Baseline · 16 Admissions	0 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Week 12 · 0 Admission	286 Participants	277 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Week 12 · 1 Admission	2 Participants	4 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Week 12 · 2 Admissions	0 Participants	0 Participants
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 Week 12 · 16 Admissions	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Number of participants who had overnight hospital stays during the past 4 weeks due to migraine has been reported at Baseline and Week 12.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=288 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=281 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Baseline · 0 Stay	282 Participants	264 Participants
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Baseline · 1 Stay	1 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Baseline · 2 Stays	0 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Baseline · 7 Stays	0 Participants	1 Participants
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Week 12 · 0 Stay	287 Participants	278 Participants
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Week 12 · 1 Stay	1 Participants	3 Participants
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Week 12 · 2 Stays	0 Participants	0 Participants
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 Week 12 · 7 Stays	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Number of participants who visited a family doctor/general practitioner has been reported.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=281 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=275 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 0 Visit	239 Participants	239 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 1 Visit	26 Participants	20 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 2 Visits	11 Participants	13 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 3 Visits	3 Participants	1 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 4 Visits	1 Participants	0 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 5 Visits	0 Participants	1 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 7 Visits	0 Participants	1 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 8 Visits	0 Participants	0 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 13 Visits	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Number of participants who visited a specialist has been reported.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=281 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=275 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 0 Visit	239 Participants	240 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 1 Visit	29 Participants	20 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 2 Visits	7 Participants	8 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 3 Visits	3 Participants	4 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 4 Visits	1 Participants	2 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 5 Visits	0 Participants	1 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 6 Visits	1 Participants	0 Participants
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 7 Visits	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Number of participants who visited the emergency department due to migraine has been reported.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=281 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=275 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 0 Visit	277 Participants	265 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 1 Visit	3 Participants	5 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 2 Visits	0 Participants	3 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 3 Visits	0 Participants	1 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 10 Visits	0 Participants	1 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 18 Visits	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Number of participants who admitted in the hospital due to migraine has been reported.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=281 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=275 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 0 Admission	281 Participants	271 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 1 Admission	0 Participants	2 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 2 Admissions	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 24

Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Number of participants with overnight hospital stays due to migraine has been reported.

Outcome measures

Outcome measures
Measure	Placebo-controlled Period: Eptinezumab n=281 Participants Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=275 Participants Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period.
Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 0 Stay	281 Participants	270 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 1 Stays	0 Participants	3 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 2 Stays	0 Participants	1 Participants
Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 12 Stays	0 Participants	1 Participants

Adverse Events

Placebo-controlled Period: Eptinezumab

Serious events: 2 serious events

Other events: 50 other events

Deaths: 0 deaths

Placebo-controlled Period: Placebo

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Open-label Period: Eptinezumab to Eptinezumab

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Open-label Period: Placebo to Eptinezumab

Serious events: 5 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo-controlled Period: Eptinezumab n=303 participants at risk Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=301 participants at risk Participants received an IV infusion of placebo at Baseline (Week 0) during the placebo-controlled period.	Open-label Period: Eptinezumab to Eptinezumab n=300 participants at risk Participants who received eptinezumab during the placebo-controlled period received eptinezumab during the open-label period.	Open-label Period: Placebo to Eptinezumab n=293 participants at risk Participants who received eptinezumab during the placebo-controlled period received eptinezumab during the open-label period.
Gastrointestinal disorders Haemorrhoids	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.34% 1/293 • Number of events 2 • Up to 32 weeks
General disorders Chest pain	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.33% 1/300 • Number of events 2 • Up to 32 weeks	0.00% 0/293 • Up to 32 weeks
Infections and infestations Appendicitis	0.33% 1/303 • Number of events 2 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.00% 0/293 • Up to 32 weeks
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.33% 1/300 • Number of events 2 • Up to 32 weeks	0.00% 0/293 • Up to 32 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.33% 1/303 • Number of events 1 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.00% 0/293 • Up to 32 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage III	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.34% 1/293 • Number of events 1 • Up to 32 weeks
Nervous system disorders Migraine	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.34% 1/293 • Number of events 1 • Up to 32 weeks
Nervous system disorders Syncope	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.34% 1/293 • Number of events 1 • Up to 32 weeks
Nervous system disorders Transient ischaemic attack	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.34% 1/293 • Number of events 1 • Up to 32 weeks
Psychiatric disorders Drug abuse	0.00% 0/303 • Up to 32 weeks	0.33% 1/301 • Number of events 1 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.00% 0/293 • Up to 32 weeks
Psychiatric disorders Suicide attempt	0.00% 0/303 • Up to 32 weeks	0.00% 0/301 • Up to 32 weeks	0.00% 0/300 • Up to 32 weeks	0.34% 1/293 • Number of events 1 • Up to 32 weeks

Other adverse events

Other adverse events
Measure	Placebo-controlled Period: Eptinezumab n=303 participants at risk Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period.	Placebo-controlled Period: Placebo n=301 participants at risk Participants received an IV infusion of placebo at Baseline (Week 0) during the placebo-controlled period.	Open-label Period: Eptinezumab to Eptinezumab n=300 participants at risk Participants who received eptinezumab during the placebo-controlled period received eptinezumab during the open-label period.	Open-label Period: Placebo to Eptinezumab n=293 participants at risk Participants who received eptinezumab during the placebo-controlled period received eptinezumab during the open-label period.
General disorders Asthenia	0.99% 3/303 • Number of events 3 • Up to 32 weeks	1.00% 3/301 • Number of events 3 • Up to 32 weeks	0.33% 1/300 • Number of events 1 • Up to 32 weeks	2.0% 6/293 • Number of events 6 • Up to 32 weeks
General disorders Fatigue	2.0% 6/303 • Number of events 7 • Up to 32 weeks	3.7% 11/301 • Number of events 11 • Up to 32 weeks	2.0% 6/300 • Number of events 6 • Up to 32 weeks	1.7% 5/293 • Number of events 6 • Up to 32 weeks
Infections and infestations COVID-19	2.0% 6/303 • Number of events 6 • Up to 32 weeks	1.3% 4/301 • Number of events 4 • Up to 32 weeks	1.7% 5/300 • Number of events 5 • Up to 32 weeks	2.0% 6/293 • Number of events 6 • Up to 32 weeks
Infections and infestations Influenza	3.6% 11/303 • Number of events 12 • Up to 32 weeks	3.3% 10/301 • Number of events 10 • Up to 32 weeks	2.3% 7/300 • Number of events 7 • Up to 32 weeks	2.0% 6/293 • Number of events 7 • Up to 32 weeks
Infections and infestations Nasopharyngitis	5.0% 15/303 • Number of events 16 • Up to 32 weeks	5.6% 17/301 • Number of events 18 • Up to 32 weeks	2.3% 7/300 • Number of events 8 • Up to 32 weeks	3.4% 10/293 • Number of events 11 • Up to 32 weeks
Musculoskeletal and connective tissue disorders Back pain	1.7% 5/303 • Number of events 5 • Up to 32 weeks	2.3% 7/301 • Number of events 8 • Up to 32 weeks	1.0% 3/300 • Number of events 3 • Up to 32 weeks	1.4% 4/293 • Number of events 4 • Up to 32 weeks
Nervous system disorders Dizziness	2.6% 8/303 • Number of events 9 • Up to 32 weeks	3.0% 9/301 • Number of events 12 • Up to 32 weeks	0.33% 1/300 • Number of events 1 • Up to 32 weeks	2.7% 8/293 • Number of events 10 • Up to 32 weeks
Psychiatric disorders Insomnia	0.66% 2/303 • Number of events 2 • Up to 32 weeks	2.7% 8/301 • Number of events 8 • Up to 32 weeks	0.67% 2/300 • Number of events 2 • Up to 32 weeks	1.0% 3/293 • Number of events 3 • Up to 32 weeks

Additional Information

Email contact via

H. Lundbeck A/S

Phone: +4536301311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place