Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741528
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2023-02-13
Brief Title:
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
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None