Selective Activation of the Adrenomedullin Receptors in Migraine

Starting soon · Not applicable · Has a placebo group

Conditions studied: Migraine, Brain Diseases, Central Nervous System Diseases, Adrenomedullin, Pain, Peptides, Neuropeptides, Signs and Symptoms

In brief

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.

Key facts

Study ID

NCT07451769

Run by

Danish Headache Center

People needed

26

Starts

2026-03-10

Expected to finish

2032-12-20

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Known risk of self-harm or harm to others, including a history of suicidal behavior.
• Any clinically significant disorder, condition, or disease (other than those permitted in the protocol) that, in the opinion of the investigator, could compromise participant safety or interfere with study procedures or data integrity.
• Positive urine pregnancy test at screening or on Day 1 in female participants of childbearing potential.
• Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during the study period.
• Evidence of current pregnancy or breastfeeding based on self-report or medical records.
• Inability or unwillingness to complete all protocol-required visits and procedures, or concerns regarding protocol adherence, as judged by the investigator.

Where it is running

• Danish Headache Center — Glostrup Municipality, Denmark

Full record on ClinicalTrials.gov

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