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

Stopped early · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT04109950

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

463

Starts

2019-11-20

Expected to finish

2023-11-09

Last updated by the study team

2024-12-16

Who can join

Age: 13 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• 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
• Female participant is pregnant or lactating.

Where it is running

• Research Site — Rogers, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Culver City, California, United States
• Research Site — Lemon Grove, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Montclair, California, United States
• Research Site — San Diego, California, United States
• Research Site — Sherman Oaks, California, United States
• Research Site — Miami Springs, Florida, United States
• Research Site — Oakland Park, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Lake Charles, Louisiana, United States
• Research Site — Gaithersburg, Maryland, United States
• Research Site — Flowood, Mississippi, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Marlton, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Austin, Texas, United States
• Research Site — Richardson, Texas, United States
• Research Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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