[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657425":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":11,"studyPopulation":11,"armGroups":64,"interventions":75,"overallOfficials":11,"centralContacts":84,"locations":90,"responsibleParty":193,"collaborators":11,"id":195,"slug":196,"hasResults":197,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":197,"sex":203,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":11,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":218,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"NovaGo Therapeutics AG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions",null,"From treatment start up to 6 months",[14,16,20],{"measure":15,"description":11,"timeFrame":12},"NG004 concentration in serum and CSF",{"measure":17,"description":18,"timeFrame":19},"Effect on neurological recovery according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol as change in ISNCSCI upper extremities motor score (UEMS) and Integrated Neurological Change Score","The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery","Baseline to 6 months",{"measure":21,"description":22,"timeFrame":23},"Effect on daily life functioning as Spinal Cord Independence Measure (SCIM-III)","The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities.","Month 6",[25,28,31,34,37,41,44,47,50],{"measure":26,"description":27,"timeFrame":23},"Effect on Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP): strength and prehension performance","The GRASSP is a validated clinical measure of hand function in tetraplegic patients and can assess changes in impairment over time. The GRASSP (Version 2) consists of 4 subtests. The subtest strength (manual muscle testing of 10 muscles of the upper limb) and the subtest prehension performance (grasping test with 4 activities of daily living) will be performed.",{"measure":29,"description":30,"timeFrame":23},"Effect on the Walking Index for Spinal Cord Injury (WISCI II)","WISCI II is a 21-item hierarchical scale of walking based on physical assistance, need of braces and devices, with an ordinal range from 0 (unable to walk) to 20 (walking without assistance for at least 10 meters).",{"measure":32,"description":33,"timeFrame":23},"Effect on 10-meter walking test (10mWT)","10mWT is a quantitative measurement of lower extremity function. The patient shall walk a set distance (10 meters) at preferred walking speed. The distance covered, the time taken, and the assistance used will be recorded.",{"measure":35,"description":36,"timeFrame":23},"Effect on 6-minute walking test (6MWT)","6MWT is a test used to determine the locomotor performance. Patients are instructed to walk as far as possible during 6 minutes, with rests being taken whenever required. The distance covered in time or until abort, the walking time until abort, and the number of rests are assessed.",{"measure":38,"description":39,"timeFrame":40},"Effect on respiratory function: Forced Vital Capacity (FVC) and Forced Expiratory volume in one second (FEV1)","The various lung parameters will include Forced Vital Capacity (FVC), Forced Expiratory volume in one second (FEV1) and peak expiratory flow (PEF).\n\nFVC measures volume in Litter delivered during an expiration made as forcefully and completely as possible starting from full inspiration.\n\nFEV1 assess the volume measured in Litter delivered in the first second of a FVC maneuver. PEF measures highest flow delivered during FVC maneuver (L\u002Fmin).","Baseline up to 6 months",{"measure":42,"description":43,"timeFrame":40},"Effect on respiratory function: Maximal Inspiratory Pressure [MIP] and Maximum Expiratory Pressure [MEP]","Effect on respiratory function measuring respiratory muscle strength: Maximal Inspiratory Pressure \\[MIP\\] and Maximum Expiratory Pressure \\[MEP\\]. MIP is assessed as the pressure (in cmH2O) during inhalation against a completely occluded airway and is used to evaluate inspiratory muscle strength. MEP a measure of the strength of expiratory muscles, obtained by having the patient exhale as strongly as possible against a resistance. It is assessed as the pressure (in cmH2O) during exhaling.",{"measure":45,"description":46,"timeFrame":19},"Effect on spinal cord morphology, lesion size, and tissue integrity using magnetic resonance imaging (MRI) scans","MRI scans of the spine will be used to characterize the extent of the lesion from the SCI by assessing morphological measures. Analyses of lesion parameters as preserved tissue bridges, lesion volume, lesion length, lesion width and spinal cord atrophy will be performed. Spinal cord atrophy is measured by calculating the cross-sectional area (CSA) of the spinal cord. Quantitative MRI will be used to assess microstructural tissue integrity, as assed by diffusion tensor imaging and quantitative magnetization transfer saturation mapping.",{"measure":48,"description":49,"timeFrame":23},"Effect on muscle spasticity (Modified Ashworth Scale [MAS])","MAS is a 6-point muscle tone assessment scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.",{"measure":51,"description":52,"timeFrame":23},"Effect on neuropathic pain (EMSCI Neuropathic Pain Assessment Form [NePAF])","Neuropathic pain will be assessed by the European Multicenter Study About Spinal Cord Injury (EMSCI) Neuropathic Pain Assessment Form (NePAF), which is based on a structured interview using rating scales, and includes specific assessment of the SCI-associated neuropathic pain in terms of location, quality and severity. The pain intensity is rated with an 11-point numeric rating scale with 0 indicating no pain and 10 indicating the worst imaginable pain.",{"allocation":54,"interventionModel":55,"interventionModelDescription":11,"primaryPurpose":56,"observationalModel":11,"timePerspective":11,"maskingInfo":57},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":58,"maskingDescription":11,"whoMasked":59},"QUADRUPLE",[60,61,62,63],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[65,70],{"label":66,"type":67,"description":11,"interventionNames":68},"NG004","EXPERIMENTAL",[69],"Drug: NG004",{"label":71,"type":72,"description":11,"interventionNames":73},"Placebo","PLACEBO_COMPARATOR",[74],"Other: Placebo",[76,80],{"type":77,"name":66,"description":78,"armGroupLabels":79,"otherNames":11},"DRUG","repeated intrathecal injections of NG004 within 30 days",[66],{"type":81,"name":71,"description":82,"armGroupLabels":83,"otherNames":11},"OTHER","repeated intrathecal injections of Placebo within 30 days",[71],[85],{"name":86,"role":87,"phone":88,"phoneExt":11,"email":89},"Director of Clinical Research","CONTACT","+41433005263","clinical@novagotx.com",[91,106,115,123,131,139,147,158,171,182],{"facility":92,"status":93,"city":94,"state":11,"zip":11,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Klinik für Querschnittgelähmte, Klinikum Bayreuth","RECRUITING","Bayreuth","Germany","DE",{"type":98,"coordinates":99},"Point",[100,101],11.57893,49.94782,{"lat":101,"lon":100},[104],{"name":11,"role":87,"phone":11,"phoneExt":11,"email":105},"qs-studien@klinikum-bayreuth.de",{"facility":107,"status":108,"city":109,"state":11,"zip":11,"country":95,"countryCode":96,"cosmosGeoPoint":110,"geoPoint":114,"contacts":11},"BG Universitätsklinikum Bergmannsheil","NOT_YET_RECRUITING","Bochum",{"type":98,"coordinates":111},[112,113],7.21648,51.48165,{"lat":113,"lon":112},{"facility":116,"status":108,"city":117,"state":11,"zip":11,"country":95,"countryCode":96,"cosmosGeoPoint":118,"geoPoint":122,"contacts":11},"Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost","Halle",{"type":98,"coordinates":119},[120,121],11.97947,51.48158,{"lat":121,"lon":120},{"facility":124,"status":108,"city":125,"state":11,"zip":11,"country":95,"countryCode":96,"cosmosGeoPoint":126,"geoPoint":130,"contacts":11},"BG Klinikum Hamburg","Hamburg",{"type":98,"coordinates":127},[128,129],9.99302,53.55073,{"lat":129,"lon":128},{"facility":132,"status":108,"city":133,"state":11,"zip":11,"country":95,"countryCode":96,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"Klinik für Paraplegiologie, Universitätsklinikum Heidelberg","Heidelberg",{"type":98,"coordinates":135},[136,137],8.69079,49.40768,{"lat":137,"lon":136},{"facility":140,"status":108,"city":141,"state":11,"zip":11,"country":95,"countryCode":96,"cosmosGeoPoint":142,"geoPoint":146,"contacts":11},"Zentrum für Rückenmarksverletzte, Unfallklinik Murnau","Murnau am Staffelsee",{"type":98,"coordinates":143},[144,145],11.20125,47.68085,{"lat":145,"lon":144},{"facility":148,"status":93,"city":149,"state":11,"zip":11,"country":95,"countryCode":96,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"BG Klinik Tübingen","Tübingen",{"type":98,"coordinates":151},[152,153],9.05222,48.52266,{"lat":153,"lon":152},[156],{"name":11,"role":87,"phone":11,"phoneExt":11,"email":157},"SPROUT@bgu-tuebingen.de",{"facility":159,"status":93,"city":160,"state":11,"zip":11,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"REHAB Basel","Basel","Switzerland","CH",{"type":98,"coordinates":164},[165,166],7.57327,47.55839,{"lat":166,"lon":165},[169],{"name":11,"role":87,"phone":11,"phoneExt":11,"email":170},"sprout-Studienteam@rehab.ch",{"facility":172,"status":93,"city":173,"state":11,"zip":11,"country":161,"countryCode":162,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Swiss Paraplegic Centre","Nottwil",{"type":98,"coordinates":175},[176,177],8.13774,47.13469,{"lat":177,"lon":176},[180],{"name":11,"role":87,"phone":11,"phoneExt":11,"email":181},"sprout@paraplegie.ch",{"facility":183,"status":93,"city":184,"state":11,"zip":11,"country":161,"countryCode":162,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Universitätsklinik Balgrist","Zurich",{"type":98,"coordinates":186},[187,188],8.55,47.36667,{"lat":188,"lon":187},[191],{"name":11,"role":87,"phone":11,"phoneExt":11,"email":192},"sprout@balgrist.ch",{"type":194,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657425","phase-1-ng004-in-incomplete-spinal-cord-injury-patients-100657425",false,"NCT07840196","NG004 in Incomplete Spinal Cord Injury Patients","A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Human Monoclonal Antibody NG004 in Acute, Incomplete Cervical Spinal Cord Injury (SCI) Patients","SPROUT-2","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) B, C and D at Screening\n* 4-28 days post-injury and no earlier than 4 days after spinal surgery\n* No required mechanical ventilation or patients that do 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\n* History of or an episode of multiple sclerosis or Guillain-Barre syndrome\n* History of recent meningitis or meningoencephalitis\n* History of refractory epilepsy\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 within the last 6 months before Screening\n* Pregnant or nursing women\n* History of a life-threatening allergic or immune-mediated reaction\n* 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","75 Years",{"count":207,"type":208},120,"ESTIMATED","INTERVENTIONAL",[211],"PHASE1","This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI. The trial will evaluate the safety and tolerability, PK, and effects on motor function and daily life functioning of NG004 compared with placebo.",[214,215,216,217],"Acute Spinal Cord Injury (SCI)","Spinal Cord Diseases","Spinal Cord Injuries","Trauma Nervous System",[219,220,201,221],"Acute spinal cord injury","Nogo-A","Regeneration","2026-09-21",{"date":224,"type":225},"2026-09-24","ACTUAL",{"date":227,"type":225},"2026-08-05",{"date":229,"type":208},"2029-07",{"name":5,"class":6},10]