Schizophrenia
Conditions
Keywords
schizophrenia
Brief summary
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.
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
Interventions
DRUGLTX-001 once daily
LTX-001 40 mg and 60 mg administered as oral suspension
DRUGPlacebo
Oral suspension without LTX-001
DRUGLTX-001 twice daily
LTX-001 30 mg and 60 mg administered as oral suspension
Sponsors
Leal Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability - Adverse Events | Screening through Day 42 | Incidence and severity of treatment-emergent adverse events (TEAEs), and treatment-emergent serious adverse events (TESAEs). |
| Safety and Tolerability - Clinical Laboratory Tests | Screening through Day 42 | Clinical laboratory tests (including serum chemistry, hematology, urinalysis) |
| Safety and Tolerability - Electrocardiograms (ECG) | Screening through Day 42 | ECGs will measure heart rate (HR), QRS complex and QT, QTcF, and PR intervals |
| Safety and Tolerability - Physical and Neurological Exams | Screening through Day 42 | Physical and neurological exams will be performed periodically to ensure participant safety. |
| Safety and Tolerability - Suicidality | Screening through Day 42 | Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) |
| Safety and Tolerability - Extrapyramidal Symptoms | Screening through Day 42 | 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) |
| Vital signs - blood pressure | Screening through Day 42 | Vital signs will be collected, including blood pressure (mm Hg) |
| Vital Signs - heart rate | Screening through Day 42 | Vital signs will be collected, including heart rate (beats per minute) |
| Vital Signs - respiratory rate | Screening through Day 42 | Vital signs will be collected, including respiratory rate (breaths per minute) |
| Vital Signs - body temperature | Screening through Day 42 | Vital signs will be collected, including body temperature (°C or °F) |
| Vital Signs - total body weight | Screening through Day 42 | Vital signs will be collected, including total body weight (kilograms) |
| Vital Signs - height | Screening through Day 42 | Vital signs will be collected, including height (centimeters) |
| Vital Signs - Body Mass Index (BMI) | Screening through Day 42 | Body Mass Index (BMI) will be calculated using the values of total body weight and height, with the formula BMI = weight in kg/(height in cm)\^2. |
| Ocular evaluation - Best Corrected Visual Acuity (BCVA) | Screening through Day 42 | Ocular evaluations, including Best Corrected Visual Acuity (BCVA) will be performed |
| Ocular evaluation - dilated Color Fundus Photography (CFP) | Screening through Day 42 | Ocular evaluations, including dilated Color Fundus Photography (CFP) will be performed |
| Ocular evaluation - Fundus Autofluorescence (FAF) | Screening through Day 42 | Ocular evaluations, including Fundus Autofluorescence (FAF) will be performed |
| Ocular evaluation - dilated Optical Coherence Tomography (OCT) | Screening through Day 42 | Ocular evaluations, including dilated Optical Coherence Tomography (OCT) of the macula and optic nerve will be performed |
| Ocular evaluation - slit lamp examination | Screening through Day 42 | Ocular evaluations, including slit lamp examination with measurement of intraocular pressure (IOP) will be performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of LTX-001 - Single Dose | Days 1 and 8 | Single-dose plasma PK parameters (Days 1 and 8) will be measured |
| Pharmacokinetics of LTX-001 - Multiple Dose | Days 8 and 35 | Multiple-dose plasma PK parameters (Day 35) will be measured. |
Countries
United States
Contacts
CONTACTClinical Trials Information Medical Monitor
CONTACTStudy Director Medical Monitor
Outcome results
None listed