NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 3

Sponsor: LB Pharmaceuticals Inc.

Conditions: Schizophrenia

Interventions: LB-102 (50 mg tablet), LB-102 (100 mg tablet), Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (13)

Bentonville, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Culver City, California, United States
Garden Grove, California, United States
Lemon Grove, California, United States
Riverside, California, United States
Boynton Beach, Florida, United States
Miami Lakes, Florida, United States
Snellville, Georgia, United States
Chicago, Illinois, United States
St Louis, Missouri, United States
North Canton, Ohio, United States