[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07328529":3,"trial-entities:NCT07328529":122,"trial-summary:NCT07328529":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":70,"locations":72,"central_contacts":114,"overall_officials":119,"references":120,"see_also_links":121},"NCT07328529","AVN014","Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome","Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome","NOT_YET_RECRUITING","2028-03","2026-01","2026-01-09","2026-03","Azevan Pharmaceuticals","INDUSTRY",true,"The goal of this clinical trial is to learn if drug SRX246 works to treat irritability, agitation, aggression and self-injury (IAAS) behaviors in adult males with Fragile X Syndrome (FXS). It will also learn about the safety of drug SRX246. The main questions it aims to answer are:\n\n* Does drug SRX246 lower the number of times participants experience IAAS behaviors?\n* What medical problems do participants have when taking drug SRX246? Researchers will compare drug SRX246 to a placebo (a look-alike substance that contains no drug) to see if drug SRX246 works to treat IAAS behaviors.\n\nParticipants will:\n\n* Take drug SRX246 or a placebo every day for up to 8 months\n* Have weekly checkups by phone or video to answer study questions\n* Have periodically scheduled home visits by nurses to conduct medical check-ups and tests\n* Keep a diary of their symptoms",null,[19],"Aggressive Behavior in Fragile X Syndome",[21,22,23,24,25,26,27],"Fragile X Syndrome","SRX246","vasopressin 1a","irritability","agitation","aggression","self-injury","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},80,"ESTIMATED",[36,40],{"type":37,"name":22,"description":38,"armGroupLabels":39},"DRUG","SRX246 120mg capsules for oral administration",[22],{"type":37,"name":41,"description":42,"armGroupLabels":43},"Placebo","Placebo capsules for oral administration",[41],[45],{"measure":46,"description":47,"timeFrame":48},"Aberrant Behavior Checklist","The Aberrant Behavior Checklist-Community Edition (ABC-C) Irritability subscale - Caregiver rated and then scored using the using the FXS-specific factoring system (ABCFX). Responses will be rated using a scale ranging from 0=not a problem to 3=severe problem.","Over an 8 month period",[],"MALE","18 Years","45 Years",false,{"inclusion":55,"exclusion":64,"raw_text":69},[56,57,58,59,60,61,62,63],"Biological male, age 18 to 45 years inclusive","Molecular genetic confirmation of the full Fragile X messenger ribonucleoprotein mutation (≥200 CGG repetitions)","IAAS symptoms leading to a CGI-S score for Disruptive Behavior of 5 or more","Reported history of aggression based on the CMAI-Agg subscale (average score \\>22) and an average associated disruptiveness scale of at least 3.","IQ \\\u003C 70","Stable medication doses for the last month","Has a caregiver who lives with or spends extensive time with the participant most days and can report behavioral symptoms","Must be able to swallow study drug capsules whole",[65,66,67,68],"Medical condition contraindicating study participation","SGPT and SGOT values 2 or more times the upper limit of normal","History of psychosis","Suicidal behavior","Inclusion Criteria:\n\n* Biological male, age 18 to 45 years inclusive\n* Molecular genetic confirmation of the full Fragile X messenger ribonucleoprotein mutation (≥200 CGG repetitions)\n* IAAS symptoms leading to a CGI-S score for Disruptive Behavior of 5 or more\n* Reported history of aggression based on the CMAI-Agg subscale (average score \\>22) and an average associated disruptiveness scale of at least 3.\n* IQ \\\u003C 70\n* Stable medication doses for the last month\n* Has a caregiver who lives with or spends extensive time with the participant most days and can report behavioral symptoms\n* Must be able to swallow study drug capsules whole\n\nExclusion Criteria:\n\n* Medical condition contraindicating study participation\n* SGPT and SGOT values 2 or more times the upper limit of normal\n* History of psychosis\n* Suicidal behavior",[71],"ADULT",[73,88,101],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"University of California, Davis, MIND Institute","Sacramento","California","95817","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"David R Hessl, PhD","CONTACT","916-703-0249","drhessl@ucdavis.edu",{"lat":86,"lon":87},38.58157,-121.4944,{"facility":89,"city":90,"state":91,"zip":92,"country":78,"contacts":93,"geoPoint":98},"Rush University Medical Center","Chicago","Illinois","60612",[94],{"name":95,"role":82,"phone":96,"email":97},"Elizabeth M Berry-Kravis, MD, PhD","312-942-4036","Elizabeth_Berry-Kravis@rush.edu",{"lat":99,"lon":100},41.85003,-87.65005,{"facility":102,"city":103,"state":104,"zip":105,"country":78,"contacts":106,"geoPoint":111},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229",[107],{"name":108,"role":82,"phone":109,"email":110},"Craig A Erickson, MD","513-636-6553","craig.erickson@cchmc.org",{"lat":112,"lon":113},39.12711,-84.51439,[115],{"name":116,"role":82,"phone":117,"email":118},"Neal G Simon, PhD","610-610-0100","ngsimon@azevan.com",[],[],[],{"nct_id":4,"conditions":123,"biomarkers":124},[21],[125],"FMR1 Gene",{"nct_id":4,"found":15,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study comparing SRX246 to a placebo. It plans to enroll 80 participants.","completed","SRX246 for Aggressive Behavior in Fragile X Syndrome","This study is testing if a drug called SRX246 can help reduce irritability, agitation, aggression, and self-injury (IAAS) in adult men with Fragile X Syndrome (FXS). Researchers also want to understand the safety of SRX246. You would be given either SRX246 capsules or a placebo (a capsule with no medicine) to see if SRX246 lowers the number of times these behaviors occur. The study is looking for 80 men, aged 18 to 45, who have a confirmed diagnosis of Fragile X Syndrome and a history of aggressive behaviors. The study's status is currently unclear.","Participants will be followed for at least 8 months, based on the primary endpoint timeframe.",94,"The primary endpoint, the Aberrant Behavior Checklist, will be measured over an 8-month period.","Not stated in the trial record.",[22,41],"v2"]