An interventional study of Adrenomedullin and Placebo in Migraine, Brain Diseases and Central Nervous System Diseases, sponsored by Danish Headache Center. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Basic science
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.
Adrenomedullin is an endogenous neuropeptide structurally related to CGRP that can activate both the adrenomedullin receptor and, to a lesser extent, the CGRP receptor. Prior human provocation studies have shown that administration of adrenomedullin can elicit migraine attacks in people with migraine. Because adrenomedullin lacks receptor selectivity, physiological responses observed after its administration might represent a composite of adrenomedullin-receptor activation and potential off-target activation of the CGRP receptor. The extent to which selective activation of the adrenomedullin receptor alone can provoke migraine-relevant responses remains unknown.
To isolate adrenomedullin receptor-mediated effects, participants will receive the monoclonal antibody erenumab prior to adrenomedullin administration in order to block CGRP receptor activation.
This study therefore aims to determine whether selective activation of adrenomedullin receptors - isolated from confounding CGRP receptor activation - can induce migraine-relevant physiological responses.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 26 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Adrenomedullin
Other: Placebo
Continous intravenous infusion of 20 mL (19.9 pmol/kg/min) adrenomedulin over 20 minutes
Continous 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.
Time frame: Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo
Headache intensity
Headache intensity, assessed using a numerical rating scale (NRS) from 0 to 10: * 0 = No headache * 10 = Worst headache imaginable
Time frame: Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo
Plan to share: Yes — Anonymized data not published within this article will be made available on reasonable request from any qualified investigator
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Studies of the drug tested here: Adrenomedullin