Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia

Purpose

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.

Condition

  • Schizophrenia

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Patients will be randomized 1:1:1 to one of three treatments
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LB-102 (50 mg tablet) 		• LB-102 50 mg given orally for 6 weeks
  • Drug: LB-102 (50 mg tablet)
    LB-102 oral tablet given for six weeks
    Other names:
    • LB-102
Experimental
LB-102 (100 mg tablet) 		LB-102 100 mg given orally for 6 weeks
  • Drug: LB-102 (100 mg tablet)
    LB-102 oral tablet given for six weeks
    Other names:
    • LB-102
Placebo Comparator
Placebo 		Placebo given orally for 6 weeks
  • Other: Placebo
    Placebo tablet given orally for six weeks

Recruiting Locations

Clinical Innovations, Inc.
Riverside, California 92506
Contact:
Evagelos Coskinas, MD, PhD
866-236-3935
info@CenExel.com

More Details

Status
Recruiting
Sponsor
LB Pharmaceuticals Inc.

Study Contact

Anna Eramo, MD
212-605-0300
Anna@lbpharma.us

Detailed 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