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NCT05741528 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05741528
Other study ID # SEP361-309
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date March 31, 2023
Est. completion date January 10, 2025

Study information
Verified date February 2024
Source Sumitomo Pharma America, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 67
Est. completion date January 10, 2025
Est. primary completion date January 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 SEP361-308. - Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308. - 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 SEP361-308. - 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. - Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308. - Female subject is pregnant or lactating.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SEP-363856
SEP-363856 tablet

Locations
Country Name City State
United States Advanced Research Center Inc. Anaheim California
United States Advanced Discovery Research LLC Atlanta Georgia
United States Atlanta Center of Medical Research Atlanta Georgia
United States Hassman Research Institute Berlin New Jersey
United States New Hope Clinical Research Charlotte North Carolina
United States Uptown Research Chicago Illinois
United States CBH Health Gaithersburg Maryland
United States Collaborative Neuroscience Research, LLC Garden Grove California
United States Charak Clinical Research Center Garfield Heights Ohio
United States Clinical Trials of America, LLC Hickory North Carolina
United States Segal Trials, Larkin Behavioral / Adaptive Clinical Research Hollywood Florida
United States Synergy San Diego Lemon Grove California
United States Premier Clinical Research Institute, Inc. Miami Florida
United States Wellness Research Center Miami Florida
United States Behavioral Clinical Research, Inc. Miami Lakes Florida
United States Nova Psychiatry, Inc. Orlando Florida
United States Clinical Innovations, Inc. Riverside California
United States PsychCare Consultants Research Saint Louis Missouri
United States CNRI - San Diego, LLC San Diego California
United States CMB Clinical Trials Santee California
United States Collaborative Neuroscience Research, LLC Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Sumitomo Pharma America, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation up to week 25
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