A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants With PTSD
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 3
- 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, at the time of signing ICF, inclusive.
- •Diagnosed with current (past month) PTSD as determined by the MINI 7.0.2 Module H (PTSD).
- •Index trauma(s) resulting in PTSD must meet DSM-5 Criterion A for PTSD as described in the CAPS 5, must have occurred within 9 years of Screening Visit 1, and must have occurred when the participant was ≥18 years of age.
- •Willing and able to withdraw and refrain from opioids for the course of the study.
- •Willing to refrain from use of all other formulations of cyclobenzaprine for the course of the study.
- •Willing and able to refrain from antidepressants and other excluded medications.
- •Capable of reading and understanding English and able to provide written informed consent to participate.
- •Willing to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- •If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
- •Body mass index (BMI) within the range 17.5 - 35 kg/m^2 (inclusive).
排除标准
- •Current or ongoing exposure to the trauma that resulted in the PTSD (ie, non-work-related trauma such as ongoing domestic abuse).
- •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 (eg, 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 participants who are pregnant or lactating.
- •History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients in TNX-102 SL or placebo formulations.
- •Seizure disorder.
- •Current moderate or severe sleep apnea not well controlled by positive airway pressure (PAP) or oral (mouthpiece) devices.
- •Has received any other investigational drug within 90 days before Screening or has taken cyclobenzaprine within 21 days of the Randomization visit.
- •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, 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
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
干预措施: Placebo (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 1, Week 4, 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, fifth edition (CAPS-5) total symptom severity score in a 12-week study.
次要结局
- Change from baseline in the disruption of psychosocial functioning assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.(Day 1, Week 4, Week 8, Week 12)
- Clinical Global Impression - Severity change from Baseline to Week 12(Day 1, Week 4, Week 8, Week 12)