Migraine
Conditions
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)
Interventions
Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
DRUGErenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Sponsors
Danish Headache Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Denmark
Contacts
Primary ContactMessoud Ashina, MD
Backup ContactHakan Ashina, MD
Outcome results
None listed