Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine

NCT04252742 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 201900082019-003646-33
• Study Type: interventional
• Target: 512
• Locations: 9 countries
• Sites: 91

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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

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

  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

  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

  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

  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

  Baseline, Month 1, Month 2, and Month 3

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Erenumab DRUG

140 mg, 2 consecutive injections of 70 mg

Erenumab

Placebo DRUG

2 consecutive injections

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (91)

Long Beach Clinical Trials Services Inc

Long Beach, California, 90806, United States

Location

Clinical Research Institute, LLC

Los Angeles, California, 90048, United States

Location

Mountain Neurological Research Center

Basalt, Colorado, 81621, United States

Location

Denver Neurological Clinic

Denver, Colorado, 80210, United States

Location

Summit Headache and Neurologic Institute

Englewood, Colorado, 80113, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Visionary Investigators Network

Miami, Florida, 33133, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Heuer Medical Doctor Research LLC

Orlando, Florida, 32819, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Visionary Investigators Network

Pembroke Pines, Florida, 33026, United States

Location

Saint Lukes Clinic

Meridian, Idaho, 83642, United States

Location

Chicago Headache Center and Research Institute

Chicago, Illinois, 60657, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

New England Regional Headache Center Inc

Worcester, Massachusetts, 14226, United States

Location

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65810, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Papillion Research Center

Papillion, Nebraska, 68046, United States

Location

Forte Family Practice

Las Vegas, Nevada, 89103, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

American Clinical Research Institute LLC

Beavercreek, Ohio, 45432, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Palmetto Clinical Trial Services

Greenville, South Carolina, 29615, United States

Location

Nashville Neuroscience Group

Nashville, Tennessee, 37203, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

North Texas Institute of Neurology and Headache

Frisco, Texas, 75034, United States

Location

University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD

Pleven, 5800, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, 4001, Bulgaria

Location

Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD

Sofia, 1113, Bulgaria

Location

University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD

Sofia, 1154, Bulgaria

Location

Medical Center Excelsior OOD

Sofia, 1407, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Alexandrovska EAD

Sofia, 1431, Bulgaria

Location

Medical Center New Rehabilitation Center EOOD

Stara Zagora, 6000, Bulgaria

Location

Neurologie Brno sro

Brno, 616 00, Czechia

Location

Fakultni nemocnice u svate Anny v Brne

Brno, 656 91, Czechia

Location

Poliklinika Chocen, Neurohk sro

Choceň, 565 01, Czechia

Location

Brain-soultherapy sro

Kladno, 272 01, Czechia

Location

Dado Medical sro

Prague, 120 00, Czechia

Location

FORBELI sro

Prague, 160 00, Czechia

Location

Institut Neuropsychiatricke pece

Prague, 186 00, Czechia

Location

NeuroMed Zlin sro

Zlín, 760 01, Czechia

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

High Tech Medical Kft

Budapest, 1064, Hungary

Location

Uno Medical Trials Kft

Budapest, 1135, Hungary

Location

S-Medicon Kutatasi Centrum

Budapest, 1138, Hungary

Location

Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

Budapest, 1145, Hungary

Location

Obudai Egeszsegugyi Centrum Kft

Zalaegerszeg, 8900, Hungary

Location

Ospedale Bellaria Carlo Alberto Pizzardi

Bologna, 40139, Italy

Location

Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliera Universitaria Renato Dulbecco

Catanzaro, 88100, Italy

Location

Ospedale Policlinico San Martino IRCCS

Genoa, 16132, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Fondazione Istituto Neurologico Nazionale C Mondino IRCCS

Pavia, 27100, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, 00128, Italy

Location

IRCCS San Raffaele Pisana

Roma, 00163, Italy

Location

Azienda della scienza di Torino

Torino, 10126, Italy

Location

Centrum Badan Klinicznych PI-House Spzoo

Gdansk, 80-546, Poland

Location

Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz

Gliwice, 44-100, Poland

Location

Care Clinic Spzoo Care Clinic Centrum Medyczne

Katowice, 40-568, Poland

Location

Vita Longa Spzoo

Katowice, 40-748, Poland

Location

NZOZ Neuromed M i M Nastaj Spolka Partnerska

Kraśnik, 23-210, Poland

Location

AppleTreeClinics Network Spzoo

Lodz, 90-349, Poland

Location

M-Zdrowie

Lodz, 91-072, Poland

Location

NZOZ Neuromed M i M Nastaj Spolka Partnerska

Lublin, 20-064, Poland

Location

Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom

Oświęcim, 32-600, Poland

Location

Osrodek Badan Klinicznych Cromed

Poznan, 61-360, Poland

Location

Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska

Rzeszów, 35-301, Poland

Location

Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, 52-210, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Vistamed and Vertigo Sp z o o

Wroclaw, 53-149, Poland

Location

Hospital da Luz, SA

Lisbon, 1500-650, Portugal

Location

Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Cuf Sintra

Sintra, 2710-204, Portugal

Location

Campus Neurologico Senior

Torres Vedras, 2560-280, Portugal

Location

Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila

Bucharest, 010825, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

Location

Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara

Timișoara, 700736, Romania

Location

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Castille and León, 47010, Spain

Location

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

Location

Related Publications (1)

• Paiva da Silva Lima G, Rao R, Szabó 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. 2025 Oct 14.

  BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: February 5, 2020
• Study Start: September 15, 2020
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: March 31, 2026
• Results First Posted: August 30, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

RO (3); PT (4); ES (8); US (31); BU (7); CZ (8); HU (6); IT (10); PL (14)