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

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

Age range

18–64 years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (25)