A Phase 3 interventional study of SEP-363856 in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Terminated at 79 sites in 8 countries. Open to participants aged 13 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 3, Interventional, and Treatment
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 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.
An open-label extension study to assess the safety and tolerability of SEP-363856 in participants 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 participants with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686).
Sumitomo Pharma America Inc. was the former Sponsor and conducted this study. Sumitomo was responsible for analysis and clinical study report (CSR) completion. Otsuka took over study after IND was transferred and is concluding activities with registry postings.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 463 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily
Drug: SEP-363856
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
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Development & Commercialization, Inc.