drugset / Trial / NCT04109950

A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

NCT04109950

NaSingle-groupOpen-labelTreatment

Summary

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

Timeline

Start
2019-11-20
Primary completion
2023-11-09
Completion
2023-11-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 25 mg Oral
Subject Ulotaront Small molecule 50 mg Oral
Subject Ulotaront Small molecule 75 mg Oral
Subject Ulotaront Small molecule 100 mg Oral

Indications