Clinical trial NCT04109950: A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
Official title: An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 463
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 treatment of participants with schizophrenia who have completed Treatment Period of one of two following double-blind studies: Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686).

The study will consist of two periods: An Open-Label Extension (OLE) Treatment Period (up to 52 weeks); and a Follow-up visit at 7±2 days after last study drug dose for participants who complete the Treatment Period \& those who prematurely discontinue from study.

The adolescent cohort includes participants who were 13 to 17 years of age, at time of consent in the SEP361-301 study. For adolescent participants, a reliable informant (e.g., parent, legal guardian, or caregiver) of participant should accompany participant at each visit and support and monitor the participants compliance with taking study medication.
Primary purpose: TREATMENT

Brief 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 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

Detailed description: An open-label extension study to assess the safety and tolerability of SEP-363856 in participants 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 participants with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686).

Sumitomo Pharma America Inc. was the former Sponsor and conducted this study. Sumitomo was responsible for analysis and clinical study report (CSR) completion. Otsuka took over study after IND was transferred and is concluding activities with registry postings.

Eligibility criteria: Inclusion Criteria:

1. Participant (or participants 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. Participant has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
3. Participant 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 participant must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
5. Female participants 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 participants 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. Participant 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. Participant 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. Participant 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 participants if the Investigator determines that the positive test is as a result of prescription medicine(s). participants 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 participant 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 participant is pregnant or lactating.

Primary outcomes:
measure: The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation
timeFrame: 53 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Rogers
country: United States
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state: Arkansas
city: Anaheim
country: United States
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state: California
city: Culver City
country: United States
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state: California
city: Lemon Grove
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state: California
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state: California
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state: Florida
city: Oakland Park
country: United States
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state: Florida
city: Atlanta
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state: Georgia
city: Atlanta
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state: Georgia
city: Atlanta
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state: Georgia
city: Decatur
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state: Georgia
city: Lake Charles
country: United States
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state: Louisiana
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state: Maryland
city: Flowood
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state: Mississippi
city: Saint Louis
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state: Missouri
city: Marlton
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state: New Jersey
city: New York
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state: New York
city: Dayton
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state: Ohio
city: Austin
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state: Texas
city: Richardson
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state: Texas
city: Burgas
country: Bulgaria
facility: Research Site
city: Kardzhali
country: Bulgaria
facility: Research Site
city: Novi Iskar
country: Bulgaria
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city: Pazardzhik
country: Bulgaria
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city: Pleven
country: Bulgaria
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city: Sofia
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
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city: Vratsa
country: Bulgaria
facility: Research Site
city: Barranquilla
country: Colombia
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city: Bogotá
country: Colombia
facility: Research Site
city: Zagreb
country: Croatia
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city: Daugavpils
country: Latvia
facility: Research Site
city: Riga
country: Latvia
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city: Strenci
country: Latvia
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Leningrad
country: Russian Federation
facility: Research Site
city: Matrosy
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
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city: Saratov
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
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city: Talagi
country: Russian Federation
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city: Belgrade
country: Serbia
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city: Gornja Toponica
country: Serbia
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city: Kovin
country: Serbia
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city: Kragujevac
country: Serbia
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city: Nis
country: Serbia
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city: Novi Knezevac
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
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city: Vrsac
country: Serbia
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
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city: Kherson
country: Ukraine
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city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Lviv
country: Ukraine
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city: Nove
country: Ukraine
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city: Odesa
country: Ukraine
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city: Odesa
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
Study officials:
References: