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

Sponsor

Amgen (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04252742

Collaborator

(none)

576

Enrollment

Locations

Arms

46.2

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Erenumab Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

576 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Sep 15, 2020

Anticipated Primary Completion Date :

Jul 21, 2024

Anticipated Study Completion Date :

Jul 21, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erenumab The 4-month DBTP has 2 phases: Main double-blind treatment phase (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden.	Drug: Erenumab 140 mg, 2 consecutive injections of 70 mg
Experimental: Placebo The 4-month DBTP has 2 phases: Main DBTP (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden.	Drug: Placebo 2 consecutive injections

Arm

Intervention/Treatment

Experimental: Erenumab

The 4-month DBTP has 2 phases: Main double-blind treatment phase (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden.

Drug: Erenumab

140 mg, 2 consecutive injections of 70 mg

Experimental: Placebo

The 4-month DBTP has 2 phases: Main DBTP (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden.

Drug: Placebo

2 consecutive injections

Outcome Measures

Primary Outcome Measures

Change from baseline in mean monthly hours of at least moderate headache pain intensity, with pain intensity measured by the 11-point NRS scale [Over months 1, 2, and 3]
To evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity

Secondary Outcome Measures

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]
To evaluate the treatment benefit of erenumab on functional impairment
Change from baseline in the mean monthly impact on usual activities domain score as measured by the MFIQ [Over months 1, 2, and 3]
To evaluate the treatment benefit of erenumab on functional impairment
Change from baseline in the mean monthly impact on emotional function domain score as measured by the MFIQ [Over months 1, 2, and 3]
To evaluate the treatment benefit of erenumab on functional impairment
Change from baseline in the mean monthly impact on social function domain score as measured by the MFIQ [Over months 1, 2, and 3]
To evaluate the treatment benefit of erenumab on functional impairment
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 [Over months 1, 2, and 3]
To evaluate the treatment benefit of erenumab on duration of migraine pain of at least moderate intensity
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]
To evaluate the treatment benefit of erenumab on peak migraine pain intensity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

In the opinion of the investigator, did not offer any evidence of a therapeutic response or
Was discontinued for less than 12 weeks from the date of initial screening or
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Institute, LLC	Los Angeles	California	United States	90048
2	Mountain Neurological Research Center	Basalt	Colorado	United States	81621
3	Denver Neurological Clinic	Denver	Colorado	United States	80210
4	Summit Headache and Neurologic Institute	Englewood	Colorado	United States	80113
5	JEM Research Institute	Atlantis	Florida	United States	33462
6	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
7	Visionary Investigators Network	Miami	Florida	United States	33133
8	Renstar Medical Research	Ocala	Florida	United States	34470
9	Heuer Medical Doctor Research LLC	Orlando	Florida	United States	32819
10	Visionary Investigators Network	Pembroke Pines	Florida	United States	33026
11	Saint Lukes Clinic	Meridian	Idaho	United States	83642
12	Chicago Headache Center and Research Institute	Chicago	Illinois	United States	60657
13	Boston Clinical Trials	Boston	Massachusetts	United States	02131
14	New England Regional Headache Center Inc	Worcester	Massachusetts	United States	01605
15	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan	United States	48104
16	Mercy Health Research	Saint Louis	Missouri	United States	63141
17	StudyMetrix Research	Saint Peters	Missouri	United States	63303
18	Clinvest Research LLC	Springfield	Missouri	United States	65810
19	Papillion Research Center	Papillion	Nebraska	United States	68046
20	Forte Family Practice	Las Vegas	Nevada	United States	89103
21	Dent Neurosciences Research Center	Amherst	New York	United States	14226
22	University of Cincinnati	Cincinnati	Ohio	United States	45229
23	Cleveland Clinic	Cleveland	Ohio	United States	44195
24	Summit Research Network	Portland	Oregon	United States	97210
25	Palmetto Clinical Trial Services LLC	Fountain Inn	South Carolina	United States	29644
26	Nashville Neuroscience Group	Nashville	Tennessee	United States	37203
27	FutureSearch Trials of Neurology	Austin	Texas	United States	78731
28	North Texas Institute of Neurology and Headache	Frisco	Texas	United States	75034
29	University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD	Pleven		Bulgaria	5800
30	University Multiprofile Hospital for Active Treatment Sveti Georgi EAD	Plovdiv		Bulgaria	4001
31	Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD	Sofia		Bulgaria	1113
32	Medical Center Excelsior OOD	Sofia		Bulgaria	1407
33	University Multiprofile Hospital for Active Treatment Alexandrovska EAD	Sofia		Bulgaria	1431
34	Medical Center New Rehabilitation Center EOOD	Stara Zagora		Bulgaria	6000
35	Neurologie Brno sro	Brno		Czechia	616 00
36	Fakultni nemocnice u svate Anny v Brne	Brno		Czechia	656 91
37	Poliklinika Chocen, Neurohk sro	Chocen		Czechia	565 01
38	Brain-soultherapy s.r.o.	Kladno		Czechia	272 01
39	Dado Medical sro	Praha 2		Czechia	120 00
40	INEP	Praha		Czechia	186 00
41	Obudai Egeszsegugyi Centrum Kft	Budapest		Hungary	1036
42	Uno Medical Trials Kft	Budapest		Hungary	1135
43	Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet	Budapest		Hungary	1145
44	Valeomed Kft	Esztergom		Hungary	2500
45	Obudai Egeszsegugyi Centrum Kft	Zalaegerszeg		Hungary	8900
46	IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria	Bologna		Italy	40139
47	Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia	Brescia		Italy	25123
48	Azienda Ospedaliero Universitaria Mater Domini	Catanzaro		Italy	88100
49	Ospedale Policlinico San Martino IRCCS	Genoa		Italy	16132
50	IRCCS Ospedale San Raffaele	Milano		Italy	20132
51	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milano		Italy	20133
52	Fondazione Istituto Neurologico Nazionale C Mondino IRCCS	Pavia		Italy	27100
53	Policlinico Universitario Campus Biomedico	Roma		Italy	00128
54	IRCCS San Raffaele Pisana	Roma		Italy	00163
55	Azienda Ospedaliera Città	Torino		Italy	10126
56	Centrum Badan Klinicznych PI-House Spzoo	Gdansk		Poland	80-546
57	Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz	Gliwice		Poland	44-100
58	Care Clinic Spzoo Care Clinic Centrum Medyczne	Katowice		Poland	40-568
59	Vita Longa Spzoo	Katowice		Poland	40-748
60	NZOZ Neuromed M i M Nastaj Spolka Partnerska	Krasnik		Poland	23-210
61	AppleTreeClinics Network Spzoo	Lodz		Poland	90-349
62	M-Zdrowie	Lodz		Poland	91-072
63	NZOZ Neuromed M i M Nastaj Spolka Partnerska	Lublin		Poland	20-064
64	Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom	Oswiecim		Poland	32-600
65	Osrodek Badan Klinicznych CROMED ul Starolecka 42A 61-360 Poznan	Poznan		Poland	61-360
66	Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska	Rzeszow		Poland	35-301
67	Centrum Medyczne Oporow	Wroclaw		Poland	52-416
68	Hospital da Luz, SA	Lisboa		Portugal	1500-650
69	Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria	Lisboa		Portugal	1649-035
70	Hospital Cuf Sintra	Sintra		Portugal	2710-204
71	Campus Neurologico Senior	Torres Vedras		Portugal	2560-280
72	Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila	Bucuresti		Romania	010825
73	Spitalul Universitar de Urgenta Bucuresti	Bucuresti		Romania	050098
74	Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara	Timisoara		Romania	700736
75	Hospital Universitario Virgen del Rocio	Sevilla	Andalucía	Spain	41013
76	Hospital Clinico Universitario Lozano Blesa	Zaragoza	Aragón	Spain	50009
77	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
78	Hospital Clinico Universitario de Valladolid	Valladolid	Castilla León	Spain	47010
79	Hospital Universitari Vall d Hebron	Barcelona	Cataluña	Spain	08035
80	Hospital Clinico Universitario de Valencia	Valencia	Comunidad Valenciana	Spain	46010
81	Hospital Universitari i Politecnic La Fe	Valencia	Comunidad Valenciana	Spain	46026
82	Clinica Universidad de Navarra	Pamplona	Navarra	Spain	31008

Sponsors and Collaborators

Amgen

Investigators

Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

AmgenTrials clinical trials website

Publications

None provided.

Responsible Party:

Amgen

ClinicalTrials.gov Identifier:

NCT04252742

Other Study ID Numbers:

20190008
2019-003646-33

First Posted:

Feb 5, 2020

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Migraine Disorders

Erenumab

Study Results

No Results Posted as of Aug 12, 2022