A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT04109950|
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : February 28, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: SEP-363856||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||555 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Masking Description:||open - label|
|Official Title:||An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia|
|Actual Study Start Date :||October 4, 2019|
|Estimated Primary Completion Date :||September 10, 2024|
|Estimated Study Completion Date :||September 10, 2024|
SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily
SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily
- The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation [ Time Frame: 53 Weeks ]
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|Ages Eligible for Study:||13 Years to 65 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- . 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109950
|Contact: CNS Medical Director||1-866-503-6351||ClinicalTrialDisclosure@sunovion.com|
|Study Chair:||CNS Medical Director||Sunovion|
|Other Study ID Numbers:||
2019-000696-16 ( EudraCT Number )
|First Posted:||October 1, 2019 Key Record Dates|
|Last Update Posted:||February 28, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||IPD for this study may be made available upon request via the Clinical Study Data Request site.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||IPD will be made available upon request within 12 months of posting the study results on ct.gov.|
|Access Criteria:||Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Schizophrenia Spectrum and Other Psychotic Disorders