Medication Overuse Headache, Migraine
Conditions
Keywords
Eptinezumab, Migraine, Medication overuse headache, Brief educational intervention
Brief summary
Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications. Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.
Detailed description
The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).
Interventions
DRUGEptinezumab
Solution for infusion
DRUGPlacebo
Solution for infusion
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit. * The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit. * The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit. * The participant has had an onset of migraine diagnosis at ≤50 years of age.
Exclusion criteria
* The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). * The participant has a diagnosis of acute or active temporomandibular disorders. * 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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). * The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit. * The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4 | Baseline, Weeks 1 - 4 | A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Placebo-controlled Period: Change From Baseline in MMDs at Weeks 1 to 12 | Baseline, Weeks 1 - 12 | A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken. |
| Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12 | Baseline, Weeks 1 - 4 and Weeks 1 - 12 | A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1). |
| Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH) | Weeks 1 - 4 and Weeks 1 - 12 | CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis. MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis. |
| Placebo-controlled Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 1 to 2 | Baseline, Weeks 1 - 2 | Daily Pain assessment data were collected in the headache electronic diary (eDiary) via the question "What was the worst pain intensity of this headache today?". The pain intensity assessment was collected on a 3-point scale: Mild (score = 1), Moderate (score = 2), and Severe (score = 3). For each day, the Daily Pain assessment score was derived by averaging the worst pain intensity over all headaches of that day. For days on which no headaches took place during the relevant period, the Daily Pain score was given as a score of 0. The average Daily Pain score was calculated using the Daily Pain assessments collected during Weeks 1-2. |
| Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12 | Baseline, Weeks 1 - 4 and Weeks 1 - 12 | Acute migraine medication included those medications classified as opioid, barbiturates, ergotamine, triptan, non-opioid analgesic, and combination of analgesic ingredients. |
| Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 | Baseline, Weeks 13-16, 17-20, and 21-24 | A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken. |
| Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 | Baseline, at Weeks 13-16, 17-20, and 21-24 | A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1). |
| Open-label Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM Nor MOH at Weeks 13 to 24 | Weeks 13 - 24 | CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis. MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis. |
| Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 | Baseline, Weeks 13-16, 17-20, and 21-24 | Daily Pain assessment data were collected in the headache eDiary via the question "What was the worst pain intensity of this headache today?". The pain intensity assessment was collected on a 3-point scale: Mild (score = 1), Moderate (score = 2), and Severe (score = 3). For each day, the Daily Pain assessment score was derived by averaging the worst pain intensity over all headaches of that day. For days on which no headaches took place during the relevant period, the Daily Pain score was given as a score of 0. The average Daily Pain score was calculated using the Daily Pain assessments collected during Weeks 13-16, 17-20, and 21-24. |
| Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 | Baseline, Weeks 13-16, 17-20, and 21-24 | Acute migraine medication included paracetamol, triptans, ergotamine, combination of non-opioid analgesics, individual non-opioid analgesics, and nonsteroidal anti-inflammatory drugs (NSAIDs). Barbiturates and/or opioid analgesics were allowed when considered medically indicated providing its use does not exceed 4 days per month. |
| Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1 - 4 and Weeks 1 - 12 | CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis. |
| Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1 - 4 and Weeks 1 - 12 | MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis. |
| Placebo-controlled Period: Change From Baseline in MMDs With Use of Acute Headache Medication at Weeks 1 to 12 | Baseline, Weeks 1 - 12 | A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken. |
| Placebo-controlled Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 1 to 12 | Baseline, Weeks 1 - 12 | — |
| Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 | Baseline, Weeks 13-16, 17-20, and 21-24 | — |
| Placebo-controlled Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or Non-steroidal Anti-inflammatory Drug (NSAID) Medication Use at Weeks 1 to 12 | Baseline, Weeks 1 - 12 | — |
| Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 | Baseline, Weeks 13-16, 17-20, and 21-24 | — |
| Placebo-controlled Period: Change From Baseline in Monthly Days With Combination Non-opioid Analgesics Medication Use at Weeks 1 to 12 | Baseline, Weeks 1 - 12 | — |
| Placebo-controlled Period: Number of Participants With Migraine on the Day After Dosing | Day 1 | — |
| Open-label Period: Change From Baseline in HIT-6 Total Score at Week 24 | 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). |
| Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Baseline to Weeks 1 - 4 and 1 - 12 | A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken. |
| Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Baseline to Weeks 1 - 4 and 1 - 12 | A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken. |
| Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Baseline to Weeks 1 - 4 and 1 - 12 | A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1). |
| Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Baseline to Weeks 1 - 4 and 1 - 12 | A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1). |
| Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Baseline to Weeks 1 - 4 and 1 - 12 | A migraine that fulfilled the criteria for a migraine, was referred to as a migraine attack. |
| Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Baseline to Weeks 1 - 4 and 1 - 12 | A non-migraine headache that lasted ≥30 minutes or a migraine headache, was referred to as a headache episode. |
| Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12 | Weeks 4 and 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. |
| Open-label Period: 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. |
| Placebo-controlled Period: 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. |
| Open-label Period: MBS Score at Week 24 | Week 24 | 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. |
| Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12 | Baseline, Weeks 4 and 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). |
| Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12 | Baseline, Weeks 4 and 12 | The mMIDAS is a self-administered questionnaire that contains 7 questions about the headache a participant had in the previous month. The first 5 questions assess the impact of migraine on 3 domains of daily activity: 2 questions for paid work or schoolwork, 2 questions for household work, and 1 question for family, social and leisure activities. The 2 questions for each of the first two groups assess, respectively, the number of days off due to headache, and the number of days in which the productivity was reduced by half or more. mMIDAS total score was derived from the sum of the answers on the first 5 questions. Total score ranged from 0 (little/no disability) to 20 (severe disability) with higher scores indicating more severe disability. |
| Open-label Period: Change From Baseline in mMIDAS Total Score at Week 24 | Baseline, Week 24 | The mMIDAS is a self-administered questionnaire that contains 7 questions about the headache a participant had in the previous month. The first 5 questions assess the impact of migraine on 3 domains of daily activity: 2 questions for paid work or schoolwork, 2 questions for household work, and 1 question for family, social and leisure activities. The 2 questions for each of the first two groups assess, respectively, the number of days off due to headache, and the number of days in which the productivity was reduced by half or more. mMIDAS total score was derived from the sum of the answers on the first 5 questions. Total score ranged from 0 (little/no disability) to 20 (severe disability) with higher scores indicating more severe disability. |
| Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Baseline, Weeks 4 and 12 | The MSQ v2.1 is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0-to-100-point scale. Higher scores indicated better quality of life. |
| Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 | Baseline, Weeks 24 | The MSQ v2.1 is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0-to-100-point scale. Higher scores indicated better quality of life. |
| Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12 | Baseline, Weeks 4 and 12 | The EQ-5D-5L VAS measures participant's self-rated health-related quality of life on a VAS. The VAS score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Open-label Period: Change From Baseline in EQ-5D-5L VAS Score at Week 24 | Week 24 | The EQ-5D-5L VAS measures participant's self-rated health-related quality of life on a VAS. The VAS score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | 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, that is, worse outcomes. |
| Open-label Period: Change From Baseline in WPAI:M Sub-scores (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, that is, worse outcomes. |
| Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Baseline, Weeks 4 and 12 | The HADS is a participant-rated scale designed to assess psychological distress in non-psychiatric participants. The HADS consists of 2 sub-scales: depression and anxiety. Each sub-scale contains 7 items, and each item was rated from 0 (absent) to 3 (maximum severity). The total score of each sub-scale ranged from 0 (absent) to 21 (maximum severity). Higher scores indicated higher severity. |
| Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24 | Baseline, Week 24 | The HADS is a participant-rated scale designed to assess psychological distress in non-psychiatric participants. The HADS consists of 2 sub-scales: depression and anxiety. Each sub-scale contains 7 items, and each item was rated from 0 (absent) to 3 (maximum severity). The total score of each sub-scale ranged from 0 (absent) to 21 (maximum severity). Higher scores indicated higher severity. |
| Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Weeks 4 and 12 | TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. |
| Open-label Period: TSQM-9 Score at Week 24 | Baseline, Week 24 | TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. |
| Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline and Week 12 | Number of participants who visited to a family doctor/general practitioner during the past 4 weeks has been reported at Baseline and Week 12. |
| Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline and Week 12 | Number of participants who visited a specialist during the past 4 weeks has been reported at Baseline and Week 12. |
| Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline and Week 12 | Number of participants who visited to the emergency department due to migraine during the past 4 weeks has been reported at Baseline and Week 12. |
| Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline and Week 12 | Number of participants who were admitted to the hospital during the past 4 weeks due to migraine has been reported at Baseline and Week 12. |
| Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline and Week 12 | Number of participants who had overnight hospital stays during the past 4 weeks due to migraine has been reported at Baseline and Week 12. |
| Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | Week 24 | Number of participants who visited a family doctor/general practitioner has been reported. |
| Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | Week 24 | Number of participants who visited a specialist has been reported. |
| Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | Week 24 | Number of participants who visited the emergency department due to migraine has been reported. |
| Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 | Week 24 | Number of participants who admitted in the hospital due to migraine has been reported. |
| Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | Week 24 | Number of participants with overnight hospital stays due to migraine has been reported. |
Countries
Australia, Denmark, France, Georgia, Germany, Italy, Netherlands, Norway, Spain, Sweden, United States
Contacts
STUDY_DIRECTOREmail contact via H. Lundbeck A/S
HQ_Medinfo@Lundbeck.com
Participant flow
Pre-assignment details
The study consisted of a 12-week placebo-controlled Period followed by a 12-week open-label Period.
Participants by arm
| Arm | Count |
|---|---|
| Eptinezumab Participants received an IV infusion of eptinezumab at Baseline (Week 0) during the placebo-controlled period and at Week 12 during the open-label period. | 303 |
| Placebo Participants received a single IV infusion of placebo matched to eptinezumab at Week 0 during the placebo-controlled period and an IV infusion of eptinezumab at Week 12 during the open-label period. | 301 |
| Total | 604 |
Baseline characteristics
| Characteristic | Eptinezumab | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 11.95 | 45.2 years STANDARD_DEVIATION 12.03 | 45.5 years STANDARD_DEVIATION 11.98 |
| Monthly Migraine Days (MMDs) | 21.0 days/month STANDARD_DEVIATION 4.26 | 20.9 days/month STANDARD_DEVIATION 4.28 | 20.9 days/month STANDARD_DEVIATION 4.27 |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Not Collected/Unknown | 146 Participants | 145 Participants | 291 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 151 Participants | 147 Participants | 298 Participants |
| Sex: Female, Male Female | 264 Participants | 253 Participants | 517 Participants |
| Sex: Female, Male Male | 39 Participants | 48 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 303 | 0 / 301 | 0 / 300 | 0 / 293 |
| other Total, other adverse events | 50 / 303 | 55 / 301 | 30 / 300 | 42 / 293 |
| serious Total, serious adverse events | 2 / 303 | 1 / 301 | 2 / 300 | 5 / 293 |
Outcome results
Primary
Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4
A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.
Time frame: Baseline, Weeks 1 - 4
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4 | -6.85 days/month | Standard Error 0.518 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4 | -3.66 days/month | Standard Error 0.519 |
Comparison: Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with Baseline number of MMDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MMDs at baseline-by-month were included.p-value: <0.000195% CI: [-4.16, -2.23]Mixed model for repeated measures
Secondary
Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24
Daily Pain assessment data were collected in the headache eDiary via the question What was the worst pain intensity of this headache today?. The pain intensity assessment was collected on a 3-point scale: Mild (score = 1), Moderate (score = 2), and Severe (score = 3). For each day, the Daily Pain assessment score was derived by averaging the worst pain intensity over all headaches of that day. For days on which no headaches took place during the relevant period, the Daily Pain score was given as a score of 0. The average Daily Pain score was calculated using the Daily Pain assessments collected during Weeks 13-16, 17-20, and 21-24.
Time frame: Baseline, Weeks 13-16, 17-20, and 21-24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -0.84 units on a scale | Standard Deviation 0.638 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -0.90 units on a scale | Standard Deviation 0.628 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -0.88 units on a scale | Standard Deviation 0.641 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -0.90 units on a scale | Standard Deviation 0.602 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -0.89 units on a scale | Standard Deviation 0.63 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -0.81 units on a scale | Standard Deviation 0.667 |
Secondary
Open-label Period: Change From Baseline in EQ-5D-5L VAS Score at Week 24
The EQ-5D-5L VAS measures participant's self-rated health-related quality of life on a VAS. The VAS score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in EQ-5D-5L VAS Score at Week 24 | 5.9 units on a scale | Standard Deviation 22.69 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in EQ-5D-5L VAS Score at Week 24 | 3.9 units on a scale | Standard Deviation 22.1 |
Secondary
Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24
The HADS is a participant-rated scale designed to assess psychological distress in non-psychiatric participants. The HADS consists of 2 sub-scales: depression and anxiety. Each sub-scale contains 7 items, and each item was rated from 0 (absent) to 3 (maximum severity). The total score of each sub-scale ranged from 0 (absent) to 21 (maximum severity). Higher scores indicated higher severity.
Time frame: Baseline, Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24 | Total Depression Score | -2.1 units on a scale | Standard Deviation 3.78 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24 | Total Anxiety Score | -2.0 units on a scale | Standard Deviation 3.36 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24 | Total Depression Score | -1.3 units on a scale | Standard Deviation 3.88 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24 | Total Anxiety Score | -1.1 units on a scale | Standard Deviation 3.54 |
Secondary
Open-label Period: Change From Baseline in HIT-6 Total 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).
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in HIT-6 Total Score at Week 24 | -8.1 units on a scale | Standard Deviation 8.21 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in HIT-6 Total Score at Week 24 | -7.6 units on a scale | Standard Deviation 7.74 |
Secondary
Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24
A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.
Time frame: Baseline, Weeks 13-16, 17-20, and 21-24
Population: All-Participants-Treated-Open-Label Set (APTS-OL) included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -10.23 days/month | Standard Deviation 7.167 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -9.24 days/month | Standard Deviation 7.22 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -10.29 days/month | Standard Deviation 7.093 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -10.08 days/month | Standard Deviation 7.136 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -10.29 days/month | Standard Deviation 7.301 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -9.30 days/month | Standard Deviation 7.602 |
Secondary
Open-label Period: Change From Baseline in mMIDAS Total Score at Week 24
The mMIDAS is a self-administered questionnaire that contains 7 questions about the headache a participant had in the previous month. The first 5 questions assess the impact of migraine on 3 domains of daily activity: 2 questions for paid work or schoolwork, 2 questions for household work, and 1 question for family, social and leisure activities. The 2 questions for each of the first two groups assess, respectively, the number of days off due to headache, and the number of days in which the productivity was reduced by half or more. mMIDAS total score was derived from the sum of the answers on the first 5 questions. Total score ranged from 0 (little/no disability) to 20 (severe disability) with higher scores indicating more severe disability.
Time frame: Baseline, Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in mMIDAS Total Score at Week 24 | -17.3 units on a scale | Standard Deviation 20.71 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in mMIDAS Total Score at Week 24 | -15.2 units on a scale | Standard Deviation 19.69 |
Secondary
Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24
Acute migraine medication included paracetamol, triptans, ergotamine, combination of non-opioid analgesics, individual non-opioid analgesics, and nonsteroidal anti-inflammatory drugs (NSAIDs). Barbiturates and/or opioid analgesics were allowed when considered medically indicated providing its use does not exceed 4 days per month.
Time frame: Baseline, Weeks 13-16, 17-20, and 21-24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -12.08 days/month | Standard Deviation 6.738 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -11.82 days/month | Standard Deviation 6.69 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -10.96 days/month | Standard Deviation 6.693 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -11.67 days/month | Standard Deviation 6.47 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -10.44 days/month | Standard Deviation 7.338 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -11.39 days/month | Standard Deviation 7.08 |
Secondary
Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24
Time frame: Baseline, Weeks 13-16, 17-20, and 21-24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -6.55 days/month | Standard Deviation 7.205 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -6.65 days/month | Standard Deviation 7.193 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -6.18 days/month | Standard Deviation 7.018 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -6.66 days/month | Standard Deviation 7.108 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -6.62 days/month | Standard Deviation 7.316 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -6.44 days/month | Standard Deviation 7.468 |
Secondary
Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24
Time frame: Baseline, Weeks 13-16, 17-20, and 21-24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -8.70 days/month | Standard Deviation 6.736 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -8.24 days/month | Standard Deviation 6.54 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -7.43 days/month | Standard Deviation 6.505 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -8.79 days/month | Standard Deviation 6.781 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -8.31 days/month | Standard Deviation 6.982 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -7.56 days/month | Standard Deviation 6.7 |
Secondary
Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24
The MSQ v2.1 is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0-to-100-point scale. Higher scores indicated better quality of life.
Time frame: Baseline, Weeks 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 | Emotional function | 26.86 units on a scale | Standard Error 27.806 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 | Role function- restrictive | 26.38 units on a scale | Standard Error 23.302 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 | Role function- preventive | 20.6 units on a scale | Standard Error 23.61 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 | Role function- restrictive | 26.33 units on a scale | Standard Error 24.159 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 | Role function- preventive | 20.7 units on a scale | Standard Error 22.85 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 | Emotional function | 26.54 units on a scale | Standard Error 28.385 |
Secondary
Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24
A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).
Time frame: Baseline, at Weeks 13-16, 17-20, and 21-24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -10.31 days/month | Standard Deviation 7.113 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -10.46 days/month | Standard Deviation 6.941 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -9.46 days/month | Standard Deviation 7.206 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 21-24 | -9.47 days/month | Standard Deviation 7.382 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 13-16 | -9.99 days/month | Standard Deviation 7.082 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24 | Change at Weeks 17-20 | -10.34 days/month | Standard Deviation 7.253 |
Secondary
Open-label Period: Change From Baseline in WPAI:M Sub-scores (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, that is, worse outcomes.
Time frame: Baseline, Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Absenteeism | -9.22 units on a scale | Standard Deviation 27.236 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Presenteeism | -18.8 units on a scale | Standard Deviation 28.41 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Work productivity loss | -20.54 units on a scale | Standard Deviation 29.162 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Activity impairment | -19.6 units on a scale | Standard Deviation 28.14 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Activity impairment | -21.0 units on a scale | Standard Deviation 28.73 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Absenteeism | -4.75 units on a scale | Standard Deviation 25.007 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Work productivity loss | -24.18 units on a scale | Standard Deviation 29.102 |
| Placebo-controlled Period: Placebo | Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 | Presenteeism | -22.7 units on a scale | Standard Deviation 27.58 |
Secondary
Open-label Period: MBS Score at Week 24
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.
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: MBS Score at Week 24 | 2.6 units on a scale | Standard Deviation 1.22 |
| Placebo-controlled Period: Placebo | Open-label Period: MBS Score at Week 24 | 2.6 units on a scale | Standard Deviation 1.25 |
Secondary
Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24
Number of participants who visited the emergency department due to migraine has been reported.
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 0 Visit | 277 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 1 Visit | 3 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 2 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 3 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 10 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 18 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 10 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 0 Visit | 265 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 3 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 1 Visit | 5 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 18 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24 | 2 Visits | 3 Participants |
Secondary
Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24
Number of participants who admitted in the hospital due to migraine has been reported.
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 | 1 Admission | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 | 2 Admissions | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 | 0 Admission | 281 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 | 0 Admission | 271 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 | 1 Admission | 2 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24 | 2 Admissions | 2 Participants |
Secondary
Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24
Number of participants with overnight hospital stays due to migraine has been reported.
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 0 Stay | 281 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 1 Stays | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 2 Stays | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 12 Stays | 0 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 12 Stays | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 0 Stay | 270 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 2 Stays | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24 | 1 Stays | 3 Participants |
Secondary
Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24
Number of participants who visited a family doctor/general practitioner has been reported.
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 2 Visits | 11 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 3 Visits | 3 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 8 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 4 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 5 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 0 Visit | 239 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 7 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 13 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 1 Visit | 26 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 13 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 1 Visit | 20 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 4 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 7 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 0 Visit | 239 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 2 Visits | 13 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 3 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 5 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24 | 8 Visits | 0 Participants |
Secondary
Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24
Number of participants who visited a specialist has been reported.
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 4 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 3 Visits | 3 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 5 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 1 Visit | 29 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 6 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 0 Visit | 239 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 7 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 2 Visits | 7 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 7 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 3 Visits | 4 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 0 Visit | 240 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 1 Visit | 20 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 4 Visits | 2 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 5 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 6 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24 | 2 Visits | 8 Participants |
Secondary
Open-label Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM Nor MOH at Weeks 13 to 24
CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis. MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis.
Time frame: Weeks 13 - 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM Nor MOH at Weeks 13 to 24 | 38.9 percentage of participants |
| Placebo-controlled Period: Placebo | Open-label Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM Nor MOH at Weeks 13 to 24 | 40.2 percentage of participants |
Secondary
Open-label Period: 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.
Time frame: Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: PGIC Score at Week 24 | 2.3 units on a scale | Standard Deviation 1.18 |
| Placebo-controlled Period: Placebo | Open-label Period: PGIC Score at Week 24 | 2.3 units on a scale | Standard Deviation 1.2 |
Secondary
Open-label Period: TSQM-9 Score at Week 24
TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
Time frame: Baseline, Week 24
Population: APTS-OL included all randomized participants who received an infusion of the IMP in the Open-label Period. 'Overall number of participants analyzed' = participants analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Open-label Period: TSQM-9 Score at Week 24 | Effectiveness Score | 63.23 units on a scale | Standard Deviation 28.684 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: TSQM-9 Score at Week 24 | Convenience Score | 66.23 units on a scale | Standard Deviation 21.451 |
| Placebo-controlled Period: Eptinezumab | Open-label Period: TSQM-9 Score at Week 24 | Overall Satisfaction Score | 64.23 units on a scale | Standard Deviation 29.401 |
| Placebo-controlled Period: Placebo | Open-label Period: TSQM-9 Score at Week 24 | Effectiveness Score | 62.50 units on a scale | Standard Deviation 27.896 |
| Placebo-controlled Period: Placebo | Open-label Period: TSQM-9 Score at Week 24 | Convenience Score | 66.02 units on a scale | Standard Deviation 23.017 |
| Placebo-controlled Period: Placebo | Open-label Period: TSQM-9 Score at Week 24 | Overall Satisfaction Score | 63.51 units on a scale | Standard Deviation 27.603 |
Secondary
Placebo-controlled Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 1 to 2
Daily Pain assessment data were collected in the headache electronic diary (eDiary) via the question What was the worst pain intensity of this headache today?. The pain intensity assessment was collected on a 3-point scale: Mild (score = 1), Moderate (score = 2), and Severe (score = 3). For each day, the Daily Pain assessment score was derived by averaging the worst pain intensity over all headaches of that day. For days on which no headaches took place during the relevant period, the Daily Pain score was given as a score of 0. The average Daily Pain score was calculated using the Daily Pain assessments collected during Weeks 1-2.
Time frame: Baseline, Weeks 1 - 2
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 1 to 2 | -0.58 units on a scale | Standard Error 0.048 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 1 to 2 | -0.27 units on a scale | Standard Error 0.048 |
Comparison: Analysis of covariance (ANCOVA) was performed with the average Daily Pain at baseline as a covariate and including treatment group, country, and previous treatment failures, as categorical variables.p-value: <0.000195% CI: [-0.39, -0.22]ANCOVA
Secondary
Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12
The EQ-5D-5L VAS measures participant's self-rated health-related quality of life on a VAS. The VAS score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Baseline, Weeks 4 and 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12 | Change at Week 4 | 5.09 units on a scale | Standard Error 1.561 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12 | Change at Week 12 | 7.43 units on a scale | Standard Error 1.526 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12 | Change at Week 4 | 0.49 units on a scale | Standard Error 1.574 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12 | Change at Week 12 | 2.23 units on a scale | Standard Error 1.54 |
Secondary
Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 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).
Time frame: Baseline, Weeks 4 and 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12 | Change at Week 4 | -6.5 units on a scale | Standard Error 7.25 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12 | Change at Week 12 | -7.4 units on a scale | Standard Error 8.6 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12 | Change at Week 4 | -2.6 units on a scale | Standard Error 5.3 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12 | Change at Week 12 | -3.9 units on a scale | Standard Error 6.42 |
Secondary
Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12
The HADS is a participant-rated scale designed to assess psychological distress in non-psychiatric participants. The HADS consists of 2 sub-scales: depression and anxiety. Each sub-scale contains 7 items, and each item was rated from 0 (absent) to 3 (maximum severity). The total score of each sub-scale ranged from 0 (absent) to 21 (maximum severity). Higher scores indicated higher severity.
Time frame: Baseline, Weeks 4 and 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 4: Total Depression Score | -1.59 units on a scale | Standard Error 0.294 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 12: Total Depression Score | -1.82 units on a scale | Standard Error 0.3 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 4: Total Anxiety Score | -1.32 units on a scale | Standard Error 0.262 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 12: Total Anxiety Score | -1.37 units on a scale | Standard Error 0.257 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 12: Total Anxiety Score | -0.40 units on a scale | Standard Error 0.257 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 4: Total Depression Score | -0.61 units on a scale | Standard Error 0.296 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 4: Total Anxiety Score | -0.49 units on a scale | Standard Error 0.263 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12 | Change at Week 12: Total Depression Score | -0.64 units on a scale | Standard Error 0.302 |
Secondary
Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12
The MSQ v2.1 is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0-to-100-point scale. Higher scores indicated better quality of life.
Time frame: Baseline, Weeks 4 and 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 4: Role function- restrictive | 24.04 units on a scale | Standard Error 1.898 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 12: Role function- restrictive | 22.55 units on a scale | Standard Error 1.873 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 4: Role function- preventive | 18.58 units on a scale | Standard Error 1.862 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 12: Role function- preventive | 17.96 units on a scale | Standard Error 1.834 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 4: Emotional function | 23.82 units on a scale | Standard Error 2.143 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 12: Emotional function | 22.06 units on a scale | Standard Error 2.188 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 4: Emotional function | 10.11 units on a scale | Standard Error 2.145 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 4: Role function- restrictive | 10.15 units on a scale | Standard Error 1.902 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 12: Role function- preventive | 10.16 units on a scale | Standard Error 1.836 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 12: Role function- restrictive | 11.79 units on a scale | Standard Error 1.877 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 12: Emotional function | 11.67 units on a scale | Standard Error 2.193 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12 | Change at Week 4: Role function- preventive | 7.88 units on a scale | Standard Error 1.864 |
Secondary
Placebo-controlled Period: Change From Baseline in MMDs at Weeks 1 to 12
A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.
Time frame: Baseline, Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in MMDs at Weeks 1 to 12 | -7.44 days/month | Standard Error 0.508 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in MMDs at Weeks 1 to 12 | -4.50 days/month | Standard Error 0.508 |
Comparison: Analysis was performed using a REML-based MMRM with Baseline number of MMDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MMDs at baseline-by-month were included.p-value: <0.000195% CI: [-3.86, -2.02]Mixed model for repeated measures
Secondary
Placebo-controlled Period: Change From Baseline in MMDs With Use of Acute Headache Medication at Weeks 1 to 12
A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.
Time frame: Baseline, Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in MMDs With Use of Acute Headache Medication at Weeks 1 to 12 | -10.32 days/month | Standard Error 0.481 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in MMDs With Use of Acute Headache Medication at Weeks 1 to 12 | -7.16 days/month | Standard Error 0.481 |
Secondary
Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12
The mMIDAS is a self-administered questionnaire that contains 7 questions about the headache a participant had in the previous month. The first 5 questions assess the impact of migraine on 3 domains of daily activity: 2 questions for paid work or schoolwork, 2 questions for household work, and 1 question for family, social and leisure activities. The 2 questions for each of the first two groups assess, respectively, the number of days off due to headache, and the number of days in which the productivity was reduced by half or more. mMIDAS total score was derived from the sum of the answers on the first 5 questions. Total score ranged from 0 (little/no disability) to 20 (severe disability) with higher scores indicating more severe disability.
Time frame: Baseline, Weeks 4 and 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12 | Change at Week 4 | -14.73 units on a scale | Standard Error 1.475 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12 | Change at Week 12 | -13.83 units on a scale | Standard Error 1.494 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12 | Change at Week 4 | -6.62 units on a scale | Standard Error 1.476 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12 | Change at Week 12 | -8.76 units on a scale | Standard Error 1.496 |
Secondary
Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12
Acute migraine medication included those medications classified as opioid, barbiturates, ergotamine, triptan, non-opioid analgesic, and combination of analgesic ingredients.
Time frame: Baseline, Weeks 1 - 4 and Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -11.18 days/month | Standard Error 0.49 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -11.32 days/month | Standard Error 0.508 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -7.69 days/month | Standard Error 0.509 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -7.83 days/month | Standard Error 0.49 |
Comparison: Analysis was performed using a REML-based MMRM with Baseline number of monthly days with acute migraine medication use as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of monthly days with acute migraine medication use at baseline-by-month were included.p-value: <0.000195% CI: [-4.59, -2.67]Mixed model for repeated measures
Comparison: Analysis was performed using a REML-based MMRM with Baseline number of monthly days with acute migraine medication use as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of monthly days with acute migraine medication use at baseline-by-month were included.p-value: <0.000195% CI: [-4.23, -2.48]Mixed model for repeated measures
Secondary
Placebo-controlled Period: Change From Baseline in Monthly Days With Combination Non-opioid Analgesics Medication Use at Weeks 1 to 12
Time frame: Baseline, Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Monthly Days With Combination Non-opioid Analgesics Medication Use at Weeks 1 to 12 | -1.24 days/month | Standard Error 0.202 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Monthly Days With Combination Non-opioid Analgesics Medication Use at Weeks 1 to 12 | -1.12 days/month | Standard Error 0.201 |
Secondary
Placebo-controlled Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or Non-steroidal Anti-inflammatory Drug (NSAID) Medication Use at Weeks 1 to 12
Time frame: Baseline, Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or Non-steroidal Anti-inflammatory Drug (NSAID) Medication Use at Weeks 1 to 12 | -5.94 days/month | Standard Error 0.402 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or Non-steroidal Anti-inflammatory Drug (NSAID) Medication Use at Weeks 1 to 12 | -4.80 days/month | Standard Error 0.402 |
Secondary
Placebo-controlled Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 1 to 12
Time frame: Baseline, Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 1 to 12 | -8.35 days/month | Standard Error 0.411 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 1 to 12 | -5.49 days/month | Standard Error 0.409 |
Secondary
Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12
A migraine that fulfilled the criteria for a migraine, was referred to as a migraine attack.
Time frame: Baseline to Weeks 1 - 4 and 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -10.30 percentage of migraine attacks | Standard Error 1.912 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -5.21 percentage of migraine attacks | Standard Error 1.859 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -1.60 percentage of migraine attacks | Standard Error 1.916 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -1.60 percentage of migraine attacks | Standard Error 1.86 |
Secondary
Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12
A non-migraine headache that lasted ≥30 minutes or a migraine headache, was referred to as a headache episode.
Time frame: Baseline to Weeks 1 - 4 and 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -11.78 percentage of headache episodes | Standard Error 1.867 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -6.99 percentage of headache episodes | Standard Error 1.822 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -3.36 percentage of headache episodes | Standard Error 1.872 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -2.79 percentage of headache episodes | Standard Error 1.825 |
Secondary
Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).
Time frame: Baseline, Weeks 1 - 4 and Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -6.54 days/month | Standard Error 0.502 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -7.38 days/month | Standard Error 0.497 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-12 | -4.45 days/month | Standard Error 0.497 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12 | Change at Weeks 1-4 | -3.40 days/month | Standard Error 0.502 |
Comparison: Analysis was performed using a REML-based MMRM with Baseline number of MHDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MHDs at baseline-by-month were included.p-value: <0.000195% CI: [-4.07, -2.22]Mixed model for repeated measures
Comparison: Analysis was performed using a REML-based MMRM with Baseline number of MHDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MHDs at baseline-by-month were included.p-value: <0.000195% CI: [-3.83, -2.02]Mixed model for repeated measures
Secondary
Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12
The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Time frame: Baseline, Week 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Absenteeism | -4.73 units on a scale | Standard Error 2.342 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Presenteeism | -19.10 units on a scale | Standard Error 2.602 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Work productivity loss | -19.88 units on a scale | Standard Error 2.79 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Activity impairment | -18.87 units on a scale | Standard Error 2.065 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Activity impairment | -10.42 units on a scale | Standard Error 2.079 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Absenteeism | -1.18 units on a scale | Standard Error 2.324 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Work productivity loss | -9.04 units on a scale | Standard Error 2.727 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 | Presenteeism | -10.12 units on a scale | Standard Error 2.544 |
Secondary
Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12
Number of participants who visited to the emergency department due to migraine during the past 4 weeks has been reported at Baseline and Week 12.
Time frame: Baseline and Week 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 0 Visit | 281 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 1 Visit | 7 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 1 Visit | 5 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 0 Visit | 275 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 2 Visits | 2 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 2 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 9 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 9 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 9 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 9 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 0 Visit | 256 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 1 Visit | 7 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Baseline | 2 Visits | 3 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 0 Visit | 268 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 1 Visit | 10 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12 | Week 12 | 2 Visits | 3 Participants |
Secondary
Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12
Number of participants who were admitted to the hospital during the past 4 weeks due to migraine has been reported at Baseline and Week 12.
Time frame: Baseline and Week 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 16 Admissions | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 16 Admissions | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 1 Admission | 3 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 0 Admission | 286 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 0 Admission | 279 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 1 Admission | 2 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 2 Admissions | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 2 Admissions | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 2 Admissions | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 16 Admissions | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 0 Admission | 258 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 1 Admission | 7 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 2 Admissions | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Baseline | 16 Admissions | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 0 Admission | 277 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12 | Week 12 | 1 Admission | 4 Participants |
Secondary
Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12
Number of participants who had overnight hospital stays during the past 4 weeks due to migraine has been reported at Baseline and Week 12.
Time frame: Baseline and Week 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 0 Stay | 282 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 1 Stay | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 2 Stays | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 7 Stays | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 0 Stay | 287 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 1 Stay | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 2 Stays | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 7 Stays | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 7 Stays | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 0 Stay | 264 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 0 Stay | 278 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 1 Stay | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 2 Stays | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 2 Stays | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Week 12 | 1 Stay | 3 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12 | Baseline | 7 Stays | 1 Participants |
Secondary
Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12
Number of participants who visited a specialist during the past 4 weeks has been reported at Baseline and Week 12.
Time frame: Baseline and Week 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 0 Visit | 245 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 12 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 1 Visit | 30 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 3 Visits | 6 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 2 Visits | 7 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 1 Visit | 71 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 3 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 4 Visits | 3 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 4 Visits | 4 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 0 Visit | 180 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 5 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 5 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 6 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 2 Visits | 21 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 12 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 6 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 12 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 0 Visit | 224 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 0 Visit | 156 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 1 Visit | 83 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 2 Visits | 18 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 3 Visits | 5 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 4 Visits | 2 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 5 Visits | 2 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 6 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 1 Visit | 43 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 2 Visits | 8 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 3 Visits | 5 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 4 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 5 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Week 12 | 6 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12 | Baseline | 12 Visits | 1 Participants |
Secondary
Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12
Number of participants who visited to a family doctor/general practitioner during the past 4 weeks has been reported at Baseline and Week 12.
Time frame: Baseline and Week 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 15 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 1 Visit | 44 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 0 Visit | 242 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 4 Visits | 2 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 1 Visit | 29 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 0 Visit | 213 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 2 Visits | 7 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 5 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 3 Visits | 5 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 2 Visits | 10 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 4 Visits | 4 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 6 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 5 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 15 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 6 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 10 Visits | 1 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 10 Visits | 0 Participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 3 Visits | 11 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 15 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 0 Visit | 198 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 1 Visit | 42 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 2 Visits | 17 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 3 Visits | 4 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 4 Visits | 3 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 5 Visits | 2 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 6 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 10 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Baseline | 15 Visits | 1 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 0 Visit | 217 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 1 Visit | 41 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 2 Visits | 15 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 3 Visits | 4 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 4 Visits | 2 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 5 Visits | 2 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 6 Visits | 0 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12 | Week 12 | 10 Visits | 0 Participants |
Secondary
Placebo-controlled Period: 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.
Time frame: Week 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Most Bothersome Symptom (MBS) Score at Week 12 | 2.87 units on a scale | Standard Error 0.106 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Most Bothersome Symptom (MBS) Score at Week 12 | 3.59 units on a scale | Standard Error 0.107 |
Secondary
Placebo-controlled Period: Number of Participants With Migraine on the Day After Dosing
Time frame: Day 1
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Number of Participants With Migraine on the Day After Dosing | 162 Participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Number of Participants With Migraine on the Day After Dosing | 203 Participants |
Secondary
Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 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.
Time frame: Weeks 4 and 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12 | Week 4 | 2.62 units on a scale | Standard Error 0.1 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12 | Week 12 | 2.64 units on a scale | Standard Error 0.101 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12 | Week 4 | 3.63 units on a scale | Standard Error 0.1 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12 | Week 12 | 3.54 units on a scale | Standard Error 0.101 |
Secondary
Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12
CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis.
Time frame: Weeks 1 - 4 and Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 44.4 percentage of participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 55.0 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 32.4 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 23.0 percentage of participants |
Secondary
Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12
MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis.
Time frame: Weeks 1 - 4 and Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 52.2 percentage of participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 40.1 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 31.9 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 24.0 percentage of participants |
Secondary
Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH)
CM: - Headache on ≥15 days/month for \>3 months. - Participants had experienced ≥5 attacks that fulfilled the criteria for either migraine without aura or with aura. - On ≥8 days/month for \>3 months, headache meeting the criteria for either: Migraine without aura (headache with ≥2 of these features: unilateral location, pulsating quality, moderate to severe pain, or aggravation by physical activity; plus either nausea/vomiting or photophobia/phonophobia); Migraine with aura (headache preceded or accompanied by transient focal neurological symptoms, such as visual or sensory disturbances); or headache believed to be migraine by participant and relieved by a triptan or ergot derivative. - Not better accounted for by another ICHD-3 diagnosis. MOH: Headache occurring on ≥15 days/month with a pre-existing headache. - Regular overuse for \>3 months of ≥1 drug that can be taken for acute and/or symptomatic treatment of headache. - Not better accounted for by another ICHD-3 diagnosis.
Time frame: Weeks 1 - 4 and Weeks 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH) | Weeks 1-12 | 27.2 percentage of participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH) | Weeks 1-4 | 37.8 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH) | Weeks 1-4 | 18.1 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH) | Weeks 1-12 | 12.7 percentage of participants |
Comparison: The logistic regression model with baseline MMDs as a covariate, and treatment group (eptinezumab versus placebo), country and previous treatment failures (≤2, \>2) as categorical variables based on the eDiary data collected over Weeks 1-4, Weeks 5-8, Weeks 9-12 and over Weeks 1-12 separately, was fitted using the maximum likelihood method and the logit link function.p-value: <0.000195% CI: [2.18, 4.94]Regression, Logistic
Comparison: The logistic regression model with baseline MMDs as a covariate, and treatment group (eptinezumab versus placebo), country and previous treatment failures (≤2, \>2) as categorical variables based on the eDiary data collected over Weeks 1-4, Weeks 5-8, Weeks 9-12 and over Weeks 1-12 separately, was fitted using the maximum likelihood method and the logit link function.p-value: <0.000195% CI: [1.93, 4.9]Regression, Logistic
Secondary
Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).
Time frame: Baseline to Weeks 1 - 4 and 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 33.0 percentage of participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 35.8 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 11.0 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 15.3 percentage of participants |
Secondary
Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12
A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.
Time frame: Baseline to Weeks 1 - 4 and 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 36.7 percentage of participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 40.4 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 13.7 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 18.0 percentage of participants |
Secondary
Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or that met the definition of a migraine day (as defined in outcome measure 1).
Time frame: Baseline to Weeks 1 - 4 and 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 9.3 percentage of participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 10.9 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 3.3 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 5.3 percentage of participants |
Secondary
Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12
A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.
Time frame: Baseline to Weeks 1 - 4 and 1 - 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Number analyzed' = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 13.0 percentage of participants |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 12.9 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-4 | 4.3 percentage of participants |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12 | Weeks 1-12 | 5.3 percentage of participants |
Secondary
Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12
TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
Time frame: Weeks 4 and 12
Population: FAS included all randomized participants who received an infusion of the IMP in the Placebo-controlled Period and had a valid Baseline assessment and at least 1 valid post-Baseline 4-week assessment of MMDs in Weeks 1-12. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified category.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 4: Convenience Score | 69.60 units on a scale | Standard Error 1.736 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 12: Overall Satisfaction Score | 62.54 units on a scale | Standard Error 2.136 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 12: Convenience Score | 69.42 units on a scale | Standard Error 1.786 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 12: Effectiveness Score | 57.95 units on a scale | Standard Error 2.264 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 4: Overall Satisfaction Score | 59.56 units on a scale | Standard Error 2.094 |
| Placebo-controlled Period: Eptinezumab | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 4: Effectiveness Score | 58.21 units on a scale | Standard Error 2.228 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 12: Overall Satisfaction Score | 46.98 units on a scale | Standard Error 2.146 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 4: Effectiveness Score | 39.01 units on a scale | Standard Error 2.236 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 12: Effectiveness Score | 40.89 units on a scale | Standard Error 2.278 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 4: Convenience Score | 63.62 units on a scale | Standard Error 1.743 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 12: Convenience Score | 63.12 units on a scale | Standard Error 1.797 |
| Placebo-controlled Period: Placebo | Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12 | Week 4: Overall Satisfaction Score | 43.57 units on a scale | Standard Error 2.099 |