[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391815":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":32,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":95,"whyStopped":32,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: NAC 1800mg then Placebo","EXPERIMENTAL","NAC 1800 milligrams (mg), oral solution, every 8 hours for 8 weeks, followed by a 2-week wash-out period, followed by NAC Placebo-matching solution, orally every 8 hours, for 8 weeks. Dosage will be titrated weekly starting at 600 mg daily and then increased by 600 mg every week to a target dose of 1800 mg per day.",[13,14],"Drug: N-acetyl cysteine","Other: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B: Placebo then NAC 1800mg","NAC Placebo-matching solution, orally every 8 hours, for 8 weeks, followed by a 2-week wash-out period, followed by NAC 1800 milligrams (mg), oral solution, every 8 hours for 8 weeks. Dosage will be titrated weekly starting at 600 mg daily and then increased by 600 mg every week to a target dose of 1800 mg per day.",[13,14],[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","N-acetyl cysteine","Oral solution for N-acetyl cysteine is prepared in syringes and provided to the participants along with instructions on how to administer them.",[9,16],[26,27],"Acetylcysteine","National Drug Code (NDC): 63323-690",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","NAC Placebo-matching solution is prepared in syringes and provided to the participants along with instructions on how to administer them.",[9,16],null,[34],{"name":35,"affiliation":36,"role":37},"Marco A Grados, M.D., M.P.H.","Department of Psychiatry & Behavioral Sciences, Johns Hopkins School of Medicine","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Masoud Salehi, M.D.","CONTACT","443-857-9365","msalehi3@jhmi.edu",[45],{"facility":46,"status":32,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Johns Hopkins University School of Medicine","Baltimore","Maryland","21205","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-76.61219,39.29038,{"lat":56,"lon":55},[59,61],{"name":60,"role":41,"phone":42,"phoneExt":32,"email":43},"Masoud Salehi, MD",{"name":62,"role":37,"phone":32,"phoneExt":32,"email":32},"Marco A Grados, MD, PHD",{"type":64,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[66],{"name":67,"class":68},"Cornelia de Lange Syndrome Foundation","UNKNOWN","100391815","phase-2-use-of-n-acetylcysteine-in-the-treatment-of-repetitive-and-self-injurious-behaviors-in-cornelia-de-lange-syndrome-100391815",false,"NCT04381897","Use of N-Acetylcysteine in the Treatment of Repetitive and Self-Injurious Behaviors in Cornelia de Lange Syndrome","Use of N-Acetylcysteine (NAC) in the Treatment of Repetitive Behaviors (RB) and Self-Injurious Behaviors (SIB) in Cornelia de Lange Syndrome: A Randomized Double-Blind Placebo-Controlled Pilot Study","Inclusion Criteria:\n\n* Ages 13 to 35 years\n* A diagnosis of CdLS as determined by a physician during routine care meeting the major and minor criteria from CdLS guidelines\n* Threshold criteria for the presence of RB\u002FSIB as reported on initial screening Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders (CYBOCS-PDD) \\> 6 OR Aberrant Behavior Checklist (ABC) stereotypy subscale \\> 7)\n* Being able to attend 4 visits over the course of 18 weeks at the Johns Hopkins Hospital\n* No acute safety concerns or need for hospitalization due to psychotic, manic or depressive episode\n* Not currently pregnant or lactating\u002Fbreastfeeding. Whether a participant is pregnant or not will be determined by the participant\u002Fcaregiver report based on date last menses. If there is any suspicion of pregnancy, the PI will confer with the family to obtain testing through the primary care provider.\n\nExclusion Criteria:\n\n* Allergy to NAC\n* Allergy to Quinine\n* Contraindication to NAC (organ transplant; untreated or symptomatic gastric condition)\n* Need for another medication with which NAC is contraindicated (antibiotics)","ALL","13 Years","35 Years",{"count":80,"type":81},10,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This research project is a randomized cross-over pilot trial which aims to test the efficacy of N-acetylcysteine (NAC) for the treatment of Repetitive Behaviors (RB) and self-injurious behavior (SIB) in patients with Cornelia de Lange Syndrome (CdLs).\n\nNAC is a known anti-oxidative stress and neuroprotective agent, which has been shown to decrease the occurrence of SIB such as skin picking. NAC has also shown partial response in trials for compulsive behaviors in Obsessive Compulsive Disorder (OCD) and related disorders in autism.\n\nCornelia de Lange syndrome (CdLS) is a genetic disorder with autistic features, including RBs and SIB. In this randomized clinical trial, participants with CdLS will be blindly assigned one of two possible treatment arms: 1) placebo (8 weeks) and NAC (8 weeks); or 2) NAC (8 weeks) and placebo (8 weeks), with an intermediate 2-week washout period.",[87],"Cornelia de Lange Syndrome",[89,90,91,92,93,94],"Repetitive behaviors","Self-injurious behavior","N-acetylcysteine","Genetic disorder","Children","Psychiatric disease","NOT_YET_RECRUITING","2026-03-05",{"date":98,"type":99},"2026-03-06","ACTUAL",{"date":101,"type":81},"2026-08-01",{"date":103,"type":81},"2027-05-01",{"name":5,"class":6},1]