An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

Otsuka

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: SEP-363856

Study type

Interventional

Funder types

Industry

Identifiers

NCT02970929

2016-001556-21 (EudraCT Number)

SEP361-202

Details and patient eligibility

About

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

Full description

This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201 (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial.

No statistical hypothesis tests will be performed.

Enrollment

157 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.