Long-term safety and tolerability of LB-102 in adults with stable 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 is a 52-week, open-label, multicenter Phase 3 trial evaluating the long-term safety and tolerability of LB-102 in adults with stable schizophrenia. Participants are adults on an oral antipsychotic for at least 30 days and who have moderate illness not fully controlled or who have tolerability concerns with their current medication. Key assessments include the PANSS and CGI-S to establish stability at screening, with ongoing safety monitoring throughout the study. The trial seeks to support continued use of LB-102 in patients seeking to change medications or extend prior LB-102 exposure, under real-world treatment conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provide ICF
* Patients clinically stable PANSS \</= 80 at screening
* CGI-S \</+ 3 at screening
* Medically stable
* BMI 18 -40
* Taking oral antipsychotic treatment for at least 30 days
* Have stable living environment

Exclusion Criteria:

* Sexually active M/F patients not willing to use highly effective contraception
* Breast feeding
* History of treatment resistance to schizophrenia medications
* DSM-5 current diagnosis other than schizophrenia
* Risk of suicidal behavior
* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other

Where it's running

• Chandler Clinical Trials
  Chandler, Arizona, United States Recruiting
• 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
• Advanced Research Center
  Anaheim, California, United States Recruiting
• Synapse Clinical Trials
  Cerritos, 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.