NCT07059546

Hypersensitivity to Adrenomedullin in Post-Traumatic Headache

Hypersensitivity to Adrenomedullin in Post- Traumatic Headache: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (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 headache. This study investigates whether adrenomedullin induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

Detailed description

Adrenomedullin is a potent vasoactive peptide that acts on the vascular smooth muscle and is known to induce vasodilation. It is endogenously expressed in the trigeminovascular system, a key anatomical substrate involved in headache pathogenesis. Evidence suggests that individuals with persistent post-traumatic headache (PTH) frequently experience headache with migraine-like symptoms. This study investigates whether intravenous infusion of adrenomedullin can provoke migraine-like headache in individuals with persistent PTH attributed to mild traumatic brain injury. To test this hypothesis, the investigators will carry out a randomized, double-blind, placebo-controlled, two-way crossover trial.

Conditions

• Posttraumatic Headache

Interventions

Type	Name	Description
DRUG	Adrenomedullin	The participants will receive continuous intravenous infusion of 20 mL of 19.9 pmol/kg/min adrenomedullin over 20 minutes.
DRUG	Placebo	The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-05-01
• Completion: 2028-12-01
• First posted: 2025-07-10
• Last updated: 2025-07-30

Locations

1 site across 1 country: Denmark