CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 359 enrolled
Drug / intervention
LB-102drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06179108
NCT06179108Phase 2Completed

A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Acute Schizophrenia

LB Pharmaceuticals Inc.·interventional·Posted Dec 21, 2023·Updated Oct 22, 2025

In Brief

A Phase 2 clinical trial evaluating LB-102 for Schizophrenia. Completed, enrolled 359 participants across 25 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedDec 21, 2023
Enrollment StartNov 29, 2023
Primary CompletionDec 4, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 2.5 years ago

Interventions

LB-102drug

LB-102 is a dopamine D2/3 and 5HT7 antagonist.