A Phase 2, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Post-Traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29
研究概览
简要总结
This trial is comprised of a 4-week randomized, double-blind, placebo-controlled treatment period followed by an optional 8-week open-label extension (OLE) period.
This trial will evaluate the efficacy and safety of oral PRAX-114 flexibly dosed at 40 to 60 mg for 4 weeks compared to placebo in adults with PTSD. The OLE period consisting of treatment with 40 mg PRAX-114 for 8 weeks will provide additional efficacy and safety data.
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
- •DSM-5 diagnosis of PTSD with duration >6 months, as confirmed by psychiatric evaluation.
- •CAPS-5 total score ≥30 at Screening and Baseline.
- •Body mass index (BMI) of 18 to 38 kg/m2.
排除标准
- •Experienced the index traumatic event before age
- •Has an active legal, worker's compensation, or disability claim for PTSD.
- •Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive-compulsive disorder or a history of a psychotic mood episode in last 2 years.
- •HAM-D17 score of >18 at Screening or Baseline.
- •Any current psychiatric disorder (other than PTSD).
- •Lifetime history of seizures, including febrile seizures.
- •Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.
研究组 & 干预措施
Double-blind PRAX-114
Double-blind period - 40 or 60 mg PRAX-114 once daily in the evening
干预措施: 60 mg PRAX-114 or 40 mg PRAX-114 (Drug)
Double-blind Placebo
Double-blind period - placebo once daily in the evening
干预措施: Placebo (Drug)
Open-label Extension PRAX-114
Open-label extension period - 40 mg PRAX-114 once daily in the evening
干预措施: 40 mg PRAX-114 (Drug)
结局指标
主要结局
Change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Day 29
时间窗: 29 days
The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.
次要结局
- Patient Global Impression-Improvement (PGI-I) score at Day 29, Day 15 and all other time points(8 days, 15 days, 22 days, 29 days, 35 days, and 43 days)
- Change from baseline in the Insomnia Severity Index (ISI) at Day 29, Day 15, and all other timepoints(8 days, 15 days, 22 days, 29 days, 35 days, and 43 days)
- Change from baseline in the CAPS-5 total score at Day 15 and 43(15 days and 43 days)
- Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 29, Day 15, and Day 43(15 days, 29 days, and 43 days)
- Change from baseline in Clinical Global Impression-Improvement (CGI-I) score at Day 29, Day 15, and Day 43(15 days, 29 days, and 43 days)
- Change from baseline in the CAPS-5 symptom cluster scores at Day 29, Day 15, and Day 43(15 days, 29 days, and 43 days)
- Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) at Day 29, Day 15, and all other timepoints(8 days, 15 days, 22 days, 29 days, 35 days, and 43 days)
- Change from baseline in the Sheehan Disability Scale (SDS) at Day 29, Day 15, and Day 43(15 days, 29 days, 43 days)