EUCTR2021-002076-39-ES进行中（未招募）1 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
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd0 个研究点目标入组 108 人开始时间: 2022年1月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Participants who are between the ages >=18 and <=80 years at the time of signing Informed Consent Form
- •? Diagnosis of large vessel occlusion (LVO) in the anterior circulation such that study drug administration can be initiated within 12 hours of last known well (LKW) and at risk of malignant cerebral edema (MCE) development, as defined as follows: Documented occlusion of terminus ICA and/or MCA on CTA or magnetic resonance angiogram AND ASPECTS score <= 5 AND National Institutes of Health Stroke Scale (NIHSS) > 15 for the non-dominant hemisphere and > 20 for the dominant hemisphere
- •? Participants who present with a wake-up stroke (WUS) who are <=8 hours from awakening
- •? 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 agreement to remain abstinent or use contraception and agree to refrain from donating eggs, during the treatment period and for at least 28 days after the final dose of balovaptan
- •? No specific contraception methods for males are required
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 59
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 parenchymatous hematoma ([PH]1 or PH2) on baseline imaging (per Heidelberg classification)
- •? 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
研究者
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