Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LTX-001 once daily · 1 trial · 1 indication
Incidence and severity of treatment-emergent adverse events (TEAEs), and treatment-emergent serious adverse events (TESAEs).
Clinical laboratory tests (including serum chemistry, hematology, urinalysis)
ECGs will measure heart rate (HR), QRS complex and QT, QTcF, and PR intervals
Physical and neurological exams will be performed periodically to ensure participant safety.
Suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
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 will be collected, including blood pressure (mm Hg)
Vital signs will be collected, including heart rate (beats per minute)
Vital signs will be collected, including respiratory rate (breaths per minute)
Vital signs will be collected, including body temperature (°C or °F)
Vital signs will be collected, including total body weight (kilograms)
Vital signs will be collected, including height (centimeters)
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 evaluations, including Best Corrected Visual Acuity (BCVA) will be performed
Ocular evaluations, including dilated Color Fundus Photography (CFP) will be performed
Ocular evaluations, including Fundus Autofluorescence (FAF) will be performed
Ocular evaluations, including dilated Optical Coherence Tomography (OCT) of the macula and optic nerve will be performed
Ocular evaluations, including slit lamp examination with measurement of intraocular pressure (IOP) will be performed
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| LTX-001 once daily | EXPERIMENTAL | LTX-001 |
| LTX-001 twice daily | EXPERIMENTAL | LTX-001 |
| Name | Type | Description |
|---|---|---|
| LTX-001 once daily | DRUG | LTX-001 40 mg and 60 mg administered as oral suspension |
| Placebo | DRUG | Oral suspension without LTX-001 |
| LTX-001 twice daily | DRUG | LTX-001 30 mg and 60 mg administered as oral suspension |
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 th...