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New migraine drug cuts headache hours in half for frequent sufferers

NCT ID NCT04252742

Symptom relief Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug erenumab in 512 adults who have frequent migraines (7 to 14 headache days per month) and had already tried at least one other preventive treatment that didn't work. The main goal was to see if erenumab could reduce the number of hours they spent with moderate or severe headache pain each month. Results showed that people taking erenumab had fewer headache hours compared to those on a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

512 people

The number who actually took part.

Started

Sep 2020

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key inclusion criteria include: * 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. 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: 1. In the opinion of the investigator, did not offer any evidence of a therapeutic response or 2. Was discontinued for less than 12 weeks from the date of initial screening or 3. 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.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • American Clinical Research Institute LLC

    Beavercreek, Ohio, 45432, United States

  • AppleTreeClinics Network Spzoo

    Lodz, 90-349, Poland

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, 88100, Italy

  • Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Azienda della scienza di Torino

    Torino, 10126, Italy

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • Brain-soultherapy sro

    Kladno, 272 01, Czechia

  • Campus Neurologico Senior

    Torres Vedras, 2560-280, Portugal

  • Care Clinic Spzoo Care Clinic Centrum Medyczne

    Katowice, 40-568, Poland

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

    Lisbon, 1649-035, Portugal

  • Centrum Badan Klinicznych PI-House Spzoo

    Gdansk, 80-546, Poland

  • Centrum Medyczne Oporow

    Wroclaw, 52-416, Poland

  • Chicago Headache Center and Research Institute

    Chicago, Illinois, 60657, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinical Research Institute, LLC

    Los Angeles, California, 90048, United States

  • Clinvest Research LLC

    Springfield, Missouri, 65810, United States

  • Dado Medical sro

    Prague, 120 00, Czechia

  • Dent Neurosciences Research Center

    Amherst, New York, 14226, United States

  • Denver Neurological Clinic

    Denver, Colorado, 80210, United States

  • FORBELI sro

    Prague, 160 00, Czechia

  • Fakultni nemocnice u svate Anny v Brne

    Brno, 656 91, Czechia

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Fondazione Istituto Neurologico Nazionale C Mondino IRCCS

    Pavia, 27100, Italy

  • Forte Family Practice

    Las Vegas, Nevada, 89103, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz

    Gliwice, 44-100, Poland

  • Heuer Medical Doctor Research LLC

    Orlando, Florida, 32819, United States

  • High Tech Medical Kft

    Budapest, 1064, Hungary

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010, Spain

  • Hospital Clinico Universitario de Valladolid

    Valladolid, Castille and León, 47010, Spain

  • Hospital Cuf Sintra

    Sintra, 2710-204, Portugal

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013, Spain

  • Hospital da Luz, SA

    Lisbon, 1500-650, Portugal

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • IRCCS San Raffaele Pisana

    Roma, 00163, Italy

  • Institut Neuropsychiatricke pece

    Prague, 186 00, Czechia

  • Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom

    Oświęcim, 32-600, Poland

  • JEM Research Institute

    Atlantis, Florida, 33462, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Long Beach Clinical Trials Services Inc

    Long Beach, California, 90806, United States

  • M-Zdrowie

    Lodz, 91-072, Poland

  • Medical Center Excelsior OOD

    Sofia, 1407, Bulgaria

  • Medical Center New Rehabilitation Center EOOD

    Stara Zagora, 6000, Bulgaria

  • Mercy Health Research

    St Louis, Missouri, 63141, United States

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104, United States

  • Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, 52-210, Poland

  • Mountain Neurological Research Center

    Basalt, Colorado, 81621, United States

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

    Sofia, 1113, Bulgaria

  • NZOZ Neuromed M i M Nastaj Spolka Partnerska

    Kraśnik, 23-210, Poland

  • NZOZ Neuromed M i M Nastaj Spolka Partnerska

    Lublin, 20-064, Poland

  • Nashville Neuroscience Group

    Nashville, Tennessee, 37203, United States

  • NeuroMed Zlin sro

    Zlín, 760 01, Czechia

  • Neurologie Brno sro

    Brno, 616 00, Czechia

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174, United States

  • New England Regional Headache Center Inc

    Worcester, Massachusetts, 14226, United States

  • North Texas Institute of Neurology and Headache

    Frisco, Texas, 75034, United States

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036, Hungary

  • Obudai Egeszsegugyi Centrum Kft

    Zalaegerszeg, 8900, Hungary

  • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

    Budapest, 1145, Hungary

  • Ospedale Bellaria Carlo Alberto Pizzardi

    Bologna, 40139, Italy

  • Ospedale Policlinico San Martino IRCCS

    Genoa, 16132, Italy

  • Osrodek Badan Klinicznych Cromed

    Poznan, 61-360, Poland

  • Palmetto Clinical Trial Services

    Greenville, South Carolina, 29615, United States

  • Papillion Research Center

    Papillion, Nebraska, 68046, United States

  • Policlinico Universitario Campus Biomedico

    Roma, 00128, Italy

  • Poliklinika Chocen, Neurohk sro

    Choceň, 565 01, Czechia

  • Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska

    Rzeszów, 35-301, Poland

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • S-Medicon Kutatasi Centrum

    Budapest, 1138, Hungary

  • Saint Lukes Clinic

    Meridian, Idaho, 83642, United States

  • Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara

    Timișoara, 700736, Romania

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098, Romania

  • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila

    Bucharest, 010825, Romania

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303, United States

  • Summit Headache and Neurologic Institute

    Englewood, Colorado, 80113, United States

  • Summit Research Network

    Portland, Oregon, 97210, United States

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

    Sofia, 1154, Bulgaria

  • University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD

    Pleven, 5800, Bulgaria

  • University Multiprofile Hospital for Active Treatment Alexandrovska EAD

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4001, Bulgaria

  • University of Cincinnati

    Cincinnati, Ohio, 45229, United States

  • Uno Medical Trials Kft

    Budapest, 1135, Hungary

  • Visionary Investigators Network

    Miami, Florida, 33133, United States

  • Visionary Investigators Network

    Pembroke Pines, Florida, 33026, United States

  • Vistamed and Vertigo Sp z o o

    Wroclaw, 53-149, Poland

  • Vita Longa Spzoo

    Katowice, 40-748, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.