[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578921":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":28,"responsibleParty":82,"collaborators":11,"id":84,"slug":11,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":109,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"NovaGo Therapeutics AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NG004","EXPERIMENTAL",null,[13],"Drug: NG004",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","repeated intrathecal injections of NG004",[9],[20],{"name":21,"affiliation":5,"role":22},"Director of Clinical Research","STUDY_DIRECTOR",[24],{"name":21,"role":25,"phone":26,"phoneExt":11,"email":27},"CONTACT","+41433005263","clinical@novagotx.com",[29,40,49,57,65,74],{"facility":30,"status":31,"city":32,"state":11,"zip":11,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":11},"Klinik für Querschnittgelähmte, Klinikum Bayreuth","RECRUITING","Bayreuth","Germany",{"type":35,"coordinates":36},"Point",[37,38],11.57893,49.94782,{"lat":38,"lon":37},{"facility":41,"status":42,"city":43,"state":11,"zip":11,"country":33,"cosmosGeoPoint":44,"geoPoint":48,"contacts":11},"Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost","NOT_YET_RECRUITING","Halle",{"type":35,"coordinates":45},[46,47],11.97947,51.48158,{"lat":47,"lon":46},{"facility":50,"status":31,"city":51,"state":11,"zip":11,"country":33,"cosmosGeoPoint":52,"geoPoint":56,"contacts":11},"Klinik für Paraplegiologie, Universitätsklinikum Heidelberg","Heidelberg",{"type":35,"coordinates":53},[54,55],8.69079,49.40768,{"lat":55,"lon":54},{"facility":58,"status":31,"city":59,"state":11,"zip":11,"country":33,"cosmosGeoPoint":60,"geoPoint":64,"contacts":11},"Zentrum für Rückenmarksverletzte, Unfallklinik Murnau","Murnau am Staffelsee",{"type":35,"coordinates":61},[62,63],11.20125,47.68085,{"lat":63,"lon":62},{"facility":66,"status":31,"city":67,"state":11,"zip":11,"country":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"Swiss Paraplegic Centre","Nottwil","Switzerland",{"type":35,"coordinates":70},[71,72],8.13774,47.13469,{"lat":72,"lon":71},{"facility":75,"status":31,"city":76,"state":11,"zip":11,"country":68,"cosmosGeoPoint":77,"geoPoint":81,"contacts":11},"Universitätsklinik Balgrist","Zurich",{"type":35,"coordinates":78},[79,80],8.55,47.36667,{"lat":80,"lon":79},{"type":83,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100578921",false,"NCT06817577","NG004 in Spinal Cord Injury Patients","A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients","SPROUT","Inclusion Criteria:\n\n* Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening\n* 4-28 days post-injury\n* No required mechanical ventilation or patients that not completely depend on mechanical ventilation\n* Hemodynamically and clinical stable patient according to the acute SCI condition at baseline\n\nExclusion Criteria:\n\n* Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds\n* Multiple levels of clinically relevant spinal cord lesions\n* Major brachial or lumbar plexus damage\u002Ftrauma\n* Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function\n* Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy\n* History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis\n* History of refractory epilepsy\n* History of or current autoimmune disease\n* Patients with uncontrolled bleeding diathesis and\u002For who require concomitant therapeutic anticoagulation and not related to SCI\n* Presence of any unstable medical or psychiatric condition\n* Drug dependence any time during the 6 month's preceding trial entry\n* Pregnant or nursing women\n* History of a life-threatening allergic or immune mediated reaction\n* Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections\n* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations\n* Patients who are unconscious","ALL","18 Years","70 Years",{"count":95,"type":96},21,"ESTIMATED","INTERVENTIONAL",[99],"PHASE1","This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.",[102,103,104,105,106,107,108],"Acute Spinal Cord Injury (SCI)","Spinal Cord Diseases","Central Nervous System Diseases","Nervous System Diseases","Trauma, Nervous System","Spinal Cord Injuries (SCI)","Wounds and Injuries",[110,111,89,112],"Acute spinal cord injury","Nogo-A","Regeneration","2025-02-04",{"date":115,"type":116},"2025-02-10","ACTUAL",{"date":118,"type":116},"2024-12-18",{"date":120,"type":96},"2026-09",{"name":5,"class":6},6]