An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
Study Details
Study Description
Brief Summary
An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is a 24-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed Study SEP361-308 treatment period, during which they were switched from a previous antipsychotic treatment to SEP-363856.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SEP-363856
|
Drug: SEP-363856
SEP-363856 tablet
|
Outcome Measures
Primary Outcome Measures
- The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation [up to week 25]
Eligibility Criteria
Criteria
Inclusion Criteria: (list is not all inclusive)
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Subject has given written informed consent and privacy authorization prior to participation in the study.
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Subject has completed the Treatment Period of Study SEP361-308.
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Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
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Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
Exclusion Criteria: (list is not all inclusive)
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Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
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Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
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Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
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Female subject is pregnant or lactating.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sunovion
Investigators
- Study Chair: CNS Medical Director, Sunovion
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SEP361-309