NCT05399550撤回2 期
A Phase II, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate The Safety and Efficacy of Balovaptan in Patients With Acute Ischemic Stroke at High Risk of Developing Malignant Cerebral Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW)
研究概览
简要总结
This study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (AIS) at risk of developing Malignant Cerebral Edema (MCE)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of LVO in the anterior circulation such that study drug administration can be initiated within 12 hours of LKW and at risk of MCE development, as defined as follows:
- •Documented occlusion of terminus ICA and/or MCA on CTA or magnetic resonance angiogram and
- •ASPECTS score </=5 on NCCT and
- •NIHSS >15 for the non-dominant hemisphere and >20 for the dominant hemisphere (or > 20 if dominant/non-dominant hemisphere unknown)
- •Present with a WUS </=8 hours from awakening provided the above criteria are met
- •Participants with a history of seizures on anti-epileptic medications may be included if they have been on stable doses of those medications for at least 12 weeks prior to LKW, they have not experienced seizures during that time frame, and their anti-epileptic medicines are continued during the study
- •For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception and agree to refrain from donating eggs
- •No specific contraception methods for males are required.
排除标准
- •Participants who are >12 hours from LKW at the start of treatment with study drug or >8 hours from awakening with WUS
- •Any MLS on brain imaging
- •Evidence of intracranial hemorrhage at screening based on NCCT
- •Contraindication to MRI examination
- •Evidence of additional anterior cerebral artery (ACA) infarction
- •Diagnosis of brain death
- •Planned surgical decompression prior to randomization
- •Participants with a known history of a hereditary bleeding disorder which increases bleeding risk
- •Chronic kidney disease stage III or higher
- •Hepatic injury
- •Diagnosis of diabetes insipidus
- •Participants who have received any prophylactic hyperosmolar therapy
- •Participants who have received treatment with any other V1a and/or V2 receptor-blocking agent or glyburide
- •A preexisting medical condition for which the participant is unlikely to survive the next 6 months
- •Planned limitation or withdrawal of life-sustaining treatment during hospital admission
- •Participants who are pregnant or breastfeeding, or intending to become pregnant
研究组 & 干预措施
Balovaptan
Experimental
Balovaptan will be administered as IV infusion once a day over 3 days
干预措施: Balovaptan (Drug)
Placebo
Placebo Comparator
Placebo will be administered as IV infusion once a day over 3 days
干预措施: Placebo (Drug)
结局指标
主要结局
Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW)
时间窗: 72 Hours from Last Known Well
Midline shift will be measured in millimeter on non-contrast computer tomography (NCCT)
次要结局
- Mortality(At Day 30)
- mRS-SI score(At Day 30)
- Amount of MLS(At 48 hours and 96-120 hours from LKW)
- Percentage of Participants with Surgical DHC Performed(From Baseline up to Day 90)
- Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment(From Baseline up to Day 90)
- National Institute of Health Stroke Scale (NIHSS) score(At Day 4 and Day 90)
- Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4(At Day 90)
- Functional Independence Measure (FIM) score(At Discharge or Day 10 and Day 90)
- Glasgow Outcome Scale Extended (GOSE) Score(at Discharge or Day 10, Day 30 and Day 90)
- Stroke Impact Scale-16 (SIS-16) score(At Day 30 and Day 90)
- Length (in days) of ICU and Hospital Stay(From Baseline to Day 90)
- Number of participants with adverse events and severity of adverse events(From Baseline to Day 90)
- Plasma concentrations of balovaptan at specified timepoints(From Baseline to 120 Hours After the End of the Last Infusion (or at discharge))
- Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr)(From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)])
- Maximum observed concentration (Cmax)(From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)])
- Plasma drug concentration 24hours after the administration of a given dose (C24hr)(From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)])
- Number of participants with safety findings on brain imaging(From Baseline to Day 90)
研究者
研究点 (1)
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