[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644586":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":25,"responsibleParty":38,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":25},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug: Branched Chain Amino Acids","EXPERIMENTAL","The three BCAAs will be combined together into a powder formulation.",[13],"Drug: BCAA",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.",[19],"Other: Placebo",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","BCAA",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Daniel Corwin, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Olivia E. Podolak","CONTACT","8626687645","podolako@chop.edu",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Akiva Cohen","Researcher","100644586","phase-2-bcaas-in-concussion-30-100644586",false,"NCT07670195","BCAAs in Concussion 3.0","HIT HEADS 3.0: Head Injury Treatment: A Randomized, Placebo-controlled, Double-blinded, Therapeutic Clinical Trial of Branched Chain Amino Acids (BCAAs) in the Treatment of Concussion","Inclusion Criteria:\n\n1. Males and females,11 - 23 years of age.\n2. Weigh at least 40kg.\n3. Meeting concussion criteria for the American Congress of Rehabilitative Medicine.\n\n   a. One or more clinical signs or two or more acute symptoms with at least one VVE abnormality.\n4. Present within 4 days of injury.\n5. Post-menarchal females must have a negative urine pregnancy test.\n6. Informed consent by the participant, or for participants \\\u003C18 years old both informed consent by a parent\u002Fguardian and child assent.\n\nExclusion Criteria:\n\n1. Evidence of moderate or severe TBI, including GCS \\\u003C13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.\n2. Prior concussion or TBI within 90 days.\n3. Known history of maple syrup urine disease or known family history of maple syrup urine disease.\n4. Any investigational drug use within 30 days prior to enrollment.\n5. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.\n6. Non-English speaking participants or parent\u002Fguardian.",true,"ALL","11 Years","23 Years",{"count":54,"type":55},150,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.",[61,62,63,64],"Concussion (Diagnosis)","MTBI - Mild Traumatic Brain Injury","Concussion, Brain","Concussion",[64,66,67,68],"mTBI","BCAAs","Branched Chain Amino Acids","NOT_YET_RECRUITING","2026-06-19",{"date":72,"type":73},"2026-06-26","ACTUAL",{"date":75,"type":55},"2026-07",{"date":77,"type":55},"2027-12",{"name":40,"class":6}]