A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia

SEP361-202

An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia

2017-01-31

2019-01-29

2019-01-29

Completed

Early phase I

157

Inclusion Criteria: Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator. * Subject has completed Study SEP361 201 through Week 4 * Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201. * Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test. * Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration Exclusion Criteria: * Subject answers "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 C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation. * Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study. * Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201. * Subject is pregnant or lactating. * Subject is at high risk of non-compliance in the Investigator's opinion. * Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 157, 'type': 'ACTUAL'}}

2024-07-04