A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
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
2 other identifiers
interventional
620
11 countries
90
Brief 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 (MOH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2019
Longer than P75 for phase_4
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2023
CompletedResults Posted
Study results publicly available
October 13, 2023
CompletedSeptember 19, 2025
September 1, 2025
3.2 years
May 23, 2019
September 14, 2023
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary Outcomes (5)
Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6
Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Number of Participants With Sustained MOH Remission at Month 6
Month 3 (week 12) to month 6 (week 24) of the DBTP
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)
Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID
Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)
Study Arms (3)
Placebo
PLACEBO 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.
Erenumab 70 mg
ACTIVE 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.
Erenumab 140 mg
ACTIVE 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.
Interventions
Erenumab once every 4 weeks. Subcutaneous injection.
Erenumab once every 4 weeks. Subcutaneous injection.
Eligibility Criteria
You may qualify if:
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures
- Age ≥ 18 years on entry into the study
- Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 classification for ≥ 12 months at screening
- Documented history of CM for a minimal duration of 6 months before screening
- Current diagnosis of MOH
- History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability
You may not qualify if:
- 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
- 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.
- ≥ 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:
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (94)
Core Healthcare Group
Cerritos, California, 90703, United States
Axiom Research
Colton, California, 92324, United States
Clinical Research Institute
Los Angeles, California, 90048, United States
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Floridian Clinical Research LLC
Miami Lakes, Florida, 33016, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32504, United States
University of South Florida
Tampa, Florida, 33612, United States
Saint Lukes Clinic
Meridian, Idaho, 83642, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
College Park Family Care Center
Overland Park, Kansas, 66212, United States
Collective Medical Research
Prairie Village, Kansas, 66208, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
Neurology Center of New England PC
Foxborough, Massachusetts, 02035, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute Inc
Minneapolis, Minnesota, 55402, United States
Citizens Memorial Healthcare
Bolivar, Missouri, 65613, United States
Mercy Research
St Louis, Missouri, 63141, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Onsite Clinical Solutions LLC
Charlotte, North Carolina, 28277, United States
Clinical Trial Investigator Clinical Research Center
Cincinnati, Ohio, 45212, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania, 15224, United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15236, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
Texas Neurology, PA
Dallas, Texas, 75214, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah, 84107, United States
Marshall University
Huntington, West Virginia, 25701, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Holdsworth House Medical Practice
Sydney, New South Wales, 2010, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Klinikum Klagenfurt am Woerthersee
Klagenfurt, 9020, Austria
Konventhospital der Barmherzigen Brueder Linz
Linz, 4021, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Neurologie Brno sro
Brno, 616 00, Czechia
Fakultni nemocnice u svate Anny v Brne
Brno, 656 91, Czechia
Dado Medical sro
Prague, 120 00, Czechia
Thomayerova nemocnice
Prague, 140 59, Czechia
INEP
Prague, 186 00, Czechia
Mudr Stanislav Bartek sro
Přerov, 750 02, Czechia
Vestra Clinics sro
Rychnov nad Kněžnou, 516 01, Czechia
Helsingin Paansarkykeskus Aava
Helsinki, 00930, Finland
Northern Cinical Trial Coordinators
Oulu, 90590, Finland
Suomen Terveystalo
Tampere, 33100, Finland
Terveystalo Pulssi
Turku, 20100, Finland
Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer
Bron, 69677, France
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
Lille, 59037, France
Hopital La Timone
Marseille, 13385, France
Centre Hospitalier Universitaire de Nice - Hopital de Cimiez
Nice, 06003, France
Hopital Lariboisiere
Paris, 75010, France
Groupe hospitalier Paris Saint Joseph
Paris, 75014, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Centre Hospitalier Annecy Genevois
Pringy, 74374, France
Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord
Saint-Etienne, 42055, France
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Swiss Premium Egeszsegkozpont
Budapest, 1123, Hungary
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
Budapest, 1145, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen, 4026, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6725, Hungary
IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria
Bologna, 40139, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, 88100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
Pavia, 27100, Italy
IRCCS San Raffaele Pisana
Roma, 00163, Italy
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna
Ksawerów, 95-054, Poland
Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej
Legionowo, 05-120, Poland
Gabinet Lekarski Jacek Rozniecki
Lodz, 90-338, Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, 60-848, Poland
RCMed Oddzial Sochaczew
Sochaczew, 96-500, Poland
Hospital Professor Doutor Fernando Fonseca, EPE
Amadora, 2720-276, Portugal
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Campus Neurologico Senior
Torres Vedras, 2560-280, Portugal
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Castille and León, 47010, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026, Spain
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ, United Kingdom
Kings College London
London, SE5 9RS, United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Related Publications (2)
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.
PMID: 39283627BACKGROUNDTepper 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.
PMID: 40838472BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2019
First Posted
June 3, 2019
Study Start
October 7, 2019
Primary Completion
December 1, 2022
Study Completion
June 13, 2023
Last Updated
September 19, 2025
Results First Posted
October 13, 2023
Record last verified: 2025-09
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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.