LB-102 treatment for adults with acute schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, double-blind, placebo-controlled, fixed-dose multicenter trial compares once-daily LB-102 (50 mg and 100 mg) with placebo in adults experiencing an acute exacerbation of schizophrenia. Participants are hospitalized for the duration of the study and randomized to one of the three arms. The study tracks symptom change (including PANSS scores), safety, tolerability, and pharmacokinetics. Key eligibility includes DSM-5 schizophrenia diagnosis, PANSS 80–120, BMI 18–40, ability to consent, and agreement to required contraception where applicable.

Why it matters

Who can join: the full rules

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

Where it's running

• Pillar Clinical Research
  Bentonville, Arkansas, United States Recruiting
• Pillar Clinical Research
  Little Rock, Arkansas, United States Recruiting
• Woodland International Research Group
  Little Rock, Arkansas, United States Recruiting
• ProScience Research Group
  Culver City, California, United States Recruiting
• CenExel
  Garden Grove, California, United States Recruiting
• Synergy San Diego
  Lemon Grove, California, United States Recruiting

Study contacts

• Study coordinator: Branislav Mancevski, MD
• Email: clinicaltrials@lbpharma.us
• Phone: 212-605-0300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.