[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564661":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":54,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Danish Headache Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Substance P","EXPERIMENTAL","Substance P will be administered by intravenous infusion.",[13],"Drug: Substance P",{"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 a continuous intravenous infusion of 20 mL of substance P (1.5 pmol\u002Fkg\u002Fmin) 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},"Hakan Ashina, MD, PhD","CONTACT","+45 28 10 24 95","haakan.ashina@regionh.dk",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Haidar Al-Khazali, MD","+45 41 59 84 94","haidardk@hotmail.com",[40],{"facility":41,"status":25,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Danish Headache Center, Copenhagen University Hospital - Rigshospitalet","Glostrup Municipality","2600","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],12.40377,55.6666,{"lat":50,"lon":49},[53],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Håkan Ashina","Senior Researcher","100564661","effects-of-substance-p-on-headache-induction-in-healthy-individuals-100564661",false,"NCT06632080","Effects of Substance P on Headache Induction in Healthy Individuals","Effects of Substance P on Headache Induction in Healthy Individuals: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 18 to 65 years of age upon entry into screening\n* A body weight of 50 to 100 kg\n* Provision of informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n\nExclusion Criteria:\n\n* Any history of a primary or secondary headache disorder, except for infrequent episodic tensiontype headache\n* Any first-degree relatives with a history of a primary headache disorder, except for infrequent episodic tension-type headache\n* Any history of moderate to severe traumatic brain injury\n* Any history of cardiovascular disease, including cerebrovascular diseases\n* Any history of pulmonary disease\n* Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results\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* Abnormalities on the electrocardiogram that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results\n* Daily use of any medication other than contraceptives\n* Intake of any medication other than contraceptives within 48 hours of infusion start\n* Intake of caffeine, nicotine, and alcohol within 12 hours of infusion start\n* Headache of any intensity within 48 hours of infusion start",true,"ALL","18 Years","65 Years",{"count":70,"type":71},21,"ESTIMATED","INTERVENTIONAL",[74],"NA","Substance P is a signaling molecule that has been implicated in the pathogenesis of headache. This study aims to ascertain whether administration of substance P can induce headache in healthy adults.",[77],"Healthy Volunteers Only",[79],"Headache","NOT_YET_RECRUITING","2024-10-11",{"date":83,"type":84},"2024-10-15","ACTUAL",{"date":86,"type":71},"2024-10-14",{"date":88,"type":71},"2025-12-31",{"name":5,"class":6},1]