[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spinogenix\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,37,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":4,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":23,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":33,"locationsCount":36},"100599720","intermediate-size-patient-population-expanded-access-protocol-100599720",false,"NCT07088159","Intermediate-size Patient Population Expanded Access Protocol","Intermediate-size Patient Population Expanded Access Protocol for Tazbentetol in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n* ALS diagnosis\n* Age 18 -85 years at time of signing informed consent form\n* Ineligible for other interventional ALS clinical research participation\n* Vital Capacity greater than 35% of predicted capacity for age, height, and sex\n* If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking tazbentetol.\n* Life expectancy of at least 6 months, according to Investigator's judgement\n\nExclusion Criteria:\n\n* Clinically significant and\u002For unstable medical condition (other than ALS) that would pose a risk to the patient\n* Known ongoing or clinically uncontrolled cardiac disease\n* Clinically significant liver disease\n* Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement\n* Concomitant use of another investigational medical product for treatment of ALS\n* Unable to reliably and regularly swallow whole oral medications on a daily basis","ALL","18 Years","85 Years","EXPANDED_ACCESS","The purpose of this Expanded Access Program is to provide tazbentetol to ALS patients who are not eligible to enroll in an ALS clinical trial. This Expanded Access Program will assess safety and tolerability, and clinical efficacy of tazbentelol.",[22],"ALS (Amyotrophic Lateral Sclerosis)",[24,25,22,26,27],"Expanded Access Protocol","synapse","neural connectivity","tazbentelol","AVAILABLE","2026-06-23",{"date":31,"type":32},"2026-06-25","ACTUAL",{"name":34,"class":35},"Spinogenix","INDUSTRY",15,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":44,"enrollmentInfo":45,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100617974","phase-2-efficacy-and-safety-of-tazbentetol-in-als-participants-100617974","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","80 Years",{"count":46,"type":47},430,"ESTIMATED","INTERVENTIONAL",[50,51],"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.",[54],"Amyotrophic Lateral Sclerosis",[56,25,54,57],"regenerative","placebo-controlled","NOT_YET_RECRUITING","2026-02-26",{"date":61,"type":32},"2026-03-02",{"date":63,"type":47},"2026-03-01",{"date":65,"type":47},"2028-03-01",{"name":34,"class":35},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":74,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":48,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100626736","phase-2-a-study-to-investigate-the-effects-and-safety-of-spg601-for-the-treatment-of-fragile-x-syndrome-in-male-participants-100626736","NCT07439510","A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants","A Phase 2b\u002F3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SPG601 in Male Participants With Fragile X Syndrome","Inclusion Criteria:\n\n* Adult males aged 18 to 45 years, inclusive\n* Diagnosis of Fragile X as confirmed with genetic testing\n* Patient must have caregiver\n* Must be in good health with no significant medical history\n\nExclusion Criteria:\n\n* Any physical or psychological condition that prohibits study completion\n* Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months.\n* Auditory or visual impairments that cannot be corrected\n* History of suicidal behavior or suicidal ideation\n* Screening vital signs that are abnormal per protocol specification\n* ECG that are clinically significant abnormal\n* History of substance abuse or dependence within 6 months\n* Other investigational products within 30 days\n* Unable to swallow capsules","MALE","45 Years",{"count":77,"type":47},248,[50,51],"This Phase 2b\u002F3, randomized, double-blind, placebo-controlled, 2-part study will evaluate the efficacy, safety and tolerability of different dose regimens of SPG601 in adult male participants with Fragile X syndrome.",[81],"Fragile X Syndrome (FXS)",[83,84,85],"Fragile X Syndrome","Fragile X Chromosome","cognitive outcomes","2026-02-24",{"date":88,"type":32},"2026-02-27",{"date":63,"type":47},{"date":91,"type":47},"2030-06-30",{"name":34,"class":35},""]