A Randomized Double-Blind Placebo-Controlled 12-Week Phase 2 Study of Two Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist(EVP-6124)or Placebo in Schizophrenia Subjects on Chronic Stable Atypical Anti-Psychotic Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 17
- 主要终点
- Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function.
研究概览
简要总结
This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.
详细描述
This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication.
Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)
- •Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
- •Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
- •A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
- •A minimal level of depression; Calgary Depression Scale total score ≤10
- •Must have a general health status acceptable for participation in a 12-week clinical trial
- •Fluency (oral and written) in the language in which the standardized tests will be administered
- •If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing
排除标准
- •Insufficiently controlled diabetes mellitus in the judgment of the investigator
- •Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
- •Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
- •Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction
研究组 & 干预措施
EVP-6124 0.3 mg
one 0.3 mg capsule every day for 84 days
干预措施: EVP-6124 (Drug)
EVP-6124 1.0 mg
one 1.0 mg capsule every day for 84 days.
干预措施: EVP-6124 (Drug)
Placebo
Placebo every day for 84 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function.
时间窗: 84 days
次要结局
- Assessment of Clinical Efficacy(84 days)