A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia
LB Pharmaceuticals Inc.
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.
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
- Age range
- 18–65 years
- Sex
- All
- 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…
Interventions
- DrugLB-102 (50 mg tablet)
LB-102 oral tablet given for six weeks
- DrugLB-102 (100 mg tablet)
LB-102 oral tablet given for six weeks
- OtherPlacebo
Placebo tablet given orally for six weeks
Locations (13)
- Pillar Clinical ResearchBentonville, Arkansas
- Pillar Clinical ResearchLittle Rock, Arkansas
- Woodland International Research GroupLittle Rock, Arkansas
- ProScience Research GroupCulver City, California
- CenExelGarden Grove, California
- Synergy San DiegoLemon Grove, California