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

October 21, 2022 updated by: Messoud Ashina, MD, Danish Headache Center
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • CGRP
Drug: Erenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Other Names:
  • Aimovig

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline Phase (Day -28 to Day 1) to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Provocation Phase (12 Hours)
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).
1 Hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2020

Primary Completion (Anticipated)

August 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20047793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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