[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612930":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Biogen","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tofersen",null,"Data for participants with SOD1-ALS will be collected via ALS disease registries, the TRICALS network's Precision-ALS programme and ALS\u002FMND NHC.",[13],"Drug: Tofersen",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Administered as specified in the treatment arm.",[9],[20],"BIIB067, Qalsody",[22],{"name":23,"affiliation":5,"role":24},"Medical Director","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Study US Biogen Clinical Trial Center","CONTACT","866-633-4636","clinicaltrials@biogen.com",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":30},"Global Biogen Clinical Trial Center",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Mass General Hospital -MGH","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-71.05977,42.35843,{"lat":46,"lon":45},[49,51],{"name":10,"role":28,"phone":50,"phoneExt":10,"email":10},"617-643-2935",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Alex Sherman","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100612930","a-study-to-learn-more-about-the-long-term-safety-of-tofersen-qalsody-in-participants-with-superoxide-dismutase-1-sod-1-amyotrophic-lateral-sclerosis-als-100612930",false,"NCT07259980","A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)","An Observational Registry-Based Study to Evaluate the Long-Term Safety of Tofersen in People With SOD1-ALS","Key Inclusion Criteria:\n\n* Participants with an ALS diagnosis and a confirmed SOD1 mutation from contributing registry networks will be considered for inclusion in the study.\n\nKey Exclusion Criteria:\n\n* Data collected while a person with SOD1-ALS is participating in an interventional clinical trial (with tofersen or any other investigational medicinal product) will be excluded.\n\nNOTE: Other protocol- defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":66,"type":67},125,"ESTIMATED","7 Years","OBSERVATIONAL","In this study, researchers will learn more about the safety of tofersen, also known as Qalsody®. This is a drug available for doctors to prescribe for participant with a certain type of amyotrophic lateral sclerosis, also known as ALS. This type is in participant who have a mutation in the superoxide dismutase 1 gene, also known as SOD-1.\n\nThis is known as an \"observational\" study, which collects health information about study participants without changing their medical care. Participants for this study will be found using 2 different groups of study research centers that help provide clinical care for participant with ALS. These groups are in Europe and the United States and are called:\n\n* the Precision-ALS programme\n* the ALS\u002FMotor Neuron Disease (MND) Natural History Consortium (NHC)\n\nThe main goal of this study is to collect safety information in participants with SOD-1 ALS who were in either of the groups.\n\nThe main question researchers want to answer in this study is:\n\n* What are the characteristics of the participants in this study?\n* How many participants had serious adverse events (SAEs), including ones that affect the brain, spinal cord, or nerves?\n\nAn adverse event is a health problem that may or may not be caused by a drug during the study. An adverse event is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care.\n\nResearchers will also learn more about:\n\n* How many participants develop other health conditions or become pregnant, including how the pregnancy turned out\n* Why and when participants stopped treatment\n\nThis study will be done as follows:\n\n* Participants will be screened to check if they can join the study.\n* Data from the participants' regular visits to their clinic will be collected based on which study research center they are in.\n* Each participant will be in the study until they decide to leave or until death. Currently, the study is planned to last at least 7 years.",[72],"Amyotrophic Lateral Sclerosis","2026-04-06",{"date":75,"type":76},"2026-04-09","ACTUAL",{"date":78,"type":76},"2026-01-02",{"date":80,"type":67},"2033-12-30",{"name":5,"class":6},1]