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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003646-33 | EudraCT Number |
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The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Experimental | The 4-month DBTP has 2 phases:
|
|
| Placebo | Experimental | The 4-month DBTP has 2 phases:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | 140 mg, 2 consecutive injections of 70 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 | At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity was collected. A negative change from baseline indicates a reduction in mean monthly hours of at least moderate headache pain intensity. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The least squares mean (LSM) estimates of change from baseline in reported headache pain intensity utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | Baseline, Month 1, Month 2, and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including on Physical Functioning (5 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the past 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. |
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Key inclusion criteria include:
Key exclusion criteria include:
History of hemiplegic migraine, cluster headache, or other trigeminal autonomic cephalalgia.
Has any medical contraindication to the use of an oral triptan.
Previously treated with erenumab.
Previously treated with a gepant (small molecule calcitonin gene related peptide receptor [CGRP-R] antagonist) in a preventive fashion in a manner consistent with migraine prevention that either:
Currently being treated with lasmiditan and/or a gepant in the acute setting.
No therapeutic response with greater than 4 of the defined medication categories after an adequate therapeutic trial.
Currently has a history of consistent excellent response to oral triptans, defined as achievement of pain-freedom in ≤ 1 hour for ≥ 50% of treated attacks of at least moderate pain intensity during the 3 months prior to screening.
Use of triptans administered via a non-oral (e.g. subcutaneous [SC] or intranasal delivery systems) or sublingual route at the time of screening, during the run-in and baseline periods, and throughout the study duration.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Clinical Trials Services Inc | Long Beach | California | 90806 | United States | ||
| Clinical Research Institute, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41084999 | Background | Paiva da Silva Lima G, Rao R, Szabo G, Szklener S, Tassorelli C, Nastaj M, Chou DE, Khodavirdi AC, Chehrenama M, Zhu Y, Bhatia AK, Dodick DW. Comprehensive assessment of erenumab efficacy in participants with high-frequency episodic migraine with at least one previously failed preventive treatment: The EMBRACE study. Headache. 2026 Mar;66(3):658-671. doi: 10.1111/head.15071. Epub 2025 Oct 14. |
| 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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Eligible adult participants with high frequency episodic migraine (EP) who met specific eligibility criteria during a 2-week run-in period and 4-week baseline period entered the double-blind treatment period (DBTP). The DBTP included a 12-week main-DBTP (M-DBTP) and a 4-week exploratory DBTP (E-DBTP)
This study was conducted at 61 study centers in North America and Europe from September 2020 to October 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive matching placebo subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks. |
| FG001 | Erenumab 140 mg SC Q4W | Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. |
| 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 | Jun 29, 2022 | Aug 6, 2024 |
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| Drug |
2 consecutive injections |
|
| Baseline, Month 1, Month 2, and Month 3 |
| Change From Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Usual Activities (10 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | Baseline, Month 1, Month 2, and Month 3 |
| Change From Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Emotional Functioning (5 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | Baseline, Month 1, Month 2, and Month 3 |
| Change From Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Social Functioning (5 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | Baseline, Month 1, Month 2, and Month 3 |
| Change From Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3 | At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity during a migraine attack was collected. A negative change from baseline indicates a reduction in mean monthly average duration of at least moderate headache pain intensity during a migraine attack. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | Baseline, Month 1, Month 2, and Month 3 |
| Change From Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3 | The NRS assesses headache pain intensity ranging from 0 to 10 with a higher score indicating more severe pain. Participants recorded the pain intensity using the e-diary at the headache end-time or in an evening diary entry on a daily basis for an ongoing headache. A negative change from baseline indicates an improvement in pain intensity. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | Baseline, Month 1, Month 2, and Month 3 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Mountain Neurological Research Center | Basalt | Colorado | 81621 | United States |
| Denver Neurological Clinic | Denver | Colorado | 80210 | United States |
| Summit Headache and Neurologic Institute | Englewood | Colorado | 80113 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Visionary Investigators Network | Miami | Florida | 33133 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Heuer Medical Doctor Research LLC | Orlando | Florida | 32819 | United States |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | United States |
| Visionary Investigators Network | Pembroke Pines | Florida | 33026 | United States |
| Saint Lukes Clinic | Meridian | Idaho | 83642 | United States |
| Chicago Headache Center and Research Institute | Chicago | Illinois | 60657 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| New England Regional Headache Center Inc | Worcester | Massachusetts | 14226 | United States |
| Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65810 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Papillion Research Center | Papillion | Nebraska | 68046 | United States |
| Forte Family Practice | Las Vegas | Nevada | 89103 | United States |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | United States |
| American Clinical Research Institute LLC | Beavercreek | Ohio | 45432 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Palmetto Clinical Trial Services | Greenville | South Carolina | 29615 | United States |
| Nashville Neuroscience Group | Nashville | Tennessee | 37203 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| North Texas Institute of Neurology and Headache | Frisco | Texas | 75034 | United States |
| University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD | Pleven | 5800 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv | 4001 | Bulgaria |
| Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD | Sofia | 1113 | Bulgaria |
| University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD | Sofia | 1154 | Bulgaria |
| Medical Center Excelsior OOD | Sofia | 1407 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Alexandrovska EAD | Sofia | 1431 | Bulgaria |
| Medical Center New Rehabilitation Center EOOD | Stara Zagora | 6000 | Bulgaria |
| Neurologie Brno sro | Brno | 616 00 | Czechia |
| Fakultni nemocnice u svate Anny v Brne | Brno | 656 91 | Czechia |
| Poliklinika Chocen, Neurohk sro | Choceň | 565 01 | Czechia |
| Brain-soultherapy sro | Kladno | 272 01 | Czechia |
| Dado Medical sro | Prague | 120 00 | Czechia |
| FORBELI sro | Prague | 160 00 | Czechia |
| Institut Neuropsychiatricke pece | Prague | 186 00 | Czechia |
| NeuroMed Zlin sro | Zlín | 760 01 | Czechia |
| Obudai Egeszsegugyi Centrum Kft | Budapest | 1036 | Hungary |
| High Tech Medical Kft | Budapest | 1064 | Hungary |
| Uno Medical Trials Kft | Budapest | 1135 | Hungary |
| S-Medicon Kutatasi Centrum | Budapest | 1138 | Hungary |
| Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet | Budapest | 1145 | Hungary |
| Obudai Egeszsegugyi Centrum Kft | Zalaegerszeg | 8900 | Hungary |
| Ospedale Bellaria Carlo Alberto Pizzardi | Bologna | 40139 | Italy |
| Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Azienda Ospedaliera Universitaria Renato Dulbecco | Catanzaro | 88100 | Italy |
| Ospedale Policlinico San Martino IRCCS | Genoa | 16132 | Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| Fondazione Istituto Neurologico Nazionale C Mondino IRCCS | Pavia | 27100 | Italy |
| Policlinico Universitario Campus Biomedico | Roma | 00128 | Italy |
| IRCCS San Raffaele Pisana | Roma | 00163 | Italy |
| Azienda della scienza di Torino | Torino | 10126 | Italy |
| Centrum Badan Klinicznych PI-House Spzoo | Gdansk | 80-546 | Poland |
| Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz | Gliwice | 44-100 | Poland |
| Care Clinic Spzoo Care Clinic Centrum Medyczne | Katowice | 40-568 | Poland |
| Vita Longa Spzoo | Katowice | 40-748 | Poland |
| NZOZ Neuromed M i M Nastaj Spolka Partnerska | Kraśnik | 23-210 | Poland |
| AppleTreeClinics Network Spzoo | Lodz | 90-349 | Poland |
| M-Zdrowie | Lodz | 91-072 | Poland |
| NZOZ Neuromed M i M Nastaj Spolka Partnerska | Lublin | 20-064 | Poland |
| Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom | Oświęcim | 32-600 | Poland |
| Osrodek Badan Klinicznych Cromed | Poznan | 61-360 | Poland |
| Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska | Rzeszów | 35-301 | Poland |
| Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak | Wroclaw | 52-210 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| Vistamed and Vertigo Sp z o o | Wroclaw | 53-149 | Poland |
| Hospital da Luz, SA | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital Cuf Sintra | Sintra | 2710-204 | Portugal |
| Campus Neurologico Senior | Torres Vedras | 2560-280 | Portugal |
| Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila | Bucharest | 010825 | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 050098 | Romania |
| Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara | Timișoara | 700736 | Romania |
| Hospital Universitario Virgen del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Aragon | 50009 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | Castille and León | 47010 | Spain |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | 08035 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | 46026 | Spain |
| Received Investigational Product (IP) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set included all participants who were randomized in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive matching placebo SC QW4 for up to 16 weeks in the DBTP. |
| BG001 | Erenumab 140 mg SC Q4W | Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Monthly Hours of at Least Moderate Headache Pain Intensity | At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity was collected. Baseline data was collected during the 4-week baseline period. | Participants with observed data within the 4-week baseline period are included. | Mean | Standard Deviation | hours/month |
|
| 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 | Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 | At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity was collected. A negative change from baseline indicates a reduction in mean monthly hours of at least moderate headache pain intensity. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The least squares mean (LSM) estimates of change from baseline in reported headache pain intensity utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | The M-DBTP efficacy analysis set consisted of a subset the full analysis set (all participants randomized in the study) who received at least 1 dose of IP and had observed monthly hours of at least moderate headache pain intensity at baseline and at least 1 measurement during the M-DBTP. | Posted | Least Squares Mean | Standard Error | hours/month | Baseline, Month 1, Month 2, and Month 3 |
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| Secondary | Change From Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including on Physical Functioning (5 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the past 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | The M-DBTP efficacy analysis set consisted of a subset the full analysis set (all participants randomized in the study) who received at least 1 dose of IP and had observed monthly hours of at least moderate headache pain intensity at baseline and at least 1 measurement during the M-DBTP. Data for participants included in the model for the MFIQ Physical Function Domain are presented. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 1, Month 2, and Month 3 |
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| Secondary | Change From Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Usual Activities (10 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | The M-DBTP efficacy analysis set consisted of a subset the full analysis set (all participants randomized in the study) who received at least 1 dose of IP and had observed monthly hours of at least moderate headache pain intensity at baseline and at least 1 measurement during the M-DBTP. Data for participants included in the model for the MFIQ Usual Activities Domain are presented. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 1, Month 2, and Month 3 |
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| Secondary | Change From Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Emotional Functioning (5 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | The M-DBTP efficacy analysis set consisted of a subset the full analysis set (all participants randomized in the study) who received at least 1 dose of IP and had observed monthly hours of at least moderate headache pain intensity at baseline and at least 1 measurement during the M-DBTP. Data for participants included in the model for the MFIQ Emotional Functioning Domain are presented. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 1, Month 2, and Month 3 |
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| Secondary | Change From Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Social Functioning (5 items). Participants responded to items 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 and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | The M-DBTP efficacy analysis set consisted of a subset the full analysis set (all participants randomized in the study) who received at least 1 dose of IP and had observed monthly hours of at least moderate headache pain intensity at baseline and at least 1 measurement during the M-DBTP. Data for participants included in the model for the MFIQ Social Functioning Domain are presented. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 1, Month 2, and Month 3 |
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| Secondary | Change From Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3 | At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity during a migraine attack was collected. A negative change from baseline indicates a reduction in mean monthly average duration of at least moderate headache pain intensity during a migraine attack. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | The M-DBTP efficacy analysis set consisted of a subset the full analysis set (all participants randomized in the study) who received at least 1 dose of IP and had observed monthly hours of at least moderate headache pain intensity at baseline and at least 1 measurement during the M-DBTP. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 1, Month 2, and Month 3 |
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| Secondary | Change From Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3 | The NRS assesses headache pain intensity ranging from 0 to 10 with a higher score indicating more severe pain. Participants recorded the pain intensity using the e-diary at the headache end-time or in an evening diary entry on a daily basis for an ongoing headache. A negative change from baseline indicates an improvement in pain intensity. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure. | The M-DBTP efficacy analysis set consisted of a subset the full analysis set (all participants randomized in the study) who received at least 1 dose of IP and had observed monthly hours of at least moderate headache pain intensity at baseline and at least 1 measurement during the M-DBTP. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 1, Month 2, and Month 3 |
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Day 1 to end of the DBTP (up to 16 weeks)
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.
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 | Placebo | Participants were randomized to receive matching placebo SC QW4 for up to 16 weeks in the DBTP. | 0 | 256 | 2 | 256 | 0 | 256 |
| EG001 | Erenumab 140 mg SC Q4W | Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. | 0 | 256 | 0 | 254 | 0 | 254 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Psychogenic tremor | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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Not provided
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 | Nov 15, 2023 | Aug 6, 2024 | SAP_001.pdf |
| 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
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| OG001 | Erenumab 140 mg SC Q4W | Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. |
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| OG001 | Erenumab 140 mg SC Q4W | Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. |
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| OG001 | Erenumab 140 mg SC Q4W | Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. |
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| OG001 | Erenumab 140 mg SC Q4W | Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. |
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| OG001 |
| Erenumab 140 mg SC Q4W |
Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP. |
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Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP.
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