Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline, Weeks 1 - 12 |
|
| Secondary |
Percentage of Participants With =50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline to Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline, Weeks 13 - 24 |
|
| Secondary |
Percentage of Participants With =75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline to Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12 |
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (=60), substantial (56-59), some (50-55), little to none (=49). |
Baseline, Week 12 |
|
| Secondary |
Percentage of Participants With =50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline to Weeks 13 - 24 |
|
| Secondary |
Percentage of Participants With =75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline to Weeks 13 - 24 |
|
| Secondary |
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline to Weeks 1 - 12 |
|
| Secondary |
Percentage of Participants With =50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 |
A headache day was defined as a day with a headache that lasted =30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). |
Baseline to Weeks 1 - 12 |
|
| Secondary |
Percentage of Participants With =75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 |
A headache day was defined as a day with a headache that lasted =30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). |
Baseline to Weeks 1 - 12 |
|
| Secondary |
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 |
A headache day was defined as a day with a headache that lasted =30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). |
Baseline to Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12 |
A headache day was defined as a day with a headache that lasted =30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). |
Baseline, Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12 |
A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). |
Baseline, Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12 |
A headache episode was defined as a headache lasted =30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1). |
Baseline, Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12 |
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication. |
Baseline, Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24 |
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication. |
Baseline, Weeks 13- 24 |
|
| Secondary |
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12 |
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes". |
Baseline, Weeks 1 - 12 |
|
| Secondary |
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24 |
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes". |
Baseline, Weeks 13 - 24 |
|
| Secondary |
Patient Global Impression of Change (PGIC) Score at Week 12 |
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. |
Week 12 |
|
| Secondary |
PGIC Score at Week 24 |
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. |
Week 24 |
|
| Secondary |
Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12 |
|
Baseline, Weeks 1 - 12 |
|
| Secondary |
Percentage of Participants With Migraine on the Day After First Dosing |
|
Day 1 |
|
| Secondary |
Most Bothersome Symptom (MBS) Score at Week 12 |
Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms. |
Week 12 |
|
| Secondary |
Change From Baseline in the HIT-6 Score at Week 24 |
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (=60), substantial (56-59), some (50-55), little to none (=49). |
Baseline, Week 24 |
|
| Secondary |
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12 |
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. |
Baseline, Week 12 |
|
| Secondary |
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12 |
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). |
Baseline, Week 12 |
|
| Secondary |
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 |
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. |
Baseline, Week 24 |
|
| Secondary |
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24 |
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). |
Baseline, Week 24 |
|
| Secondary |
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 |
The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. |
Baseline, Week 12 |
|
| Secondary |
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 |
The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. |
Baseline, Week 24 |
|
| Secondary |
Percentage of Participants With =5-Point Reduction From Baseline to Week 12 in HIT-6 Score |
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (=60), substantial (56-59), some (50-55), little to none (=49). |
Baseline to Week 12 |
|
| Secondary |
Percentage of Participants With =5-Point Reduction From Baseline to Week 24 in HIT-6 Score |
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (=60), substantial (56-59), some (50-55), little to none (=49). |
Baseline to Week 24 |
|
| Secondary |
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner |
Number of participants who visited to a family doctor/general practitioner has been reported. |
Week 12 |
|
| Secondary |
HCRU: Visits to a Specialist |
Number of participants who visited to a specialist has been reported. |
Week 12 |
|
| Secondary |
HCRU: Number of Emergency Department Visits Due to Your Migraine |
Number of participants who visited to emergency department due to your migraine has been reported. |
Week 12 |
|
| Secondary |
HCRU: Number of Hospital Admissions Due to Migraine |
Number of participants who admitted in the hospital due to migraine has been reported. |
Week 12 |
|
| Secondary |
HCRU: Total Number of Overnight Hospital Stays Due to Migraine |
Number of participants who had total number of overnight hospital stays due to migraine has been reported. |
Week 12 |
|
| Secondary |
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72 |
|
| Secondary |
Percentage of Participants With =50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72 |
|
| Secondary |
Percentage of Participants With =75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 |
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted =30 minutes and the participant had an aura with the headache. Criterion C: lasted =30 minutes and met =2 of the following criteria: lasted =4 hours, had =2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by =1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine. |
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72 |
|
| Secondary |
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72 |
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (=60), substantial (56-59), some (50-55), little to none (=49). |
Baseline, Weeks 36, 48, 60, and 72 |
|
