[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642854":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Montefiore Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metoclopramide 10 mg","ACTIVE_COMPARATOR","Metoclopramide 10 mg IV over 15 minutes",[13],"Drug: Metoclopramide 10mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Acetaminophen","1000 Mg IV over 15 minutes",[18],"Drug: Acetaminophen",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Metoclopramide 10mg","Intravenous drip",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Intravenous drip over 15 minutes",[15],[30],{"name":31,"affiliation":5,"role":32},"Benjamin W Friedman, MD,MS","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Hamed Sarikhani, MD","CONTACT","929-731-2137","hsarikhani@montefiore.org",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Benjamin W W.Friedman, MD,MS","7189043333","befriedman@montefiore.org",[44],{"facility":5,"status":25,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"New York","10467","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-74.00597,40.71427,{"lat":53,"lon":52},[56,58],{"name":57,"role":36,"phone":37,"phoneExt":25,"email":38},"Hamed Sarikhani Assistant Professor of Emergency Medicine, MD",{"name":59,"role":36,"phone":60,"phoneExt":25,"email":42},"Benjamin W.Friedman, MD,MS","718-904-3333",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100642854","phase-4-intravenous-metoclopramide-versus-intravenous-acetaminophen-for-acute-concussion-treatment-100642854",false,"NCT07634393","Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment","A Randomized Study of Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment","IMPACT","Inclusion Criteria:\n\n* Adults presenting to one of the study emergency departments (EDs)\n* Acute minor traumatic brain injury\u002Fconcussion as defined by the Zurich Consensus Statement, including symptoms in somatic, cognitive, emotional, behavioral, physical, cognitive impairment, or sleep domains\n* ED visit occurring within 7 days of the head injury\n* Overall pain intensity greater than \\>=6 on a 0-10 scale\n* Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10\n* Reported post-concussion symptoms were not present prior to the injury\n* Treating attending physician plans to administer a parenteral medication\n\nExclusion Criteria:\n\n* Already treated with an anti-dopaminergic medication for post-concussion symptoms\n* Contraindications to study medications, including:\n* Pheochromocytoma\n* Seizure disorder\n* Parkinson's disease\n* Use of monoamine oxidase (MAO) inhibitors\n* Use of anti-rejection transplant medications\n* Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.","ALL","18 Years",{"count":74,"type":75},200,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","The IMPACT study is a randomized, double-blind clinical trial evaluating two commonly used intravenous medications - metoclopramide and acetaminophen - for treating acute post-concussion symptoms in emergency department patients after mild head injury. The study aims to determine which treatment more effectively improves symptoms such as headache, dizziness, nausea, concentration difficulties, and emotional changes within the first week after injury.\n\nParticipants will be enrolled across two Montefiore emergency departments and followed using a validated post-concussion symptom questionnaire. Findings from this study may help improve evidence-based treatment strategies for patients experiencing concussion-related symptoms after head trauma.",[81,82],"Concussion Post Syndrome","Head Trauma Injury",[84,85,15,86],"Concussion","Head Trauma","Metoclopramide","NOT_YET_RECRUITING","2026-06-06",{"date":90,"type":91},"2026-06-10","ACTUAL",{"date":93,"type":75},"2026-08-01",{"date":95,"type":75},"2028-08-04",{"name":5,"class":6},1]