A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 22
- 主要终点
- Newly Treatment Emergent Adverse Events
研究概览
简要总结
This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) [NCT02277704]. Patients will not be made aware of the therapy they received during the double-blind study.
详细描述
The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.
Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
- •Signed informed consent
- •Met all prior inclusion and exclusion requirements for lead-in study
- •No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
- •Willing to refrain from use of specific medication (ask PI)
- •Female patients of childbearing potential continue to practice medically acceptable methods of birth control
排除标准
- 未提供
研究组 & 干预措施
TNX-102 SL
TNX-102 SL taken daily at bedtime for 12 weeks
干预措施: TNX-102 SL (Drug)
结局指标
主要结局
Newly Treatment Emergent Adverse Events
时间窗: Week 12
Number of patients with new treatment emergent AEs since completing lead-in study
次要结局
- Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)(P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12)
- Response Rates a in Total CAPS-5 Score(P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12)
- CAPS-5 Cluster Score Items(P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12)
- Montgomery-Asberg Depression Rating Scale(P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12)
- PROMIS (Patient -Reported Outcome Measurement Information System)(P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12)