Overview
This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.
Description
This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia
Eligibility
Inclusion Criteria:
- Able to provide ICF
- Willing to be hospitalized for duration of the study
- Diagnosis of schizophrenia as defined by DSM-5
- BMI - 18-40
- PANSS 80-120
Exclusion Criteria:
- Sexually active m/f not willing to adhere to highly effect birth control
- Breast feeding
- Increase in PANSS of \> 20% between screening and baseline
- History of resistant treatment to schizophrenia medications
- DSM-5 diagnosis other than schizophrenia
- Risk of suicidal behavior
- Risk of violent or destructive behavior
- Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening
- Score of ≥3 on the BARS global clinical assessment of akathisia at Screening
- Insulin dependent diabetes
- Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient