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

NCT04109950 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: SEP361-3032019-000696-16
• Study Type: interventional
• Target: 463
• Locations: 8 countries
• Sites: 78

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.

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation

  53 Weeks

Study Arms (1)

SEP-363856

EXPERIMENTAL

SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily

Drug: SEP-363856

Interventions

SEP-363856 DRUG

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

SEP-363856

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participant has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
• 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.
• Female participant must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• Female participant is pregnant or lactating.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (78)

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Little Rock, Arkansas, 72211, United States

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Rogers, Arkansas, 72758, United States

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Anaheim, California, 92805, United States

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Culver City, California, 90230, United States

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Lemon Grove, California, 91945, United States

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Long Beach, California, 90806, United States

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Long Beach, California, 90807, United States

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Montclair, California, 91763, United States

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San Diego, California, 92102, United States

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Sherman Oaks, California, 91403, United States

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Miami Springs, Florida, 33166, United States

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Oakland Park, Florida, 33334, United States

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Atlanta, Georgia, 30030, United States

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Atlanta, Georgia, 30318, United States

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Atlanta, Georgia, 30331, United States

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Decatur, Georgia, 30030, United States

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Lake Charles, Louisiana, 70629, United States

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Gaithersburg, Maryland, 20877, United States

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Flowood, Mississippi, 39232, United States

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St Louis, Missouri, 63125, United States

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Marlton, New Jersey, 08053, United States

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New York, New York, 10032, United States

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Dayton, Ohio, 45417, United States

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Austin, Texas, 78754, United States

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Richardson, Texas, 75080, United States

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Burgas, 8000, Bulgaria

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Kardzhali, 6600, Bulgaria

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Novi Iskar, 1282, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Pleven, 5800, Bulgaria

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Sofia, 1431, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Vratsa, 3000, Bulgaria

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Barranquilla, 080020, Colombia

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Bogotá, 111166, Colombia

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Zagreb, 10090, Croatia

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Daugavpils, LV-5417, Latvia

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Riga, LV-1005, Latvia

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Strenči, LV-4730, Latvia

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Chelyabinsk, 454087, Russia

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Matrosy, 186131, Russia

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Moscow, 107076, Russia

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Moscow, 117152, Russia

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Moscow, 141371, Russia

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Nizhny Novgorod, 603155, Russia

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Saint Petersburg, 188357, Russia

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Saint Petersburg, 188820, Russia

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Saint Petersburg, 190005, Russia

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Saint Petersburg, 191167, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, 197341, Russia

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Samara, 443016, Russia

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Saratov, 410028, Russia

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Saratov, 410060, Russia

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Saratov, 413124, Russia

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Stavropol, 357034, Russia

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Talagi, 163530, Russia

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Belgrade, 11000, Serbia

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Gornja Toponica, 18202, Serbia

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Kovin, 26220, Serbia

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Kragujevac, 34000, Serbia

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Niš, 18000, Serbia

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Novi Kneževac, 23330, Serbia

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Novi Sad, 21000, Serbia

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Vršac, 26300, Serbia

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Ivano-Frankivsk, 76011, Ukraine

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Kharkiv, 61068, Ukraine

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Kherson, 73488, Ukraine

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Kyiv, 01030, Ukraine

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Kyiv, 01133, Ukraine

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Kyiv, 02192, Ukraine

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Kyiv, 04080, Ukraine

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Kyiv, 08631, Ukraine

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Lviv, 79021, Ukraine

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Nove, 25491, Ukraine

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Odesa, 65006, Ukraine

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Odesa, 67513, Ukraine

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Vinnytsia, 21005, Ukraine

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MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: open - label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: November 20, 2019
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

CR (1); US (25); BU (8); RU (18); LA (3); UA (13); SE (8); CO (2)