LB-102 for Schizophrenia

Palo Alto (17 mi)

Overseen byJohn Kane, MD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: LB Pharmaceuticals Inc.

Prior Safety Data

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.

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.

I am between 18 and 55 years old and have been diagnosed with schizophrenia.

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

Exclusion Criteria

I am not pregnant or breastfeeding.

I was diagnosed with schizophrenia for the first time.

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

I have noticeable involuntary movements.

I have a thyroid condition that affects its function.

I do not use insulin for my diabetes.

I have high blood pressure that isn't managed or I often feel dizzy when standing up.

I have a history of heart disease or heart failure.

I have undergone electroconvulsive therapy or TMS.

I have had neuroleptic malignant syndrome in the past.

Treatment Details

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).

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LB-102, 75 mg QDExperimental Treatment1 Intervention

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

Group II: LB-102, 50 mg QDExperimental Treatment1 Intervention

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

Group III: LB-102, 100 mgExperimental Treatment1 Intervention

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

Group IV: Placebo comparatorPlacebo Group1 Intervention

Drug: Placebo Matched placebo tablets