Hypersensitivity to Adrenomedullin in Post-Traumatic Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adrenomedullin, Placebo.
- Who it may be relevant to
- Registry conditions: Posttraumatic Headache. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypersensitivity to Adrenomedullin in Post- Traumatic Headache: A Randomized Clinical Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of headache with migraine-like features [Time frame: 12 hours]
Secondary outcome measures (1)
- Headache Intensity Scores [Time frame: 12 hours]
Eligibility criteria
Inclusion criteria
- Age 18 to 65 years of age upon entry into screening
- History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- ≥ 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.
Exclusion criteria
- > 1 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 (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- The subject is at 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 blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
- Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
- Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
- Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
- Baseline headache intensity of >3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
- Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Rigshospitalet-Glostrup — Glostrup Municipality
Identifiers
NCT: NCT07059546 · H-21067681