Clinical trial NCT04252742: Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
Official title: Comprehensive Assessment of Erenumab Efficacy in Subjects With High Frequency Episodic Migraine With at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3
timeFrame: Baseline, Month 1, Month 2, and Month 3
Secondary outcomes:
measure: Change From Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3
timeFrame: Baseline, Month 1, Month 2, and Month 3
measure: Change From Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3
timeFrame: Baseline, Month 1, Month 2, and Month 3
measure: Change From Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3
timeFrame: Baseline, Month 1, Month 2, and Month 3
measure: Change From Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3
timeFrame: Baseline, Month 1, Month 2, and Month 3
measure: Change From Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3
timeFrame: Baseline, Month 1, Month 2, and Month 3
measure: Change From Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3
timeFrame: Baseline, Month 1, Month 2, and Month 3
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services Inc
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute, LLC
state: California
city: Basalt
country: United States
facility: Mountain Neurological Research Center
state: Colorado
city: Denver
country: United States
facility: Denver Neurological Clinic
state: Colorado
city: Englewood
country: United States
facility: Summit Headache and Neurologic Institute
state: Colorado
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Heuer Medical Doctor Research LLC
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Pembroke Pines
country: United States
facility: Visionary Investigators Network
state: Florida
city: Meridian
country: United States
facility: Saint Lukes Clinic
state: Idaho
city: Chicago
country: United States
facility: Chicago Headache Center and Research Institute
state: Illinois
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Worcester
country: United States
facility: New England Regional Headache Center Inc
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Papillion
country: United States
facility: Papillion Research Center
state: Nebraska
city: Las Vegas
country: United States
facility: Forte Family Practice
state: Nevada
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Beavercreek
country: United States
facility: American Clinical Research Institute LLC
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Frisco
country: United States
facility: North Texas Institute of Neurology and Headache
state: Texas
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD
city: Sofia
country: Bulgaria
facility: University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Alexandrovska EAD
city: Stara Zagora
country: Bulgaria
facility: Medical Center New Rehabilitation Center EOOD
city: Brno
country: Czechia
facility: Neurologie Brno sro
city: Brno
country: Czechia
facility: Fakultni nemocnice u svate Anny v Brne
city: Chocen
country: Czechia
facility: Poliklinika Chocen, Neurohk sro
city: Kladno
country: Czechia
facility: Brain-soultherapy sro
city: Praha 2
country: Czechia
facility: Dado Medical sro
city: Praha 6
country: Czechia
facility: FORBELI sro
city: Praha
country: Czechia
facility: Institut Neuropsychiatricke pece
city: Zlin
country: Czechia
facility: NeuroMed Zlin sro
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: High Tech Medical Kft
city: Budapest
country: Hungary
facility: Uno Medical Trials Kft
city: Budapest
country: Hungary
facility: S-Medicon Kutatasi Centrum
city: Budapest
country: Hungary
facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
city: Zalaegerszeg
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Bologna
country: Italy
facility: Ospedale Bellaria Carlo Alberto Pizzardi
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria Renato Dulbecco
city: Genoa
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
city: Torino
country: Italy
facility: Azienda della scienza di Torino
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Spzoo
city: Gliwice
country: Poland
facility: Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz
city: Katowice
country: Poland
facility: Care Clinic Spzoo Care Clinic Centrum Medyczne
city: Katowice
country: Poland
facility: Vita Longa Spzoo
city: Krasnik
country: Poland
facility: NZOZ Neuromed M i M Nastaj Spolka Partnerska
city: Lodz
country: Poland
facility: AppleTreeClinics Network Spzoo
city: Lodz
country: Poland
facility: M-Zdrowie
city: Lublin
country: Poland
facility: NZOZ Neuromed M i M Nastaj Spolka Partnerska
city: Oswiecim
country: Poland
facility: Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom
city: Poznan
country: Poland
facility: Osrodek Badan Klinicznych Cromed
city: Rzeszow
country: Poland
facility: Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska
city: Wroclaw
country: Poland
facility: Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Wroclaw
country: Poland
facility: Vistamed and Vertigo Sp z o o
city: Lisboa
country: Portugal
facility: Hospital da Luz, SA
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
city: Sintra
country: Portugal
facility: Hospital Cuf Sintra
city: Torres Vedras
country: Portugal
facility: Campus Neurologico Senior
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
state: Aragón
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
state: Castilla León
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: