A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, 6-Week, In-Patient Study to Assess Efficacy and Safety of HP-3070 in Subjects Diagnosed With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 1
- 主要终点
- Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6.
研究概览
简要总结
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.
详细描述
This is a Phase 3, randomized, double-blind, placebo-controlled, in-patient, efficacy, and safety study to evaluate HP-3070 for the treatment of schizophrenia.
This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia, who are in an acute exacerbation and to assess the impacts of covariates on asenapine exposure as delivered in a patch formulation, using a population-based approach.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of schizophrenia.
- •Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of the following PANSS items at Screening and at Baseline: conceptual disorganization delusions; hallucinatory behavior; unusual thought content.
- •Subjects must be able to wear a transdermal patch for 24 hours.
排除标准
- •Subject has been diagnosed with schizophrenia less than 6 months prior to Screening Visit.
- •Subject has received within 90 days of Screening Visit: electroconvulsive therapy; transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation treatments
- •Subject has experienced acute depressive symptoms within 30 days prior to Screening Visit that requires treatment with an antidepressant, as determined by the Investigator.
- •Currently taking clozapine for the treatment of schizophrenia.
- •Has hypothyroidism or hyperthyroidism.
- •Subject is currently being treated with insulin for diabetes.
- •Subject has epilepsy or history of seizures.
- •Positive urine pregnancy test.
研究组 & 干预措施
Low dose Asenapine maleate patch
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
干预措施: Low Dose Asenapine maleate transdermal patch (Drug)
Low dose Asenapine maleate patch
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
干预措施: Placebo (Drug)
High dose asenapine maleate patch
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
干预措施: High Dose Asenapine maleate transdermal patch (Drug)
High dose asenapine maleate patch
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
干预措施: Placebo (Drug)
Placebo transdermal patch
Low dose or high dose asenapine maleate transdermal patch will be compared against placebo patches
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6.
时间窗: 6 weeks
To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity.
次要结局
- Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Clinical Global Impression - Severity of Illness Scale: Change From Baseline to Week 6.(6 weeks)