A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in the Total CAPS-5 Score
研究概览
简要总结
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
- •Index trauma must have occurred within 9 years of Screening Visit
- •Must have occurred when the patient was ≥18 years of age
排除标准
- •Use of antidepressant medication within 2 months of Baseline
研究组 & 干预措施
TNX-102 SL Tablet 2.8 mg
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
干预措施: TNX-102 SL (Drug)
Placebo SL Tablet
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
干预措施: Placebo SL Tablets (Drug)
结局指标
主要结局
Mean Change From Baseline in the Total CAPS-5 Score
时间窗: Day 1, Week 12
The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms.
次要结局
- Clinical Global Impression of Severity (CGI-S)(Day 1, Week 12)
- Sheehan Disability Scale (SDS)(Day 1, Week 12)
- Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance(Day 1, Week 12)