A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 23
- 主要终点
- The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).
研究概览
简要总结
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly 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 65 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 65 years of age
- •Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
- •For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
- •Willing and able to withdraw and refrain from specific therapies (ask PI)
- •Use medically acceptable form of contraception (female only)
- •Signed informed consent
排除标准
- •Significant traumatic brain injury
- •Severe depression
- •Bipolar and psychotic disorders
- •Increase risk of suicide
- •Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
- •Unable to wash-out specific medications (ask PI)
- •History of violent behavior within past 2 years, unrelated to work duties
- •History of drug or alcohol abuse within past 6 months
- •Positive illegal substance test
- •Known hypersensitivity to cyclobenzaprine
- •Others: seizure disorders, uncontrolled sleep apnea, BMI>40
- •Participation in an investigational study in past 30 days
- •In the process of litigating for compensation for a psychiatric disorder
- •Females that are pregnant or breastfeeding
研究组 & 干预措施
Placebo
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
干预措施: Placebo (Drug)
TNX-102 SL, 2.8 mg
1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
干预措施: TNX-102 SL (Drug)
TNX-102 SL, 2.8 mg
1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
干预措施: Placebo (Drug)
TNX-102 SL, 5.6 mg
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
干预措施: TNX-102 SL (Drug)
结局指标
主要结局
The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).
时间窗: Day 1, Week 12
The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms.
次要结局
- Clinician Global Impression - Improvement Scale Responder Rate at Week 12(Week 12)
- Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment(Day 1, Week 12)
- Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score(Day 1, Week 12)