Selective activation of the adrenomedullin receptor to provoke migraine in adults with migraine without aura

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will give erenumab to block CGRP receptors, then administer adrenomedullin or placebo to adults with migraine without aura to see if activating the adrenomedullin receptor can provoke migraine-related responses. Adrenomedullin is a neuropeptide related to CGRP and can activate multiple receptors; this design aims to isolate the adrenomedullin receptor effect. The trial uses an interventional, randomized approach to compare adrenomedullin against placebo and assess physiological migraine endpoints. Results could clarify whether adrenomedullin receptor signaling contributes to migraine initiation independent of CGRP receptor activity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Danish Headache Center
  Glostrup Municipality, Denmark Recruiting

Study contacts

• Study coordinator: Annette Maria Ellekaer Fuchs, PhD Fellow
• Email: annette.maria.ellekaer.fuchs@regionh.dk
• Phone: +4526232421

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.