Clinical trial NCT04592952: Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
Official title: Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Eligibility 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

Primary outcomes:
measure: Headache Diary (Baseline Phase and Treatment Phase)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
Secondary outcomes:
measure: Headache Diary (Provocation Phase)
timeFrame: Provocation Phase (12 Hours)
measure: Semi-Structured Interview
timeFrame: 1 Hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Glostrup
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, MD
role: PRINCIPAL_INVESTIGATOR
References: