Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07059546

Hypersensitivity to Adrenomedullin in Post-Traumatic Headache

Led by Danish Headache Center · Updated on 2025-07-30

21

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Hypersensitivity to Adrenomedullin in Post-Traumatic Headache

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years of age upon entry into screening
  • History of persistent headache attributed to mild traumatic injury to the head for 2 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
  • 2 4 monthly headache days on average across the 3 months prior to screening
  • Provision of informed consent prior to initiation of any study-specific activities/procedures.
Not Eligible

You will not qualify if you...

  • More than one mild traumatic injury to the head
  • History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
  • History of moderate or severe injury to the head
  • History of whiplash injury
  • History of craniotomy
  • History or evidence of any other clinically significant disorder, condition or disease that would pose a risk to safety or interfere with study evaluation
  • Risk of self-harm or harm to others as evidenced by past suicidal behavior
  • Female subjects of childbearing potential with a positive pregnancy test during any study visit
  • Cardiovascular disease of any kind, including cerebrovascular diseases
  • Hypertension (systolic 2 150 mmHg and/or diastolic 2 100 mmHg) prior to infusion
  • Hypotension (systolic C 90 mmHg and/or diastolic C 50 mmHg)
  • Changes in dosing of prophylactic medications within 2 months prior to study inclusion
  • Intake of acute medications within 48 hours of infusion start
  • Baseline headache intensity greater than 3 on an 11-point numeric scale
  • Baseline headache with migraine-like features or mimicking usual headache with migraine-like features

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rigshospitalet-Glostrup

Glostrup Municipality, Denmark, 2600

Actively Recruiting

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Research Team

H

Haidar Al-Khazali, MD

CONTACT

H

Hakan Ashina, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Hypersensitivity to Adrenomedullin in Post-Traumatic Headache | DecenTrialz