[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734493":3,"trial-entities:NCT07734493":277,"trial-summary:NCT07734493":280},{"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":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":98,"sex":107,"minimum_age":108,"maximum_age":109,"healthy_volunteers":110,"eligibility_criteria":111,"std_ages":128,"locations":130,"central_contacts":267,"overall_officials":274,"references":275,"see_also_links":276},"NCT07734493","LTX-001-103","A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia","A Phase 1b, Multicenter, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Early Signs of Efficacy of Orally Administered LTX-001 As Monotherapy in Adult Participants With Acute Exacerbation of Schizophrenia","RECRUITING","2027-03","2026-08","2026-08-04","Leal Therapeutics, Inc","INDUSTRY",true,"The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are:\n\n* how does the amount of the study drug in the body change over time (pharmacokinetics)\n* how does the study drug affect the symptoms of schizophrenia\n* how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics)\n\nResearchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments.\n\nAfter successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.","After providing informed consent, eligible participants will be asked to visit the study site 3 times and stay overnight for 35 nights (up to 49 nights if up to 14 days of antipsychotic washout is applicable). Procedures will include:\n\n* A review of medical history and medications\n* Physical exams, including a neurologic (nervous system) assessment\n* Electrocardiograms (a measure of the heart's electrical activity)\n* Blood and urine collection\n* Psychiatric assessments including the Mini International Neuropsychiatric Exam (MINI), the Brief Assessment of Cognition in Schizophrenia (BACS), and the Positive and Negative Syndrome Scale (PANSS)\n* Overall assessment of status via the Clinical Global Impression Scale - Severity (CGI-S)\n* Assessment of extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS)\n* Assessment of suicidality risk via the Columbia Suicidality Severity Rating Scale (C-SSRS)\n* Quantitative electroencephalography (qEEG) assessments\n* Ophthalmologic examinations\n* Administration of the study drug (or placebo) by mouth",[18],"Schizophrenia",[20],"schizophrenia","INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},90,"ESTIMATED",[29,34,38],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","LTX-001 once daily","LTX-001 40 mg and 60 mg administered as oral suspension",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Placebo","Oral suspension without LTX-001",[35],{"type":30,"name":39,"description":40,"armGroupLabels":41},"LTX-001 twice daily","LTX-001 30 mg and 60 mg administered as oral suspension",[39],[43,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95],{"measure":44,"description":45,"timeFrame":46},"Safety and Tolerability - Adverse Events","Incidence and severity of treatment-emergent adverse events (TEAEs), and treatment-emergent serious adverse events (TESAEs).","Screening through Day 42",{"measure":48,"description":49,"timeFrame":46},"Safety and Tolerability - Clinical Laboratory Tests","Clinical laboratory tests (including serum chemistry, hematology, urinalysis)",{"measure":51,"description":52,"timeFrame":46},"Safety and Tolerability - Electrocardiograms (ECG)","ECGs will measure heart rate (HR), QRS complex and QT, QTcF, and PR intervals",{"measure":54,"description":55,"timeFrame":46},"Safety and Tolerability - Physical and Neurological Exams","Physical and neurological exams will be performed periodically to ensure participant safety.",{"measure":57,"description":58,"timeFrame":46},"Safety and Tolerability - Suicidality","Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)",{"measure":60,"description":61,"timeFrame":46},"Safety and Tolerability - Extrapyramidal Symptoms","Extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS)",{"measure":63,"description":64,"timeFrame":46},"Vital signs - blood pressure","Vital signs will be collected, including blood pressure (mm Hg)",{"measure":66,"description":67,"timeFrame":46},"Vital Signs - heart rate","Vital signs will be collected, including heart rate (beats per minute)",{"measure":69,"description":70,"timeFrame":46},"Vital Signs - respiratory rate","Vital signs will be collected, including respiratory rate (breaths per minute)",{"measure":72,"description":73,"timeFrame":46},"Vital Signs - body temperature","Vital signs will be collected, including body temperature (°C or °F)",{"measure":75,"description":76,"timeFrame":46},"Vital Signs - total body weight","Vital signs will be collected, including total body weight (kilograms)",{"measure":78,"description":79,"timeFrame":46},"Vital Signs - height","Vital signs will be collected, including height (centimeters)",{"measure":81,"description":82,"timeFrame":46},"Vital Signs - Body Mass Index (BMI)","Body Mass Index (BMI) will be calculated using the values of total body weight and height, with the formula BMI = weight in kg\u002F(height in cm)\\^2.",{"measure":84,"description":85,"timeFrame":46},"Ocular evaluation - Best Corrected Visual Acuity (BCVA)","Ocular evaluations, including Best Corrected Visual Acuity (BCVA) will be performed",{"measure":87,"description":88,"timeFrame":46},"Ocular evaluation - dilated Color Fundus Photography (CFP)","Ocular evaluations, including dilated Color Fundus Photography (CFP) will be performed",{"measure":90,"description":91,"timeFrame":46},"Ocular evaluation - Fundus Autofluorescence (FAF)","Ocular evaluations, including Fundus Autofluorescence (FAF) will be performed",{"measure":93,"description":94,"timeFrame":46},"Ocular evaluation - dilated Optical Coherence Tomography (OCT)","Ocular evaluations, including dilated Optical Coherence Tomography (OCT) of the macula and optic nerve will be performed",{"measure":96,"description":97,"timeFrame":46},"Ocular evaluation - slit lamp examination","Ocular evaluations, including slit lamp examination with measurement of intraocular pressure (IOP) will be performed",[99,103],{"measure":100,"description":101,"timeFrame":102},"Pharmacokinetics of LTX-001 - Single Dose","Single-dose plasma PK parameters (Days 1 and 8) will be measured","Days 1 and 8",{"measure":104,"description":105,"timeFrame":106},"Pharmacokinetics of LTX-001 - Multiple Dose","Multiple-dose plasma PK parameters (Day 35) will be measured.","Days 8 and 35","ALL","18 Years","55 Years",false,{"inclusion":112,"exclusion":119,"raw_text":127},[113,114,115,116,117,118],"BMI \\> 17.5 and \\\u003C 38.0 kg\u002Fm2 and a total body weight \\> 50.0 kg (110 lbs)","Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)","Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study","PANSS total score ≥ 80 at the time of screening for the study","Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period","Sexually active adults must be willing to use an acceptable contraceptive method throughout the study",[120,121,122,123,124,125,126],"Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination","History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine","Current DSM-5-TR diagnosis other than schizophrenia","Pregnant or lactating female","Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening","Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening","Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening","Inclusion Criteria:\n\n* BMI \\> 17.5 and \\\u003C 38.0 kg\u002Fm2 and a total body weight \\> 50.0 kg (110 lbs)\n* Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)\n* Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study\n* PANSS total score ≥ 80 at the time of screening for the study\n* Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period\n* Sexually active adults must be willing to use an acceptable contraceptive method throughout the study\n\nExclusion Criteria:\n\n* Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination\n* History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine\n* Current DSM-5-TR diagnosis other than schizophrenia\n* Pregnant or lactating female\n* Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening\n* Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening\n* Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening",[129],"ADULT",[131,149,163,177,190,200,211,225,239,254],{"facility":132,"status":133,"city":134,"state":135,"zip":136,"country":137,"contacts":138,"geoPoint":146},"Pillar Clinical Research, LLC","NOT_YET_RECRUITING","Little Rock","Arkansas","72204","United States",[139,143],{"name":140,"role":141,"email":142},"Leslie Smith","CONTACT","Studies@pillarhc.com",{"name":144,"role":145},"Leslie Smith, MD","PRINCIPAL_INVESTIGATOR",{"lat":147,"lon":148},34.74648,-92.28959,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":137,"contacts":154,"geoPoint":160},"Collaborative Neuroscience Research, LLC","Los Alamitos","California","90720",[155,158],{"name":156,"role":141,"phone":157},"Study Recruiter","(714)-891-0971",{"name":159,"role":145},"David Walling, PhD",{"lat":161,"lon":162},33.80307,-118.07256,{"facility":164,"status":133,"city":165,"state":166,"zip":167,"country":137,"contacts":168,"geoPoint":174},"University Clinical Research-DeLand, LLC d\u002Fb\u002Fa Accel Research Sites - DeLand Clinical Research Unit","DeLand","Florida","32720",[169,172],{"name":170,"role":141,"email":171},"Bruce Rankin","bruce.rankin@accelclinical.com",{"name":173,"role":145},"Bruce Rankin, MD",{"lat":175,"lon":176},29.02832,-81.30312,{"facility":178,"status":133,"city":179,"state":166,"zip":180,"country":137,"contacts":181,"geoPoint":187},"Behavioral Clinical Research, Inc.","Hollywood","33021",[182,185],{"name":183,"role":141,"email":184},"Leandro Rueda","lrueda@segaltrials.com",{"name":186,"role":145},"Olga Lapeyra, MD",{"lat":188,"lon":189},26.0112,-80.14949,{"facility":191,"status":8,"city":179,"state":166,"zip":192,"country":137,"contacts":193,"geoPoint":199},"CenExel Hollywood FL","33024",[194,197],{"name":195,"role":141,"phone":196},"Edwin A Gomez","954-990-7649",{"name":198,"role":145},"Edwin A Gomez, MD",{"lat":188,"lon":189},{"facility":201,"status":8,"city":202,"state":166,"zip":203,"country":137,"contacts":204,"geoPoint":208},"Innovative Clinical Research, Inc.","Miami Lakes","33016",[205,206],{"name":183,"role":141,"email":184},{"name":207,"role":145},"Rishi Kakar, MD",{"lat":209,"lon":210},25.90871,-80.30866,{"facility":212,"status":8,"city":213,"state":214,"zip":215,"country":137,"contacts":216,"geoPoint":222},"CenExel iResearch, LLC","Decatur","Georgia","30030",[217,220],{"name":218,"role":141,"email":219},"Michael Mahaffey","m.mahaffey@cenexel.com",{"name":221,"role":145},"Kimball Johnson, MD",{"lat":223,"lon":224},33.77483,-84.29631,{"facility":226,"status":133,"city":227,"state":228,"zip":229,"country":137,"contacts":230,"geoPoint":236},"CBH Health LLC., dba CenExel Gaithersburg MD","Gaithersburg","Maryland","20877",[231,234],{"name":232,"role":141,"phone":233},"Elia Acevedo-Diaz","301-251-4702",{"name":235,"role":145},"Elia Acevedo-Diaz, MD",{"lat":237,"lon":238},39.14344,-77.20137,{"facility":240,"status":8,"city":241,"state":242,"zip":243,"country":137,"contacts":244,"geoPoint":251},"Hassman Research Institute, LLC","Marlton","New Jersey","08053",[245,249],{"name":246,"role":141,"phone":247,"email":248},"Lisa Wilkins","888-437-4104","L.Wilkins@CenExel.com",{"name":250,"role":145},"Elan Cohen, MD",{"lat":252,"lon":253},39.89122,-74.92183,{"facility":132,"status":133,"city":255,"state":256,"zip":257,"country":137,"contacts":258,"geoPoint":264},"Richardson","Texas","75080",[259,262],{"name":260,"role":141,"email":261},"Scott Bartley","studies@pillarhc.com",{"name":263,"role":145},"Scott Bartley, MD",{"lat":265,"lon":266},32.94818,-96.72972,[268,272],{"name":269,"role":141,"phone":270,"email":271},"Clinical Trials Information Medical Monitor","267-503-4800","clinical.trials@lealtx.com",{"name":273,"role":141},"Study Director Medical Monitor",[],[],[],{"nct_id":4,"conditions":278,"biomarkers":279},[18],[],{"nct_id":4,"found":14,"summary":281,"prompt_version":291},{"design":282,"status":283,"heading":284,"summary":285,"follow_up":286,"word_count":287,"commitments":288,"compensation":289,"drugs_mentioned":290},"This interventional study plans to enroll 90 adult participants. It will compare different doses of LTX-001 to a placebo.","completed","A Study of LTX-001 for Acute Exacerbation of Schizophrenia","This study is testing an investigational drug called LTX-001 in adults with schizophrenia who are experiencing a recent worsening of their symptoms. Researchers want to see if LTX-001 is safe and well-tolerated. They will compare different doses of LTX-001 (40 mg, 60 mg once daily, or 30 mg, 60 mg twice daily) to a placebo (an inactive substance) to understand how the drug affects the body and symptoms of schizophrenia. The study is looking for about 90 participants aged 18 to 55 who have a schizophrenia diagnosis and a recent acute exacerbation (relapse of symptoms). The main goal is to check for side effects and how well people tolerate the treatment over about six weeks.","Safety and tolerability will be measured from screening through Day 42 after starting the study.",115,"You would visit the study site 3 times and stay overnight for 35 nights (up to 49 nights). Procedures include physical exams, blood and urine tests, heart activity measurements (ECGs), and psychiatric assessments.","Not stated in the trial record.",[35],"v2"]