[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659880":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":30,"interventions":36,"overallOfficials":42,"centralContacts":47,"locations":52,"responsibleParty":69,"collaborators":23,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":32,"officialTitle":32,"acronym":23,"eligibilityCriteria":75,"healthyVolunteers":73,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":23,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":23,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Xijing Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"the Epworth Sleepiness Scale （ESS ：0-24）","The ESS scale contain eight items. Each item is rated from 0 to 3, with 0 meaning you would never doze or fall asleep in a given situation, and 3 meaning there is a very high chance that you would doze or fall asleep in that situation. The ESS score was assessed at baseline and after the first dose, higher scores mean a worse outcome.","one month",{"measure":14,"description":15,"timeFrame":12},"cataplexy rate","cataplexy rate was assessed through completion of an electronic patient-reported outcome diary.",[17,21],{"measure":18,"description":19,"timeFrame":20},"assessment of adverse events","the incidence and severity of adverse events and serious adverse events were assessed.","one week",{"measure":18,"description":19,"timeFrame":22},"within one week",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE",[31],{"label":32,"type":33,"description":23,"interventionNames":34},"Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1","EXPERIMENTAL",[35],"Biological: ofatumumab 20mg",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":23},"BIOLOGICAL","ofatumumab 20mg","all participants will be treated with one dose of subcutaneous injections of ofatumumab",[32],[43],{"name":44,"affiliation":45,"role":46},"Yonghong Liu, MD;PhD","The First Affiliated Hospital of Air Force Medicial University","PRINCIPAL_INVESTIGATOR",[48],{"name":44,"role":49,"phone":50,"phoneExt":23,"email":51},"CONTACT","029-84771058","xjwxl2012@163.com",[53],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Xi'an","Shaanxi","710032","China","CN",{"type":61,"coordinates":62},"Point",[63,64],108.92861,34.25833,{"lat":64,"lon":63},[67],{"name":68,"role":49,"phone":50,"phoneExt":23,"email":51},"Xiaoli Wang, MSc",{"type":70,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100659880","phase-1-ofatumumab-in-treatment-refractory-narcolepsy-type-1-100659880",false,"NCT07871006","Inclusion Criteria:\n\n* patients who were clinically diagnosed with narcolepsy type 1\n* aged10-60 years, male or female.\n* A lumbar puncture was performed to evaluate the CSF orexin-A level.\n* HLA typing was performed.\n* Patients who had previously failed (no response or no maintenance) guideline- specified first-line therapy for narcolepsy and had previously received at least one guideline-specified second-line treatment for narcolepsy type 1and failed (no response or no maintenance). Or patients who refused to drug treatment.\n* Subjects with no significant laboratory abnormalities during screening.\n* Patients and their legal guardians must comprehensively understand and be able to adhere to the study protocol requirements and willingly sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients allergic to ofatumumab, or had failed to respond to previous treatment with ofatumumab.\n* Patients were excluded if they had a previous immune disease, or patients diagnosed with various secondary and hereditary auto-immune disorders, contraindications to lumbar puncture, conditions or medication with known substantial impact on the immune system, with impact on the result of lumbar puncture.\n* Patients with uncontrollable primary diseases of important organs, such as liver failure, heart failure, renal failure and other diseases.\n* Patients who are positive for HIV antibodies or syphilis antibodies.\n* Patients accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, etc.","ALL","10 Years","60 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","The goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1. It will also learn about the safety of ofatumumab. The main questions it aims to answer are:\n\n* Does ofatumumab could improve persistent or chronic NT1 who had insufficient responses to multiple prior treatment regimens or declined conventional medications?\n* The safety -What medical problems do participants have when taking ofatumumab? Researchers will compare Epworth Sleepiness Scale and cataplexy frequency before and after ofatumumab treatment to see if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1.\n\nParticipants will:\n\n* Take one dose of ofatumumab and monitoring one day for the injection-related reactions\n* Visit the clinic at one month after ofatumumab for checkups and tests\n* Keep a diary of their symptoms",[88],"Narcolepsy Type 1 (NT1)","2026-10-07",{"date":91,"type":92},"2026-10-13","ACTUAL",{"date":94,"type":92},"2025-10-01",{"date":96,"type":81},"2027-12-31",{"name":5,"class":6},1]