[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619142":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":93,"overallStatus":95,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Danish Headache Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amylin","EXPERIMENTAL","Pramlintide (Amylin) will be administered by intravenous infusion.",[13],"Drug: Amylin",{"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 6 μg\u002Fmin of pramlintide (amylin) over 20 minutes.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The participants will receive 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, PhD","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":25,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Rigshospitalet Glostrup","Glostrup Municipality","2600","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],12.40377,55.6666,{"lat":50,"lon":49},[53,54],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ksenija Cucanic","PhD Fellow","100619142","hypersensitivity-to-amylin-in-post-traumatic-headache-100619142",false,"NCT07340775","Hypersensitivity to Amylin in Post-Traumatic Headache","Hypersensitivity to Amylin 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 migraine-like headache or self-reported baseline headache that mimics the subjects' usual migraine-like headache","ALL","18 Years","65 Years",{"count":70,"type":71},21,"ESTIMATED","INTERVENTIONAL",[74],"NA","Pramlintide is a peptide analogue of human amylin which is a vasoactive substance involved in the pathogenesis of headache. This study investigates whether pramlintide induces migraine-like headache in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).",[77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,9,92],"Headache Disorders, Secondary","Brain Diseases","Headache Disorders","Nervous System Diseases","Central Nervous System Diseases","Neurologic Manifestations","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Post-Traumatic Headache","Pain","Peptide Hormones","Hormones","Hormones, Hormone Substitutes, and Hormone Antagonists","Peptides","Amino Acids, Peptides, and Proteins","Pramlintide",[94,86,9],"Post-traumatic headache","NOT_YET_RECRUITING","2026-01-05",{"date":98,"type":99},"2026-01-14","ACTUAL",{"date":101,"type":71},"2026-02",{"date":103,"type":71},"2028-12",{"name":5,"class":6},1]