Long-Term Study of ML-007C-MA Treatment in Adults with Schizophrenia Evaluating Safety, Tolerability, and Effectiveness Over 52 Weeks

What this Trial Is About

Researchers are conducting a 52-week open-label study to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with schizophrenia. This study includes participants who have recently completed a prior study ML-007C-MA-211 as well as new participants enrolling directly. The goal is to better understand how ML-007C-MA performs over an extended period in managing schizophrenia symptoms. Participants will receive ML-007C-MA dosed as 2103 mg twice daily throughout the 52-week treatment period. The study is designed as an open-label trial, meaning both researchers and participants know the treatment being administered. No placebo or comparator groups are involved in this phase 2 research. During the study, participants will undergo assessments to monitor safety and tolerability from the initial dose through the end of treatment. Researchers will also evaluate the effectiveness of ML-007C-MA in managing schizophrenia symptoms. The study involves outpatient care, regular clinical interviews, and the involvement of reliable informants to support assessments. Participants will be observed for up to one year to gather comprehensive data on long-term treatment outcomes.

A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia