RecruitingPhase 2NCT07038876

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Orally Administered ML-007C-MA in Inpatient Adult Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis


Sponsor

MapLight Therapeutics

Enrollment

300 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis. The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new medication called ML-007C-MA in adults hospitalized with schizophrenia, to evaluate whether it can safely and effectively reduce symptoms like hallucinations, disorganized thinking, and withdrawal. **You may be eligible if...** - You have a primary diagnosis of schizophrenia based on DSM-5 criteria - You are currently hospitalized or would benefit from hospitalization for symptom management - You are between 18 and 65 years old (typical range for such studies) - You have had at least one previous schizophrenia episode **You may NOT be eligible if...** - You have a primary diagnosis of another serious psychiatric disorder - You have serious uncontrolled medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Matched Placebo

DRUGML-007C-MA BID

ML-007C-MA dosed as 210/3 mg BID

DRUGML-007C-MA QD

ML-007C-MA dosed as 330/6 mg QD


Locations(25)

Clinical Site

Little Rock, Arkansas, United States

Clinical Site

Bellflower, California, United States

Clinical Site

Culver City, California, United States

Clinical Site

Garden Grove, California, United States

Clinical Site

Lemon Grove, California, United States

Clinical Site

Los Angeles, California, United States

Clinical Site

Montclair, California, United States

Clinical Site

Orange, California, United States

Clinical Site

Riverside, California, United States

Clinical Site

San Diego, California, United States

Clinical Site

Santee, California, United States

Clinical Site

Sherman Oaks, California, United States

Clinical Site

Torrance, California, United States

Clinical Site

Hollywood, Florida, United States

Clinical Site

Miami Lakes, Florida, United States

Clinical Site

West Palm Beach, Florida, United States

Clinical Site

Atlanta, Georgia, United States

Clinical Site

Decatur, Georgia, United States

Clinical Site

Chicago, Illinois, United States

Clinical Site

Marlton, New Jersey, United States

Clinical Site

Staten Island, New York, United States

Clinical Site

North Canton, Ohio, United States

Clinical Site

Austin, Texas, United States

Clinical Site

DeSoto, Texas, United States

Clinical Site

Richardson, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07038876


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