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The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 24 |
| 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. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation and Neurological Services LLC | Huntsville | Alabama | 35805 | United States | ||
| Elite Clinical Studies LLC |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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.
This study was conducted at 33 centers in the United States (US) from June 2021 to September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2022 | Aug 8, 2024 |
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| Week 24 |
| 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. | Baseline up to Week 24 |
| 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. | Week 24 |
| 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. | Baseline up to Week 24 |
| 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. | Baseline and Week 24 |
| 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. | Baseline up to Week 24 |
| 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. | Baseline and Week 24 |
| 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. | Baseline up to Week 24 |
| 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. | Baseline and Week 24 |
| 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. | Baseline and Week 24 |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| The Neurology Group | Pomona | California | 91767 | United States |
| Mountain Neurological Research Center | Basalt | Colorado | 81621 | United States |
| Mindscapes Counseling, LLC | Norwich | Connecticut | 06360 | United States |
| Reliable Clinical Research, LLC | Hialeah | Florida | 33012 | United States |
| Homestead Associates In Research Inc | Homestead | Florida | 33032 | United States |
| New Age Medical Research Corporation | Miami | Florida | 33186 | United States |
| The Community Research of South Florida | Miami Lakes | Florida | 33016 | United States |
| Research Institute of Orlando | Orlando | Florida | 32806 | United States |
| Pas Research | Tampa | Florida | 33613 | United States |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | United States |
| Chicago Headache Center and Research Institute | Chicago | Illinois | 60657 | United States |
| College Park Family Care Center | Overland Park | Kansas | 66212 | United States |
| Family HealthCare | Germantown | Maryland | 20876 | United States |
| Neurology Center of New England | Foxborough | Massachusetts | 02035 | United States |
| ActivMed Practices and Research, LLC | Lowell | Massachusetts | 01852 | United States |
| Memorial Healthcare Foundation | Owosso | Michigan | 48867 | United States |
| SRI International | Plymouth | Michigan | 48170 | United States |
| Citizens Memorial Healthcare | Bolivar | Missouri | 65613 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65807 | United States |
| Psych Care Consultants | St Louis | Missouri | 63128 | United States |
| Albuquerque Clinical Trials Inc | Albuquerque | New Mexico | 87102 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | United States |
| Northwell Health Physician Partners Neuroscience Institute at Great Neck | Great Neck | New York | 11021 | United States |
| Island Neurological Associates | Plainview | New York | 11803 | United States |
| Nuvance Health Medical Practice Primary Care Division of Neurology | Poughkeepsie | New York | 12601 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Asheville Neurology Specialists PA | Asheville | North Carolina | 28806 | United States |
| Onsite Clinical Solutions LLC | Charlotte | North Carolina | 28277 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Saint Lukes Neurology Associates | Bethlehem | Pennsylvania | 18018 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| Premier Neurology | Greer | South Carolina | 29650 | United States |
| Tri-State Mountain Neurology Associates | Johnson City | Tennessee | 37604 | United States |
| Pearland Neurology Services PLLC | Houston | Texas | 77089 | United States |
| Protenium Clinical Research | Hurst | Texas | 76054 | United States |
| Houston Neurology Associates | Sugar Land | Texas | 77478 | United States |
| Sugar Lakes Family Practice | Sugar Land | Texas | 77479 | United States |
| Vaught Neurological Services | Crab Orchard | West Virginia | 25827 | United States |
| FG001 | 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. |
| Received Investigational Product |
|
| Received Erenumab QM 70 mg | Participants who remained on 70 mg and did not receive any 140 mg dose |
|
| Received Erenumab QM 140 mg | Participants who increased dose to 140 mg |
|
| Continued Standard of Care (SoC) | Participants who continued SoC migraine prevention therapy throughout the study |
|
| Discontinued SoC | Participants who discontinued SoC migraine prevention therapy during the study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): consisted of all participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 24 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Estimated percentage of participants | Baseline up to Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Estimated percentage of participants | Baseline up to Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Estimated percentage of participants | Baseline up to Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 24 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Estimated percentage of participants | Baseline up to Week 24 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 24 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 24 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erenumab QM: Continued SoC | 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. | 0 | 212 | 5 | 212 | 16 | 212 |
| EG001 | Erenumab QM: Discontinued SoC | 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. | 0 | 28 | 1 | 26 | 7 | 26 |
| EG002 | Erenumab QM: Total | 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. | 0 | 240 | 6 | 238 | 23 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2023 | Aug 8, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605816 | erenumab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
|
| Multiple |
|
| 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. | Mixed Models Analysis | 0.058 | P-value is nominal to compare the mean change from Baseline at Week 24 to zero. | LSM | 30.84 | Standard Error of the Mean | 14.53 | 2-Sided | 95 | -1.30 | 62.98 | Other |
| OG001 | 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. |
|
|
|
| Erenumab QM: Discontinued SoC |
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. |
|
|
| OG001 | Erenumab QM: Discontinued SoC | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | Erenumab QM: Discontinued SoC | 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. |
|
|
| OG001 | Erenumab QM: Discontinued SoC | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | Erenumab QM: Discontinued SoC | 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. |
|
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|
| OG001 | 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. |
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