NCT02970929已完成2 期
A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.30 个研究点 分布在 5 个国家目标入组 157 人开始时间: 2017年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 30
- 主要终点
- The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
研究概览
简要总结
An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
SEP-363856
Experimental
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
干预措施: SEP-363856 (Drug)
结局指标
主要结局
The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
时间窗: From first dose of study drug to last study visit (27 weeks)
Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
次要结局
- Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856(From the time of clinical response to relapse or censor (one day after the last study drug dose))
- Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)(Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26))
- Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26)
- Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)(Overall post Open-label Baseline treatment period (26 weeks))
- Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)(Overall post Open-label Baseline treatment period (26 weeks))
- Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856(From the time of clinical response to relapse or censor (one day after the last study drug dose))
- Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score(Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26)
- Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201(Week 26)
- Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score(Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26)
研究者
研究点 (30)
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