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Recruiting NCT07363577

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

Phase III Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LB-102 (50 mg tablet), LB-102 (100 mg tablet), Placebo.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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

Interventions

  • Drug LB-102 (50 mg tablet)
    LB-102 oral tablet given for six weeks
  • Drug LB-102 (100 mg tablet)
    LB-102 oral tablet given for six weeks
  • Other Placebo
    Placebo tablet given orally for six weeks

Primary outcome measures

  • Change from baseline to Week 6 on the Positive and Negative Syndrome Scale [Time frame: 6 weeks]
Secondary outcome measures (2)
  • Evaluate the Safety and Tolerability of LB-102 [Time frame: 10 weeks]
  • Change in Clinical Global Impressions-Severity of Illness scale (CGI-S) [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 13 centers
  • Pillar Clinical Research — Bentonville
  • Pillar Clinical Research — Little Rock
  • Woodland International Research Group — Little Rock
  • ProScience Research Group — Culver City
  • CenExel — Garden Grove
  • Synergy San Diego — Lemon Grove
  • Clinical Innovations, Inc. — Riverside
  • Health Synergy Clinical Research — Boynton Beach
  • … and 5 more centers

Identifiers

NCT: NCT07363577 · LB-102-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗