Migraine
Conditions
Keywords
Migraine, Chronic Migraine, Episodic Migraine, Erenumab
Brief summary
The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.
Interventions
DRUGErenumab
Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Participant has provided informed consent * History of migraine (with or without aura) for ≥ 12 months before screening * ≥ 4 migraine days per month on average across the 3 months prior to screening * Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention. * Participant reports to their provider intolerance or insufficient response with their current preventative treatment
Exclusion criteria
* History of cluster headache or hemiplegic migraine headache * Unable to differentiate migraine from other headaches * Evidence of substance-related disorders * Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain) * No therapeutic response with \> 3 migraine preventive medication categories * Used a prohibited medication, device, or procedure * Other clinically significant disorder, condition, or disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC | Baseline and Week 24 | 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. |
| Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type | Baseline and Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type | Week 24 | 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. |
| GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type | Baseline up to Week 24 | 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. |
| Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC | Baseline and Week 24 | 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. |
| GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC | Baseline up to Week 24 | 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. |
| Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC | Week 24 | 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. |
| GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type | Baseline up to Week 24 | 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. |
| Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC | Baseline and Week 24 | 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. |
| Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type | Baseline and Week 24 | 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. |
| Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type | Baseline and Week 24 | 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. |
| GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC | Baseline up to Week 24 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 33 centers in the United States (US) from June 2021 to September 2023.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Erenumab QM: EM 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. | 53 |
| 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. | 187 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Decision by Sponsor | 2 | 3 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Never Received Investigational Product | 1 | 1 |
| Overall Study | Withdrawal of Consent From Study | 7 | 9 |
Baseline characteristics
| Characteristic | Erenumab QM: CM | Total | Erenumab QM: EM |
|---|---|---|---|
| Age, Continuous | 47.0 years STANDARD_DEVIATION 14.1 | 46.9 years STANDARD_DEVIATION 13.8 | 46.6 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 103 Participants | 116 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 124 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 20 Participants | 27 Participants | 7 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 162 Participants | 205 Participants | 43 Participants |
| Sex: Female, Male Female | 169 Participants | 212 Participants | 43 Participants |
| Sex: Female, Male Male | 18 Participants | 28 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 212 | 0 / 28 | 0 / 240 |
| other Total, other adverse events | 16 / 212 | 7 / 26 | 23 / 238 |
| serious Total, serious adverse events | 5 / 212 | 1 / 26 | 6 / 238 |
Outcome results
Primary
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type | 43.44 Score on a scale | Standard Deviation 32.03 |
Comparison: Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.p-value: <0.00195% CI: [28.62, 47.12]Mixed Models Analysis
Comparison: Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.p-value: <0.00195% CI: [38.06, 48.44]Mixed Models Analysis
Primary
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC | 34.42 Score on a scale | Standard Deviation 57.66 |
Comparison: Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline monthly migraine days (MMD), and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.p-value: <0.00195% CI: [36.05, 45.39]Mixed Models Analysis
Comparison: Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.p-value: 0.05895% CI: [-1.3, 62.98]Mixed Models Analysis
Secondary
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
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.
Time frame: Baseline up to Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erenumab QM: Continued SoC | GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type | 76.2 Estimated percentage of participants |
| Erenumab QM: Discontinued SoC | GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type | 93.2 Estimated percentage of participants |
Secondary
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
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.
Time frame: Baseline up to Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erenumab QM: Continued SoC | GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC | 91.8 Estimated percentage of participants |
| Erenumab QM: Discontinued SoC | GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC | NA Estimated percentage of participants |
Secondary
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
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.
Time frame: Baseline up to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type | Participant Global Impression | 95.5 Estimated percentage of participants |
| Erenumab QM: Discontinued SoC | GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type | Treating Clinician's Global Impression | 94.5 Estimated percentage of participants |
| Erenumab QM: Discontinued SoC | 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 |
Secondary
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC
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.
Time frame: Baseline up to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC | Participant Global Impression | NA Estimated percentage of participants |
| Erenumab QM: Discontinued SoC | GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC | Treating Clinician's Global Impression | NA Estimated percentage of participants |
| Erenumab QM: Discontinued SoC | GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC | Key Family Member's Impression | NA Estimated percentage of participants |
Secondary
Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 30.5 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type | Emotional Function Domain | -50.72 Score on a scale | Standard Deviation 27.67 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type | Physical Function Domain | -50.42 Score on a scale | Standard Deviation 25.58 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type | Social Function Domain | -48.95 Score on a scale | Standard Deviation 26.23 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type | Usual Activities Domain | -47.84 Score on a scale | Standard Deviation 24 |
Comparison: EM: Physical Function Domainp-value: <0.00195% CI: [-41.72, -27.03]Mixed Models Analysis
Comparison: CM: Physical Function Domainp-value: <0.00195% CI: [-54.44, -44.69]Mixed Models Analysis
Comparison: EM: Usual Activities Domainp-value: <0.00195% CI: [-41.47, -30.06]Mixed Models Analysis
Comparison: CM: Usual Activities Domainp-value: <0.00195% CI: [-51.1, -42.29]Mixed Models Analysis
Comparison: EM: Social Function Domainp-value: <0.00195% CI: [-42.89, -29.96]Mixed Models Analysis
Comparison: CM: Social Function Domainp-value: <0.00195% CI: [-51.49, -41.98]Mixed Models Analysis
Comparison: EM: Emotional Function Domainp-value: <0.00195% CI: [-49.47, -33.4]Mixed Models Analysis
Comparison: CM: Emotional Function Domainp-value: <0.00195% CI: [-52.95, -42.39]Mixed Models Analysis
Secondary
Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erenumab QM: Continued SoC | 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 26.7 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC | Emotional Function Domain | -57.31 Score on a scale | Standard Deviation 31.73 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC | Physical Function Domain | -49.04 Score on a scale | Standard Deviation 30.2 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC | Social Function Domain | -46.15 Score on a scale | Standard Deviation 30.63 |
| Erenumab QM: Discontinued SoC | Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC | Usual Activities Domain | -45.00 Score on a scale | Standard Deviation 27.86 |
Comparison: Continued SoC: Physical Function Domainp-value: <0.00195% CI: [-49.39, -40.41]Mixed Models Analysis
Comparison: Discontinued SoC: Physical Function Domainp-value: <0.00195% CI: [-73.43, -34.86]Mixed Models Analysis
Comparison: Continued SoC: Usual Activities Domainp-value: <0.00195% CI: [-48.26, -40.44]Mixed Models Analysis
Comparison: Discontinued SoC: Usual Activities Domainp-value: <0.00195% CI: [-53.51, -34.08]Mixed Models Analysis
Comparison: Continued SoC: Social Function Domainp-value: <0.00195% CI: [-48.65, -40.14]Mixed Models Analysis
Comparison: Discontinued SoC: Social Function Domainp-value: <0.00195% CI: [-60.28, -29.79]Mixed Models Analysis
Comparison: Continued SoC: Emotional Function Domainp-value: <0.00195% CI: [-50.29, -40.7]Mixed Models Analysis
Comparison: Discontinued SoC: Emotional Function Domainp-value: <0.00195% CI: [-85.16, -34.96]Mixed Models Analysis
Secondary
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erenumab QM: Continued SoC | Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type | 75.6 Percentage of participants |
| Erenumab QM: Discontinued SoC | Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type | 92.6 Percentage of participants |
Secondary
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erenumab QM: Continued SoC | Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC | 91.0 Percentage of participants |
| Erenumab QM: Discontinued SoC | Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC | 66.7 Percentage of participants |
Secondary
Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type | Participant Global Impression | 95.5 Percentage of participants |
| Erenumab QM: Discontinued SoC | Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type | Treating Clinician's Global Impression | 94.4 Percentage of participants |
| Erenumab QM: Discontinued SoC | Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type | Key Family Member's Impression | 94.5 Percentage of participants |
Secondary
Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Continued SoC | 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 |
| Erenumab QM: Discontinued SoC | Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC | Participant Global Impression | 83.3 Percentage of participants |
| Erenumab QM: Discontinued SoC | 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 | 84.6 Percentage of participants |
| Erenumab QM: Discontinued SoC | 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 | 100.0 Percentage of participants |