Current partner codePEPTIDESDE
NCT04592952·Phase 4·INTERVENTIONAL

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

Status

Unknown

Phase

Phase 4

Enrollment

400

Locations

1

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

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

Full 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)

Interventions

Treatment arms and agents.

DRUG

Calcitonin Gene-Related Peptide

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

DRUG

Erenumab

Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)

Timeline

From registration to results.

  1. First posted

    Oct 19, 2020

  2. Study start

    Oct 8, 2020

  3. Primary completion

    Aug 1, 2025

  4. Study completion

    Aug 1, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Oct 24, 2022

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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)

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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
50 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Danish Headache Center

Copenhagen, Glostrup, Denmark

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

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