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A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

NCT05359081 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-03-19

No results posted yet for this study

Summary

A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.

Conditions

Interventions

DRUG

SEP-363856

SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2024-03-21
Completion
2024-03-28
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05359081 on ClinicalTrials.gov