A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 or SEP361-302. This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SEP-363856

Detailed Description

An open-label extension study to assess the safety and tolerability of SEP-363856 in subjects with schizophrenia This is an open-label extension study to evaluate long-term safety and tolerability of SEP-363856. This is a 52-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (25 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 or Study SEP361-302.

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: CNS Medical Director; Phone Number: 1-866-503-6351; Email: ClinicalTrialDisclosure@sunovion.com

Study Locations

• Bulgaria
  • Burgas, Bulgaria, 8000
    • Mental Health Centre Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions
  • Kardzhali, Bulgaria, 6600
    • State Psychiatric Hospital - Kardzhali, First Women Department, Third Men Department
  • Novi Iskar, Bulgaria, 1282
    • State Psychiatric Hospital Sv. Ivan Rilski, Department general Psychiatry for Adults, "Closed" type - Men, Department General Psychiatry for Adults, "Closed" Type Women
  • Pazardzhik, Bulgaria, 4400
    • State Psychiatric Hospital-Pazardzhik AD, Department for Active Treatment of Men Department for Active Treatment of Women , Department of Active Treatment of Men and Women
  • Pleven, Bulgaria, 5800
    • UMHAT-Dr. Georgi Stranski EAD, First Psychiatric Clinic
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska EAD First Department of Psychiatry at Clinic of Psychiatry
  • Veliko Tarnovo, Bulgaria, 5000
    • Mental Health Center - Veliko Tarnovo EOOD-Department of psychiatry for active treatment of persons with acute psychiotic disorders
  • Vratsa, Bulgaria, 3000
    • Mental Health Center-Vratsa EOOD, Department of General Psychiatry
• Colombia
  • Barranquilla, Colombia, 080020
    • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  • Bogotá, Colombia, 111166
    • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
• Croatia
  • Zagreb, Croatia, 10090
    • Psychiatric Hospital "Sveti Ivan"
• Latvia
  • Daugavpils, Latvia, LV-5417
    • LTD Psychoneurological Hospital of Daugavpils
  • Riga, Latvia, LV-1005
    • SLLC Riga Centre of Psychiatry and Narcology
  • Strenci, Latvia, LV-4730
    • SLLC Psychoneurological Hospital of Strenci
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • State Budgetary Institution of Healthcare "Regional Clinical Specialized Psychiatric Hospital #1"
  • Leningrad, Russian Federation, 188820
    • State PUblic Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
  • Moscow, Russian Federation, 107076
    • SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
  • Moscow, Russian Federation, 117152
    • Institution of Healthcare Moscow "Psychiatric Clinical Hospital #1 Named after N.A. Alekseev of Department of Health Moscow"
  • Moscow, Russian Federation, 141371
    • State Budgetary institution of Healthcare of Moscow "Psychiatric Hospital №5
  • Nizhniy Novgorod, Russian Federation, 603155
    • State Budgetary Institution of Healthcare of Nizhniy Novgorod region " Clinical Psychiatric Hospital # 1 of Nizhniy Novgorod
  • Republic Karelia, Russian Federation, 186131
    • State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy
  • Saint Petersburg, Russian Federation, 188357
    • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:
  • Saint Petersburg, Russian Federation, 190005
    • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hosptial named after P.P. Kashchenko, inpatient no 2 legg add: 10
  • Saint Petersburg, Russian Federation, 191167
    • FSBI "NMRC of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF 3, Bekhtereva str, Saint Petersbur, 192019, Russia based on SPb SI of Healthcare "City Psychiatric Hospital #6"
  • Saint Petersburg, Russian Federation, 192019
    • Federal State Budgetary Institution "National Medical Research Center o Psychiatry and Neurology named after V.M. Bekhterev" of the Ministry of Healthcare of the Russian Fereration
  • Saint Petersburg, Russian Federation, 192019
    • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n. a. V. M. Bekhterev" of the Ministry of Healthcare of the Russian Federation
  • Saint Petersburg, Russian Federation, 197341
    • Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortson"
  • Samara, Russian Federation, 443016
    • State Budgetary Institution of Healthcrae "Samara Regional Clinical Psychiatric Hospital"
  • Saratov, Russian Federation, 410028
    • State Institution of Healthcare "Saratov City Clinical Hospital # 2 named after V.I. Razumovskiy" 20 and 21 department
  • Saratov, Russian Federation, 410028
    • State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy", psychiatric departments
  • Saratov, Russian Federation, 410060
    • State Institution of Healthcare "Regional Clinical Psychiatric Hospital of Saint Sofia"
  • Saratov, Russian Federation, 413124
    • State Institution of Healthcare "Engels Psychiatric Hospital" Ministry of Healthcare of Saratov region
  • St. Petersburg, Russian Federation, 192019
    • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology named after V. M. Bekhterev" of the Ministry of the Healthcare of Russian federation
  • Stavropol, Russian Federation, 357034
    • State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2",
  • Talagi, Russian Federation, 163530
    • State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Mental Health
  • Belgrade, Serbia, 11000
    • Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
  • Belgrade, Serbia, 11000
    • Clinic of Psychiatry, Clinical Center of Serbia
  • Gornja Toponica, Serbia, 18202
    • Special Hospital for Psychiatric Diseases Gornja Toponica
  • Kovin, Serbia, 26220
    • Special Neuropsychiatric Hospital Kovin
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac, Clinic of Psychiatry
  • Kragujevac, Serbia, 34000
    • Clinic of Psychiatry, Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • University Clinical Center Nis, Clinic of Psychiatry
  • Novi Knezevac, Serbia, 23330
    • Special Hospital for Psychiatric Diseases Sveti Vracevi, Kralja Petra I
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina, Clinic of Psychiatry
  • Vrsac, Serbia, 26300
    • Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76011
    • Regional Psychoneurological Hospital#3, Department of Critical Conditions and Primary Psychotic Episode for Adult Population #1, Ivano-Frankivsk National Medical University, Chair of Psychiatry, Narcology and Medical Pschology
  • Kharkiv, Ukraine, 61068
    • State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry
  • Kharkiv, Ukraine, 61068
    • Commercial Non-Commercial Enterprise of Kharkiv Regional Council Psychiatric Department of Primary Psychotic Episode
  • Kherson, Ukraine, 73488
    • Communal Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10,
  • Kyiv, Ukraine, 02192
    • Kyiv City Psychoneurological Hospital #2
  • Kyiv, Ukraine, 01133
    • National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients
  • Kyiv, Ukraine, 08631
    • Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2
  • Kyiv, Ukraine, 01030
    • Kyiv Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian Railway", Department of Psychoneurology
  • Kyiv, Ukraine, 04080
    • Territorial Medical Association Psychiatry in Kyiv, Center of Novel Methods of Treatment and Rehabilitation of Psychotic Conditions, Department #29 (male), Department #30 (female), Outpatient and Polyclinic Office at Department #30
  • Lviv, Ukraine, 79021
    • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional clinical Psychiatric Hospital, Department #20
  • Lviv, Ukraine, 79021
    • Communial Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
  • Nove, Ukraine, 25491
    • 2-A Metalurgiv street
  • Odesa, Ukraine, 67513
    • Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)
  • Odesa, Ukraine, 65006
    • Communal Non-commercial Enterprise Odesa Regional Medical Center of Mental Health of Odesa Regional Council, Department #6 (male), Department #12 (female)
  • Vinnytsia, Ukraine, 21005
    • Communal Institution O.I. Yushchenko Vinnytsia Regional Psychoneurological Hospital, Female Department #10, Male Department #7, Vinnytsia M.I.Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Education
  • Vinnytsia, Ukraine, 21005
    • Communal Institution O.I.Yushchenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group, LLC
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Culver City, California, United States, 90230
      • ProScience Research Group
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Long Beach, California, United States, 90806
      • Collaborative NeuroScience Network
    • Long Beach, California, United States, 90807
      • Alliance for Research
    • Montclair, California, United States, 91763
      • Catalina Research Institute
    • San Diego, California, United States, 92102
      • California Neuropsychopharmacology Clinical Research Institute
    • San Diego, California, United States, 92102
      • California Neuropsychopharmacology Clinical research Institute (CNRI-LA, LLC)
    • Sherman Oaks, California, United States, 91403
      • Schuster Medical Research Institute
  • Florida
    • Miami Springs, Florida, United States, 33166
      • South Florida Research Phase I-Iv, Inc.
    • Oakland Park, Florida, United States, 33334
      • Fort Lauderdale Behavioral Health Center
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30318
      • Advanced Discovery Research LLC
    • Atlanta, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health, LLC
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Saint Louis, Missouri, United States, 63125
      • Arch Clinical Trials, LLC
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78754
      • Dr. David Brown, Community Clinical Research
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject (or subject's parent/legal guardian for adolescents) must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
2. Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
3. Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
4. Female subject must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
5. Female subjects of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken.
6. Male subjects must agree to avoid fathering a child and use highly effective methods of birth control from screening in Study SEP361-301 or Study SEP361-302, until at least 30 days after the last study drug administration in the present study (SEP361-303).

Exclusion Criteria

1. . Subject answered "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment at the End of treatment (EO) Visit of Study SEP361-301 or SEP361-302.
2. Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
3. Subject has a positive urine drug screen (UDS) at the EOT Visit of Study SEP361-301 or SEP361-302. However, a positive UDS test may not result in exclusion of subjects if the Investigator determines that the positive test is as a result of prescription medicine(s). Subjects may enter this study before the urine drug screen results are received from the central laboratory. However, after receipt and review of the results any subject meeting this exclusion criterion must be discontinued from the study. Retesting of the UDS is allowed once with prior approval from the Medical Monitor with the retest used to determine eligibility
4. Female subject is pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEP-363856; SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily	Drug: SEP-363856; SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation	53 Weeks

Collaborators and Investigators

• Sponsor: Sumitomo Pharma America, Inc.
• Investigators: Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 361-303; 2019-000696-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study may be made available upon request via the Vivli Global Center for Clinical Research Data site.
• IPD Sharing Time Frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No