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Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab

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: NCT04592952
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Messoud Ashina, Danish Headache Center

Brief Summary:
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: Calcitonin Gene-Related Peptide Drug: Erenumab Phase 4

Detailed Description:

This is a single-center, non-randomized, single-arm, open-label study, in which adults with episodic or chronic migraine will receive intravenous infusion with calcitonin gene-related peptide and subsequently be treated with erenumab. The study will consist of the following elements:

  • Provocation Phase (1 experimental day with intravenous infusion of calcitonin gene-related peptide)
  • Screening/Baseline Phase (4 weeks)
  • Open-Label Treatment Phase (24 weeks)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
Estimated Study Start Date : October 8, 2020
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arm Intervention/treatment
Experimental: Single-Arm

Provocation Phase: Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.

Open-Label Treatment Phase: Erenumab packed in a SureClick® Autoinjector Pen (AI)

Drug: Calcitonin Gene-Related Peptide
Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
Other Name: CGRP

Drug: Erenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Other Name: Aimovig




Primary Outcome Measures :
  1. Headache Diary (Baseline Phase and Treatment Phase) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    Headache diary with daily entries to record migraine-related data (e.g. migraine days, headache days, number of days with use of acute migraine medication, number of days with aura).


Secondary Outcome Measures :
  1. Headache Diary (Provocation Phase) [ Time Frame: Provocation Phase (12 Hours) ]
    Subjects will be instructed to fill out a headache diary during the 12-hour observational period. The diary will be used to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, and phonophobia)

  2. Semi-Structured Interview [ Time Frame: 1 Hour ]
    In-person semi-structured interview to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, phonophobia, premonitory symptoms, postdromal symptoms, trigger factors, autonomic symptoms).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age upon entry into screening
  • History of migraine with or without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
  • ≥ 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening
  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
  • Must have demonstrated greater than or equal to 75% compliance in Headache Diary usage during the 4-week run-period prior to Day 1 of the open-label treatment phase.

Exclusion Criteria:

  • > 50 years of age at migraine onset
  • History of cluster headache or hemiplegic migraine
  • Inability to differentiate migraine from other headaches
  • The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
  • Previously received erenumab (Aimovig)
  • Received anti-CGRP monoclonal antibody within 3 months prior to the CGRP-infusion
  • 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.
  • Female subjects of childbearing potential with a positive pregnancy test during any study visit
  • Female subject is pregnant or breastfeeding or planning to become pregnant during the study
  • Evidence of current pregnancy or breastfeeding
  • Female subject of childbearing potential unwilling to use an acceptable method of effective contraception
  • Hypertension on the experimental day defined as systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg
  • Hypotension on the experimental day defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 50mmHg
  • Any headache (including migraine) within 24 hours prior to the start of the CGRP-infusion
  • Intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the CGRP-infusion
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study 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): NCT04592952


Contacts
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Contact: Messoud Ashina, MD +4538633385 ashina@dadlnet.dk
Contact: Hakan Ashina, MD +4528102495 haakan.ashina@regionh.dk

Locations
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Denmark
Danish Headache Center Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Hakan Ashina, MD       haakan.ashina@regionh.dk   
Contact: Messoud Ashina, MD       ashina@dadlnet.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Messoud Ashina, MD Danish Headache Center
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Responsible Party: Messoud Ashina, Professor of Neurology, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04592952    
Other Study ID Numbers: H-20047793
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Hypersensitivity
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Immune System Diseases
Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Erenumab
Katacalcin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents