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 : October 19, 2020
|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 :||November 17, 2022|
|Estimated Study Completion Date :||November 17, 2022|
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 ]
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|