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

Condition(s) studied

Investigational drug(s) / intervention(s)

LTX-001 once daily: LTX-001 40 mg and 60 mg administered as oral suspension

Placebo: Oral suspension without LTX-001

LTX-001 twice daily: LTX-001 30 mg and 60 mg administered as oral suspension

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (10)

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