NCT07038876

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: MapLight Therapeutics · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Placebo	Matched Placebo
DRUG	ML-007C-MA BID	ML-007C-MA dosed as 210/3 mg BID
DRUG	ML-007C-MA QD	ML-007C-MA dosed as 330/6 mg QD

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-06-26
• Last updated: 2026-03-09

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study