Trials / Not Yet Recruiting
Not Yet RecruitingNCT07451769
Selective Activation of the Adrenomedullin Receptors in Migraine
Selective Activation of the Adrenomedullin Receptors in Migraine: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- Danish Headache Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Migraine
- Brain Diseases
- Central Nervous System Diseases
- Adrenomedullin
- Pain
- Peptides
- Neuropeptides
- Signs and Symptoms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adrenomedullin | Continous intravenous infusion of 20 mL (19.9 pmol/kg/min) adrenomedulin over 20 minutes |
| OTHER | Placebo | Continous intravenous infusion of 20 mL isotonic saline over 20 minutes |
Timeline
- Start date
- 2026-03-10
- Primary completion
- 2027-03-10
- Completion
- 2032-12-20
- First posted
- 2026-03-05
- Last updated
- 2026-03-09
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT07451769. Inclusion in this directory is not an endorsement.