Actively Recruiting
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
Eligibility Criteria
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.
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
Trial Site Locations
Total: 1 location
1
Rigshospitalet-Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
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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