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drugset / Trial / NCT04825860

A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

NCT04825860 ↗

Phase 2/3 Terminated 83 enrolled Sumitomo Pharma Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A clinical study to investigate the effect of 2 doses of an investigational drug in acutely psychotic adult patients with schizophrenia. The study will consist of a double-blind phase followed by an open-label extension phase.

Timeline

Start
2021-03-29
Primary completion
2023-10-12
Completion
2023-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 50 mg Oral
Subject Ulotaront Small molecule 75 mg Oral

Indications

schizophrenia