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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04109950
• Other study ID #: 361-303
• Secondary ID: 2019-000696-16
• Status: Terminated
• Phase: Phase 3
• Start date: October 4, 2019
• Est. completion date: November 9, 2023

Study information

• Verified date: December 2023
• Source: Sumitomo Pharma America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 452
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SEP-363856
SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily

Locations

Country	Name	City	State
Bulgaria	Mental Health Centre Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions	Burgas
Bulgaria	State Psychiatric Hospital - Kardzhali, First Women Department, Third Men Department	Kardzhali
Bulgaria	State Psychiatric Hospital Sv. Ivan Rilski, Department general Psychiatry for Adults, "Closed" type - Men, Department General Psychiatry for Adults, "Closed" Type Women	Novi Iskar
Bulgaria	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	Pazardzhik
Bulgaria	UMHAT-Dr. Georgi Stranski EAD, First Psychiatric Clinic	Pleven
Bulgaria	UMHAT Alexandrovska EAD First Department of Psychiatry at Clinic of Psychiatry	Sofia
Bulgaria	UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry	Sofia
Bulgaria	Mental Health Center - Veliko Tarnovo EOOD-Department of psychiatry for active treatment of persons with acute psychiotic disorders	Veliko Tarnovo
Bulgaria	Mental Health Center-Vratsa EOOD, Department of General Psychiatry	Vratsa
Colombia	Centro de Investigaciones y Proyectos en Neurociencias CIPNA	Barranquilla
Colombia	Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda	Bogotá
Croatia	Psychiatric Hospital "Sveti Ivan"	Zagreb
Latvia	LTD Psychoneurological Hospital of Daugavpils	Daugavpils
Latvia	SLLC Riga Centre of Psychiatry and Narcology	Riga
Latvia	SLLC Psychoneurological Hospital of Strenci	Strenci
Russian Federation	State Budgetary Institution of Healthcare "Regional Clinical Specialized Psychiatric Hospital #1"	Chelyabinsk
Russian Federation	State PUblic Institution of Healthcare Leningrad Regional Psychoneurological Dispensary	Leningrad
Russian Federation	Institution of Healthcare Moscow "Psychiatric Clinical Hospital #1 Named after N.A. Alekseev of Department of Health Moscow"	Moscow
Russian Federation	SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"	Moscow
Russian Federation	State Budgetary institution of Healthcare of Moscow "Psychiatric Hospital ?5	Moscow
Russian Federation	State Budgetary Institution of Healthcare of Nizhniy Novgorod region " Clinical Psychiatric Hospital # 1 of Nizhniy Novgorod	Nizhniy Novgorod
Russian Federation	State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy	Republic Karelia
Russian Federation	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	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	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	Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:	Saint Petersburg
Russian Federation	Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hosptial named after P.P. Kashchenko, inpatient no 2 legg add: 10	Saint Petersburg
Russian Federation	Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortson"	Saint Petersburg
Russian Federation	State Budgetary Institution of Healthcrae "Samara Regional Clinical Psychiatric Hospital"	Samara
Russian Federation	State Institution of Healthcare "Engels Psychiatric Hospital" Ministry of Healthcare of Saratov region	Saratov
Russian Federation	State Institution of Healthcare "Regional Clinical Psychiatric Hospital of Saint Sofia"	Saratov
Russian Federation	State Institution of Healthcare "Saratov City Clinical Hospital # 2 named after V.I. Razumovskiy" 20 and 21 department	Saratov
Russian Federation	State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy", psychiatric departments	Saratov
Russian Federation	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	St. Petersburg
Russian Federation	State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2",	Stavropol
Russian Federation	State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"	Talagi
Serbia	Clinic of Psychiatry, Clinical Center of Serbia	Belgrade
Serbia	Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry	Belgrade
Serbia	Institute of Mental Health	Belgrade
Serbia	Special Hospital for Psychiatric Diseases Gornja Toponica	Gornja Toponica
Serbia	Special Neuropsychiatric Hospital Kovin	Kovin
Serbia	Clinic of Psychiatry, Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Kragujevac, Clinic of Psychiatry	Kragujevac
Serbia	University Clinical Center Nis, Clinic of Psychiatry	Nis
Serbia	Special Hospital for Psychiatric Diseases Sveti Vracevi, Kralja Petra I	Novi Knezevac
Serbia	Clinical Center of Vojvodina, Clinic of Psychiatry	Novi Sad
Serbia	Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"	Vrsac
Ukraine	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	Ivano-Frankivsk
Ukraine	Commercial Non-Commercial Enterprise of Kharkiv Regional Council Psychiatric Department of Primary Psychotic Episode	Kharkiv
Ukraine	State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry	Kharkiv
Ukraine	Communal Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10,	Kherson
Ukraine	Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2	Kyiv
Ukraine	Kyiv City Psychoneurological Hospital #2	Kyiv
Ukraine	Kyiv Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian Railway", Department of Psychoneurology	Kyiv
Ukraine	National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients	Kyiv
Ukraine	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	Kyiv
Ukraine	Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional clinical Psychiatric Hospital, Department #20	Lviv
Ukraine	Communial Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25	Lviv
Ukraine	2-A Metalurgiv street	Nove
Ukraine	Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)	Odesa
Ukraine	Communal Non-commercial Enterprise Odesa Regional Medical Center of Mental Health of Odesa Regional Council, Department #6 (male), Department #12 (female)	Odesa
Ukraine	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	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	Vinnytsia
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Advanced Discovery Research LLC	Atlanta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	iResearch Atlanta, LLC	Atlanta	Georgia
United States	Dr. David Brown, Community Clinical Research	Austin	Texas
United States	ProScience Research Group	Culver City	California
United States	Midwest Clinical research Center	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Precise Research Centers	Flowood	Mississippi
United States	CBH Health, LLC	Gaithersburg	Maryland
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Synergy San Diego	Lemon Grove	California
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Alliance for Research	Long Beach	California
United States	Collaborative Neuroscience Network	Long Beach	California
United States	Hassman Research Institute	Marlton	New Jersey
United States	South Florida Research Phase I-IV, Inc.	Miami Springs	Florida
United States	Catalina Research Institute	Montclair	California
United States	New York State Psychiatric Institute	New York	New York
United States	Fort Lauderdale Behavioral Health Center	Oakland Park	Florida
United States	Pillar Clinical Research	Richardson	Texas
United States	Woodland Research Northwest	Rogers	Arkansas
United States	Arch Clinical Trials, LLC	Saint Louis	Missouri
United States	California Neuropsychopharmacology clinical Research Institute	San Diego	California
United States	California Neuropsychopharmacology Clinical research Institute (CNRI-LA, LLC)	San Diego	California
United States	Schuster Medical Research Institute	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Colombia,  Croatia,  Latvia,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation		53 Weeks