A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
Recruiting · NCT07734493 · Interventional (participants receive a specific treatment) · Lead sponsor: Leal Therapeutics, Inc
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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: * how does the amount of the study drug in the body change over time (pharmacokinetics) * how does the study drug affect the symptoms of schizophrenia * how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics) Researchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments. After 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.
Who can take part
Inclusion criteria
- BMI \> 17.5 and \< 38.0 kg/m2 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
Exclusion criteria
- 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
Where it is running
10 locations listed across 7 US states.
- Pillar Clinical Research, LLC - Little Rock, Arkansas, United States
- Collaborative Neuroscience Research, LLC - Los Alamitos, California, United States
- University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit - DeLand, Florida, United States
- Behavioral Clinical Research, Inc. - Hollywood, Florida, United States
- CenExel Hollywood FL - Hollywood, Florida, United States
- Innovative Clinical Research, Inc. - Miami Lakes, Florida, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- CBH Health LLC., dba CenExel Gaithersburg MD - Gaithersburg, Maryland, United States
- Hassman Research Institute, LLC - Marlton, New Jersey, United States
- Pillar Clinical Research, LLC - Richardson, Texas, United States