LB-102 for Schizophrenia

No longer recruiting at 24 trial locations

Overseen By Shiskuka Malhotra, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: LB Pharmaceuticals Inc.

Must be taking: Antipsychotics

Must not be taking: Antidepressants, MAOIs, Anticonvulsants, others

Disqualifiers: Substance use, Cardiovascular disease, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, LB-102, for individuals with schizophrenia experiencing a sudden worsening of symptoms. The study compares different doses of LB-102, an experimental treatment, to a placebo, a pill with no active medication, to determine its effectiveness in reducing symptoms like delusions and hallucinations over 28 days. The trial seeks adults diagnosed with schizophrenia who are currently experiencing a significant increase in symptoms requiring hospitalization. Participants should have previously responded positively to antipsychotic treatments. As a Phase 2 trial, this research measures how well LB-102 works in an initial, smaller group, offering participants a chance to contribute to important advancements in schizophrenia treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications, like oral antipsychotics and some antidepressants, before joining the trial. However, this should only be done if it's safe and appropriate according to the study doctor.

Is there any evidence suggesting that LB-102 is likely to be safe for humans?

Research shows that LB-102 appears safe for people with schizophrenia. Earlier studies have not found any major safety issues. LB-102 is similar to amisulpride, a drug already used to treat schizophrenia, and is taken once a day. This similarity suggests that LB-102 might also be well-tolerated.

Previous research has shown LB-102 to be effective in improving schizophrenia symptoms. This is promising because treatments that work well and have few problems are ideal. However, the study remains in an early stage. While there is some evidence of safety, more information is needed to fully understand how well people tolerate LB-102. Participants might experience common side effects, but these have not been detailed in the available research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

LB-102 is unique because it offers a novel approach to treating schizophrenia by being a derivative of amisulpride, a medication not yet widely used in the U.S. Most current treatments for schizophrenia, like risperidone and olanzapine, focus on the dopamine and serotonin systems, often leading to side effects like weight gain and sedation. LB-102 is designed to target these systems with potentially fewer side effects, making it a promising option for those who struggle with the adverse effects of existing medications. Researchers are excited about its potential to offer similar or improved therapeutic benefits with a better side effect profile.

What evidence suggests that LB-102 might be an effective treatment for schizophrenia?

Research has shown that LB-102, which participants in this trial may receive, may help treat schizophrenia. Studies have found that LB-102 significantly lowers scores on tests measuring schizophrenia symptoms, indicating potential benefits for both positive symptoms, like hallucinations, and negative symptoms, like lack of emotion. Early results suggest that different doses of LB-102, tested in this trial, work differently, but all show promise. The drug works similarly to amisulpride, a well-known antipsychotic. Overall, the results so far are encouraging for people with acute schizophrenia. ^{1 2 4 5 6}

Who Is on the Research Team?

John Kane, MD

Principal Investigator

The Zucker Hillside Hospital

Are You a Good Fit for This Trial?

This trial is for adults with acute schizophrenia experiencing a worsening of symptoms. Participants must have a diagnosis of schizophrenia and be currently experiencing an acute episode to qualify.

Inclusion Criteria

I am willing to stay in the hospital for the study period.

Have stable living environment when not in a hospital

I am currently experiencing a severe worsening of my psychotic symptoms.

Exclusion Criteria

I am using two forms of birth control or will remain abstinent during and for 30 days after the trial.

My schizophrenia hasn't improved after two different medications or I've needed clozapine in the last year.

I have noticeable involuntary movements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LB-102 or placebo for 28 days to evaluate antipsychotic efficacy and safety

4 weeks

Daily inpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LB-102

Trial Overview The study tests LB-102's effectiveness in treating acute schizophrenia. It's randomized, meaning patients are randomly assigned to receive either LB-102 or a placebo, and neither the participants nor the researchers know who gets which (double-blind).

How Is the Trial Designed?

Group I: LB-102, 75 mg QD Experimental Treatment 1 Intervention

Oral LB-102: 75 mg (n \~ 105)

Group II: LB-102, 50 mg QD Experimental Treatment 1 Intervention

Oral LB-102: 50 mg (n \~ 105)

Group III: LB-102, 100 mg Experimental Treatment 1 Intervention

Oral LB-102: 100 mg (n \~ 35)

Group IV: Placebo comparator Placebo Group 1 Intervention

Drug: Placebo Matched placebo tablets

Who Is Running the Clinical Trial?

LB Pharmaceuticals Inc.

Lead Sponsor

Trials

3

Recruited

430+

Citations

1. nature.com nature.com/articles/s41386-024-01951-x

PET clinical study of novel antipsychotic LB-102 ... Results from the study did suggest that once-a-day dosing of LB-102 could be effective in treating schizophrenia (amisulpride is typically dosed ...

2. psychiatrictimes.com psychiatrictimes.com/view/lb-102-sees-positive-phase-2-topline-results

LB-102 for Schizophrenia Sees Positive Phase 2 Topline ... Key Takeaways. LB-102 demonstrated significant efficacy in reducing PANSS scores in acute schizophrenia, with varying effect sizes across doses.

3. drugtargetreview.com drugtargetreview.com/article/158966/lb-102-redefining-schizophrenia-treatment-in-drug-discovery/

LB-102: Redefining schizophrenia treatment in drug ... Find out how LB Pharmaceuticals' LB-102 is advancing schizophrenia treatment. This first-in-class antipsychotic demonstrates strong efficacy ...

4. lbpharma.us lbpharma.us/pipeline/

Pipeline LB-102 is supported by its mechanism of action, positive Phase 2 data in acute schizophrenia, and the established clinical experience of amisulpride, ...

5. hcplive.com hcplive.com/view/lb-102-significantly-improves-disease-severity-in-acute-schizophrenia-with-john-kane-md

LB-102 Significantly Improves Disease Severity in Acute ... LB Pharmaceuticals announced additional positive data from NOVA, a phase 2 study evaluating LB-102 in acute schizophrenia , at the 2025 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06179108

NCT06179108 | Randomized, Double-blinded, Placebo ... ... safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. The primary objective of the study is to assess the efficacy of LB-102 ...