[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443028":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":120,"collaborators":31,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":31,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":31,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":31,"overallStatus":46,"whyStopped":31,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Henry M. Jackson Foundation for the Advancement of Military Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Drug","EXPERIMENTAL","Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.",[13],"Drug: Erenumab 140 Mg\u002FmL Subcutaneous Solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Erenumab 140 Mg\u002FmL Subcutaneous Solution","Active erenumab delivered via subcutaneous injection.",[9],[27],"Aimovig",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo delivered via subcutaneous injection.",[15],null,[33],{"name":34,"affiliation":35,"role":36},"David L Brody, MD, PhD","Uniformed Services University of the Health Sciences","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Amy Guthrie, RN","CONTACT","202-924-2729","amy.guthrie.ctr@usuhs.edu",[44,69,87,103],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Womack Army Medical Center - Fort Liberty","RECRUITING","Fort Bragg","North Carolina","28310","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-79.00603,35.139,{"lat":56,"lon":55},[59,63,67],{"name":60,"role":40,"phone":61,"phoneExt":31,"email":62},"Jennifer Robles, RN","240-749-1042","jennifer.robles.ctr@usuhs.edu",{"name":64,"role":40,"phone":65,"phoneExt":31,"email":66},"Alexandra Fraiser","240-749-4550","alexandra.fraiser.ctr@usuhs.edu",{"name":68,"role":36,"phone":31,"phoneExt":31,"email":31},"CDR Katherine Demers",{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":50,"countryCode":51,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University of Pittsburgh Concussion Research Laboratory","NOT_YET_RECRUITING","Pittsburgh","Pennsylvania","15203",{"type":53,"coordinates":76},[77,78],-79.99589,40.44062,{"lat":78,"lon":77},[81,85],{"name":82,"role":40,"phone":83,"phoneExt":31,"email":84},"Courtney Perry","412-904-1298","cap236@pitt.edu",{"name":86,"role":36,"phone":31,"phoneExt":31,"email":31},"Anthony Kontos, MD",{"facility":88,"status":46,"city":89,"state":90,"zip":91,"country":50,"countryCode":51,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"William Beaumont Army Medical Center","El Paso","Texas","79918",{"type":53,"coordinates":93},[94,95],-106.48693,31.75872,{"lat":95,"lon":94},[98,101],{"name":99,"role":40,"phone":31,"phoneExt":31,"email":100},"Cecilia Valdovinos, NP","cecilia.valdovinos.ctr@usuhs.edu",{"name":102,"role":36,"phone":31,"phoneExt":31,"email":31},"Sean Sebesta, MD",{"facility":104,"status":71,"city":105,"state":106,"zip":107,"country":50,"countryCode":51,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Madigan Army Medical Center","Tacoma","Washington","98431",{"type":53,"coordinates":109},[110,111],-122.44429,47.25288,{"lat":111,"lon":110},[114,118],{"name":115,"role":40,"phone":116,"phoneExt":31,"email":117},"Janel Cuevas","240-890-6518","janel.cuevas.ctr@usuhs.edu",{"name":119,"role":36,"phone":31,"phoneExt":31,"email":31},"Melissa Belle, NP",{"type":121,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100443028","phase-2-treatment-of-acute-pth-with-a-cgrp-receptor-mab-in-military-service-members-and-civilians-with-mtbi-100443028",false,"NCT05049057","Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI","Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension","Inclusion Criteria:\n\n* Male or female ≥18 and ≤50 years of age\n* mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days\n* PTH has occurred within the prior 7 days\n* Able to provide informed consent\n* Likely to stay in the same geographical area for the duration of study\n* Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider\n\nExclusion Criteria:\n\n* Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:\n\n  1. abnormal structural imaging\n  2. loss of consciousness for \\>30 minutes\n  3. alteration of consciousness\u002Fmental state for \\>24 hours 3. post-traumatic amnesia for \\>1 day\n* Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury","ALL","18 Years","50 Years",{"count":133,"type":134},404,"ESTIMATED","INTERVENTIONAL",[137],"PHASE2","This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).",[140,141],"Posttraumatic Headache","Mild Traumatic Brain Injury","2024-02-21",{"date":144,"type":145},"2024-02-22","ACTUAL",{"date":147,"type":145},"2022-07-19",{"date":149,"type":134},"2027-05-19",{"name":5,"class":6},4]