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

RecruitingPhase 3Ages 18 Years - 65 YearsAllLB Pharmaceuticals Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ3 on Item 8 of the AIMS at Screening * Score of โ‰ฅ3 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
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What it tests

  • LB-102 (50 mg tablet)
  • LB-102 (100 mg tablet)
  • Placebo
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Where

13 sites
Pillar Clinical Research
Bentonville, United States
Pillar Clinical Research
Little Rock, United States
Woodland International Research Group
Little Rock, United States
ProScience Research Group
Culver City, United States
CenExel
Garden Grove, United States
Synergy San Diego
Lemon Grove, United States
Clinical Innovations, Inc.
Riverside, United States
Health Synergy Clinical Research
Boynton Beach, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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