Trial Outcomes & Findings for Efficacy of Erenumab on Functional Impact of Migraine (NCT NCT04465357)
NCT ID: NCT04465357
Last Updated: 2022-10-05
Results Overview
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.
COMPLETED
PHASE4
55 participants
Baseline and Treatment Month 3
2022-10-05
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Protocol specified withdrawal criterion met
|
2
|
Baseline Characteristics
Efficacy of Erenumab on Functional Impact of Migraine
Baseline characteristics by cohort
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
Age, Continuous
|
40.35 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
|
MFIQ Global Item
|
43.64 units on a scale
STANDARD_DEVIATION 23.18 • n=5 Participants
|
|
Monthly Migraine Days
|
10.01 Days per month
STANDARD_DEVIATION 3.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Treatment Month 3Population: Full analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Month 3Population: Full analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Month 3Population: Full analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Month 3Population: Full analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Month 3Population: Full analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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 23.50
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 23.10
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 20.50
|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis Population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis Population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis Population
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 \[simple analgesics combined with opioids or barbiturate with or without caffeine\]).
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3.
Baseline
|
10.06 days per month
Standard Deviation 3.90
|
|
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
|
|
Number of Migraine Days at Baseline and at Treatment Months 1, 2, and 3.
Treatment Month 2
|
6.96 days per month
Standard Deviation 4.60
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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 7.10
|
|
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 9.80
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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 26.30
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 9.40
|
SECONDARY outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline and Treatment Months 1, 2, and 3Population: Full Analysis population
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.
Outcome measures
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Erenumab-Aooe 140 MG/ML [Aimovig]
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Erenumab-Aooe 140 MG/ML [Aimovig]
n=55 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.5%
3/55 • Number of events 3 • 12 weeks (from Visit 2 [enrollment visit] to Visit 5 [end of study])
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per contractual agreement PIs agree to submit drafts of all publications to sponsor and funding sponsor between a period of 5 and 45 days depending on publication type (e.g. manuscript, poster, etc.).
- Publication restrictions are in place
Restriction type: OTHER