EUCTR2017-004854-41-DE进行中（未招募）1 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction - CHARM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 535
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
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations or consent provided by an independent physician where local regulation allows, and/or provision of informed consent by the subject’s legally authorized representative (LAR) in accordance with all local and national regulations or according to the local ethics committee’s guidelines or by another process compliant with applicable national laws and regulations and ethics committee requirements.
- •2. A clinical diagnosis of acute ischemic stroke in the MCA territory (PCA and/or ACA territory involvement in addition to primary MCA territory stroke is acceptable).
- •3. Aged 18 to 85 years old, inclusive, at the time of informed consent.
- •4. Screening NIHSS =10.
- •5. Prior to the current stroke, no significant disability in the opinion of the Investigator (able to independently perform all duties and activities of daily living without assistance from a caregiver, spouse, or another person).
- •6. A large hemispheric infarction defined, in order of preference, as either:
- •a)a magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) lesion volume of 80 to 300 cm3, or
- •b)a computed tomography perfusion (CTP) core lesion volume of 80 to 300 cm3, or
- •c)an Alberta Stroke Program Early computed tomography (CT) Score (ASPECTS) on non-contrast computed tomography (NCCT) of 1 to 5 with involvement of at least 2 defined cortical regions, if lesion volume from MRI DWI or CTP is not available.
- •In the event that more than one scan is available for a particular subject resulting in disagreement, the investigator should make the determination about eligibility considering all patient information including but not limited to: 1) scan timing and 2) scan modality that in the opinion of the investigator best represents the infarct size. The scan used for eligibility will be documented
- •7. For subjects who receive thrombectomy prior to randomization, inclusion into the study must be based on an infarct volume of 80 to 300 cm3 measured by post-thrombectomy MRI-DWI.
- •8. At the time of randomization and in the Investigator’s judgment, it must be feasible for study drug treatment infusion to be initiated no later than 10 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown). Investigators should refer to Section 11.1.
- •Subjects who wake with stroke may be included if neurological and other exclusion criteria are satisfied. These wake up” strokes are defined as having no symptoms at sleep onset and a known sleep onset time, but stroke symptoms on waking. The time of stroke onset is to be taken as the midpoint between sleep onset and time of waking. The maximum time window for initiation of study drug treatment infusion is then 10 hours from the midpoint as described. If sleep onset time is unknown, then last known normal time must be used and the midpoint does not apply.
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 268
排除标准
- •1.Participant is likely to have supportive care withdrawn on the first day
- •2.Commitment to decompressive craniectomy (DC) prior to enrollment
- •3.Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome
- •NOTE: Other protocol defined Exclusion criteria may apply
研究者
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