Migraine
Conditions
Brief summary
The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine in adults.
Detailed description
This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 20 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 54 participants will be enrolled to study intervention. All participants in this single-group study will complete a 4-week run-in period. After the run-in period, eligible participants will be enrolled to study intervention and enter a 12-week treatment period.
Interventions
DRUGErenumab-Aooe 140 MG/ML [Aimovig]
140 mg/mL administered subcutaneously
Sponsors
Clinvest Research, LLC
Smith, Timothy R., M.D.
Merle Diamond
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply: 1. willing to participate and sign informed consent; 2. ability to understand informed consent and study procedures, including able to use the electronic Daily Headache Diary; 3. in good general health based on investigator's judgment; 4. must be between 18 to 65 years of age, inclusive, at time of Visit 2; 5. have migraine with or without aura meeting the diagnostic criteria listed in the International Classification of Headache Disorders 3rd edition (ICHD-III; Appendix 5); 6. verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase reporting 4-20 migraine days and no more than 20 total headache days; 7. onset of migraine before age 50; 8. able to differentiate migraine from other primary headache types allowed in the study (e.g., tension-type headache); 9. stable history of migraine at least 3 months prior to screening with headache free periods; 10. not currently taking a migraine preventive OR has been taking a stable dose of a preventive for at least 90 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period; \*\*participants on migraine preventive should have stable headache pattern 11. must have a score of ≥ 3 on the Migraine Functional Impact Questionnaire (MFIQ) overall impact on usual activities item at screening; 12. women may be included only if they have a negative pregnancy test at screening and baseline, are sterile, or postmenopausal. Women of childbearing potential (WOCBP) whose male partners are potentially fertile (i.e., no vasectomy) must use highly effective birth control methods for the duration of the study (i.e., starting at screening). Definitions of WOCBP, sterile and postmenopausal women, male contraception, and highly effective and acceptable birth control methods are to be determined based on investigator's judgment; 13. demonstrated compliance with the electronic Daily Headache Diary during the 28-day screening/baseline phase as defined by entry of headache data on a minimum of 23 days; 14. is willing to wear activity/sleep tracker throughout the duration of the trial; 15. has a smartphone and willing to install activity tracker app on phone.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: 1. unable to understand the study requirements, the informed consent, or complete headache records as required per protocol; 2. pregnant, actively trying to become pregnant, or breast-feeding; 3. history of substance abuse and/or dependence, in the opinion of the Investigator; 4. history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study; 5. suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events; 6. a psychiatric condition, in the opinion of the investigator, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study; 7. received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study; 8. prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway; 9. has failed more than 3 classes of medications for the prevention of migraine, or \>6 migraine preventative medications of any type due to lack of efficacy; 10. received any investigational agents within 30 days prior to Visit 1 (6 months for any investigational biological products unless previous study blind has been broken and subject was known to have received placebo); 11. plans to participate in another clinical study at any time during this study; 12. history of medication overuse of opioids or butalbital, as defined by opioid or butalbital use ≥10 days/month in previous 12 months or during run-in period; Medication Overuse Headache (MOH) with other medication types will be allowed but must be documented; 13. unstable medication use for migraine prevention (changes in the last 3 months); 14. clinically relevant lab results at screening as determine by the investigator; 15. clinically relevant or significant ECG abnormalities as determine by the investigator, including ECG with QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) \> 500 msec; 16. history of any of the following cardiovascular conditions: 1. Moderate to severe congestive heart failure (New York Heart Association class III or IV); 2. Recent (within past 12 months) cerebrovascular accident, myocardial infarction, coronary stenting; 3. Uncontrolled hypertension as defined by a confirmed systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg. 17. active HIV or Hepatitis C infection; 18. allergy to latex; 19. score of \> 0 on question 9 on Patient Health Questionnaire (PHQ-9) at any visit; 20. have any other condition, that in the judgment of the investigator, would make the participant unsuitable for inclusion, or would interfere with the participant participating in or completing the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at End of Treatment (Treatment Month 3). | Baseline and Treatment Month 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline and Treatment Month 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Usual Activities. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline and Treatment Month 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Emotional Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline and Treatment Month 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Social Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Physical Function The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Usual Activities. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Emotional Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Social Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Domain Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline and Treatment Month 3 | The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Physical Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant. |
| Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | Comparison of the mean change from baseline in the frequency of migraine headache days per 28-day period ending with the cessation of treatment month 3. A migraine headache day will be defined as a calendar day (00:00 to 23:59) with 4 or more hours of migraine headache, fulfilling International Classification of Headache Disorders-3 criteria, and/or any headache of any duration with the use of migraine-specific acute medications(s) (i.e. ergot alkaloids, ergot combinations, opioids, triptans, combination analgesics \[simple analgesics combined with opioids or barbiturate with or without caffeine\]). |
| Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity. |
| Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity. |
| Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity. |
| Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity. |
| Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Neuro-QoL Sleep Disturbance Short Form (SDSF) is an 8-item, self-administered questionnaire which measures quality of sleep including difficulties and perception of sleep satisfaction. Possible transformed t-scores ranging from 32 to 84.20, with higher scores indicating worse sleep habits. |
| General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The General Self-Efficacy Severity Scale (GSESS) is a 4 item, self-administered questionnaire where the participant is asked to rate their confidence in managing situations, problems, and events. Final scores range from 18.60 to 64.70 and are represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate the participant has more self-efficacy managing difficult situations. |
| Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3 | Baseline and Treatment Months 1, 2, and 3 | The Brief Measure of Worry Severity (BMWS) is a 8-item, self-administered questionnaire that measures various components of dysfunctional worry. Score range from 0-24 with higher scores indicating more worry within the participant. |
| Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline and Treatment Months 1, 2, and 3 | The Migraine Interictal Burden Scale (MIBS-4) is a 4-item, self-administered questionnaire which measures interictal migraine-related burden in 4 domains: impairment in work or school, impairment in family and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress. Possible scores range from 0 (No interictal burden) to 12 (Severe interictal burden). Higher scores indicate worse interictal burden. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] Participants received 140 mg/mL administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for three months (12 weeks).
Erenumab-Aooe 140 MG/ML \[Aimovig\]: 140 mg/mL administered subcutaneously | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol specified withdrawal criterion met | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Erenumab-Aooe 140 MG/ML [Aimovig] |
|---|---|
| Age, Continuous | 40.35 years STANDARD_DEVIATION 11.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| MFIQ Global Item | 43.64 units on a scale STANDARD_DEVIATION 23.18 |
| Monthly Migraine Days | 10.01 Days per month STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 52 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 3 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Month 3
Population: Full analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at End of Treatment (Treatment Month 3). | Baseline | 43.64 score on a scale | Standard Deviation 23.18 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at End of Treatment (Treatment Month 3). | Treatment Month 3 | 21.82 score on a scale | Standard Deviation 20.44 |
Secondary
Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3
The Brief Measure of Worry Severity (BMWS) is a 8-item, self-administered questionnaire that measures various components of dysfunctional worry. Score range from 0-24 with higher scores indicating more worry within the participant.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3 | Treatment Month 3 | 5.16 score on a scale | Standard Deviation 5.09 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3 | Baseline | 7.42 score on a scale | Standard Deviation 5.87 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3 | Treatment Month 1 | 5.84 score on a scale | Standard Deviation 5.17 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3 | Treatment Month 2 | 5.75 score on a scale | Standard Deviation 5.19 |
Secondary
General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3.
The General Self-Efficacy Severity Scale (GSESS) is a 4 item, self-administered questionnaire where the participant is asked to rate their confidence in managing situations, problems, and events. Final scores range from 18.60 to 64.70 and are represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate the participant has more self-efficacy managing difficult situations.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 50.20 T-Scores | Standard Deviation 8.83 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 53.42 T-Scores | Standard Deviation 8.13 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 52.95 T-Scores | Standard Deviation 8.75 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 54.87 T-Scores | Standard Deviation 8.42 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Emotional Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Month 3
Population: Full analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline | 43.00 score on a scale | Standard Deviation 27.67 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at the End of Treatment (Treatment Month 3). | Treatment Month 3 | 19.64 score on a scale | Standard Deviation 22.13 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Emotional Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 43.00 score on a scale | Standard Deviation 27.67 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 22.00 score on a scale | Standard Deviation 24.39 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 21.55 score on a scale | Standard Deviation 25.42 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Emotional Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 19.64 score on a scale | Standard Deviation 22.13 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Domain Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Physical Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Month 3
Population: Full analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Domain Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline | 48.82 score on a scale | Standard Deviation 17.56 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Domain Scores at Baseline and at the End of Treatment (Treatment Month 3). | Treatment Month 3 | 25.84 score on a scale | Standard Deviation 21.41 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Physical Function The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 29.34 score on a scale | Standard Deviation 23.1 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 28.91 score on a scale | Standard Deviation 23.74 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 25.84 score on a scale | Standard Deviation 21.41 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 48.82 score on a scale | Standard Deviation 17.56 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Social Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Month 3
Population: Full analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline | 40.36 score on a scale | Standard Deviation 21.49 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at the End of Treatment (Treatment Month 3). | Treatment Month 3 | 17.86 score on a scale | Standard Deviation 20.52 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Social Function. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 40.36 score on a scale | Standard Deviation 21.49 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 18.55 score on a scale | Standard Deviation 20.96 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 18.98 score on a scale | Standard Deviation 22.75 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Social Function Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 17.86 score on a scale | Standard Deviation 20.52 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at the End of Treatment (Treatment Month 3).
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Usual Activities. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Month 3
Population: Full analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at the End of Treatment (Treatment Month 3). | Baseline | 39.16 score on a scale | Standard Deviation 21.36 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at the End of Treatment (Treatment Month 3). | Treatment Month 3 | 17.81 score on a scale | Standard Deviation 18.36 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the MFIQ domain, Usual Activities. The domain's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 39.6 score on a scale | Standard Deviation 21.36 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 21.18 score on a scale | Standard Deviation 20.5 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 20.02 score on a scale | Standard Deviation 21.73 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 17.81 score on a scale | Standard Deviation 18.36 |
Secondary
Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Functional Impact Questionnaire (MFIQ) is a 26-item self-report questionnaire. It is designed to measure the impact of migraine on physical, social, and emotional functioning over 5 domains: Physical Function (PF), Usual Activities (UA), Overall impact on Usual Activities, Social Function (SF), and Emotional Function (EF). Final transformed scores range from 0-100, with higher scores indicating more impact on the participant. For this endpoint we will be measuring changes in participant's response on the single MFIQ Global Item Overall Impact on Usual Activities (item # 16). The item's transformed score can range from 0-100, with higher scores indicating more impact on the participant.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 43.64 score on a scale | Standard Deviation 23.18 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 23.18 score on a scale | Standard Deviation 21.44 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 23.18 score on a scale | Standard Deviation 23.5 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Functional Impact Questionnaire (MFIQ) - Overall Impact on Usual Activities Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 21.82 score on a scale | Standard Deviation 20.44 |
Secondary
Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3.
The Migraine Interictal Burden Scale (MIBS-4) is a 4-item, self-administered questionnaire which measures interictal migraine-related burden in 4 domains: impairment in work or school, impairment in family and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress. Possible scores range from 0 (No interictal burden) to 12 (Severe interictal burden). Higher scores indicate worse interictal burden.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 5.11 score on a scale | Standard Deviation 3.23 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 3.44 score on a scale | Standard Deviation 3.09 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 3.31 score on a scale | Standard Deviation 3.05 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Migraine Interictal Burden Scale (MIBS-4) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 3.00 score on a scale | Standard Deviation 3.03 |
Secondary
Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3.
The Neuro-QoL Sleep Disturbance Short Form (SDSF) is an 8-item, self-administered questionnaire which measures quality of sleep including difficulties and perception of sleep satisfaction. Possible transformed t-scores ranging from 32 to 84.20, with higher scores indicating worse sleep habits.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 56.58 score on a scale | Standard Deviation 7.04 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 52.50 score on a scale | Standard Deviation 8.14 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 52.89 score on a scale | Standard Deviation 7.72 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Neuro-QoL Sleep Disturbance Short Form (SDSF) Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 50.93 score on a scale | Standard Deviation 9.4 |
Secondary
Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3.
Comparison of the mean change from baseline in the frequency of migraine headache days per 28-day period ending with the cessation of treatment month 3. A migraine headache day will be defined as a calendar day (00:00 to 23:59) with 4 or more hours of migraine headache, fulfilling International Classification of Headache Disorders-3 criteria, and/or any headache of any duration with the use of migraine-specific acute medications(s) (i.e. ergot alkaloids, ergot combinations, opioids, triptans, combination analgesics \[simple analgesics combined with opioids or barbiturate with or without caffeine\]).
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 10.06 days per month | Standard Deviation 3.9 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 7.82 days per month | Standard Deviation 5.13 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 6.96 days per month | Standard Deviation 4.6 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 6.33 days per month | Standard Deviation 4.64 |
Secondary
Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 9.11 score on a scale | Standard Deviation 13.02 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 3.50 score on a scale | Standard Deviation 7.1 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 4.43 score on a scale | Standard Deviation 9.8 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Absenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 3.09 score on a scale | Standard Deviation 6.76 |
Secondary
Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 52.18 score on a scale | Standard Deviation 25.94 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 31.82 score on a scale | Standard Deviation 27.83 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 25.82 score on a scale | Standard Deviation 26.3 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Activity Impairment Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 26.00 score on a scale | Standard Deviation 25.86 |
Secondary
Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 23.23 score on a scale | Standard Deviation 23.58 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 48.07 score on a scale | Standard Deviation 21.82 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 30.32 score on a scale | Standard Deviation 22.73 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Presenteeism Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 26.77 score on a scale | Standard Deviation 22.42 |
Secondary
Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3.
The Work Productivity and Activity Impairment- Migraine (WPAI-M) is a 6-item self-administered questionnaire that measures work productivity and the amount of time missed from work due to migraine. Domain scores are expressed as a percentage, with a range of scores form 0-100%, with higher scores indicating greater impairment and less productivity.
Time frame: Baseline and Treatment Months 1, 2, and 3
Population: Full Analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Baseline | 48.12 score on a scale | Standard Deviation 25.04 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 1 | 30.09 score on a scale | Standard Deviation 24.55 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 2 | 27.90 score on a scale | Standard Deviation 24.83 |
| Erenumab-Aooe 140 MG/ML [Aimovig] | Work Productivity and Activity Impairment- Migraine (WPAI-M): Work Productivity Loss Domain Scores at Baseline and at Treatment Months 1, 2, and 3. | Treatment Month 3 | 22.79 score on a scale | Standard Deviation 24.85 |