[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578921":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":28,"responsibleParty":84,"collaborators":11,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":112,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"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",[29,41,50,58,66,76],{"facility":30,"status":31,"city":32,"state":11,"zip":11,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":11},"Klinik für Querschnittgelähmte, Klinikum Bayreuth","RECRUITING","Bayreuth","Germany","DE",{"type":36,"coordinates":37},"Point",[38,39],11.57893,49.94782,{"lat":39,"lon":38},{"facility":42,"status":43,"city":44,"state":11,"zip":11,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":49,"contacts":11},"Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost","NOT_YET_RECRUITING","Halle",{"type":36,"coordinates":46},[47,48],11.97947,51.48158,{"lat":48,"lon":47},{"facility":51,"status":31,"city":52,"state":11,"zip":11,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":57,"contacts":11},"Klinik für Paraplegiologie, Universitätsklinikum Heidelberg","Heidelberg",{"type":36,"coordinates":54},[55,56],8.69079,49.40768,{"lat":56,"lon":55},{"facility":59,"status":31,"city":60,"state":11,"zip":11,"country":33,"countryCode":34,"cosmosGeoPoint":61,"geoPoint":65,"contacts":11},"Zentrum für Rückenmarksverletzte, Unfallklinik Murnau","Murnau am Staffelsee",{"type":36,"coordinates":62},[63,64],11.20125,47.68085,{"lat":64,"lon":63},{"facility":67,"status":31,"city":68,"state":11,"zip":11,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":11},"Swiss Paraplegic Centre","Nottwil","Switzerland","CH",{"type":36,"coordinates":72},[73,74],8.13774,47.13469,{"lat":74,"lon":73},{"facility":77,"status":31,"city":78,"state":11,"zip":11,"country":69,"countryCode":70,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"Universitätsklinik Balgrist","Zurich",{"type":36,"coordinates":80},[81,82],8.55,47.36667,{"lat":82,"lon":81},{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100578921","phase-1-ng004-in-spinal-cord-injury-patients-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":98,"type":99},21,"ESTIMATED","INTERVENTIONAL",[102],"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.",[105,106,107,108,109,110,111],"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",[113,114,92,115],"Acute spinal cord injury","Nogo-A","Regeneration","2025-02-04",{"date":118,"type":119},"2025-02-10","ACTUAL",{"date":121,"type":119},"2024-12-18",{"date":123,"type":99},"2026-09",{"name":5,"class":6},6]