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Biomarker and Genetic Predictors of Erenumab Treatment Response (INTERROGATE)

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: NCT04265755
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
To explore the relationship between clinical response to erenumab and genetic biomarkers

Condition or disease Intervention/treatment Phase
Migraine Drug: Erenumab Phase 4

Detailed Description:

This is a phase 4 open-label study aiming to explore the relationship between clinical response to erenumab and genetic biomarkers.

Subjects with episodic or chronic migraine will be treated with Erenumab 70mg or 140mg for a 4-week baseline/screening period, followed by a 24-week treatment period.

Subjects will collect migraine-related parameters daily using an eDiary and blood samples will be collected for biomarker research. All analysis will be descriptive in nature.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE)
Estimated Study Start Date : April 19, 2020
Estimated Primary Completion Date : October 3, 2021
Estimated Study Completion Date : October 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Single arm
Erenumab packed in a SureClick® Autoinjector Pen (AI)
Drug: Erenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)




Primary Outcome Measures :
  1. Achievement of at least a 50% reduction from baseline in mean monthly migraine days (MMD) in relation to each individual genome-wide significant single-nucleotide polymorphism (SNP) contributing to the migraine polygenic risk score (mPRS) [ Time Frame: From baseline over months 4, 5, and 6 ]
    To explore the relationship between clinical response to erenumab and genetic biomarkers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
  • Age greater than or equal to 18 years upon entry into screening
  • History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report
  • Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening After baseline period
  • Must have demonstrated greater than or equal to 75% compliance in eDiary usage during baseline period.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

Disease Related

  • Greater than 50 years of age at migraine onset
  • History of cluster headache or hemiplegic migraine headache
  • Inability to differentiate between migraine from other headaches Other Medical Conditions
  • The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Prior/Concomitant Therapy
  • Previously received erenumab (Aimovig®)
  • Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period Prior/Concurrent Clinical Study Experience
  • Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study (ies). Other investigational procedures while participating in this study are excluded.

Other Exclusions

  • Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
  • Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
  • Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. Refer to Section 11.5 for additional contraceptive information.
  • Evidence of current pregnancy or breastfeeding per subject self-report or medical records
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.

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): NCT04265755


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

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: NCT04265755    
Other Study ID Numbers: 20190006
2019-002331-28 ( EudraCT Number )
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Episodic and Chronic Migraine
Link between clinical response and biomarker
Phase 4
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
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunologic Factors