A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Military-Related PTSD
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 358
- 试验地点
- 43
- 主要终点
- Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
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 5.6 mg TNX-102 SL (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 or female between 18 and 75 years of age, who have served in any branch of the military.
- •Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-
- •Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
- •Willing to refrain from use of all other formulations of cyclobenzaprine.
- •Willing and able to refrain from antidepressants and other excluded medications.
- •Capable of reading and understanding English and able to provide written informed consent.
- •If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
- •Willing and able to comply with all protocol-specified requirements.
排除标准
- •Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
- •Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
- •Severe depressive symptoms at screening or baseline.
- •Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
- •Use of antidepressant medication within 2 months of baseline.
- •Female patients who are pregnant or lactating.
- •History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
- •Seizure disorder.
- •Patients with a body mass index (BMI) >
- •Has received any other investigational drug within 30 days before Screening.
- •Previous participation in any other study with TNX-102 SL.
- •Family member of investigative staff.
研究组 & 干预措施
TNX-102 SL Tablet, 5.6 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 Tablet taken sublingually each day at bedtime for 12 weeks.
干预措施: Placebo SL Tablet (Drug)
结局指标
主要结局
Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
时间窗: Day 0 and Week 12
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.
次要结局
- Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.(Day 0, Week 12.)
- Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment.(Week 12)
- Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.(Day 0, Week 12.)
- Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment.(Day 0, Week 12.)