A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Patients With Bipolar I Disorder and Acute Agitation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 6
- 主要终点
- Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo
研究概览
简要总结
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
详细描述
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adult patients with bipolar 1 disorder and acute agitation
排除标准
- •Agitation caused primarily by acute intoxication
- •History of drug or alcohol dependence
- •Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
研究组 & 干预措施
Inhaled Loxapine 5 mg
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
干预措施: Inhaled loxapine 5 mg (Drug)
Inhaled Placebo
Inhaled Staccato Placebo, may repeat after 2 hours x 2
干预措施: Inhaled Placebo (Drug)
Inhaled Loxapine 10 mg
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
干预措施: Inhaled loxapine 10 mg (Drug)
结局指标
主要结局
Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo
时间窗: Baseline and 2 hours
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
次要结局
- CGI-I Responders(Baseline and 2 hours)
- Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo(Baseline and 2 hours)