LB-102 for Stable Schizophrenia Treatment

52-week Open Label Safety-Tolerability Study

Recruiting Phase 3 Interventional Study
Schizophrenia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
900 (estimated)
Sponsor
LB Pharmaceuticals Inc. · Industry
Who this trial is looking for

This trial is looking for adults with stable schizophrenia who want to participate in a long-term treatment study. Participants will take LB-102 for 52 weeks to see how safe and tolerable the treatment is.

Are You a Good Fit for This Trial?
Must be taking Oral antipsychotic treatment

You may be able to join if

  • I have been diagnosed with schizophrenia.
  • I am clinically stable with a PANSS score of 80 or less.
  • I have a CGI-S score of 3 or less.
  • I am medically stable.
  • I have a BMI between 18 and 40.
  • I have been taking oral antipsychotic treatment for at least 30 days.
  • I have a stable living environment.

You may not be able to join if

  • I am sexually active and not willing to use highly effective contraception.
  • I am breastfeeding.
  • I have a history of treatment resistance to schizophrenia medications.
  • I have a current diagnosis other than schizophrenia.
  • I am at risk of suicidal behavior.
  • I have a significant medical history involving my heart, lungs, liver, kidneys, blood, stomach, hormones, immune system, skin, nervous system, or cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
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 …
Contacts

Branislav Mancevski, MD

212-605-0300

clinicaltrials@lbpharma.us

CONTACT