AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia

RecruitingPhase 1Ages 18 Years - 55 YearsAllLeal Therapeutics, Inc
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 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
๐Ÿ’Š

What it tests

  • LTX-001 once daily
  • Placebo
  • LTX-001 twice daily
๐Ÿ“

Where

10 sites
Pillar Clinical Research, LLC
Little Rock, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, United States
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit
DeLand, United States
Behavioral Clinical Research, Inc.
Hollywood, United States
CenExel Hollywood FL
Hollywood, United States
Innovative Clinical Research, Inc.
Miami Lakes, United States
CenExel iResearch, LLC
Decatur, United States
CBH Health LLC., dba CenExel Gaithersburg MD
Gaithersburg, United States

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy