An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
Overview
- Phase
- Phase 3
- Intervention
- SEP-363856
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(list is not all inclusive)
- •Subject has given written informed consent and privacy authorization prior to participation in the study.
- •Subject has completed the Treatment Period of Study SEP361-
- •Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-
- •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)
- •Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-
- •Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-
- •Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-
- •Female subject is pregnant or lactating.
Arms & Interventions
SEP-363856
Intervention: SEP-363856
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose of study drug up to end of 1 week follow up period (up to Week 25)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Number of Participants With Serious Adverse Events
Time Frame: From first dose of study drug up to end of 1 week follow up period (up to Week 25)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event is any AE occurring at any dose that results in death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization, or is a congenital anomaly/birth defect.
Number of Participants With AEs Leading to Discontinuation of Study
Time Frame: From first dose of study drug up to end of 1 week follow up period (up to Week 25)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs leading to discontinuation from the study are those AEs which caused participant to discontinue from the study.