Clinical trial NCT05741528: 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
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 SEP361-308.
* 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.

Primary outcomes:
measure: The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
timeFrame: up to week 25
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center Inc.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Riverside
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Diego
country: United States
facility: CNRI - San Diego, LLC
state: California
city: Santee
country: United States
facility: CMB Clinical Trials
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Hollywood
country: United States
facility: Segal Trials, Larkin Behavioral / Adaptive Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Wellness Research Center
state: Florida
city: Orlando
country: United States
facility: Nova Psychiatry, Inc.
state: Florida
city: Atlanta
country: United States
facility: Advanced Discovery Research LLC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center of Medical Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research
state: Illinois
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, LLC
state: North Carolina
city: Garfield Heights
country: United States
facility: Charak Clinical Research Center
state: Ohio
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: CNS Medical Director
role: STUDY_CHAIR
References: