[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626736":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":34,"responsibleParty":44,"collaborators":34,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":34,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":34,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":34,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":34},{"fullName":5,"class":6},"Spinogenix","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 2b: Active comparator","ACTIVE_COMPARATOR","Phase 2b: Active SPG601 to be administered to participants with Fragile X Syndrome Participants with Fragile X Syndrome will be randomized to receive SPG601 daily for 4 weeks",[13],"Drug: SPG601",{"label":15,"type":16,"description":17,"interventionNames":18},"Phase 2b: Placebo","PLACEBO_COMPARATOR","Participants with Fragile X Syndrome will be randomized to receive placebo over 4 weeks.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Phase 3: Active comparator","Participants with Fragile X Syndrome will be randomized to receive dose of SPG601 determined from Phase 2b over 12 weeks",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Phase 3: Placebo","Participants with Fragile X Syndrome will be randomized to receive placebo for 12 weeks",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","SPG601","synthetic small molecule",[9,21],null,{"type":30,"name":36,"description":36,"armGroupLabels":37,"otherNames":34},"Placebo",[15,25],[39],{"name":40,"role":41,"phone":42,"phoneExt":34,"email":43},"Contact","CONTACT","(503) 673-3842","contact@spinogenix.com",{"type":45,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100626736","phase-2-a-study-to-investigate-the-effects-and-safety-of-spg601-for-the-treatment-of-fragile-x-syndrome-in-male-participants-100626736",false,"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","18 Years","45 Years",{"count":57,"type":58},248,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE2","PHASE3","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.",[65],"Fragile X Syndrome (FXS)",[67,68,69],"Fragile X Syndrome","Fragile X Chromosome","cognitive outcomes","NOT_YET_RECRUITING","2026-02-24",{"date":73,"type":74},"2026-02-27","ACTUAL",{"date":76,"type":58},"2026-03-01",{"date":78,"type":58},"2030-06-30",{"name":5,"class":6}]