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

Primary Purpose

Migraine

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Erenumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

    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.

Sites / Locations

  • Long Beach Clinical Trials Services Inc
  • Clinical Research Institute, LLC
  • Mountain Neurological Research Center
  • Denver Neurological Clinic
  • Summit Headache and Neurologic Institute
  • JEM Research Institute
  • Jacksonville Center for Clinical Research
  • Visionary Investigators Network
  • Renstar Medical Research
  • Heuer Medical Doctor Research LLC
  • Neurology Associates of Ormond Beach
  • Visionary Investigators Network
  • Saint Lukes Clinic
  • Chicago Headache Center and Research Institute
  • Boston Clinical Trials
  • New England Regional Headache Center Inc
  • Michigan Head Pain and Neurological Institute
  • Mercy Health Research
  • StudyMetrix Research
  • Clinvest Research LLC
  • Papillion Research Center
  • Forte Family Practice
  • Dent Neurosciences Research Center
  • American Clinical Research Institute LLC
  • University of Cincinnati
  • Cleveland Clinic
  • Summit Research Network
  • Palmetto Clinical Trial Services
  • Nashville Neuroscience Group
  • FutureSearch Trials of Neurology
  • North Texas Institute of Neurology and Headache
  • University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD
  • University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD
  • Medical Center Excelsior OOD
  • University Multiprofile Hospital for Active Treatment Alexandrovska EAD
  • Medical Center New Rehabilitation Center EOOD
  • Neurologie Brno sro
  • Fakultni nemocnice u svate Anny v Brne
  • Poliklinika Chocen, Neurohk sro
  • Brain-soultherapy sro
  • Dado Medical sro
  • FORBELI sro
  • Institut Neuropsychiatricke pece
  • NeuroMed Zlin sro
  • Obudai Egeszsegugyi Centrum Kft
  • High Tech Medical Kft
  • Uno Medical Trials Kft
  • S-Medicon Kutatasi Centrum
  • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
  • Obudai Egeszsegugyi Centrum Kft
  • Ospedale Bellaria Carlo Alberto Pizzardi
  • Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia
  • Azienda Ospedaliera Universitaria Renato Dulbecco
  • Ospedale Policlinico San Martino IRCCS
  • IRCCS Ospedale San Raffaele
  • Fondazione IRCCS Istituto Neurologico Carlo Besta
  • Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
  • Policlinico Universitario Campus Biomedico
  • IRCCS San Raffaele Pisana
  • Azienda della scienza di Torino
  • Centrum Badan Klinicznych PI-House Spzoo
  • Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz
  • Care Clinic Spzoo Care Clinic Centrum Medyczne
  • Vita Longa Spzoo
  • NZOZ Neuromed M i M Nastaj Spolka Partnerska
  • AppleTreeClinics Network Spzoo
  • M-Zdrowie
  • NZOZ Neuromed M i M Nastaj Spolka Partnerska
  • Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom
  • Osrodek Badan Klinicznych Cromed
  • Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska
  • Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • Centrum Medyczne Oporow
  • Vistamed and Vertigo Sp z o o
  • Hospital da Luz, SA
  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
  • Hospital Cuf Sintra
  • Campus Neurologico Senior
  • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario Lozano Blesa
  • Hospital Universitario Marques de Valdecilla
  • Hospital Clinico Universitario de Valladolid
  • Hospital Universitari Vall d Hebron
  • Hospital Clinico Universitario de Valencia
  • Hospital Universitari i Politecnic La Fe
  • Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Erenumab

Placebo

Arm Description

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.

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.

Outcomes

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
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)
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
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
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
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
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)
To evaluate the treatment benefit of erenumab on peak migraine pain intensity

Full Information

First Posted
January 22, 2020
Last Updated
October 10, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04252742
Brief Title
Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
November 3, 2023 (Anticipated)
Study Completion Date
November 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erenumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erenumab
Intervention Description
140 mg, 2 consecutive injections of 70 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 consecutive injections
Primary Outcome Measure Information:
Title
Change from baseline in mean monthly hours of at least moderate headache pain intensity, with pain intensity measured by the 11-point NRS scale
Description
To evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity
Time Frame
Over months 1, 2, and 3
Secondary Outcome Measure Information:
Title
Change from baseline in mean monthly physical function domain score as measured by the Migraine Functional Impact Questionnaire (MFIQ)
Description
To evaluate the treatment benefit of erenumab on functional impairment
Time Frame
Over months 1, 2, and 3
Title
Change from baseline in the mean monthly impact on usual activities domain score as measured by the MFIQ
Description
To evaluate the treatment benefit of erenumab on functional impairment
Time Frame
Over months 1, 2, and 3
Title
Change from baseline in the mean monthly impact on emotional function domain score as measured by the MFIQ
Description
To evaluate the treatment benefit of erenumab on functional impairment
Time Frame
Over months 1, 2, and 3
Title
Change from baseline in the mean monthly impact on social function domain score as measured by the MFIQ
Description
To evaluate the treatment benefit of erenumab on functional impairment
Time Frame
Over months 1, 2, and 3
Title
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
Description
To evaluate the treatment benefit of erenumab on duration of migraine pain of at least moderate intensity
Time Frame
Over months 1, 2, and 3
Title
Change from baseline in mean monthly average peak migraine pain intensity as assessed by the 11-point Numeric Rating Scale (NRS)
Description
To evaluate the treatment benefit of erenumab on peak migraine pain intensity
Time Frame
Over months 1, 2, and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Long Beach Clinical Trials Services Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Clinical Research Institute, LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mountain Neurological Research Center
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
Denver Neurological Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Summit Headache and Neurologic Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Visionary Investigators Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Heuer Medical Doctor Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Visionary Investigators Network
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Saint Lukes Clinic
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Chicago Headache Center and Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
New England Regional Headache Center Inc
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
14226
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Papillion Research Center
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Forte Family Practice
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
American Clinical Research Institute LLC
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Palmetto Clinical Trial Services
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Nashville Neuroscience Group
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
North Texas Institute of Neurology and Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD
City
Sofia
ZIP/Postal Code
1154
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Alexandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center New Rehabilitation Center EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Neurologie Brno sro
City
Brno
ZIP/Postal Code
616 00
Country
Czechia
Facility Name
Fakultni nemocnice u svate Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Poliklinika Chocen, Neurohk sro
City
Chocen
ZIP/Postal Code
565 01
Country
Czechia
Facility Name
Brain-soultherapy sro
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
Dado Medical sro
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
FORBELI sro
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Institut Neuropsychiatricke pece
City
Praha
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
NeuroMed Zlin sro
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
High Tech Medical Kft
City
Budapest
ZIP/Postal Code
1064
Country
Hungary
Facility Name
Uno Medical Trials Kft
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
S-Medicon Kutatasi Centrum
City
Budapest
ZIP/Postal Code
1138
Country
Hungary
Facility Name
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Ospedale Bellaria Carlo Alberto Pizzardi
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Renato Dulbecco
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale Policlinico San Martino IRCCS
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
IRCCS San Raffaele Pisana
City
Roma
ZIP/Postal Code
00163
Country
Italy
Facility Name
Azienda della scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Centrum Badan Klinicznych PI-House Spzoo
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
Care Clinic Spzoo Care Clinic Centrum Medyczne
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Vita Longa Spzoo
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
NZOZ Neuromed M i M Nastaj Spolka Partnerska
City
Krasnik
ZIP/Postal Code
23-210
Country
Poland
Facility Name
AppleTreeClinics Network Spzoo
City
Lodz
ZIP/Postal Code
90-349
Country
Poland
Facility Name
M-Zdrowie
City
Lodz
ZIP/Postal Code
91-072
Country
Poland
Facility Name
NZOZ Neuromed M i M Nastaj Spolka Partnerska
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Osrodek Badan Klinicznych Cromed
City
Poznan
ZIP/Postal Code
61-360
Country
Poland
Facility Name
Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska
City
Rzeszow
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
City
Wroclaw
ZIP/Postal Code
52-210
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Vistamed and Vertigo Sp z o o
City
Wroclaw
ZIP/Postal Code
53-149
Country
Poland
Facility Name
Hospital da Luz, SA
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Cuf Sintra
City
Sintra
ZIP/Postal Code
2710-204
Country
Portugal
Facility Name
Campus Neurologico Senior
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Facility Name
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
City
Timisoara
ZIP/Postal Code
700736
Country
Romania
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
State/Province
Castilla León
ZIP/Postal Code
47010
Country
Spain
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s)and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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