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day.",[70],"Drug: NAC",{"label":72,"type":73,"description":74,"interventionNames":75},"Placebo","PLACEBO_COMPARATOR","Coated Placebo capsules, taken orally twice a day",[76],"Drug: Placebo",[78,84],{"type":79,"name":66,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","1g of clinical grade N-Acetylcysteine capsules, taken orally twice a day",[66],[83],"N-Acetylcysteine",{"type":79,"name":72,"description":85,"armGroupLabels":86,"otherNames":51},"Coated Placebo capsules, manufactured to match appearance and taste, taken orally twice a day",[72],[88,92,95,98,101,104],{"name":89,"affiliation":90,"role":91},"Clement Loy","University of Sydney","PRINCIPAL_INVESTIGATOR",{"name":93,"affiliation":94,"role":91},"Yenni Lie","Calvary Health Care Bethlehem",{"name":96,"affiliation":97,"role":91},"Dennis Velakoulis","Melbourne Health",{"name":99,"affiliation":100,"role":91},"Carolyn Orr","Perron Institute",{"name":102,"affiliation":103,"role":91},"John O'Sullivan","The University of 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Royal Melbourne Hospital","Parkville","3050",{"type":125,"coordinates":167},[168,169],144.95,-37.78333,{"lat":169,"lon":168},[172,174],{"name":96,"role":108,"phone":51,"phoneExt":51,"email":173},"Dennis.Velakoulis@mh.org.au",{"name":96,"role":91,"phone":51,"phoneExt":51,"email":51},{"facility":100,"status":135,"city":176,"state":177,"zip":178,"country":122,"countryCode":123,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Nedlands","Western Australia","6009",{"type":125,"coordinates":180},[181,182],115.8073,-31.98184,{"lat":182,"lon":181},[185,187],{"name":99,"role":108,"phone":51,"phoneExt":51,"email":186},"carolyn.orr@me.com",{"name":99,"role":91,"phone":51,"phoneExt":51,"email":51},{"type":91,"investigatorFullName":89,"investigatorTitle":189,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Director and Neurologist, Huntington Disease Service",[191,193,195,197,198],{"name":192,"class":6},"Deakin University",{"name":194,"class":6},"Monash University",{"name":196,"class":6},"Royal Perth Hospital",{"name":103,"class":6},{"name":199,"class":6},"University of Melbourne","100478375",false,"NCT05509153","A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers","NAC-preHD","Inclusion Criteria:\n\n* Able to provide informed consent\n* Huntingtin gene expansion carrier with \\>= 39 CAG repeats\n* Absence of unequivocal motor signs of HD - that is, UHDRS\n* Diagnostic Confidence Level needs to be \\\u003C4 upon enrolment\n* Expected to develop clinical HD within 10 years of trial enrolment using the Langbehn formula\n* Availability of an informant for corroborative history\n* Negative serum pregnancy test for women of childbearing potential\n* If of childbearing potential, is able and agrees to remain abstinent or use adequate contraceptive methods\n* Ability to tolerate MRI scans\n* Ability to tolerate blood draws\n* Able to comply with all study protocol requirements, according to the investigators judgement\n* In the opinion of the investigator, medically, psychiatrically and neurologically stable at the time of enrolment\n\nExclusion Criteria:\n\n* Diagnosis of clinical HD\n* Known hypersensitivity to NAC\n* Pregnancy, breastfeeding or intention to do so prior to the end of the study\n* Exposure to any investigational drugs within 30 days of Baseline Visit\n* Use of supplemental NAC\n* Abnormalities in laboratory measurements, ECG or vital signs at screening, which precludes safe participation in the study\n* Current or history of substance abuse within one year of Baseline visit\n* Unstable psychiatric or acute medical illness including cancer, as determined by investigator\n* Current use of antipsychotic medications or Tetrabenazine\n* History of gene therapy, cell transplantation, or any experimental brain surgery\n* History of attempted suicide or suicidal ideation within 12 months prior to screening\n* Pre-existing structural brain lesion as assessed by a centrally read MRI scan during the screening period","ALL","18 Years",{"count":209,"type":210},160,"ESTIMATED","INTERVENTIONAL",[213],"PHASE2","NAC-preHD is a phase II randomized placebo controlled study of oral NAC among premanifest HD gene expansion carriers, with clinical and radiological outcome at three years.",[216],"Huntington Disease",[83],"2025-02-25",{"date":220,"type":221},"2025-02-28","ACTUAL",{"date":223,"type":221},"2024-06-01",{"date":225,"type":210},"2027-05-01",{"name":5,"class":6},5]