[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598913":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":34,"collaborators":20,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":20,"eligibilityCriteria":42,"healthyVolunteers":39,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":20,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":20},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Patients who meet the inclusion and exclusion criteria are required to come to the hospital at the following time points to complete the intrathecal bolus injection of quantitative RAG - 17, relevant examinations, and evaluations by the research physicians: baseline, 60 ± 3 days, 120 ± 3 days, 180 ± 3 days, 240 ± 3 days, 300 ± 3 days, 360 ± 3 days, 450 ± 3 days, 540 ± 3 days. An online follow - up will be conducted at 570 ± 3 days.",[13],"Drug: A sterile aqueous solution of RAG - 17 preparation (sodium salt)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","A sterile aqueous solution of RAG - 17 preparation (sodium salt)","Patients who meet the inclusion and exclusion criteria are required to come to the hospital at the following time points to complete the intrathecal bolus injection of RAG - 17 for 150 mg: baseline, 60 ± 3 days, 120 ± 3 days, 180 ± 3 days, 240 ± 3 days, 300 ± 3 days, 360 ± 3 days, 450 ± 3 days, 540 ± 3 days.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Wang YiLong","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","13911666571","yilong528@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Chen WeiQI","15652813380","weiqichen@aliyun.com",{"type":24,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"yilong Wang","Vice-President of Beijing Tiantan Hospital,Chief Scientist of Neurology Center","100598913","early-phase-1-extended-study-of-rag-17-in-the-treatment-of-amyotrophic-lateral-sclerosis-patients-with-sod1-gene-mutation-100598913",false,"NCT07077668","Extended Study of RAG-17 in the Treatment of Amyotrophic Lateral Sclerosis Patients With SOD1 Gene Mutation","Inclusion Criteria:\n\n* 18 ≤ Age ≤ 75 years old, regardless of gender.\n* ALS patients with confirmed SOD1 gene mutations (known SOD1 mutation sites with reported relevant disease progression).\n* The diagnosis meets the criteria for definite or probable familial or sporadic ALS in the El Escorial diagnostic criteria for amyotrophic lateral sclerosis revised by the World Federation of Neurology.\n* The patient himself\u002Fherself or their legal representative clearly understands, voluntarily participates in this study, and signs the informed consent form.\n\nExclusion Criteria:\n\n* Patients with SOD1 mutation sites occurring at nucleotides 44 - 66 (counting from the start of SOD1 protein translation) and patients with P.F21C mutation.\n* Patients diagnosed with other mental illnesses according to the DSM - V diagnostic criteria, or those with obvious suicidal intent.\n* Patients with severe hepatic insufficiency, severe renal insufficiency, or severe cardiac insufficiency. (Severe hepatic insufficiency refers to an ALT value ≥ 2.0 times the upper limit of normal or an AST value ≥ 2.0 times the upper limit of normal; severe renal insufficiency refers to a CRE ≥ 1.5 times the upper limit of normal or an eGFR \\\u003C 40 mL\u002Fmin\u002F1.73m²; severe cardiac insufficiency refers to a NYHA score of 3 - 4.)\n* Patients with a history of alcohol or drug abuse.\n* Pregnant, lactating patients, those with a possibility of pregnancy, or patients planning to become pregnant.\n* Patients who have received any vaccination within 28 days.\n* Patients who are unable to cooperate with the follow - up for other reasons.","ALL","18 Years","75 Years",{"count":47,"type":48},10,"ESTIMATED","INTERVENTIONAL",[51],"EARLY_PHASE1","This study primarily evaluates the safety, tolerability, and efficacy of RAG - 17 in adult ALS patients with SOD1 - mutated genes in the real - world setting.",[54],"ALS (Amyotrophic Lateral Sclerosis)",[56,57,58],"Amyotrophic lateral sclerosis","RAG-17","SOD1","NOT_YET_RECRUITING","2025-07-13",{"date":62,"type":63},"2025-07-22","ACTUAL",{"date":65,"type":48},"2025-07",{"date":67,"type":48},"2026-12-31",{"name":5,"class":6}]