LB-102 (50 mg tablet): LB-102 oral tablet given for six weeks
LB-102 (100 mg tablet): LB-102 oral tablet given for six weeks
Placebo: Placebo tablet given orally for six weeks
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline to Week 6 on the Positive and Negative Syndrome Scale — 6 weeks Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.