drugset / Trial / NCT07038876

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

NCT07038876 ↗

Phase 2 Completed 307 enrolled MapLight Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-06-27
Primary completion
2026-06-04
Completion
2026-06-11

Outcome

Met primary endpoint

release “In schizophrenia, ZEPHYR met its primary endpoint and achieved meaningful efficacy results” maplightrx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ML-007C-MA Unknown 210 mg Oral
Subject ML-007C-MA Unknown 330 mg Oral

Indications