NCT00480571已完成2 期
An Open-label, Multi-center, 6-week, Sequential Cohort Study Designed to Determine the Safety and Tolerability of Two Dose Ranges of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-affective Disorder
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
- 90
- 试验地点
- 2
- 主要终点
- To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder
研究概览
简要总结
An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •18 to 65 years of age, inclusive
- •meet criteria for chronic (diagnosis established > 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a PANSS total score > 60
- •current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with DSM-IV
- •Agree to be fully hospitalized until at least Day 14 of the study
- •Females must be of non-childbearing potential: surgically sterilized (i.e. tubal ligation), have had a hysterectomy prior to the screening phase, or be post-menopausal. Females who have been post-menopausal for more than 12 months but less than 24 months must have a FSH > 40 mU/mL.
排除标准
- •Pregnant or lactating women
- •administration of clozapine within 60 days prior to Baseline
- •DSM-IV diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder
- •Severity of psychosis rated severe or higher (CGI-S 6 or 7)
- •Known suicidal risk (modified ISST score>7)
- •Requiring disallowed concomitant psychotropic medication following enrolment into the study
- •Current evidence of clinically significant or unstable illness
- •Clinically significant abnormal laboratory data (e.g. creatinine, AST or ALT greater than 3 x the upper limit of normal, TSH>10 IU) at screening, or any abnormal laboratory values that could interfere with the assessment of safety (e.g. blood cell count, etc.).
研究组 & 干预措施
1
Experimental
BL 1020 low dose
干预措施: BL-1020 (Drug)
2
Experimental
BL 1020 High Dose
干预措施: BL 1020 High Dose (Drug)
结局指标
主要结局
To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder
时间窗: 6 weeks
次要结局
- To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose(6 weeks)
- To compare the efficacy of the two dose ranges of BL-1020(6 weeks)
- To determine the pharmacokinetics of BL-1020 and its metabolites(6 weeks)
研究者
研究点 (2)
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