Adrenomedullin is a neuropeptide implicated in the pathogenesis of migraine. This study investigates whether its administration, after pre-treatment with erenumab (a CGRP-receptor blocking monoclonal antibody), can trigger migraine attacks in individuals with migraine without aura.
Written informed consent has been obtained prior to the initiation of any study-specific procedures.
Age ≥18 years at the time of screening.
History of migraine without aura for at least 12 months prior to screening, with a frequency of 1-5 migraine attacks per month, based on medical records and/or patient self-report, and diagnosed in accordance with the ICHD-3 criteria.
History of any other primary headache disorder, except for tension-type headache with <5 headache days per month, based on ICHD-3 classification.
History of any secondary headache disorder, per ICHD-3 criteria, prior to screening.
Use of prophylactic migraine medication within 30 days or within 5 plasma half-lives (whichever is longer) prior to screening.
Previous use of any therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, or small molecule CGRP receptor antagonists.
Crossover
Adrenomedullin
DrugContinous intravenous infusion of 20 mL (19.9 pmol/kg/min) adrenomedulin over 20 minutes
Placebo
Other interventionContinous intravenous infusion of 20 mL isotonic saline over 20 minutes
Incidence of migraine attacks
Incidence of migraine attacks, defined by either: I. Headache fulfilling criteria C and D for migraine without aura according to ICHD-3 2 * Criterion C: At least two of the following: * Unilateral location * Pulsating quality * Moderate to severe pain intensity (≥4 on an 11-point numerical rating scale) * Aggravation by cough (in-hospital setting) or avoidance of routine physical activity (out-hospital setting) * Criterion D: At least one of the following: * Nausea and/or vomiting * Photophobia and phonophobia OR II. Headache that mimics the participant's usual spontaneous migraine attacks and is treated with acute migraine (rescue) medication.
Headache intensity
Headache intensity, assessed using a numerical rating scale (NRS) from 0 to 10: * 0 = No headache * 10 = Worst headache imaginable
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