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 Clinical Trial Results and Information

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

ClinicalTrials.gov processed this data on September 8, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified September 2023 by H. Lundbeck A/S

Sponsor

H. Lundbeck A/S

Information Provided by (Responsible Party)

H. Lundbeck A/S

Clinicaltrials.gov Identifier

NCT04418765
Other Study ID Numbers: 18898A
First Submitted: June 3, 2020
First Posted: June 5, 2020
Results First Posted: July 22, 2022
Last Update Posted: September 29, 2023
Last Verified: September 2023
History of Changes

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Study 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.

Condition or Disease	Intervention/Treatment
Migraine	Drug: Eptinezumab Drug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	892 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
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
Study Start Date	June 1, 2020
Actual Primary Completion Date	July 15, 2021
Actual Study Completion Date	September 15, 2022

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Placebo 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 Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.	Drug: Eptinezumab Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)
Eptinezumab 300 mg Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.	Drug: Eptinezumab Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 [Baseline to Weeks 1 - 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.
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24 [Baseline, Weeks 13 - 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.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 [Baseline to Weeks 1 - 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.
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12 [Baseline, 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).
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24 [Baseline to Weeks 13 - 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.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24 [Baseline to Weeks 13 - 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.
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 [Baseline to Weeks 1 - 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.
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 [Baseline to Weeks 1 - 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).
Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 [Baseline to Weeks 1 - 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).
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 [Baseline to Weeks 1 - 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).
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12 [Baseline, Weeks 1 - 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).
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12 [Baseline, Weeks 1 - 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).
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12 [Baseline, Weeks 1 - 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).
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12 [Baseline, Weeks 1 - 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.
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24 [Baseline, Weeks 13- 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.
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12 [Baseline, Weeks 1 - 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".
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24 [Baseline, Weeks 13 - 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".
Patient Global Impression of Change (PGIC) Score at Week 12 [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.
PGIC Score at Week 24 [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.
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 [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.
Change From Baseline in the HIT-6 Score at Week 24 [Baseline, 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).
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12 [Baseline, 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.
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12 [Baseline, 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).
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 [Baseline, 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.
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24 [Baseline, 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).
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 [Baseline, 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.
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 [Baseline, 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.
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score [Baseline to 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).
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score [Baseline to 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).
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner [Week 12]
Number of participants who visited to a family doctor/general practitioner has been reported.
HCRU: Visits to a Specialist [Week 12]
Number of participants who visited to a specialist has been reported.
HCRU: Number of Emergency Department Visits Due to Your Migraine [Week 12]
Number of participants who visited to emergency department due to your migraine has been reported.
HCRU: Number of Hospital Admissions Due to Migraine [Week 12]
Number of participants who admitted in the hospital due to migraine has been reported.
HCRU: Total Number of Overnight Hospital Stays Due to Migraine [Week 12]
Number of participants who had total number of overnight hospital stays due to migraine has been reported.
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 [Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 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 [Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 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 ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 [Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 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.
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72 [Baseline, 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).

Eligibility Criteria

Ages Eligible for Study	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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). Other in- and exclusion criteria may apply

Contacts and Locations

Sponsors and Collaborators	H. Lundbeck A/S
Locations	Diablo Clinical Research \| Walnut Creek, California, United States, 94598 Sarkis Clinical Trials - Gainesville \| Gainesville, Florida, United States, 32607 Accel Research Sites - Maitland \| Maitland, Florida, United States, 32751 Michigan Headache and Neurological Institute \| Ann Arbor, Michigan, United States, 48104-5131 Clinical Research Institute Inc. - Minneapolis \| Minneapolis, Minnesota, United States, 55402 Albuqerque Clinical Trials \| Albuquerque, New Mexico, United States, 87102 Dent Neurologic Institute - Amherst \| Amherst, New York, United States, 14226 Integrative Clinical Trials \| Brooklyn, New York, United States, 11229 CTI Clinical Research Center \| Cincinnati, Ohio, United States, 45212 Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights \| Dayton, Ohio, United States, 45424 Lynn Health Science Institute - Oklahoma City \| Oklahoma City, Oklahoma, United States, 73112 Clinical Neuroscience Solutions - Memphis \| Memphis, Tennessee, United States, 38119 Northwest Clinical Research Center (NWCRC) \| Bellevue, Washington, United States, 98007 Northwest Neurological \| Spokane, Washington, United States, 99202 Universitair Ziekenhuis Brussel \| Brussels, Bruxelles-Capitale, Belgium, 1090 Jessa Ziekenhuis - Campus Virga Jesse \| Hasselt, Limburg, Belgium, 3500 Universitair Ziekenhuis Gent \| Gent, Oost-Vlaanderen, Belgium, 9000 Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan \| Brugge, West-Vlaanderen, Belgium, 8000 Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum \| Sofia, Sofia City, Bulgaria, 1113 First Multiprofile Hospital for Active Treatment - Sofia \| Sofia, Sofia City, Bulgaria, 1142 Multiprofile Hospital for Active Treatment Heart and Brain EAD \| Pleven, Bulgaria, 5804 Medical Center - Teodora EOOD \| Ruse, Bulgaria, 7012 Acibadem City Clinic Tokuda Hospital \| Sofia, Bulgaria, 1407 Medical Center Medica Plus \| Veliko Tarnovo, Bulgaria, 5006 MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance \| Hradec Kralove, Hradec Kralové, Czechia, 500 03 Vestra Clinics \| Rychnov nad Kneznou, Hradec Kralové, Czechia, 516 01 CCR Brno \| Brno, Jihormoravsky Kraj, Czechia, 602 00 Fakultni nemocnice Ostrava \| Ostrava-Poruba-Poruba, Moravian-Silesian, Czechia, 708 52 Fakultní Thomayerova nemocnice \| Praha 4, Prague, Czechia, 140 59 Neurologicka Ambulance - Forbeli \| Praha 6, Prague, Czechia, 160 00 Neuropsychiatrie S.R.O. \| Praha 6, Prague, Czechia, 160 00 Institut Neuropsychiatrické Péce \| Praha 8, Prague, Czechia, 186 00 CCR Prague \| Praha 3, Praha, Czechia, 130 00 CCR Ostrava \| Ostrava, Severomoravsky Kraj, Czechia, 702 00 Fakultní Nemocnice u sv. Anny v Brne \| Brno, South Moravian, Czechia, 656 91 Nemocnice Jihlava \| Jihlava, Czechia, 586 01 Neurosanatio s.r.o \| Litomyshl, Czechia, 57001 Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon \| Slezska Ostrava, Czechia, 710 00 NeuroMed Zlín s.r.o. \| Zlín, Czechia, 760 01 Rigshospitalet Glostrup \| Glostrup, Hovedstaden, Denmark, 2600 Odense Universitetshospital \| Odense, Syddanmark, Denmark, 5000 Sydvestjysk Sygehus - Esbjerg \| Esbjerg, Denmark, 6700 Tampereen Yliopistollinen Sairaala \| Tampere, Länsi-Suomen Lääni, Finland, 33520 Terveystalo Ruoholahti \| Helsinki, Southern Finland, Finland, 00180 Terveystalo Turku Pulssi \| Turku, Western Finland, Finland, 20100 Itä-Suomen Yliopisto - Kuopion Kampus \| Kuopio, Finland, 70210 Terveystalo Tampere \| Tampere, Finland, 33100 Hôpital Cimiez \| Nice Cedex 1, Côte-d'Or, France, 91179 - 06003 Hôpital Charles-Nicolle \| Rouen, Haute-Normandie, France, 76000 Hôpital Roger Salengro \| Lille Cedex, Nord, France, 59037 Centre Hosptitalier Universitaire d'Angers \| Angers, Pays De La Loire, France, 49 933 Assistance Publique Hôpitaux de Marseille \| Marseille cedex 5, Provence Alpes Cote D'Azure, France, 13 354 Hôpital Pierre Wertheimer \| Bron, Rhone-Alps, France, 69500 Helsicore - Israeli-Georgian Medical Research Clinic \| T'bilisi, Tbilisi, Georgia, 0112 LLC Todua Clinic \| T'bilisi, Tbilisi, Georgia, 0112 Pineo Medical Ecosystem \| Tbilisi, Georgia, 0114 Archangel Saint Michael Multiprofile Clinical Hospital \| Tbilisi, Georgia, 0159 Aversi Clinic - Central Branch \| Tbilisi, Georgia, 0160 Mediclub Georgia Medical \| Tbilisi, Georgia, 0160 Jerarsi Clinic \| Tbilisi, Georgia, 0167 Malkhaz Katsiashvili Multiprofile Emergency Center \| Tbilisi, Georgia, 0172 Simon Khechinashvili University Hospital \| Tbilisi, Georgia, 0179 Consilium Medulla Multiprofile Clinic \| Tbilisi, Georgia, 0186 MVZ Dr. Roth & Kollegen GbR \| Ostfildern, Baden-Wuerttemberg, Germany, 73760 Neuroplus \| Mannheim, Baden-Württemberg, Germany, 68163 NeuroConcept AG \| Stuttgart, Baden-Württemberg, Germany, 70182 Praxis Dr. Steinwachs \| Nürnberg, Bayern, Germany, 90402 CTC North \| Hamburg, Hamburg (Hansestadt), Germany, 20251 Migräne- und Kopfschmerzklinik Königstein \| Königstein Im Taunus, Hessen, Germany, 61462 Synexus - Prüfzentrum Frankfurt/Main \| Frankfurt am Main, Hesse, Germany, 60313 Studienzentrum Nord West \| Westerstede, Niedersachsen, Germany, 26655 Neurozentrum Bielefeld \| Bielefeld, Nordrhein-Westfalen, Germany, 33647 Neurologische Praxis Dr. Stude \| Bochum, Nordrhein-Westfalen, Germany, 44787 Praxis Astrid Gendolla \| Essen, Nordrhein-Westfalen, Germany, 45133 Universitätsklinikum Essen \| Essen, Nordrhein-Westfalen, Germany, 45147 Synexus - Leipzig \| Leipzig, Sachsen, Germany, 04103 Synexus Clinical Research - Berlin \| Berlin, Germany, 12627 Neuropraxis München Süd \| Unterhaching, Germany, 82008 Valeomed Diagnosztikai Kozpont \| Esztergom, Komarom-Esztergom County, Hungary, 2500 Pest Megyei Flor Ferenc Korhaz \| Kistarcsa, Pest, Hungary, 2143 UNO Medical Trials Kft. \| Budapest, Hungary, 1152 Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana \| Rome, Roma, Italy, 00163 Universita Campus Bio-Medico di Roma \| Roma, Rome, Italy, 00128 Azienda Ospedaliera - Universitaria Sant' Andrea \| Roma, Rome, Italy, 00189 IRCCS Istituto Delle Scienze Neurologiche di Bologna \| Bologna, Italy, 40139 Azienda Ospedaliero - Universitaria Careggi \| Florence, Italy, 50139 Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS \| Pavia, Italy, 27100 Centrum Medyczne Oporow \| Wroclaw, Dolnoslaskie, Poland, 52-416 Centrum Medyczne Pratia - Bydgoszcz \| Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796 Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz \| Lublin, Lubelskie, Poland, 20-093 Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej \| Lublin, Lubelskie, Poland, 20-582 Pratia MCM Krakow \| Krakow, Malopolskie, Poland, 30-510 Specjalistyczne Gabinety Sp. z o.o. \| Krakow, Malopolskie, Poland, 30-539 Instytut Zdrowia dr Boczarska-Jedynak \| Oswiecim, Malopolskie, Poland, 32-600 Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz \| Warszawa, Mazowieckie, Poland, 00-773 SOMED CR - Warsaw \| Warszawa, Mazowieckie, Poland, 01-737 MTZ Clinical Research Powered by Pratia \| Warszawa, Mazowieckie, Poland, 01-868 Synexus - Gdynia \| Gdynia, Pomorskie, Poland, 81-537 Neuro-Care Katowice \| Siemianowice Slaskie, Silesia, Poland, 41-100 Synexus - Czestochowa \| Czestochowa, Slaskie, Poland, 42-202 Synexus - Katowice \| Katowice, Slaskie, Poland, 40-040 Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska \| Elblag, Warminsko-Mazurskie, Poland, 82-300 Centrum Medyczne Solumed \| Poznan, Wielkopolskie, Poland, 60-529 Synexus - Poznan \| Poznan, Wielkopolskie, Poland, 60-702 Centrum Medyczne Pratia - Czestochowa \| Czestochowa, Poland, 42-200 SOMED CR - Lodz \| Lodz, Poland, 90-368 University Headache Clinic \| Moscow, Russian Federation, 121467 Neurologicka ambulancia MUDr. Dupejova s.r.o. \| Banska Bystrica, Slovakia, 97404 In Medic \| Bardejov, Slovakia, 8501 MEDBAJ s.r.o. \| Dolny Kubin, Slovakia, 026 01 Medicínske Centrum Konzílium - Dubnica nad Vahom \| Dubnica nad Vahom, Slovakia, 01841 Hospital Universitario de Basurto \| Bilbao, Biscay, Spain, 48013 Hospital Universitario Puerta de Hierro - Majadahonda \| Majadahonda, Madrid, Spain, 28222 Hospital Universitario Quironsalud Madrid \| Pozuelo de Alarcon, Madrid, Spain, 28223 Clinica Universidad de Navarra - Pamplona \| Pamplona, Navarre, Spain, 31008 Hospital Alvaro Cunqueiro - Clinico Universitario Vigo \| Vigo, Pontevedra, Spain, 36213 Hospital Universitari Vall d'Hebron \| Barcelona, Spain, 08035 Hospital Universitario La Paz \| Madrid, Spain, 28046 Hospital Universitario Virgen del Rocío \| Sevilla, Spain, 41013 Hospital Clínico Universitario de Valladolid \| Valladolid, Spain, 47003 Hospital Clínico Universitario de Valencia \| València, Spain, 46010 Hospital Clinico Universitario Lozano Blesa \| Zaragoza, Spain, 50009 Migränkliniken Europa AB \| Värnamo, Kronoborgs Län, Sweden, 331 50 Stortorgets neurologmottagning \| Helsingborg, Skåne Län, Sweden, 25220 Centralsjukhuset Kristianstad \| Kristianstad, Skåne Län, Sweden, 291 85 Universitetssjukhuset i Linköping \| Linkoeping, Östergötlands Län, Sweden, 581 85 Synexus - Scotland Clinical Research Centre \| Bellshill, England, United Kingdom, ML4 3NJ Synexus - The Lancashire Clinic \| Chorley, England, United Kingdom, PR7 7NA Synexus Midlands Clinical Research Centre \| Edgbaston, England, United Kingdom, B15 2SQ Synexus - The Hexham Clinic \| Hexham, England, United Kingdom, NE46 1QJ Synexus - Merseyside Clinical Research Centre \| Liverpool, England, United Kingdom, L22 0LG Panthera Biopartners - North London \| London, England, United Kingdom, EN3 4GS Synexus - Manchester Clinical Research Centre \| Manchester, England, United Kingdom, M15 6SE Panthera Biopartners - Manchester \| Manchester, England, United Kingdom, OL11 4AU Panthera Biopartners - Preston \| Preston, England, United Kingdom, PR2 9QB Synexus - Thames Valley Clinical Research Centre \| Reading, England, United Kingdom, RG2 0TG Northern Care Alliance NHS Foundation Trust \| Salford, England, United Kingdom, M6 8HD Synexus - Wales \| Cardiff, Wales, United Kingdom, CF15 9SS
Investigators

Study Documents (Full Text)

Documents Provided by H. Lundbeck A/S: Study Protocol January 22, 2021
Documents Provided by H. Lundbeck A/S: Statistical Analysis Plan October 13, 2021

More Information

Publications

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.

Additional Relevant MeSH Terms

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases