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Trial record 8 of 16 for:    Recruiting Studies | Episodic Migraine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252742
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 15, 2020
Estimated Primary Completion Date : December 19, 2022
Estimated Study Completion Date : December 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Erenumab

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 triptans 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 triptans as well as non-ictal burden.
Drug: Placebo
2 consecutive injections




Primary Outcome Measures :
  1. Change from baseline in mean monthly hours of at least moderate headache pain intensity, with pain intensity measured by the 11-point NRS scale [ Time Frame: 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 :
  1. Change from baseline in mean physical functioning as measured by the Migraine Functional Impact Questionnaire (MFIQ) [ Time Frame: Over months 1, 2, and 3 ]
    To evaluate the treatment benefit of erenumab on functional impairment

  2. Change from baseline on the Impact of usual activities as measured by the Migraine Functional Impact Questionnaire (MFIQ) [ Time Frame: Over months 1, 2, and 3 ]
    To evaluate the treatment benefit of erenumab on functional impairment

  3. Change from baseline on the Impact of emotional functioning as measured by the Migraine Functional Impact Questionnaire (MFIQ) [ Time Frame: Over months 1, 2, and 3 ]
    To evaluate the treatment benefit of erenumab on functional impairment

  4. Change from baseline in mean monthly function as impact on social functioning as measured by the Migraine Functional Impact Questionnaire (MFIQ) [ Time Frame: Over months 1, 2, and 3 ]
    To evaluate the treatment benefit of erenumab on functional impairment

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

  6. Change from baseline in mean monthly peak migraine pain intensity as assessed by the 11-point Numeric Rating Scale (NRS) [ Time Frame: Over months 1, 2, and 3 ]
    To evaluate the treatment benefit of erenumab on peak migraine pain intensity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

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 any agent (monoclonal antibody or small molecule) targeting the calcitonin gene-related peptide (CGRP) pathway (ligand or receptor) in the preventive setting.
  • No therapeutic response with greater than 4 of the defined medication categories after an adequate therapeutic trial.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252742


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, Colorado
Research Site Recruiting
Basalt, Colorado, United States, 81621
Research Site Recruiting
Englewood, Colorado, United States, 80113
United States, Florida
Research Site Recruiting
Jacksonville, Florida, United States, 32216
Research Site Recruiting
Ocala, Florida, United States, 34470
United States, Idaho
Research Site Recruiting
Meridian, Idaho, United States, 83642
United States, Massachusetts
Research Site Recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Research Site Recruiting
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63141
Research Site Recruiting
Saint Peters, Missouri, United States, 63303
Research Site Recruiting
Springfield, Missouri, United States, 65810
United States, New York
Research Site Recruiting
Amherst, New York, United States, 14226
United States, Oregon
Research Site Recruiting
Portland, Oregon, United States, 97210
United States, Texas
Research Site Recruiting
Austin, Texas, United States, 78731
Research Site Recruiting
Frisco, Texas, United States, 75034
Bulgaria
Research Site Recruiting
Pleven, Bulgaria, 5800
Research Site Recruiting
Plovdiv, Bulgaria, 4001
Research Site Recruiting
Sofia, Bulgaria, 1113
Research Site Recruiting
Sofia, Bulgaria, 1407
Research Site Recruiting
Stara Zagora, Bulgaria, 6000
Hungary
Research Site Recruiting
Budapest, Hungary, 1135
Research Site Recruiting
Budapest, Hungary, 1145
Research Site Recruiting
Esztergom, Hungary, 2500
Italy
Research Site Recruiting
Milano, Italy, 20133
Research Site Recruiting
Roma, Italy, 00128
Research Site Recruiting
Roma, Italy, 00163
Poland
Research Site Recruiting
Gdansk, Poland, 80-546
Research Site Recruiting
Gliwice, Poland, 44-100
Research Site Recruiting
Krasnik, Poland, 23-210
Research Site Recruiting
Lodz, Poland, 90-349
Research Site Recruiting
Lodz, Poland, 91-072
Research Site Recruiting
Lublin, Poland, 20-064
Research Site Recruiting
Poznan, Poland, 61-505
Research Site Recruiting
Wroclaw, Poland, 52-416
Romania
Research Site Recruiting
Bucuresti, Romania, 010825
Spain
Research Site Recruiting
Sevilla, Andalucía, Spain, 41013
Research Site Recruiting
Valladolid, Castilla León, Spain, 47010
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04252742    
Other Study ID Numbers: 20190008
2019-003646-33 ( EudraCT Number )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs