Selective Activation of the Adrenomedullin Receptors in Migraine

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanish Headache Center

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Adrenomedullin
  • Placebo

Treatment groups

26 Participants
are divided into 2 treatment groups

Sponsors and collaborators