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

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ClinicalTrials.gov Identifier: NCT04252742
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 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
Actual Primary Completion Date : October 26, 2023
Actual Study Completion Date : October 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Erenumab

Arms and Interventions
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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
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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 monthly physical function domain score 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 in the mean monthly impact on usual activities domain score as measured by the MFIQ [ Time Frame: Over months 1, 2, and 3 ]
    To evaluate the treatment benefit of erenumab on functional impairment

  3. Change from baseline in the mean monthly impact on emotional function domain score as measured by the MFIQ [ Time Frame: Over months 1, 2, and 3 ]
    To evaluate the treatment benefit of erenumab on functional impairment

  4. Change from baseline in the mean monthly impact on social function domain score as measured by the 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 average duration of at least moderate pain intensity in qualifying migraine attacks, 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 average 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


Eligibility Criteria
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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.
  • 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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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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 8, 2023
Last Verified: November 2023
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