LTX-001 in adults with acute worsening of schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of LTX-001 in adults with acute exacerbation of schizophrenia. Participants are randomized to receive LTX-001 at one of two doses or placebo for a short period, with careful monitoring and overnight stays in a research unit. Assessments include physical exams, ECGs, blood and urine tests, and psychiatric scales such as PANSS, CGI-S, MINI, and additional cognitive, EPS, suicidality, and qEEG measures. The study aims to determine dose-related effects and how the drug changes in the body and blood markers, to inform future trials.

Why it matters

Who can join: the full rules

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's running

• Pillar Clinical Research, LLC
  Little Rock, Arkansas, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Los Alamitos, California, United States Recruiting
• University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit
  DeLand, Florida, United States Recruiting
• Behavioral Clinical Research, Inc.
  Hollywood, Florida, United States Recruiting
• CenExel Hollywood FL
  Hollywood, Florida, United States Recruiting
• Innovative Clinical Research, Inc.
  Miami Lakes, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Information Medical Monitor
• Email: clinical.trials@lealtx.com
• Phone: 267-503-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.