A Study to Evaluate the Efficacy and Safety of Eptinezuma... | NCT04418765 | Trialant
NCT04418765
Sponsor
H. Lundbeck A/S
Status
Completed
Last Update Posted
Sep 29, 2023Actual
Enrollment
892Actual
Phase
Phase 3
Conditions
Migraine
Interventions
Eptinezumab
Placebo
Countries
United States
Belgium
Bulgaria
Czechia
Denmark
Finland
France
Georgia
Germany
Hungary
Italy
Poland
Russia
Slovakia
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04418765
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
18898A
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
Official Title
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
Acronym
DELIVER
Organization
H. Lundbeck A/SINDUSTRY
Status Module
Record Verification Date
Sep 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 1, 2020Actual
Primary Completion Date
Jul 15, 2021Actual
Completion Date
Sep 15, 2022Actual
First Submitted Date
Jun 3, 2020
First Submission Date that Met QC Criteria
Jun 3, 2020
First Posted Date
Jun 5, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jun 16, 2022
Results First Submitted that Met QC Criteria
Jul 20, 2022
Results First Posted Date
Jul 22, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 8, 2023
Last Update Posted Date
Sep 29, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
H. Lundbeck A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.
Detailed Description
The total study duration from the screening visit to the completion visit is approximately 76 weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24 weeks) and a treatment extension period (48 weeks).
The participant will start treatment at the baseline visit and follow a 12-week dosing schedule with either eptinezumab (100 or 300 milligrams [mg]) or placebo by intraveneous (IV) infusion. Participants who were assigned to placebo in the placebo-controlled treatment period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or eptinezumab 100 mg.
Conditions Module
Conditions
Migraine
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
892Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Drug: Placebo
Eptinezumab 100 mg
Experimental
Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Drug: Eptinezumab
Eptinezumab 300 mg
Experimental
Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Drug: Eptinezumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Eptinezumab
Drug
Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)
Eptinezumab 100 mg
Eptinezumab 300 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline, Weeks 1 - 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
The participant has a migraine onset of ≤50 years of age.
The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
The participant has a history of either previous or active use of triptans for migraine.
Exclusion Criteria:
The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
The participant has a diagnosis of acute or active temporomandibular disorder.
The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
Participants assigned to placebo in the Placebo-controlled Period were randomized 1:1 to treatment with either eptinezumab 100 milligrams (mg) or eptinezumab 300 mg. Participants assigned to eptinezumab 100 mg or 300 mg in the Placebo-controlled Period continued their treatment.
Recruitment Details
This study included 2 periods: Placebo-controlled Period - 24-week double-blind treatment period with placebo or eptinezumab and Extension Period - 48-week dose-blinded period with eptinezumab after completion of the Placebo-controlled Period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
FG001
Eptinezumab 100 mg
Periods
Title
Milestones
Reasons Not Completed
Placebo-controlled Period (24 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 22, 2021
Jun 16, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo
Drug
concentrate for solution for infusion, intravenously
Placebo
Baseline to Weeks 1 - 12
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline, Weeks 13 - 24
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline to Weeks 1 - 12
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12
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).
Baseline, Week 12
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline to Weeks 13 - 24
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline to Weeks 13 - 24
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline to Weeks 1 - 12
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Baseline to Weeks 1 - 12
Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Baseline to Weeks 1 - 12
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Baseline to Weeks 1 - 12
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Baseline, Weeks 1 - 12
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12
A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Baseline, Weeks 1 - 12
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12
A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).
Baseline, Weeks 1 - 12
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
Baseline, Weeks 1 - 12
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
Baseline, Weeks 13- 24
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
Baseline, Weeks 1 - 12
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
Baseline, Weeks 13 - 24
Patient Global Impression of Change (PGIC) Score at Week 12
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.
Week 12
PGIC Score at Week 24
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.
Week 24
Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12
Baseline, Weeks 1 - 12
Percentage of Participants With Migraine on the Day After First Dosing
Day 1
Most Bothersome Symptom (MBS) Score at Week 12
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.
Week 12
Change From Baseline in the HIT-6 Score at Week 24
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).
Baseline, Week 24
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
Baseline, Week 12
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Baseline, Week 12
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
Baseline, Week 24
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Baseline, Week 24
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12
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, i.e, worse outcomes.
Baseline, Week 12
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24
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, i.e, worse outcomes.
Baseline, Week 24
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score
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).
Baseline to Week 12
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score
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).
Baseline to Week 24
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner
Number of participants who visited to a family doctor/general practitioner has been reported.
Week 12
HCRU: Visits to a Specialist
Number of participants who visited to a specialist has been reported.
Week 12
HCRU: Number of Emergency Department Visits Due to Your Migraine
Number of participants who visited to emergency department due to your migraine has been reported.
Week 12
HCRU: Number of Hospital Admissions Due to Migraine
Number of participants who admitted in the hospital due to migraine has been reported.
Week 12
HCRU: Total Number of Overnight Hospital Stays Due to Migraine
Number of participants who had total number of overnight hospital stays due to migraine has been reported.
Week 12
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72
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).
Baseline, Weeks 36, 48, 60, and 72
Gainesville
Florida
32607
United States
Accel Research Sites - Maitland
Maitland
Florida
32751
United States
Michigan Headache and Neurological Institute
Ann Arbor
Michigan
48104-5131
United States
Clinical Research Institute Inc. - Minneapolis
Minneapolis
Minnesota
55402
United States
Albuqerque Clinical Trials
Albuquerque
New Mexico
87102
United States
Dent Neurologic Institute - Amherst
Amherst
New York
14226
United States
Integrative Clinical Trials
Brooklyn
New York
11229
United States
CTI Clinical Research Center
Cincinnati
Ohio
45212
United States
Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights
Pozo-Rosich P, Tassorelli C, Boserup LP, Awad SF, Lee XY, Ailani J. Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial. Neurol Ther. 2026 Apr;15(2):753-774. doi: 10.1007/s40120-026-00893-4. Epub 2026 Feb 11.
Tassorelli C, Starling AJ, Awad SF, Lee XY, Boserup LP, Asher D, Soni-Brahmbhatt S, Sperling B, Goadsby PJ. Early and Sustained Shift in Headache Day Frequency Following Eptinezumab Treatment in Adults With Migraine for Whom 2-4 Previous Preventive Treatments Have Failed: A Post Hoc Analysis of the Randomized DELIVER Trial. Eur J Neurol. 2025 Dec;32(12):e70460. doi: 10.1111/ene.70460.
Barbanti P, Awad SF, Rae-Espinoza H, Regnier SA, Lee XY, Goadsby PJ. Impact of eptinezumab on work productivity beyond reductions in monthly migraine days: post hoc analysis of the DELIVER trial. J Patient Rep Outcomes. 2024 Dec 18;8(1):146. doi: 10.1186/s41687-024-00813-w.
Jonsson L, Awad SF, Regnier SA, Talon B, Kymes S, Lee XY, Goadsby PJ. Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab. J Headache Pain. 2024 Mar 28;25(1):45. doi: 10.1186/s10194-024-01752-z.
Ashina M, Tepper SJ, Gendolla A, Sperling B, Ettrup A, Josiassen MK, Starling AJ. Long-term effectiveness of eptinezumab in patients with migraine and prior preventive treatment failures: extension of a randomized controlled trial. J Headache Pain. 2023 Nov 20;24(1):155. doi: 10.1186/s10194-023-01688-w.
Pinto S, Oliveira Santos M, Gromicho M, Swash M, de Carvalho M. Impact of diabetes mellitus on the respiratory function of amyotrophic lateral sclerosis patients. Eur J Neurol. 2024 Feb;31(2):e16129. doi: 10.1111/ene.16129. Epub 2023 Nov 13.
Jonsson L, Regnier SA, Kymes S, Awad SF, Talon B, Lee XY, Goadsby PJ. Estimating treatment effects on health utility scores for patients living with migraine: a post hoc analysis of the DELIVER trial. Expert Rev Pharmacoecon Outcomes Res. 2023 Jul-Dec;23(7):797-803. doi: 10.1080/14737167.2023.2219898. Epub 2023 Jun 2.
Ashina M, Lanteri-Minet M, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B, Pozo-Rosich P. Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures: subgroup analysis of the randomized, placebo-controlled DELIVER study. Cephalalgia. 2023 May;43(5):3331024231170807. doi: 10.1177/03331024231170807.
Goadsby PJ, Barbanti P, Lambru G, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures. Eur J Neurol. 2023 Apr;30(4):1089-1098. doi: 10.1111/ene.15670. Epub 2023 Jan 21.
Barbanti P, Goadsby PJ, Lambru G, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study. J Headache Pain. 2022 Dec 2;23(1):153. doi: 10.1186/s10194-022-01521-w.
Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
FG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
FG000299 subjects
FG001299 subjects
FG002294 subjects
Received at Least 1 Dose of Study Drug
FG000298 subjects
FG001299 subjects
FG002294 subjects
COMPLETED
FG000293 subjects
FG001288 subjects
FG002284 subjects
NOT COMPLETED
FG0006 subjects
FG00111 subjects
FG00210 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0026 subjects
Lack of Efficacy
FG0001 subjects
FG0013 subjects
FG0020 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0021 subjects
Withdrawal by Subject
FG0001 subjects
FG0015 subjects
FG0022 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
Other than specified
FG0002 subjects
FG0010 subjects
FG0021 subjects
Randomized but not treated
FG0001 subjects
FG0010 subjects
FG0020 subjects
Extension Period (48 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001433 subjects145 participants assigned to placebo in the Placebo-controlled Period were randomized to eptinezumab 100 mg.
FG002432 subjects148 participants assigned to placebo in the Placebo-controlled Period were randomized to eptinezumab 300 mg.
Received at Least 1 Dose of Study Drug
FG0000 subjects
FG001433 subjects
FG002432 subjects
COMPLETED
FG0000 subjects
FG001392 subjects
FG002390 subjects
NOT COMPLETED
FG0000 subjects
FG00141 subjects
FG00242 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0029 subjects
Lack of Efficacy
FG000
Full analysis set (FAS) included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of monthly migraine days (MMDs) in Weeks 1 to 12.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
BG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
BG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000298
BG001299
BG002293
BG003890
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002293
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Monthly Migraine Days (MMDs)
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D as defined in the outcome measure 1.
Mean
Standard Deviation
days/month
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Monthly Headache Days (MHDs)
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D in outcome measure 1).
Mean
Standard Deviation
days/month
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Headache Impact Test (HIT-6) Score
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).
Here, number analyzed = participants evaluable for this baseline measure.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000288
ParticipantsBG001
Percentage of Migraine Attacks With Severe Pain Intensity
A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D in outcome measure 1).
Mean
Standard Deviation
percentage of migraine attacks
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Percentage of Headache Episodes With Severe Pain Intensity
A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D in outcome measure 1).
Mean
Standard Deviation
percentage of headache episodes
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Acute Migraine Medication Days
Here, number analyzed = participants evaluable for this baseline measure.
Mean
Standard Deviation
days
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
MMDs With Use of Acute Medication
Mean
Standard Deviation
days/month
Title
Denominators
Categories
ParticipantsBG000298
ParticipantsBG001299
ParticipantsBG002
Migraine-Specific Quality of Life (MSQ) Subscores
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
Here, number analyzed = participants evaluable for this baseline measure.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
MSQ role function-restrictive
ParticipantsBG000288
ParticipantsBG001
Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Here, number analyzed = participants evaluable for this baseline measure.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000287
ParticipantsBG001
WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment
WPAI Questionnaire contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 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.
Here, number analyzed = participants evaluable for this baseline measure.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
WPAI Absenteeism
ParticipantsBG000218
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 0.38
OG001-4.8± 0.37
OG002-5.3± 0.37
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.
Mixed Models Analysis
<0.0001
Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 1 of testing order.
Mean Difference (Final Values)
-3.2
Standard Error of the Mean
0.36
2-Sided
95
-3.9
-2.5
Secondary
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Number
percentage of participants
Baseline to Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Secondary
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 13 - 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Secondary
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Number
percentage of participants
Baseline to Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Secondary
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline to Weeks 13 - 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Secondary
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline to Weeks 13 - 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Secondary
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Number
percentage of participants
Baseline to Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Secondary
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Number
percentage of participants
Baseline to Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Number
percentage of participants
Baseline to Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Number
percentage of participants
Baseline to Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12
A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Mean
Standard Error
percentage of migraine attacks
Baseline, Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12
A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Mean
Standard Error
percentage of headache episodes
Baseline, Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Secondary
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 13- 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Secondary
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 13 - 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Secondary
Patient Global Impression of Change (PGIC) Score at Week 12
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
PGIC Score at Week 24
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
days/month
Baseline, Weeks 1 - 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Percentage of Participants With Migraine on the Day After First Dosing
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
Posted
Number
percentage of participants
Day 1
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Secondary
Most Bothersome Symptom (MBS) Score at Week 12
Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the HIT-6 Score at Week 24
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Secondary
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Secondary
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Secondary
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12
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, i.e, worse outcomes.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified categories.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Secondary
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24
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, i.e, worse outcomes.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified categories.
Posted
Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Secondary
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline to Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline to Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner
Number of participants who visited to a family doctor/general practitioner has been reported.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
HCRU: Visits to a Specialist
Number of participants who visited to a specialist has been reported.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
HCRU: Number of Emergency Department Visits Due to Your Migraine
Number of participants who visited to emergency department due to your migraine has been reported.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
HCRU: Number of Hospital Admissions Due to Migraine
Number of participants who admitted in the hospital due to migraine has been reported.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
HCRU: Total Number of Overnight Hospital Stays Due to Migraine
Number of participants who had total number of overnight hospital stays due to migraine has been reported.
FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
OG001
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Secondary
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Full-analysis-long-term set (FAS_LT) included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.
Secondary
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Posted
Number
percentage of participants
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
ID
Title
Description
OG000
Placebo to Eptinezumab 100 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.
Secondary
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Posted
Number
percentage of participants
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
ID
Title
Description
OG000
Placebo to Eptinezumab 100 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.
Secondary
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Posted
Mean
Standard Error
units on a scale
Baseline, Weeks 36, 48, 60, and 72
ID
Title
Description
OG000
Placebo to Eptinezumab 100 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.
OG001
Placebo to Eptinezumab 300 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.
Time Frame
Baseline up to Week 72
Description
All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo-controlled Period: Placebo
Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.
0
298
3
298
85
298
EG001
Placebo-controlled Period: Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.
0
299
6
299
95
299
EG002
Placebo-controlled Period: Eptinezumab 300 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.
0
294
7
294
90
294
EG003
Extension Period: Placebo to Eptinezumab 100 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.
0
145
2
145
57
145
EG004
Extension Period: Placebo to Eptinezumab 300 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.
0
148
7
148
62
148
EG005
Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg
Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
0
288
9
288
133
288
EG006
Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg
Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
0
284
9
284
118
284
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Retinal detachment
Eye disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0012 events1 affected299 at risk
EG0020 events0 affected294 at risk
EG0030 events0 affected145 at risk
EG0040 events0 affected148 at risk
EG0050 events0 affected288 at risk
EG0060 events0 affected284 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0022 events2 affected294 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected299 at risk
EG0022 events2 affected294 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0021 events1 affected294 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0021 events1 affected294 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Migraine
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Psychogenic seizure
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0021 events1 affected294 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0021 events1 affected294 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 24.0
Non-systematic Assessment
EG0001 events1 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Conductive deafness
Ear and labyrinth disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Eye pain
Eye disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0011 events1 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Diverticulitis intestinal perforated
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Pilonidal disease
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Diastasis recti abdominis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Breast cancer in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Colorectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Intraductal papilloma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Laryngeal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Non-systematic Assessment
EG0000 events0 affected298 at risk
EG0010 events0 affected299 at risk
EG0020 events0 affected294 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
OG000
OG001
Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Mixed Models Analysis
<0.0001
Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 3 of testing order.
Mean Difference (Final Values)
-2.7
Standard Error of the Mean
0.36
2-Sided
95
-3.4
-2.0
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG00013.1
OG00142.1
OG00249.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Regression, Logistic
<0.0001
Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 2 of testing order.
Odds Ratio (OR)
6.58
2-Sided
95
4.41
10.01
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
OG000
OG001
Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Regression, Logistic
<0.0001
Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 4 of testing order.
Odds Ratio (OR)
4.91
2-Sided
95
3.29
7.47
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000295
OG001287
OG002286
Title
Denominators
Categories
Title
Measurements
OG000-2.4± 0.39
OG001-5.4± 0.39
OG002-6.1± 0.39
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Mixed Models Analysis
Testing continued only, if the previous comparison was statistically significant.
<0.0001
Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 5a of testing order.
Mean Difference (Final Values)
-3.7
Standard Error of the Mean
0.39
2-Sided
95
-4.5
-3.0
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
OG000
OG001
Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Mixed Models Analysis
Testing continued only, if the previous comparison was statistically significant.
<0.0001
Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6a of testing order.
Mean Difference (Final Values)
-3.0
Standard Error of the Mean
0.39
2-Sided
95
-3.8
-2.2
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG0002.0
OG00115.7
OG00218.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Testing continued only, if the previous comparison was statistically significant.
Regression, Logistic
<0.0001
Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 5b of testing order.
Odds Ratio (OR)
11.43
2-Sided
95
5.22
30.15
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
OG000
OG001
Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Testing continued only, if the previous comparison was statistically significant.
Regression, Logistic
<0.0001
Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6b of testing order.
Odds Ratio (OR)
9.19
2-Sided
95
4.16
24.35
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000288
OG001277
OG002283
Title
Denominators
Categories
Title
Measurements
OG000-3.1± 0.61
OG001-6.9± 0.61
OG002-8.5± 0.60
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Testing continued only, if the previous comparison was statistically significant.
Mixed Models Analysis
<0.0001
Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 5c of testing order.
Mean Difference (Final Values)
-5.4
Standard Error of the Mean
0.63
2-Sided
95
-6.7
-4.2
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
OG000
OG001
Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
Testing continued only, if the previous comparison was statistically significant.
Mixed Models Analysis
<0.0001
Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6c of testing order.
Mean Difference (Final Values)
-3.8
Standard Error of the Mean
0.63
2-Sided
95
-5.0
-2.5
Other
Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000295
OG001287
OG002286
Title
Denominators
Categories
Title
Measurements
OG00023.7
OG00152.3
OG00259.1
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000295
OG001287
OG002293
Title
Denominators
Categories
Title
Measurements
OG0006.8
OG00121.3
OG00227.6
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG0001.1
OG0015.9
OG0027.7
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG00012.8
OG00139.5
OG00245.7
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG0002.3
OG00115.1
OG00216.4
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG0001.1
OG0014.1
OG0025.3
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 0.38
OG001-4.6± 0.37
OG002-5.1± 0.37
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG000-10.2± 1.91
OG001-17.9± 1.87
OG002-21.3± 1.87
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG000-8.8± 1.85
OG001-16.2± 1.81
OG002-19.5± 1.81
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000298
OG001298
OG002290
Title
Denominators
Categories
Title
Measurements
OG000-1.6± 0.34
OG001-4.1± 0.33
OG002-4.6± 0.34
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000294
OG001287
OG002285
Title
Denominators
Categories
Title
Measurements
OG000-1.7± 0.36
OG001-4.6± 0.36
OG002-5.2± 0.36
Units
Counts
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG000-2.0± 0.36
OG001-4.6± 0.36
OG002-5.2± 0.36
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000295
OG001287
OG002286
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 0.39
OG001-4.9± 0.39
OG002-5.8± 0.38
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000297
OG001292
OG002289
Title
Denominators
Categories
Title
Measurements
OG0003.6± 0.09
OG0012.6± 0.09
OG0022.5± 0.09
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000286
OG001280
OG002281
Title
Denominators
Categories
Title
Measurements
OG0003.5± 0.09
OG0012.5± 0.09
OG0022.4± 0.09
Units
Counts
Participants
OG00037
OG00138
OG00235
Title
Denominators
Categories
Title
Measurements
OG000-2.3± 1.12
OG001-5.6± 1.07
OG002-7.3± 1.18
Participants
OG000298
OG001299
OG002293
Title
Denominators
Categories
Title
Measurements
OG00043.7
OG00127.2
OG00224.4
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000293
OG001289
OG002287
Title
Denominators
Categories
Title
Measurements
OG0003.7± 0.09
OG0012.8± 0.09
OG0022.7± 0.09
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000278
OG001266
OG002276
Title
Denominators
Categories
Title
Measurements
OG000-3.9± 0.63
OG001-8.9± 0.63
OG002-9.9± 0.62
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000288
OG001271
OG002283
Title
Denominators
Categories
MSQ Role Function-Restrictive
Title
Measurements
OG00013.7± 1.75
OG00125.0± 1.75
OG00228.7± 1.72
MSQ Role Function-Preventive
Title
Measurements
OG00011.6± 1.63
OG00122.7± 1.64
OG00225.0± 1.61
MSQ Emotional Function
Title
Measurements
OG0009.6± 1.83
OG00120.6± 1.84
OG00223.1± 1.80
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000287
OG001271
OG002281
Title
Denominators
Categories
Title
Measurements
OG000-3.1± 1.39
OG0012.0± 1.40
OG0024.4± 1.38
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000278
OG001259
OG002275
Title
Denominators
Categories
MSQ Role Function-Restrictive
Title
Measurements
OG00015.0± 1.76
OG00130.1± 1.78
OG00230.0± 1.73
MSQ Role Function-Preventive
Title
Measurements
OG00013.1± 1.63
OG00125.7± 1.65
OG00226.3± 1.61
MSQ Emotional Function
Title
Measurements
OG0009.9± 1.84
OG00124.1± 1.86
OG00224.1± 1.81
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000276
OG001258
OG002273
Title
Denominators
Categories
Title
Measurements
OG000-2.8± 1.38
OG0012.0± 1.40
OG0025.2± 1.37
Eptinezumab 100 mg
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000286
OG001268
OG002280
Title
Denominators
Categories
Absenteeism
ParticipantsOG000196
ParticipantsOG001174
ParticipantsOG002183
Title
Measurements
OG000-0.1± 1.49
OG001-5.8± 1.53
OG002-3.8± 1.50
Presenteeism
ParticipantsOG000188
ParticipantsOG001169
ParticipantsOG002179
Title
Measurements
OG000
Work productivity loss
ParticipantsOG000188
ParticipantsOG001169
ParticipantsOG002179
Title
Measurements
OG000
Activity impairment
ParticipantsOG000286
ParticipantsOG001268
ParticipantsOG002280
Title
Measurements
OG000
Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000275
OG001256
OG002273
Title
Denominators
Categories
Absenteeism
ParticipantsOG000180
ParticipantsOG001151
ParticipantsOG002168
Title
Measurements
OG000-0.7± 1.46
OG001-5.2± 1.53
OG002-5.4± 1.47
Presenteeism
ParticipantsOG000173
ParticipantsOG001145
ParticipantsOG002166
Title
Measurements
OG000
Work productivity loss
ParticipantsOG000173
ParticipantsOG001145
ParticipantsOG002166
Title
Measurements
OG000
Activity impairment
ParticipantsOG000275
ParticipantsOG001256
ParticipantsOG002273
Title
Measurements
OG000
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000288
OG001280
OG002284
Title
Denominators
Categories
Title
Measurements
OG00039.9
OG00162.1
OG00262.0
OG002
Eptinezumab 300 mg
Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Units
Counts
Participants
OG000288
OG001280
OG002285
Title
Denominators
Categories
Title
Measurements
OG00046.2
OG00172.1
OG00271.6
Units
Counts
Participants
OG000297
OG001291
OG002289
Title
Denominators
Categories
Title
Measurements
0 Visit
OG000244
OG001259
OG002256
1 Visit
OG00035
OG00122
OG00222
2 Visits
OG0006
OG0015
OG0026
3 Visits
OG0007
OG0012
OG0023
4 Visits
OG0001
OG0011
OG0021
5 Visits
OG0001
OG0012
OG0021
6 Visits
OG0002
OG0010
OG0020
8 Visits
OG0001
OG0010
OG0020
Units
Counts
Participants
OG000297
OG001291
OG002289
Title
Denominators
Categories
Title
Measurements
0 Visit
OG000249
OG001256
OG002257
1 Visit
OG00033
OG00131
OG00224
2 Visits
OG0002
OG0012
OG0024
3 Visits
OG0007
OG0012
OG0024
5 Visits
OG0001
OG0010
OG0020
6 Visits
OG0004
OG0010
OG0020
8 Visits
OG0001
OG0010
OG0020
Units
Counts
Participants
OG000297
OG001291
OG002289
Title
Denominators
Categories
Title
Measurements
0 Visit
OG000289
OG001289
OG002285
1 Visit
OG0006
OG0011
OG0023
2 Visits
OG0000
OG0011
OG0021
3 Visits
OG0001
OG0010
OG0020
8 Visits
OG0001
OG0010
OG0020
Units
Counts
Participants
OG000297
OG001291
OG002289
Title
Denominators
Categories
Title
Measurements
0 Visit
OG000295
OG001289
OG002287
1 Visit
OG0001
OG0011
OG0022
2 Visits
OG0000
OG0011
OG0020
4 Visits
OG0001
OG0010
OG0020
Units
Counts
Participants
OG000297
OG001291
OG002289
Title
Denominators
Categories
Title
Measurements
0 Visit
OG000295
OG001290
OG002289
1 Visit
OG0001
OG0010
OG0020
3 Visits
OG0001
OG0011
OG0020
OG001
Placebo to Eptinezumab 300 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.
OG002
Eptinezumab 100 mg to Eptinezumab 100 mg
Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
OG003
Eptinezumab 300 mg to Eptinezumab 300 mg
Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Units
Counts
Participants
OG000144
OG001146
OG002282
OG003282
Title
Denominators
Categories
Change at Weeks 25-36
ParticipantsOG000144
ParticipantsOG001146
ParticipantsOG002282
ParticipantsOG003282
Title
Measurements
OG000-4.7± 0.49
OG001-6.1± 0.49
OG002-5.8± 0.39
OG003
Change at Weeks 37-48
ParticipantsOG000140
ParticipantsOG001146
ParticipantsOG002282
ParticipantsOG003273
Change at Weeks 49-60
ParticipantsOG000134
ParticipantsOG001140
ParticipantsOG002270
ParticipantsOG003265
Change at Weeks 61-72
ParticipantsOG000126
ParticipantsOG001136
ParticipantsOG002252
ParticipantsOG003246
OG001
Placebo to Eptinezumab 300 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.
OG002
Eptinezumab 100 mg to Eptinezumab 100 mg
Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
OG003
Eptinezumab 300 mg to Eptinezumab 300 mg
Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Units
Counts
Participants
OG000144
OG001146
OG002282
OG003282
Title
Denominators
Categories
Weeks 25-36
ParticipantsOG000144
ParticipantsOG001146
ParticipantsOG002282
ParticipantsOG003282
Title
Measurements
OG00048.6
OG00163.0
OG00259.6
OG003
Weeks 37-48
ParticipantsOG000140
ParticipantsOG001146
ParticipantsOG002282
ParticipantsOG003273
Weeks 49-60
ParticipantsOG000134
ParticipantsOG001140
ParticipantsOG002270
ParticipantsOG003265
Weeks 61-72
ParticipantsOG000126
ParticipantsOG001136
ParticipantsOG002252
ParticipantsOG003246
OG001
Placebo to Eptinezumab 300 mg
Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.
OG002
Eptinezumab 100 mg to Eptinezumab 100 mg
Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
OG003
Eptinezumab 300 mg to Eptinezumab 300 mg
Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Units
Counts
Participants
OG000144
OG001146
OG002282
OG003282
Title
Denominators
Categories
Weeks 25-36
ParticipantsOG000144
ParticipantsOG001146
ParticipantsOG002282
ParticipantsOG003282
Title
Measurements
OG00019.4
OG00128.1
OG00225.9
OG003
Weeks 37-48
ParticipantsOG000140
ParticipantsOG001146
ParticipantsOG002282
ParticipantsOG003273
Weeks 49-60
ParticipantsOG000134
ParticipantsOG001140
ParticipantsOG002270
ParticipantsOG003265
Weeks 61-72
ParticipantsOG000126
ParticipantsOG001136
ParticipantsOG002252
ParticipantsOG003246
OG002
Eptinezumab 100 mg to Eptinezumab 100 mg
Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
OG003
Eptinezumab 300 mg to Eptinezumab 300 mg
Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.