NCT05401565已完成2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Multicenter Study To Evaluate The Efficacy And Safety Of Balovaptan In Adults With Post-Traumatic Stress Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 15
- 主要终点
- Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
研究概览
简要总结
This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have a current diagnosis of PTSD as per DSM-5 criteria, with a score of >/=33 on the PCL-5 at screening
- •The index trauma event must have occurred in adulthood, i.e., when the participant was >/=18 years old
- •The index trauma event must have occurred at least 6 months prior to screening and no more than 10 years prior to screening
- •At baseline, either taking a stable dose of a single antidepressant (SSRI or SNRI) for management of PTSD and have been on that medication for >/=6 weeks at that stable dosage and demonstrating residual symptoms of PTSD or prior demonstrated lack of tolerability or lack of efficacy and not taking an antidepressant medication at baseline for >/=6 weeks
- •Treatment with permitted medications and/or non-pharmacological interventions at a stable dose for 6 weeks prior to screening
- •For women of childbearing potential: agreement to remain abstinent or use contraception
排除标准
- •Participants who are experiencing ongoing exposure to traumatic events within 3 months of screening
- •Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug
- •Clinically significant psychiatric and/or neurological conditions, which may interfere with the assessment of safety or efficacy endpoints
- •Substance use disorders during last 12 months
- •Significant risk for suicidal behaviour
- •Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
- •Clinical diagnosis of peripheral neuropathy
- •Within the last 2 years, unstable or clinically significant cardiovascular disorders
- •Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
- •Moderate or severe hepatic or renal impairment
- •History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic)
- •Medical history of malignancy, if not considered cured
- •Participants who have received treatment with investigational therapy within 8 weeks prior to randomization
- •Known hypersensitivity to balovaptan, its components, or any of the excipients used in the formulation
研究组 & 干预措施
Balovaptan
Experimental
干预措施: Balovaptan (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Clinician-Administered PTSD Total Symptom Severity Score
时间窗: From Baseline up to Week 12
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measures the severity of PTSD where smaller scores indicate less severe PTSD and higher scores suggest more severe PTSD. Possible scores for this 30 item version range from 0 to 120. Measured 3 times over 12 weeks.
次要结局
- Symptom Severity as Measured by Clinician-Global Impression of Severity (CGI-S) Scale Score(From Baseline up to Week 12)
- Change From Baseline at Week 12 in the Patient Health Questionnaire-9 (PHQ-9) Total Score(From Baseline up to Week 12)
- Percentage of Participants With Adverse Events(From Baseline up to Week 12)
研究者
研究点 (15)
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