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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Oral suspension without LTX-001
Experimental
LTX-001 once daily 		LTX-001
  • Drug: LTX-001 once daily
    LTX-001 40 mg and 60 mg administered as oral suspension
Experimental
LTX-001 twice daily 		LTX-001
  • Drug: LTX-001 twice daily
    LTX-001 30 mg and 60 mg administered as oral suspension

Recruiting Locations

Pillar Clinical Research, LLC
Little Rock, Arkansas 72204
Contact:
Leslie Smith
Studies@pillarhc.com

Collaborative Neuroscience Research, LLC
Los Alamitos, California 90720
Contact:
Study Recruiter
(714)-891-0971

Behavioral Clinical Research, Inc.
Hollywood, Florida 33021
Contact:
Leandro Rueda
lrueda@segaltrials.com

CenExel Hollywood FL
Hollywood, Florida 33024
Contact:
Edwin A Gomez
954-990-7649

Innovative Clinical Research, Inc.
Miami Lakes, Florida 33016
Contact:
Leandro Rueda
lrueda@segaltrials.com

CenExel iResearch, LLC
Decatur, Georgia 30030
Contact:
Michael Mahaffey
m.mahaffey@cenexel.com

CBH Health LLC., dba CenExel Gaithersburg MD
Gaithersburg, Maryland 20877
Contact:
Elia Acevedo-Diaz
301-251-4702

Hassman Research Institute, LLC
Marlton, New Jersey 08053
Contact:
Lisa Wilkins
888-437-4104
L.Wilkins@CenExel.com

More Details

Status
Recruiting
Sponsor
Leal Therapeutics, Inc

Study Contact

Clinical Trials Information Medical Monitor
267-503-4800
clinical.trials@lealtx.com

Detailed Description

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: - A review of medical history and medications - Physical exams, including a neurologic (nervous system) assessment - Electrocardiograms (a measure of the heart's electrical activity) - Blood and urine collection - 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) - Overall assessment of status via the Clinical Global Impression Scale - Severity (CGI-S) - 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) - Assessment of suicidality risk via the Columbia Suicidality Severity Rating Scale (C-SSRS) - Quantitative electroencephalography (qEEG) assessments - Ophthalmologic examinations - Administration of the study drug (or placebo) by mouth

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.