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

A Randomized, Double-blind, Parallel-group, Placebo Controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in Acutely Psychotic Patients With Schizophrenia, Followed by an Open-label Extension Phase

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Sumitomo Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A Phase 2/3 Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Patients with Schizophrenia, Followed by an Open-label Extension Phase. The double-blind phase is to evaluate the efficacy and safety of 2 doses of SEP-363856 (50 and 75 mg/day) versus placebo over 6 weeks in acutely psychotic patients with schizophrenia. This phase is projected to randomize approximately 480 subjects to 3 treatments (SEP-363856 50 mg/day, SEP-363856 75 mg/day, placebo) in a 1:1:1 ratio. The completers of the double-blind phase will be able to enroll into the 12-week open-label phase during which the long term safety and effectiveness of-SEP 363856 will be evaluated.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856 50 mg	Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
DRUG	SEP-363856 75 mg	Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
DRUG	Placebo	Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.

Timeline

• Start date: 2021-03-29
• Primary completion: 2023-10-12
• Completion: 2023-10-19
• First posted: 2021-04-01
• Last updated: 2024-03-15

Locations

54 sites across 4 countries: China, Japan, Philippines, Taiwan