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Recruiting Not applicable

Selective Activation of the Adrenomedullin Receptors in Migraine

NCT07451769 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2026-03-12
Last updated
2026-08-28

Condition(s) studied

MigraineBrain DiseasesCentral Nervous System DiseasesAdrenomedullinPainPeptidesNeuropeptidesSigns and Symptoms

Investigational drug(s) / intervention(s)

Adrenomedullin →Placebo

Adrenomedullin: Continous intravenous infusion of 20 mL (19.9 pmol/kg/min) adrenomedulin over 20 minutes

Placebo: Continous intravenous infusion of 20 mL isotonic saline over 20 minutes

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent has been obtained prior to the initiation of any study-specific procedures. 2. Age ≥18 years at the time of screening. 3. 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. Exclusion Criteria: 1. History of any other primary headache disorder, except for tension-type headache with \<5 headache days per month, based on ICHD-3 classification. 2. History of any secondary headache disorder, per ICHD-3 criteria, prior to screening. 3. Use of prophylactic migraine medication within 30 days or within 5 plasma half-lives (whichever is longer) prior to screening. 4. 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. 5. Known risk of self-harm or harm to others, including a history of suicidal behavior. 6. 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. 7. Positive urine pregnancy test at screening or on Day 1 in female participants of childbearing potential. 8. Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during the study period. 9. Evidence of current pregnancy or breastfeeding based on self-report or medical records. 10. Inability or unwillingness to complete all protocol-required visits and procedures, or concerns regarding protocol adherence, as judged by the investigator.

Primary outcome measure(s)

  • Incidence of migraine attacks — Assessed from baseline to 12 hours post-infusion of adrenomedullin or placebo
    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.

Trial sites (1)

FacilityCityRegionStatus
Danish Headache Center Glostrup Municipality Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07451769 on ClinicalTrials.gov ↗ ← All trials in Denmark