NCT07059546 Hypersensitivity to Adrenomedullin in Post-Traumatic Headache
| NCT ID | NCT07059546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Headache Center |
| Condition | Posttraumatic Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 21 participants in total. It began in 2025-08-01 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07059546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Posttraumatic Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059546 currently recruiting?
Yes, NCT07059546 is actively recruiting participants. Contact the research team at haidardk@hotmail.com for enrollment information.
Where is the NCT07059546 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark.
Who is sponsoring the NCT07059546 clinical trial?
NCT07059546 is sponsored by Danish Headache Center. The trial plans to enroll 21 participants.