Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
- Registration Number
- NCT04592952
- Lead Sponsor
- 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.
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
- > 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-Arm Calcitonin Gene-Related Peptide 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) Single-Arm Erenumab 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)
- Primary Outcome Measures
Name Time Method Headache Diary (Baseline Phase and Treatment Phase) 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
Name Time Method Headache Diary (Provocation Phase) 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 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).
Trial Locations
- Locations (1)
Danish Headache Center
🇩🇰Copenhagen, Glostrup, Denmark