A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
- Conditions
- Migraine Headache
- Interventions
- Registration Number
- NCT03971071
- Lead Sponsor
- Amgen
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 620
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erenumab 140 mg Erenumab 140 mg After 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 Erenumab 70 mg After 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. Placebo Placebo After 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6 Months 4, 5, and 6 (weeks 13 through 24) of the DBTP 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP) 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.Number of Participants With Sustained MOH Remission at Month 6 Month 3 (week 12) to month 6 (week 24) of the DBTP 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).
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 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.
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 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.
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 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.
Trial Locations
- Locations (94)
Holdsworth House Medical Practice
🇦🇺Sydney, New South Wales, Australia
Axiom Research
🇺🇸Colton, California, United States
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
🇭🇺Miskolc, Hungary
Kings College London
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Castilla León, Spain
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Aragón, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Comunidad Valenciana, Spain
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
🇭🇺Debrecen, Hungary
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Andalucía, Spain
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
🇮🇹Pavia, Italy
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Azienda Ospedaliero Universitaria Mater Domini
🇮🇹Catanzaro, Italy
Hospital Universitari de Bellvitge
🇪🇸Hospitalet de Llobregat, Cataluña, Spain
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
🇭🇺Budapest, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
Preferred Primary Care Physicians, Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Terveystalo Pulssi
🇫🇮Turku, Finland
Core Healthcare Group
🇺🇸Cerritos, California, United States
The George Washington Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Floridian Clinical Research LLC
🇺🇸Miami Lakes, Florida, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Marshall University
🇺🇸Huntington, West Virginia, United States
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Fakultni nemocnice u svate Anny v Brne
🇨🇿Brno, Czechia
Neurologie Brno sro
🇨🇿Brno, Czechia
Dado Medical sro
🇨🇿Praha 2, Czechia
Thomayerova nemocnice
🇨🇿Praha 4, Czechia
Mudr Stanislav Bartek sro
🇨🇿Prerov, Czechia
INEP
🇨🇿Praha, Czechia
Vestra Clinics sro
🇨🇿Rychnov nad Kneznou, Czechia
Helsingin Paansarkykeskus Aava
🇫🇮Helsinki, Finland
Northern Cinical Trial Coordinators
🇫🇮Oulu, Finland
Suomen Terveystalo
🇫🇮Tampere, Finland
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
🇫🇷Lille, France
Groupe hospitalier Paris Saint Joseph
🇫🇷Paris, France
Clinical Research Institute
🇺🇸Los Angeles, California, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Citizens Memorial Healthcare
🇺🇸Bolivar, Missouri, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Mercy Research
🇺🇸Saint Louis, Missouri, United States
Clinical Trial Investigator Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Onsite Clinical Solutions LLC
🇺🇸Charlotte, North Carolina, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
Allegheny Health Network Cancer Institute at Mellon Pavilion
🇺🇸Pittsburgh, Pennsylvania, United States
Clinical Research Institute Inc
🇺🇸Minneapolis, Minnesota, United States
Nashville Neuroscience Group
🇺🇸Nashville, Tennessee, United States
Wasatch Clinical Research LLC
🇺🇸Salt Lake City, Utah, United States
College Park Family Care Center
🇺🇸Overland Park, Kansas, United States
Collective Medical Research
🇺🇸Prairie Village, Kansas, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Klinikum Klagenfurt am Woerthersee
🇦🇹Klagenfurt, Austria
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers Cedex, France
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Gabinet Lekarski Jacek Rozniecki
🇵🇱Lodz, Poland
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Emerald Coast Center for Neurological Disorders
🇺🇸Pensacola, Florida, United States
Hopital Lariboisiere
🇫🇷Paris, France
Obudai Egeszsegugyi Centrum Kft
🇭🇺Budapest, Hungary
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Universitaetsklinikum Allgemeines Krankenhaus Wien
🇦🇹Wien, Austria
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna
🇵🇱Ksawerow, Poland
Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej
🇵🇱Legionowo, Poland
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Swiss Premium Egeszsegkozpont
🇭🇺Budapest, Hungary
Hopital La Timone
🇫🇷Marseille cedex 05, France
Centre Hospitalier Annecy Genevois
🇫🇷Pringy Cedex, France
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
🇭🇺Szeged, Hungary
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Hospital da Luz, SA
🇵🇹Lisboa, Portugal
Centre Hospitalier Universitaire de Nice - Hopital de Cimiez
🇫🇷Nice cedex 1, France
IRCCS San Raffaele Pisana
🇮🇹Roma, Italy
Konventhospital der Barmherzigen Brueder Linz
🇦🇹Linz, Austria
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Italy
RCMed Oddzial Sochaczew
🇵🇱Sochaczew, Poland
Campus Neurologico Senior
🇵🇹Torres Vedras, Portugal
Saint Lukes Clinic
🇺🇸Meridian, Idaho, United States
Neurology Center of New England PC
🇺🇸Foxboro, Massachusetts, United States
Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer
🇫🇷Bron cedex, France
Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord
🇫🇷Saint-Etienne cedex 2, France
IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria
🇮🇹Bologna, Italy
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
🇵🇱Poznan, Poland
Hospital Professor Doutor Fernando Fonseca, EPE
🇵🇹Amadora, Portugal
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
The Walton Centre NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
University of South Florida
🇺🇸Tampa, Florida, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia