LB-102 for Schizophrenia

Recruiting at 24 trial locations

Overseen By Anna Eramo

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

359 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.

Research Team

John Kane, MD

Principal Investigator

The Zucker Hillside Hospital

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+