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

Study Overview
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Brief Summary
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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 or SEP361-302. This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

Detailed Description
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An open-label extension study to assess the safety and tolerability of SEP-363856 in subjects with schizophrenia This is an open-label extension study to evaluate long-term safety and tolerability of SEP-363856. This is a 52-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (25 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 or Study SEP361-302.

Official Title
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An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: SEP-363856


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject (or subject's parent/legal guardian for adolescents) must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent. 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. Female subject must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302. Female subjects of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken. Male subjects must agree to avoid fathering a child and use highly effective methods of birth control from screening in Study SEP361-301 or Study SEP361-302, until at least 30 days after the last study drug administration in the present study (SEP361-303). 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 Columbia Suicide Severity Rating Scale (C-SSRS) assessment at the End of treatment (EO) 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. Subject has a positive urine drug screen (UDS) at the EOT Visit of Study SEP361-301 or SEP361-302. However, a positive UDS test may not result in exclusion of subjects if the Investigator determines that the positive test is as a result of prescription medicine(s). Subjects may enter this study before the urine drug screen results are received from the central laboratory. However, after receipt and review of the results any subject meeting this exclusion criterion must be discontinued from the study. Retesting of the UDS is allowed once with prior approval from the Medical Monitor with the retest used to determine eligibility Female subject is pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a 52-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (25 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 or Study SEP361-302. The study will consist of two periods: An Open-Label Extension (OLE) Treatment Period (up to 52 weeks); and a Follow-up visit at 7 ±2 days after last study drug dose for subjects who complete the Treatment Period and those who prematurely discontinue from the study. The adolescent cohort includes subjects who were 13 to 17 years of age, at the time of consent in the SEP361-301 study. For adolescent subjects, a reliable informant (e.g., parent, legal guardian, or caregiver) of the subject should accompany the subject at each visit and support and monitor the subject's compliance with taking study medication.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEP-363856<br>SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily | Drug: SEP-363856<br>* SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation |  | 53 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia