MigrainePhase 4EMBRACENCT04252742
Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
A Phase 4 study testing Erenumab in people with Migraine, run by Amgen at 91 sites in 9 countries.
Trial summary
The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 91 sitesin 9 countries
- Study dates
- 15 Sep 2020to 26 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years upon entry into initial screening.
- Documented history of migraine with or without aura according to the International Headache Society (IHS) International Classification of Headache Disorders, Third Edition (ICHD-III) for greater than or equal to 12 months.
- Have high-frequency episodic migraine (HFEM): Defined as history of ≥ 7 to < 15 migraine days and < 15 headache days per month on average during the 3 months prior to screening.
- History of ≥ 4 migraine attacks of at least moderate severity per month on average during the 3 months prior to screening.
- History of treatment failure with at least 1 preventive treatment for migraine. Failure of preventive treatment for migraine is defined as treatment discontinuation due to lack of efficacy, adverse event, or general poor tolerability.
- Regular use of an oral triptan (using only eletriptan, rizatriptan, sumatriptan, or zolmitriptan) for acute migraine treatment, and typically initiating acute treatment with an oral triptan on > 50% of attacks of at least moderate pain intensity. Regular use is defined as ≥ 4 days of oral triptan use per month during the 3 months prior to screening.
Who cannot join
- 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:
- In the opinion of the investigator, did not offer any evidence of a therapeutic response or
- Was discontinued for less than 12 weeks from the date of initial screening or
Show all 11Show fewer
- Was previously discontinued due to a known adverse drug reaction
- 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.
Trial locations and contacts
91 sites in 9 countries.
91 sites in 9 countries
United States31 sites
Dent Neurosciences Research Center
Amherst, New York, 14226
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
JEM Research Institute
Atlantis, Florida, 33462
FutureSearch Trials of Neurology
Austin, Texas, 78731
Mountain Neurological Research Center
Basalt, Colorado, 81621
American Clinical Research Institute LLC
Beavercreek, Ohio, 45432
Boston Clinical Trials
Boston, Massachusetts, 02131
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
University of Cincinnati
Cincinnati, Ohio, 45229
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Cleveland Clinic
Cleveland, Ohio, 44195
Denver Neurological Clinic
Denver, Colorado, 80210
Summit Headache and Neurologic Institute
Englewood, Colorado, 80113
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034
Palmetto Clinical Trial Services
Greenville, South Carolina, 29615
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Forte Family Practice
Las Vegas, Nevada, 89103
Long Beach Clinical Trials Services Inc
Long Beach, California, 90806
Clinical Research Institute, LLC
Los Angeles, California, 90048
Saint Lukes Clinic
Meridian, Idaho, 83642
Visionary Investigators Network
Miami, Florida, 33133
Nashville Neuroscience Group
Nashville, Tennessee, 37203
Renstar Medical Research
Ocala, Florida, 34470
Heuer Medical Doctor Research LLC
Orlando, Florida, 32819
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
Papillion Research Center
Papillion, Nebraska, 68046
Visionary Investigators Network
Pembroke Pines, Florida, 33026
Summit Research Network
Portland, Oregon, 97210
Clinvest Research LLC
Springfield, Missouri, 65810
Mercy Health Research
St Louis, Missouri, 63141
New England Regional Headache Center Inc
Worcester, Massachusetts, 14226
Poland14 sites
Centrum Badan Klinicznych PI-House Spzoo
Gdansk, 80-546
Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz
Gliwice, 44-100
Care Clinic Spzoo Care Clinic Centrum Medyczne
Katowice, 40-568
Vita Longa Spzoo
Katowice, 40-748
NZOZ Neuromed M i M Nastaj Spolka Partnerska
Kraśnik, 23-210
AppleTreeClinics Network Spzoo
Lodz, 90-349
M-Zdrowie
Lodz, 91-072
NZOZ Neuromed M i M Nastaj Spolka Partnerska
Lublin, 20-064
Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom
Oświęcim, 32-600
Osrodek Badan Klinicznych Cromed
Poznan, 61-360
Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska
Rzeszów, 35-301
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, 52-210
Centrum Medyczne Oporow
Wroclaw, 52-416
Vistamed and Vertigo Sp z o o
Wroclaw, 53-149
Italy10 sites
Ospedale Bellaria Carlo Alberto Pizzardi
Bologna, 40139
Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia
Brescia, 25123
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, 88100
Ospedale Policlinico San Martino IRCCS
Genoa, 16132
IRCCS Ospedale San Raffaele
Milan, 20132
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
Pavia, 27100
Policlinico Universitario Campus Biomedico
Roma, 00128
IRCCS San Raffaele Pisana
Roma, 00163
Azienda della scienza di Torino
Torino, 10126
Czechia8 sites
Neurologie Brno sro
Brno, 616 00
Fakultni nemocnice u svate Anny v Brne
Brno, 656 91
Poliklinika Chocen, Neurohk sro
Choceň, 565 01
Brain-soultherapy sro
Kladno, 272 01
Dado Medical sro
Prague, 120 00
FORBELI sro
Prague, 160 00
Institut Neuropsychiatricke pece
Prague, 186 00
NeuroMed Zlin sro
Zlín, 760 01
Spain8 sites
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Hospital Clinico Universitario de Valladolid
Valladolid, Castille and León, 47010
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009
Bulgaria7 sites
University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD
Pleven, 5800
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4001
Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD
Sofia, 1113
University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD
Sofia, 1154
Medical Center Excelsior OOD
Sofia, 1407
University Multiprofile Hospital for Active Treatment Alexandrovska EAD
Sofia, 1431
Medical Center New Rehabilitation Center EOOD
Stara Zagora, 6000
Hungary6 sites
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036
High Tech Medical Kft
Budapest, 1064
Uno Medical Trials Kft
Budapest, 1135
S-Medicon Kutatasi Centrum
Budapest, 1138
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
Budapest, 1145
Obudai Egeszsegugyi Centrum Kft
Zalaegerszeg, 8900
Portugal4 sites
Hospital da Luz, SA
Lisbon, 1500-650
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Hospital Cuf Sintra
Sintra, 2710-204
Campus Neurologico Senior
Torres Vedras, 2560-280
Romania3 sites
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucharest, 010825
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
Timișoara, 700736
About this study
Official title: Comprehensive Assessment of Erenumab Efficacy in Subjects With High Frequency Episodic Migraine With at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study
The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
- Conditions
- Migraine
- Being tested
- Erenumab, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
140 mg, 2 consecutive injections of 70 mg
PlaceboDrug
2 consecutive injections
| Study group | Role | What they receive |
|---|---|---|
| Erenumab | Experimental | The 4-month DBTP has 2 phases:
* Main double-blind treatment phase (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment.
* Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden. Receives: Drug: Erenumab |
| Placebo | Experimental | The 4-month DBTP has 2 phases:
* Main DBTP (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment.
* Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 1, Month 2, and Month 3
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 1, Month 2, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Sep 2020
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252742
- Sponsor's protocol ID
- 20190008
- Other IDs
- 2019-003646-33, 2019
- Acronym
- EMBRACE
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2020
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
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.
PubMed 41084999
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Erenumab Efficacy in Subjects With High Frequency Episodic Migraine With at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study
- ClinicalTrials.gov ID
- NCT04252742
- Acronym / sponsor ID
- EMBRACE / 20190008
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erenumab | Experimental | Drug: ErenumabThe 4-month DBTP has 2 phases: * Main double-blind treatment phase (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. * Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden. |
| Placebo | Experimental | Drug: PlaceboThe 4-month DBTP has 2 phases: * Main DBTP (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. * Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years upon entry into initial screening.
- Documented history of migraine with or without aura according to the International Headache Society (IHS) International Classification of Headache Disorders, Third Edition (ICHD-III) for greater than or equal to 12 months.
- Have high-frequency episodic migraine (HFEM): Defined as history of ≥ 7 to < 15 migraine days and < 15 headache days per month on average during the 3 months prior to screening.
- History of ≥ 4 migraine attacks of at least moderate severity per month on average during the 3 months prior to screening.
- History of treatment failure with at least 1 preventive treatment for migraine. Failure of preventive treatment for migraine is defined as treatment discontinuation due to lack of efficacy, adverse event, or general poor tolerability.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erenumab140 mg, 2 consecutive injections of 70 mg | Drug | Erenumab |
| Placebo2 consecutive injections | Drug | Placebo |
Primary outcome
Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3
Time frame: Baseline, Month 1, Month 2, and Month 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.
6 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Month 1, Month 2, and Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 41084999Paiva 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
91 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erenumab in people with Migraine, run by Amgen at 91 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Poland, Italy, Czechia, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 (time frame: Baseline, Month 1, Month 2, and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.