[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617974":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":31,"responsibleParty":38,"collaborators":31,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":31,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":31,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":31,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":31},{"fullName":5,"class":6},"Spinogenix","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tazbentetol","EXPERIMENTAL","synthetic small molecule",[13],"Drug: Tazbentetol",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","placebo",[19],"Drug: placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tazbentetol","Participants in both Phase 2B and Phase 3 will be randomized to received study drug tazbentetol or placebo tablets. Participants in the open-label extension phase will receive the dose determined from Phase 2.",[9],[27],"SPG302",{"type":22,"name":17,"description":29,"armGroupLabels":30,"otherNames":31},"participants in double blind placebo controlled phase will be randomized to received placebo tablets",[15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Study Contact","CONTACT","503 915 1400","contact@spinogenix.com",{"type":39,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100617974","phase-2-efficacy-and-safety-of-tazbentetol-in-als-participants-100617974",false,"NCT07325591","Efficacy and Safety of Tazbentetol in ALS Participants","A Phase 2B\u002F3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tazbentetol in Participants With Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n* Age 18-80\n* ALS TRICALS risk score\n* Stable dose of standard of care treatment\n* Contraception use by men or women consistent with local regulations\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Underlying physical or psychological condition prohibiting study completion\n* Clinically significant cardiac disease\n* Active or history of malignancy in the past 5 years\n* Serious infection within 1 month of screening\n* Acute illness within 30 days of Day 1\n* History of suicidal behavior or suicidal ideation\n* Active cigarette smokers and users of nicotine-containing products\n* Neurodegenerative disease\n* External respiratory support or supplemental oxygen requirement\n* HIV, hepatitis B and hepatitis C positive\n* Vaccines within 14 days\n* Other investigational products within 30 days\n* Blood donation within 30 days\n* Plasma donation within 7 days\n* Pregnant or breastfeeding","ALL","18 Years","80 Years",{"count":51,"type":52},430,"ESTIMATED","INTERVENTIONAL",[55,56],"PHASE2","PHASE3","The objectives of this study are to examine the effects of tazbentetol on clinical measures of ALS, patient reported outcomes (PROs), long-term safety and tolerability.",[59],"Amyotrophic Lateral Sclerosis",[61,62,59,63],"regenerative","synapse","placebo-controlled","NOT_YET_RECRUITING","2026-02-26",{"date":67,"type":68},"2026-03-02","ACTUAL",{"date":70,"type":52},"2026-03-01",{"date":72,"type":52},"2028-03-01",{"name":5,"class":6}]