drugset / Trial / NCT07038876
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ML-007C-MA | Unknown | 210 mg | Oral |
| Subject | ML-007C-MA | Unknown | 330 mg | Oral |