[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734103":3,"trial-entities:NCT07734103":103,"trial-summary:NCT07734103":107},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":49,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":80,"overall_officials":87,"references":91,"see_also_links":102},"NCT07734103","ITI-IIT-001","Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder","A Single-Center, Double-Blind, Placebo-Controlled, Study to Evaluate Lumateperone, Flexible Doses of 21mg or 42mg in Patients With Moderate to Severe Childhood Onset Fluency Disorder, Stuttering.","RECRUITING","2027-10-31","2026-07","2026-07-29","2026-04-18","CSTrials Inc.","NETWORK",false,"The primary objective of this study is to evaluate the efficacy and tolerability of Lumateperone in reducing stuttering symptoms.\n\nThe following scales and samples will be collected for clinical and functional outcomes. • MLGSSS • SSS • Stuttering Severity Instrument (SSI-IV) • PHQ-9 • Barnes Akathisia • SAS • AIMS • CGI-I • CGI-S","This is a double-blind, placebo-controlled trial of Lumateperone in adults who suffer from developmental stuttering. Subjects with moderate to severe stuttering as measure by MLGSS scale will be enrolled. We anticipate screening a total of 30 subjects in anticipation of enrolling 24 suitable subjects for the trial. The subjects will be adults between the ages of 18-65, who have the capacity to consent for themselves. After providing written informed consent, potential subjects will undergo a thorough clinical screening.",[19],"Stuttering, Adult",[21],"stuttering","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},24,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Lumateperone (ITI-007)","This medication is a tablet that is taken once daily",[35],"Lumateperone 21mg up to 42mg",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Placebo Tablet or Capsule","Matching Placebo",[38],[41,45],{"measure":42,"description":43,"timeFrame":44},"Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)","A self rater CBSA-SR includes 10 items to evaluate the different aspects of stuttering during the prior week (last 7 days)","last seven days, previous week (Minimum score 0 to Maximum score 100)",{"measure":46,"description":47,"timeFrame":48},"Clinical Global Impression - Severity (CGI-S)","Global assessment of stuttering severity (minimum score \"1 Normal\u002FNot ill\" maximum score \"7 Among the most extremely ill patients\"","Based primarily on symptoms and functioning over the past 7 days",[50],{"measure":51,"description":52,"timeFrame":53},"Clinical Global Impression - Improvement (CGI-I)","Global improvement assessment based on post randomization (Minimum score \"1 Very much improved\" Maximum score \"7 Very much worse\")","Rating for patients illness the past 7 days and measuring if symptoms and functioning have improved or worsened relative to their initial baseline","ALL","18 Years","65 Years",{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Inclusion Criteria:\n\nSubjects will be included in the study only if they meet all the following criteria:\n\n1. Subject must satisfy DSM-V criteria for childhood onset fluency disorder (stuttering).\n2. The nature of stuttering must be developmental in origin with the onset prior to 8 years of age.\n3. Subject must have a score of moderate or higher on the MLGSSS.\n4. Subject agrees to use an acceptable method of contraception for the duration of the study.\n5. Subject must be able to speak English.\n6. Subjects must be adults between the ages of 18 - 65.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they meet one or more of the following criteria:\n\n1. Subject has an unstable neurologic, psychiatric, or medical condition in the judgement of the investigator.\n2. Subject (female) is pregnant.\n3. Subject has evidence of moderate or severe renal or hepatic impairment at Screening.\n4. Subjects currently taking any moderate or strong CYP3A4 inhibitor medications.\n5. Subject who meets the DSM-5 criteria for moderate to severe substance use disorder within twelve months prior to study inclusion.\n6. Subject has a positive pregnancy test at screening or on Day 1 prior to the start of study drug.\n7. Subject that is lactating at screening or Day 1, prior to the start of study drug and does not agree to cease giving breast milk to child(ren), donating breast milk and\u002For providing breast milk to anyone for consumption, from Day 1 until 14 days after the last dose of study medication.\n8. Any history of neuroleptic malignant syndrome (NMS).\n9. Subject with a glycosylate hemoglobin (A1c) of greater than 6.4 percent.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"CSTrials","Costa Mesa","California","92662","United States",[72],{"name":73,"role":74,"phone":75,"email":76},"Tommy Gonzalez, MA","CONTACT","714-900-3969","Tommy@CSTrials.com",{"lat":78,"lon":79},33.64113,-117.91867,[81,83],{"name":73,"role":74,"phone":82,"email":76},"1-714-900-3969",{"name":84,"role":74,"phone":85,"email":86},"Debra Hoffmeyer, MA","1-888-421-2782","debra@cstrials.com",[88],{"name":89,"affiliation":13,"role":90},"Gerald A Maguire, MD","PRINCIPAL_INVESTIGATOR",[92,96,99],{"pmid":93,"type":94,"citation":95},"33642973","RESULT","Maguire GA, Yoo BR, SheikhBahaei S. Investigation of Risperidone Treatment Associated With Enhanced Brain Activity in Patients Who Stutter. Front Neurosci. 2021 Feb 12;15:598949. doi: 10.3389\u002Ffnins.2021.598949. eCollection 2021.",{"pmid":97,"type":94,"citation":98},"28738099","Charoensook J, Maguire GA. A case series on the effectiveness of lurasidone in patients with stuttering. Ann Clin Psychiatry. 2017 Aug;29(3):191-194.",{"pmid":100,"type":94,"citation":101},"31369655","Maguire GA, LaSalle L, Hoffmeyer D, Nelson M, Lochhead JD, Davis K, Burris A, Yaruss JS. Ecopipam as a pharmacologic treatment of stuttering. Ann Clin Psychiatry. 2019 Aug;31(3):164-168.",[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Stuttering, Childhood Onset Fluency Disorder",[],{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is a double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving Lumateperone or the placebo. It aims to enroll 24 adult participants.","completed","Lumateperone for Stuttering (Childhood Onset Fluency Disorder)","This study is testing a medication called Lumateperone (ITI-007) to see if it can help reduce stuttering symptoms in adults. You might be able to join if you are between 18 and 65 years old, have stuttering that started before age 8, and your stuttering is considered moderate to severe. Researchers will compare Lumateperone to a placebo (a pill with no active medicine) to see how well it works and if it's well-tolerated. Success will be measured by changes in your self-rated stuttering severity and how much your overall condition has improved. The study is currently unclear on its recruitment status and plans to enroll about 24 participants.","Your stuttering will be measured during the last seven days of the study, and your overall condition will be assessed based on symptoms over the past 7 days.",108,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]