A Phase 3 Open-Label Extension Study to Assess the Long-term Safety and Efficacy of TSND-201 for the Treatment of PTSD
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
研究概览
简要总结
This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial.
Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of a double-blind Transcend-sponsored clinical trial with TSND-201 (e.g., TSND201-PTSD-301) and considered in good standing with the study site.
- •Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
- •Agree to not participate in any other interventional clinical trials for the duration of this study.
排除标准
- •Experienced an intolerable side effect following dosing with TSND-201 in the prior study.
- •Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
- •Change or development of any physical or psychological finding that would make participant unsuitable for study.
研究组 & 干预措施
TSND-201
干预措施: TSND-201 (Drug)
结局指标
主要结局
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
时间窗: Up to 48 weeks
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
次要结局
未报告次要终点