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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03971071
Other study ID # 20170703
Secondary ID 2018-003342-16
Status Completed
Phase Phase 4
First received
Last updated
Start date October 7, 2019
Est. completion date June 13, 2023

Study information

Verified date February 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (MOH).


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 information / eligibility

Status Completed
Enrollment 620
Est. completion date June 13, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Eligibility criteria will be evaluated during the up to 3-week screening period (part 1) and a 4-week baseline period (part 2). At the end of baseline period, participants who successfully met eligibility criteria will be randomized on study. Key Inclusion Criteria Part 1: To be assessed during the 3-week screening period, prior to the baseline period. Participants are eligible to be included in the study only if all of the following criteria apply: - 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 Key Exclusion Criteria Part 1 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. 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) Key Exclusion Criteria Part 2 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

Study Design


Intervention

Drug:
Erenumab 70 mg
Erenumab once every 4 weeks. Subcutaneous injection.
Erenumab 140 mg
Erenumab once every 4 weeks. Subcutaneous injection.
Placebo
Placebo once every 4 weeks. Subcutaneous injection.

Locations

Country Name City State
Australia The Alfred Hospital Melbourne Victoria
Australia Holdsworth House Medical Practice Sydney New South Wales
Austria Medizinische Universitaet Innsbruck Innsbruck
Austria Klinikum Klagenfurt am Woerthersee Klagenfurt
Austria Konventhospital der Barmherzigen Brueder Linz Linz
Austria Universitaetsklinikum Allgemeines Krankenhaus Wien Wien
Czechia Fakultni nemocnice u svate Anny v Brne Brno
Czechia Neurologie Brno sro Brno
Czechia INEP Praha
Czechia Dado Medical sro Praha 2
Czechia Thomayerova nemocnice Praha 4
Czechia Mudr Stanislav Bartek sro Prerov
Czechia Vestra Clinics sro Rychnov nad Kneznou
Finland Helsingin Paansarkykeskus Aava Helsinki
Finland Northern Cinical Trial Coordinators Oulu
Finland Suomen Terveystalo Tampere
Finland Terveystalo Pulssi Turku
France Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer Bron cedex
France Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro Lille
France Hopital La Timone Marseille cedex 05
France Centre Hospitalier Universitaire de Nice - Hopital de Cimiez Nice cedex 1
France Groupe hospitalier Paris Saint Joseph Paris
France Hopital Lariboisiere Paris
France Centre Hospitalier Universitaire de Poitiers Poitiers Cedex
France Centre Hospitalier Annecy Genevois Pringy Cedex
France Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord Saint-Etienne cedex 2
Hungary Jahn Ferenc Del-pesti Korhaz es Rendelointezet Budapest
Hungary Obudai Egeszsegugyi Centrum Kft Budapest
Hungary Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet Budapest
Hungary Swiss Premium Egeszsegkozpont Budapest
Hungary Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz Debrecen
Hungary Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz Miskolc
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar Szeged
Italy IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria Bologna
Italy Azienda Ospedaliero Universitaria Mater Domini Catanzaro
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy Fondazione IRCCS Istituto Neurologico Carlo Besta Milano
Italy Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Italy Fondazione Istituto Neurologico Nazionale C Mondino IRCCS Pavia
Italy IRCCS San Raffaele Pisana Roma
Poland Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna Ksawerow
Poland Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej Legionowo
Poland Gabinet Lekarski Jacek Rozniecki Lodz
Poland Clinical Research Center Spzoo Medic-R Spolka Komandytowa Poznan
Poland RCMed Oddzial Sochaczew Sochaczew
Portugal Hospital Professor Doutor Fernando Fonseca, EPE Amadora
Portugal Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria Lisboa
Portugal Hospital da Luz, SA Lisboa
Portugal Campus Neurologico Senior Torres Vedras
Spain Hospital Universitari Vall d Hebron Barcelona Cataluña
Spain Hospital Universitari de Bellvitge Hospitalet de Llobregat Cataluña
Spain Hospital Universitario Virgen del Rocio Sevilla Andalucía
Spain Hospital Clinico Universitario de Valencia Valencia Comunidad Valenciana
Spain Hospital Universitari i Politecnic La Fe Valencia Comunidad Valenciana
Spain Hospital Clinico Universitario de Valladolid Valladolid Castilla León
Spain Hospital Clinico Universitario Lozano Blesa Zaragoza Aragón
United Kingdom Queen Elizabeth University Hospital Glasgow
United Kingdom Hull Royal Infirmary Hull
United Kingdom The Walton Centre NHS Foundation Trust Liverpool
United Kingdom Kings College London London
United Kingdom Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle Upon Tyne
United Kingdom John Radcliffe Hospital Oxford
United States Dent Neurosciences Research Center Amherst New York
United States Michigan Head Pain and Neurological Institute Ann Arbor Michigan
United States Citizens Memorial Healthcare Bolivar Missouri
United States Core Healthcare Group Cerritos California
United States Onsite Clinical Solutions LLC Charlotte North Carolina
United States Clinical Trial Investigator Clinical Research Center Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Axiom Research Colton California
United States Texas Neurology, PA Dallas Texas
United States Fort Wayne Neurological Center Fort Wayne Indiana
United States Neurology Center of New England PC Foxboro Massachusetts
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Marshall University Huntington West Virginia
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States University of Kentucky Lexington Kentucky
United States Clinical Research Institute Los Angeles California
United States Saint Lukes Clinic Meridian Idaho
United States University of Miami Miller School of Medicine Miami Florida
United States Floridian Clinical Research LLC Miami Lakes Florida
United States Clinical Research Institute Inc Minneapolis Minnesota
United States Nashville Neuroscience Group Nashville Tennessee
United States DelRicht Research New Orleans Louisiana
United States Clinical Neuroscience Solutions Orlando Florida
United States College Park Family Care Center Overland Park Kansas
United States Emerald Coast Center for Neurological Disorders Pensacola Florida
United States Allegheny Health Network Cancer Institute at Mellon Pavilion Pittsburgh Pennsylvania
United States Preferred Primary Care Physicians, Inc Pittsburgh Pennsylvania
United States Collective Medical Research Prairie Village Kansas
United States Mercy Research Saint Louis Missouri
United States Wasatch Clinical Research LLC Salt Lake City Utah
United States University of South Florida Tampa Florida
United States The George Washington Medical Faculty Associates Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Czechia,  Finland,  France,  Hungary,  Italy,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary 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). Month 3 (week 12) to month 6 (week 24) of the DBTP
Secondary 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. Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary 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. Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Secondary 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.
Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)
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