Trial Outcomes & Findings for A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine (NCT NCT04825678)
NCT ID: NCT04825678
Last Updated: 2024-09-19
Results Overview
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
COMPLETED
PHASE4
240 participants
Baseline and Week 24
2024-09-19
Participant Flow
This study was conducted at 33 centers in the United States (US) from June 2021 to September 2023.
This study enrolled participants with episodic migraine (EM) or chronic migraine (CM) in an approximately 1:1 ratio. The study comprised of a combined screening/baseline period and a 24-week open-label treatment period.
Participant milestones
| Measure |
Erenumab QM: EM
Participants with EM were administered erenumab QM subcutaneously (SC). EM was defined as \< 15 headache days a month over the last 3 months, which on some days was migraine but did not fulfil International Headache Society (IHS) International Classification of Headache Disorders (ICHD) Classification III criteria for CM per participant self-report and investigator assessment.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: CM
Participants with CM were administered erenumab QM SC. CM was defined as ≥ 15 headache days a month of which ≥ 8 headache days met criteria as migraine days per participant self-report and investigator assessment.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
187
|
|
Overall Study
Received Investigational Product
|
52
|
186
|
|
Overall Study
Received Erenumab QM 70 mg
|
32
|
124
|
|
Overall Study
Received Erenumab QM 140 mg
|
20
|
62
|
|
Overall Study
Continued Standard of Care (SoC)
|
41
|
171
|
|
Overall Study
Discontinued SoC
|
12
|
16
|
|
Overall Study
COMPLETED
|
40
|
170
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
Reasons for withdrawal
| Measure |
Erenumab QM: EM
Participants with EM were administered erenumab QM subcutaneously (SC). EM was defined as \< 15 headache days a month over the last 3 months, which on some days was migraine but did not fulfil International Headache Society (IHS) International Classification of Headache Disorders (ICHD) Classification III criteria for CM per participant self-report and investigator assessment.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: CM
Participants with CM were administered erenumab QM SC. CM was defined as ≥ 15 headache days a month of which ≥ 8 headache days met criteria as migraine days per participant self-report and investigator assessment.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Overall Study
Decision by Sponsor
|
2
|
3
|
|
Overall Study
Withdrawal of Consent From Study
|
7
|
9
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Never Received Investigational Product
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
Baseline characteristics by cohort
| Measure |
Erenumab QM: EM
n=53 Participants
Participants with EM were administered erenumab QM SC. EM was defined as \< 15 headache days a month over the last 3 months, which on some days was migraine but did not fulfil IHS Classification ICHD III criteria for CM per participant self-report and investigator assessment.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: CM
n=187 Participants
Participants with CM were administered erenumab QM SC. CM was defined as ≥ 15 headache days a month of which ≥ 8 headache days met criteria as migraine days per participant self-report and investigator assessment.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Efficacy Analysis Set (EAS): consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.5. Only participants with available data were included.
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=184 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=14 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC
|
42.33 Score on a scale
Standard Deviation 32.48
|
34.42 Score on a scale
Standard Deviation 57.66
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by migraine type, as pre-specified in SAP section 9.5. Only participants with available data were included.
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=38 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=160 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type
|
34.76 Score on a scale
Standard Deviation 44.00
|
43.44 Score on a scale
Standard Deviation 32.03
|
SECONDARY outcome
Timeframe: Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.5. Only participants with available data were included.
Overall satisfaction is defined as the percentage of participants reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction. Summary statistics using observed data (after intercurrent event handling) presented. The 95% confidence interval (CI) is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=188 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=15 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
|
91.0 Percentage of participants
Interval 85.92 to 94.64
|
66.7 Percentage of participants
Interval 38.38 to 88.18
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.5. Only participants with available data were included.
Overall satisfaction is defined as the percentage of participants reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction. The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes Baseline achievement of overall satisfaction, visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=197 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=15 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
|
91.8 Estimated percentage of participants
Interval 81.64 to 96.54
|
NA Estimated percentage of participants
Due to limited number of participants, the GLIMMIX model did not converge.
|
SECONDARY outcome
Timeframe: Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by migraine type, as pre-specified in SAP section 9.5. Only participants with available data were included.
Overall satisfaction is defined as the percentage of participants reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction. Summary statistics using observed data (after intercurrent event handling) presented. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=41 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=162 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
|
75.6 Percentage of participants
Interval 59.7 to 87.64
|
92.6 Percentage of participants
Interval 87.42 to 96.11
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by migraine type, as pre-specified in SAP section 9.5. Only participants with available data were included.
Overall satisfaction is defined as the percentage of participants reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction. The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes Baseline achievement of overall satisfaction, visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=45 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=167 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
|
76.2 Estimated percentage of participants
Interval 58.5 to 87.9
|
93.2 Estimated percentage of participants
Interval 84.16 to 97.23
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.5. Only participants with available data were included.
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days. Summary statistics using observed data (after intercurrent event handling) presented. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=189 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=13 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC
Participant Global Impression
|
94.0 Percentage of participants
Interval 88.99 to 97.24
|
83.3 Percentage of participants
Interval 51.59 to 97.91
|
|
Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC
Treating Clinician's Global Impression
|
93.7 Percentage of participants
Interval 89.17 to 96.68
|
84.6 Percentage of participants
Interval 54.55 to 98.08
|
|
Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC
Key Family Member's Impression
|
92.8 Percentage of participants
Interval 84.93 to 97.3
|
100.0 Percentage of participants
Interval 39.76 to 100.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.5. Only participants with available data were included.
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days. The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=202 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=13 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC
Treating Clinician's Global Impression
|
90.9 Estimated percentage of participants
Interval 82.71 to 95.46
|
NA Estimated percentage of participants
Due to limited number of participants, the GLIMMIX model did not converge.
|
|
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC
Key Family Member's Impression
|
92.6 Estimated percentage of participants
Interval 81.09 to 97.37
|
NA Estimated percentage of participants
Due to limited number of participants, the GLIMMIX model did not converge.
|
|
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC
Participant Global Impression
|
94.6 Estimated percentage of participants
Interval 87.42 to 97.82
|
NA Estimated percentage of participants
Due to limited number of participants, the GLIMMIX model did not converge.
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by migraine type, as pre-specified in SAP section 9.5. Only participants with available data were included.
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days. Summary statistics using observed data (after intercurrent event handling) presented. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=40 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=162 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Participant Global Impression
|
83.9 Percentage of participants
Interval 66.27 to 94.55
|
95.5 Percentage of participants
Interval 90.37 to 98.31
|
|
Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Treating Clinician's Global Impression
|
87.5 Percentage of participants
Interval 73.2 to 95.81
|
94.4 Percentage of participants
Interval 89.72 to 97.43
|
|
Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Key Family Member's Impression
|
85.7 Percentage of participants
Interval 57.19 to 98.22
|
94.5 Percentage of participants
Interval 86.56 to 98.49
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by migraine type, as pre-specified in SAP section 9.5. Only participants with available data were included.
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days. The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=46 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=169 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Participant Global Impression
|
NA Estimated percentage of participants
Due to limited number of participants, the GLIMMIX model did not converge.
|
95.5 Estimated percentage of participants
Interval 88.89 to 98.23
|
|
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Treating Clinician's Global Impression
|
87.3 Estimated percentage of participants
Interval 65.28 to 96.15
|
94.5 Estimated percentage of participants
Interval 85.74 to 98.02
|
|
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Key Family Member's Impression
|
NA Estimated percentage of participants
Due to limited number of participants, the GLIMMIX model did not converge.
|
NA Estimated percentage of participants
Due to limited number of participants, the GLIMMIX model did not converge.
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.5. Only participants with available data were included.
The MFIQ version 2.0 is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including 4 domains: Impact on Physical Functioning, Impact on Usual Activities, Impact on Social Functioning, and Impact on Emotional Functioning. In addition, there is 1 stand-alone global item assessing the overall impact on usual activities. Participants respond to each item using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses (i.e., raw score) and rescaled to a 0-100 scale, with higher scores representing greater burden. A negative change from baseline represents a reduction in burden. The recall period is the past 7 days. Summary statistics using observed data (after intercurrent event handling) presented.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=185 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=13 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
Physical Function Domain
|
-46.29 Score on a scale
Standard Deviation 26.70
|
-49.04 Score on a scale
Standard Deviation 30.20
|
|
Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
Usual Activities Domain
|
-44.83 Score on a scale
Standard Deviation 25.08
|
-45.00 Score on a scale
Standard Deviation 27.86
|
|
Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
Social Function Domain
|
-45.87 Score on a scale
Standard Deviation 27.62
|
-46.15 Score on a scale
Standard Deviation 30.63
|
|
Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
Emotional Function Domain
|
-47.54 Score on a scale
Standard Deviation 29.33
|
-57.31 Score on a scale
Standard Deviation 31.73
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: EAS: consists of a subset of participants from FAS who receive at least 1 dose of investigational product. Data presented by migraine type, as pre-specified in SAP section 9.5. Only participants with available data were included.
The MFIQ version 2.0 is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including 4 domains: Impact on Physical Functioning, Impact on Usual Activities, Impact on Social Functioning, and Impact on Emotional Functioning. In addition, there is 1 stand-alone global item assessing the overall impact on usual activities. Participants respond to each item using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses (i.e., raw score) and rescaled to a 0-100 scale, with higher scores representing greater burden. A negative change from baseline represents a reduction in burden. The recall period is the past 7 days. Summary statistics using observed data (after intercurrent event handling) presented.
Outcome measures
| Measure |
Erenumab QM: Continued SoC
n=38 Participants
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=160 Participants
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|
|
Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
Physical Function Domain
|
-29.84 Score on a scale
Standard Deviation 26.08
|
-50.42 Score on a scale
Standard Deviation 25.58
|
|
Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
Usual Activities Domain
|
-32.22 Score on a scale
Standard Deviation 26.47
|
-47.84 Score on a scale
Standard Deviation 24.00
|
|
Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
Social Function Domain
|
-32.99 Score on a scale
Standard Deviation 30.50
|
-48.95 Score on a scale
Standard Deviation 26.23
|
|
Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
Emotional Function Domain
|
-37.50 Score on a scale
Standard Deviation 34.66
|
-50.72 Score on a scale
Standard Deviation 27.67
|
Adverse Events
Erenumab QM: Continued SoC
Erenumab QM: Discontinued SoC
Erenumab QM: Total
Serious adverse events
| Measure |
Erenumab QM: Continued SoC
n=212 participants at risk
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=26 participants at risk
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Total
n=238 participants at risk
All participants with EM and CM who were administered erenumab QM SC.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.47%
1/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.00%
0/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.42%
1/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
3.8%
1/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.42%
1/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
Gastrointestinal disorders
Volvulus
|
0.47%
1/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.00%
0/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.42%
1/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
Infections and infestations
Abdominal abscess
|
0.47%
1/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.00%
0/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.42%
1/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
Nervous system disorders
Migraine
|
0.47%
1/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.00%
0/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.42%
1/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
1/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.00%
0/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.42%
1/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.47%
1/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.00%
0/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.42%
1/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
Other adverse events
| Measure |
Erenumab QM: Continued SoC
n=212 participants at risk
Participants with EM and CM who were administered erenumab QM SC and continued SoC migraine prevention therapy throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Discontinued SoC
n=26 participants at risk
Participants with EM and CM who were administered erenumab QM SC and discontinued SoC migraine prevention therapy at any point throughout the study.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
Erenumab QM: Total
n=238 participants at risk
All participants with EM and CM who were administered erenumab QM SC.
All participants started on a 70 mg dose of erenumab at Day 1 with provider discretion for dose optimization (either 70 mg or 140 mg), which was recommended to be completed by Week 12. All participants were required to enter the study on 1 standard of care preventive medication for their migraine, whose dose then could be adjusted by the investigator's discretion and were stable by Week 12.
No dose comparisons were pre-specified.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.7%
10/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
11.5%
3/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
5.5%
13/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
General disorders
Injection site erythema
|
0.00%
0/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
7.7%
2/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
0.84%
2/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
|
Infections and infestations
COVID-19
|
3.8%
8/212 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
11.5%
3/26 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
4.6%
11/238 • Up to Week 24
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Data presented by SoC migraine preventive treatment, as pre-specified in SAP section 9.6.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER