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Hypersensitivity to Adrenomedullin in Post-Traumatic Headache

RecruitingNAAges 18 Years - 65 YearsAllDanish Headache Center
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) * โ‰ฅ 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 โ‰ฅ150 mmHg and/or diastolic blood pressure of โ‰ฅ100 mmHg) prior to the start of infusion on the experimental day * Hypotension (systolic blood pressure of โ‰ค90 mmHg and/or diastolic blood pressure of โ‰ค50 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
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What it tests

  • Adrenomedullin
  • Placebo
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Where

1 site
Rigshospitalet-Glostrup
Glostrup Municipality, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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