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Migraine HeadachePhase 4NCT03971071

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

A Phase 4 study testing Erenumab 70 mg and Erenumab 140 mg in people with Migraine Headache, run by Amgen at 94 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Migraine Headache
What is being tested?
Erenumab 70 mg and Erenumab 140 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
620 participants
Where
94 sitesin 12 countries
Study dates
7 Oct 2019to 13 Jun 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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Disease Related
  • Age > 50 years at migraine onset or > 65 years at CM onset
  • History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
  • Current concomitant diagnosis of a secondary type of headache other than MOH
  • No therapeutic response in prevention of migraine after an adequate therapeutic trial of > 3 preventive treatment categories
Show all 28Show fewer
  • Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months prior to start of baseline
  • Received botulinum toxin in the head and/or neck region within 4 months prior to screening
  • Documented history of treatment with an anti-calcitonin gene-related peptide product preventive treatment
  • Anticipated to require any excluded medication/device or procedure during the study
  • Other Medical Conditions
  • History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen's physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
  • Evidence of "recreational use" of illicit drugs within 12 months prior to screening, based on medical records, self-report, or a positive drug test performed during screening.
  • Key Inclusion Criteria Part 2. To be assessed at the end of the baseline period and prior to enrollment into DBTP. Based on information collected through the electronic diary (eDiary) during the baseline period, the following requirements must be met:
  • -≥ 14 headache days during the 28-day baseline period out of which ≥ 8 headache days meet criteria as migraine days
  • Observation of acute migraine medication overuse during the baseline period. Medication overuse at baseline is defined as:
  • ≥ 10 days of combination treatment OR
  • ≥ 10 days of short-acting opioids/opioid-containing medication OR
  • ≥ 10 days of triptans, ergots, OR
  • ≥ 15 days of nonsteroidal anti-inflammatory drugs or simple analgesics intake
  • At least 2 acute headache medication days per week for each week with at least 5 diary days
  • Demonstrated at least 80% compliance with the eDiary (eg, must complete eDiary items on at least 23 out of 28 days during the baseline period)
  • Study Procedures
  • Changed or planning to change the dose of an allowed concomitant medication that may have migraine preventive effect during baseline period or post-randomization
  • Unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
  • Contraception, pregnancy or breastfeeding
  • Unwillingness to maintain acceptable contraception method, when applicable
  • Evidence of pregnancy or breastfeeding per participant self-report, medical records or positivity on baseline pregnancy screening tests, through end of study

Trial locations and contacts

94 sites in 12 countries.

94 sites in 12 countries

United States32 sites

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • Citizens Memorial Healthcare

    Bolivar, Missouri, 65613

  • Core Healthcare Group

    Cerritos, California, 90703

  • Onsite Clinical Solutions LLC

    Charlotte, North Carolina, 28277

  • Clinical Trial Investigator Clinical Research Center

    Cincinnati, Ohio, 45212

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Axiom Research

    Colton, California, 92324

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Neurology Center of New England PC

    Foxborough, Massachusetts, 02035

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Marshall University

    Huntington, West Virginia, 25701

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Clinical Research Institute

    Los Angeles, California, 90048

  • Saint Lukes Clinic

    Meridian, Idaho, 83642

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Floridian Clinical Research LLC

    Miami Lakes, Florida, 33016

  • Clinical Research Institute Inc

    Minneapolis, Minnesota, 55402

  • Nashville Neuroscience Group

    Nashville, Tennessee, 37203

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801

  • College Park Family Care Center

    Overland Park, Kansas, 66212

  • Emerald Coast Center for Neurological Disorders

    Pensacola, Florida, 32504

  • Allegheny Health Network Cancer Institute at Mellon Pavilion

    Pittsburgh, Pennsylvania, 15224

  • Preferred Primary Care Physicians, Inc

    Pittsburgh, Pennsylvania, 15236

  • Collective Medical Research

    Prairie Village, Kansas, 66208

  • Wasatch Clinical Research LLC

    Salt Lake City, Utah, 84107

  • Mercy Research

    St Louis, Missouri, 63141

  • University of South Florida

    Tampa, Florida, 33612

  • The George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

France9 sites

  • Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer

    Bron, 69677

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

    Lille, 59037

  • Hopital La Timone

    Marseille, 13385

  • Centre Hospitalier Universitaire de Nice - Hopital de Cimiez

    Nice, 06003

  • Hopital Lariboisiere

    Paris, 75010

  • Groupe hospitalier Paris Saint Joseph

    Paris, 75014

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Centre Hospitalier Annecy Genevois

    Pringy, 74374

  • Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord

    Saint-Etienne, 42055

Other trials in France

Czechia7 sites

  • Neurologie Brno sro

    Brno, 616 00

  • Fakultni nemocnice u svate Anny v Brne

    Brno, 656 91

  • Dado Medical sro

    Prague, 120 00

  • Thomayerova nemocnice

    Prague, 140 59

  • INEP

    Prague, 186 00

  • Mudr Stanislav Bartek sro

    Přerov, 750 02

  • Vestra Clinics sro

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Hungary7 sites

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Swiss Premium Egeszsegkozpont

    Budapest, 1123

  • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

    Budapest, 1145

  • Jahn Ferenc Del-pesti Korhaz es Rendelointezet

    Budapest, 1204

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

    Debrecen, 4026

  • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

    Miskolc, 3526

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

    Szeged, 6725

Other trials in Hungary

Italy7 sites

  • IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria

    Bologna, 40139

  • Azienda Ospedaliero Universitaria Mater Domini

    Catanzaro, 88100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Fondazione Istituto Neurologico Nazionale C Mondino IRCCS

    Pavia, 27100

  • IRCCS San Raffaele Pisana

    Roma, 00163

Other trials in Italy

Spain7 sites

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Catalonia, 08907

  • 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

Other trials in Spain

United Kingdom6 sites

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • The Walton Centre NHS Foundation Trust

    Liverpool, L9 7LJ

  • Kings College London

    London, SE5 9RS

  • Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE1 4LP

  • John Radcliffe Hospital

    Oxford, OX3 9DU

Other trials in United Kingdom

Poland5 sites

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna

    Ksawerów, 95-054

  • Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej

    Legionowo, 05-120

  • Gabinet Lekarski Jacek Rozniecki

    Lodz, 90-338

  • Clinical Research Center Spzoo Medic-R Spolka Komandytowa

    Poznan, 60-848

  • RCMed Oddzial Sochaczew

    Sochaczew, 96-500

Other trials in Poland

Austria4 sites

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Klinikum Klagenfurt am Woerthersee

    Klagenfurt, 9020

  • Konventhospital der Barmherzigen Brueder Linz

    Linz, 4021

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Finland4 sites

  • Helsingin Paansarkykeskus Aava

    Helsinki, 00930

  • Northern Cinical Trial Coordinators

    Oulu, 90590

  • Suomen Terveystalo

    Tampere, 33100

  • Terveystalo Pulssi

    Turku, 20100

Other trials in Finland

Portugal4 sites

  • Hospital Professor Doutor Fernando Fonseca, EPE

    Amadora, 2720-276

  • Hospital da Luz, SA

    Lisbon, 1500-650

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

    Lisbon, 1649-035

  • Campus Neurologico Senior

    Torres Vedras, 2560-280

Other trials in Portugal

Australia2 sites

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

Official title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache

Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

Read the detailed description

Study 20170703 is a phase 4, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the safety and efficacy of erenumab against placebo in a CM population with MOH and prior history of treatment failure. Participants will be enrolled based on fulfilment of the International Classification of Headache Disorders, 3rd Edition (ICHD-3) CM and MOH criteria and will not be advised to early discontinue acute medication.

Participants who successfully complete the 24-week double-blind treatment period (DBTP) of the study will be offered an opportunity to continue in an open-label treatment period (OLTP) of 28-weeks duration. Participants who received erenumab treatment during the DBTP will continue to receive the same erenumab dose during the OLTP. Participants who received placebo during the DBTP will be allocated in a 1:1 ratio to receive either erenumab 70 mg or 140 mg SC QM during the OLTP. All participants will remain blinded to their original DBTP treatment assignment.

Being tested
Erenumab 70 mg, Erenumab 140 mg, Placebo
Keywords
Chronic Migraine, Medication Overuse Headache
Medical subject headings
Migraine Disorders, Headache Disorders, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erenumab 70 mgDrug

    Also called Aimovig

    Erenumab once every 4 weeks. Subcutaneous injection.

  • Erenumab 140 mgDrug

    Also called Aimovig

    Erenumab once every 4 weeks. Subcutaneous injection.

  • PlaceboDrug

    Placebo once every 4 weeks. Subcutaneous injection.

Study groups in NCT03971071
Study groupRoleWhat they receive
PlaceboPlacebo comparatorAfter participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Receives: Drug: Placebo
Erenumab 70 mgActive comparatorAfter participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Receives: Drug: Erenumab 70 mg
Erenumab 140 mgActive comparatorAfter participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Receives: Drug: Erenumab 140 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6

    Absence of MOH at month 6 was defined as mean monthly acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 (weeks 13 through 24) or mean monthly headache days < 14 days over months 4, 5, and 6 (weeks 13 through 24) of the DBTP where an AHMD was defined as a calendar day in which the participant took at least 1 acute headache medication.

    Measured: Months 4, 5, and 6 (weeks 13 through 24) of the DBTP

Secondary outcomes (5)

  1. Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6

    An AHMD was defined as a calendar day in which the participant takes at least 1 acute headache medication. Acute headache medications included triptan-based, ergotamine-based and ditan-based migraine medications, non-opioid and opioid-containing acute headache medications, non-opioid butalbital and opioid-containing butalbital containing medications.

    Measured: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP

  2. Number of Participants With Sustained MOH Remission at Month 6

    Sustained MOH remission was defined as the absence of MOH at month 3 (week 12) and month 6 (week 24) of the DBTP. Absence of MOH was achieved when mean monthly AHMD < 10 days or mean monthly headache days < 14 days over the 3-month period (weeks 12 to 24).

    Measured: Month 3 (week 12) to month 6 (week 24) of the DBTP

  3. Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)

    The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The physical impairment domain includes 5 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

    Measured: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP

  4. Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID

    The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The impact on everyday activities domain includes 7 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

    Measured: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP

  5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    TEAEs were defined as any adverse event (AE) that started on or after first dose of IP, and up to the end of the study (52 weeks).

    Any clinically significant changes in vital signs were included as TEAEs.

    Measured: Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start7 Oct 2019
  3. Primary completion1 Dec 2022
  4. Study completion13 Jun 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
620 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03971071
Sponsor's protocol ID
20170703
Other IDs
2018-003342-16, 2018
Status last verified
Sep 2025
First submitted
23 May 2019
Last updated
19 Sep 2025
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

  • Tepper SJ, Dodick DW, Lanteri-Minet M, Dolezil D, Gil-Gouveia R, Lucas C, Piasecka-Stryczynska K, Szabo G, Mikol DD, Chehrenama M, Chou DE, Yang Y, Paiva da Silva Lima G. Efficacy and Safety of Erenumab for Nonopioid Medication Overuse Headache in Chronic Migraine: A Phase 4, Randomized, Placebo-Controlled Trial. JAMA Neurol. 2024 Sep 16;81(11):1140-9. doi: 10.1001/jamaneurol.2024.3043. Online ahead of print.

    PubMed 39283627

  • Tepper SJ, Dodick DW, Lanteri-Minet M, Dolezil D, Gil-Gouveia R, Lucas C, Piasecka-Stryczynska K, Szabo G, Mikol DD, Chehrenama M, Chou DE, Liu Z, da Silva Lima GP. Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache: Final Results From a Phase 4 Randomized Placebo-Controlled Study. Eur J Neurol. 2025 Aug;32(8):e70328. doi: 10.1111/ene.70328.

    PubMed 40838472

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erenumab 70 mg and Erenumab 140 mg in people with Migraine Headache, run by Amgen at 94 sites in 12 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 0 inclusion and 28 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, France, Czechia, Hungary, Italy and 7 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. Some participants in this study may receive a placebo. 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 13 Oct 2023). 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?

Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6 (time frame: Months 4, 5, and 6 (weeks 13 through 24) of the DBTP). 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 NCT03971071, which also lists 2 linked publications.

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 19 Sep 2025.

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