Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine

Migraine Clinical Trial

— EMBRACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252742
• Other study ID #: 20190008
• Secondary ID: 2019-003646-33
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2020
• Est. completion date: October 26, 2023

Study information

• Verified date: November 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Erenumab
140 mg, 2 consecutive injections of 70 mg
• Placebo
2 consecutive injections

Locations

Country	Name	City	State
Bulgaria	University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD	Pleven
Bulgaria	University Multiprofile Hospital for Active Treatment Sveti Georgi EAD	Plovdiv
Bulgaria	Medical Center Excelsior OOD	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD	Sofia
Bulgaria	University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Alexandrovska EAD	Sofia
Bulgaria	Medical Center New Rehabilitation Center EOOD	Stara Zagora
Czechia	Fakultni nemocnice u svate Anny v Brne	Brno
Czechia	Neurologie Brno sro	Brno
Czechia	Poliklinika Chocen, Neurohk sro	Chocen
Czechia	Brain-soultherapy sro	Kladno
Czechia	Institut Neuropsychiatricke pece	Praha
Czechia	Dado Medical sro	Praha 2
Czechia	FORBELI sro	Praha 6
Czechia	NeuroMed Zlin sro	Zlin
Hungary	High Tech Medical Kft	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft	Budapest
Hungary	Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet	Budapest
Hungary	S-Medicon Kutatasi Centrum	Budapest
Hungary	Uno Medical Trials Kft	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft	Zalaegerszeg
Italy	Ospedale Bellaria Carlo Alberto Pizzardi	Bologna
Italy	Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliera Universitaria Renato Dulbecco	Catanzaro
Italy	Ospedale Policlinico San Martino IRCCS	Genoa
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Fondazione Istituto Neurologico Nazionale C Mondino IRCCS	Pavia
Italy	IRCCS San Raffaele Pisana	Roma
Italy	Policlinico Universitario Campus Biomedico	Roma
Italy	Azienda della scienza di Torino	Torino
Poland	Centrum Badan Klinicznych PI-House Spzoo	Gdansk
Poland	Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz	Gliwice
Poland	Care Clinic Spzoo Care Clinic Centrum Medyczne	Katowice
Poland	Vita Longa Spzoo	Katowice
Poland	NZOZ Neuromed M i M Nastaj Spolka Partnerska	Krasnik
Poland	AppleTreeClinics Network Spzoo	Lodz
Poland	M-Zdrowie	Lodz
Poland	NZOZ Neuromed M i M Nastaj Spolka Partnerska	Lublin
Poland	Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom	Oswiecim
Poland	Osrodek Badan Klinicznych Cromed	Poznan
Poland	Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska	Rzeszow
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak	Wroclaw
Poland	Vistamed and Vertigo Sp z o o	Wroclaw
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria	Lisboa
Portugal	Hospital da Luz, SA	Lisboa
Portugal	Hospital Cuf Sintra	Sintra
Portugal	Campus Neurologico Senior	Torres Vedras
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucuresti
Romania	Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara	Timisoara
Spain	Hospital Universitari Vall d Hebron	Barcelona	Cataluña
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
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 States	Dent Neurosciences Research Center	Amherst	New York
United States	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan
United States	JEM Research Institute	Atlantis	Florida
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Mountain Neurological Research Center	Basalt	Colorado
United States	American Clinical Research Institute LLC	Beavercreek	Ohio
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Chicago Headache Center and Research Institute	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Denver Neurological Clinic	Denver	Colorado
United States	Summit Headache and Neurologic Institute	Englewood	Colorado
United States	North Texas Institute of Neurology and Headache	Frisco	Texas
United States	Palmetto Clinical Trial Services	Greenville	South Carolina
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Forte Family Practice	Las Vegas	Nevada
United States	Long Beach Clinical Trials Services Inc	Long Beach	California
United States	Clinical Research Institute, LLC	Los Angeles	California
United States	Saint Lukes Clinic	Meridian	Idaho
United States	Visionary Investigators Network	Miami	Florida
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	Renstar Medical Research	Ocala	Florida
United States	Heuer Medical Doctor Research LLC	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Papillion Research Center	Papillion	Nebraska
United States	Visionary Investigators Network	Pembroke Pines	Florida
United States	Summit Research Network	Portland	Oregon
United States	Mercy Health Research	Saint Louis	Missouri
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Clinvest Research LLC	Springfield	Missouri
United States	New England Regional Headache Center Inc	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  Italy,  Poland,  Portugal,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean monthly hours of at least moderate headache pain intensity, with pain intensity measured by the 11-point NRS scale	To evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity	Over months 1, 2, and 3
Secondary	Change from baseline in mean monthly physical function domain score as measured by the Migraine Functional Impact Questionnaire (MFIQ)	To evaluate the treatment benefit of erenumab on functional impairment	Over months 1, 2, and 3
Secondary	Change from baseline in the mean monthly impact on usual activities domain score as measured by the MFIQ	To evaluate the treatment benefit of erenumab on functional impairment	Over months 1, 2, and 3
Secondary	Change from baseline in the mean monthly impact on emotional function domain score as measured by the MFIQ	To evaluate the treatment benefit of erenumab on functional impairment	Over months 1, 2, and 3
Secondary	Change from baseline in the mean monthly impact on social function domain score as measured by the MFIQ	To evaluate the treatment benefit of erenumab on functional impairment	Over months 1, 2, and 3
Secondary	Change from baseline in mean monthly average duration of at least moderate pain intensity in qualifying migraine attacks, with pain measured by the 11-point NRS scale	To evaluate the treatment benefit of erenumab on duration of migraine pain of at least moderate intensity	Over months 1, 2, and 3
Secondary	Change from baseline in mean monthly average peak migraine pain intensity as assessed by the 11-point Numeric Rating Scale (NRS)	To evaluate the treatment benefit of erenumab on peak migraine pain intensity	Over months 1, 2, and 3

External Links

•   AmgenTrials clinical trials website