NCT02970929

An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia

Detailed description

This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201 (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial. No statistical hypothesis tests will be performed.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856	One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks

Timeline

• Start date: 2017-01-31
• Primary completion: 2019-01-29
• Completion: 2019-01-29
• First posted: 2016-11-22
• Last updated: 2024-07-05
• Results posted: 2022-02-09

Locations

30 sites across 5 countries: United States, Hungary, Romania, Russia, Ukraine

Regulatory

• FDA-regulated drug study