A study to evaluate the long-term safety and tolerability of SEP-363856 in subjects with schizophrenia.

Phase 1

• Conditions: Schizophrenia; MedDRA version: 21.1Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 100000004873; MedDRA version: 20.0Level: LLTClassification code 10008525Term: Childhood schizophreniaSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-000696-16-BG
• Lead Sponsor: Sumitomo Pharma America, Inc. (SMPA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-19
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 612

Inclusion Criteria

• Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
• Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
Are the trial subjects under 18? yes
Number of subjects for this age range: 57
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 555
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subject answered yes” to suicidal ideation” Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at the EOT Visit of Study SEP361-301 or SEP361-302.
• Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of flexibly dosed SEP-363856 (25, 50, 75, 100 mg/day) in subjects with schizophrenia who have completed Studies SEP361-301 and SEP361-302 by the incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.;Secondary Objective: • To evaluate the long-term safety and tolerability of SEP-363856 by assessing:<br> o physical examinations (PE).<br> o 12-lead electrocardiograms (ECG).<br> o vital sign measurements.<br> o clinical laboratory tests.<br> o Columbia – Suicide Severity Rating Scale (C-SSRS).<br> o Simpson-Angus Scale (SAS).<br> o Barnes Akathisia Rating Scale (BARS).<br> o Abnormal Involuntary Movement Scale (AIMS).;Primary end point(s): The incidence of overall AEs, SAEs, and AEs leading to discontinuation.;Timepoint(s) of evaluation of this end point: From the time of the first dose of study drug through 9 days following the last dose of the open-label extension study drug.