[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597519":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":58,"collaborators":25,"id":63,"slug":25,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Danish Headache Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adrenomedullin","EXPERIMENTAL","Adrenomedullin will be administered by intravenous infusion.",[13],"Drug: Adrenomedullin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo (isotonic saline) will be administered by intravenous infusion.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","The participants will receive continuous intravenous infusion of 20 mL of 19.9 pmol\u002Fkg\u002Fmin adrenomedullin over 20 minutes.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Haidar Al-Khazali, MD","CONTACT","+4541598494","haidardk@hotmail.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Hakan Ashina, MD,PhD","+4528102495","haakan.ashina@regionh.dk",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Rigshospitalet-Glostrup","RECRUITING","Glostrup Municipality","2600","Denmark",{"type":47,"coordinates":48},"Point",[49,50],12.40377,55.6666,{"lat":50,"lon":49},[53,54,56],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":55,"role":32,"phone":37,"phoneExt":25,"email":38},"Hakan Ashina, MD, PhD",{"name":31,"role":57,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":62,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Haidar Al-Khazali","Sub-Investigator","Rigshospitalet, Denmark","100597519",false,"NCT07059546","Hypersensitivity to Adrenomedullin in Post-Traumatic Headache","Hypersensitivity to Adrenomedullin in Post- Traumatic Headache: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 18 to 65 years of age upon entry into screening\n* 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)\n* ≥ 4 monthly headache days on average across the 3 months prior to screening\n* Provision of informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n\nExclusion Criteria:\n\n* \\> 1 mild traumatic injury to the head\n* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)\n* History of moderate or severe injury to the head\n* History of whiplash injury\n* History of craniotomy\n* 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\n* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior\n* Female subjects of childbearing potential with a positive pregnancy test during any study visit\n* Cardiovascular disease of any kind, including cerebrovascular diseases\n* Hypertension (systolic blood pressure of ≥150 mmHg and\u002For diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day\n* Hypotension (systolic blood pressure of ≤90 mmHg and\u002For diastolic blood pressure of ≤50 mmHg)\n* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion\n* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start\n* Baseline headache intensity of \\>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)\n* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features","ALL","18 Years","65 Years",{"count":73,"type":74},21,"ESTIMATED","INTERVENTIONAL",[77],"NA","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).",[80],"Posttraumatic Headache",[82,83,84],"pain","adrenomedullin","posttraumatic headache","2025-07-28",{"date":87,"type":88},"2025-07-30","ACTUAL",{"date":90,"type":74},"2025-08-01",{"date":92,"type":74},"2028-12-01",{"name":5,"class":6},1]