EUCTR2015-005033-53-DK进行中（未招募）1 期
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standardof Care Oral Nimodipine in Adults with Aneurysmal SubarachnoidHemorrhage - NEWTON 2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 374
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. Male or female between the ages of 18 to 75 years, inclusive.
- •2. Ruptured saccular aneurysm confirmed by angiography (catheter, CTA
- •MRA) and repaired by neurosurgical clipping or endovascular coiling
- •3. Subarachnoid hemorrhage on computed tomography (CT) scan (prerepair)
- •of grade 2-4 on the modified Fisher scale (diffuse [clot present in both
- •hemispheres] thick or thin, or local thick)
- •4. External ventricular drain in place.
- •5. WFNS grade 2, 3, or 4 assessed during the Pre-randomization Phase
- •after repair of the aneurysm but prior to randomization
- •6. The subject must be able to receive intraventricular IP within 48
- •hours after the onset of aSAH and within 4 hours after the start time of
- •intraventricular IP suspension in the pharmacy. Onset of aSAH is defined as the time the subject experiences the first symptom of aSAH (e.g., severe headache or
- •loss of consciousness reported either by the subject or by a witness). If
- •found unconscious, the onset of aSAH is defined as the time the subject was
- •last known normal
- •7. Female subjects of child-bearing potential must have a negative
- •pregnancy test (urine or serum) during the Pre-randomization Phase and
- •must agree to use adequate birth control for at least 30 days following
- •the end of the Treatment Period. Male subjects must agree to use
- •adequate birth for at least 30 days after the end of the Treatment Period
- •8. Signed informed consent from the subject or the subject's legal
- •representative after the completion of aneurysm repair but prior to any study-specific procedures being performed
- •9. Able and willing to comply with follow up visit schedule
- •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 262
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •1. Major complication during aneurysm repair such as, but not limited to,
- •massive intraoperative hemorrhage, brain swelling, arterial occlusion, or
- •inability to secure the ruptured aneurysm
- •2. Angiographic vasospasm prior to randomization
- •3. Clinical or radiological evidence of a cerebral infarction with
- •neurological deficit
- •4. Increased intracranial (ICP) pressure >30 mm Hg lasting >4 hours
- •anytime during the Prerandomization Phase
- •5. Substantial intraventricular hemorrhage XML File Identifier: VEXf+8u4fMzYuKwngc4kWLH47P4= Page 15/31
- •6. Aneurysm repair requiring flow diverting stent or stent-assisted
- •coiling and dual antiplatelet therapy
- •7. Subject is expected to undergo repair of additional aneurysms within
- •90 days in cases where multiple aneurysms were identified during the Pre-randomization Phase
- •8. Hemodynamically unstable during the Pre-randomization Phase (i.e., systolic blood pressure (SBP) <100 mm Hg, requiring >6 L colloid, or crystalloid fluid resuscitation)
- •9. Cardiopulmonary resuscitation was required during the Prerandomization
- •10. Symptoms or electrocardiogram (ECG) signs of acute myocardial
- •infarction or unstable angina pectoris prior to randomization
- •11. Electrocardiogram evidence and/or physical findings compatible with
- •second or third degree heart block or of cardiac arrhythmia associated
- •with hemodynamic instability
- •12. Echocardiogram, if performed as part of standard of care before
- •randomization, revealing a left ventricular ejection fraction <40%
- •13. Severe or unstable concomitant condition or disease (e.g., known
- •significant neurologic deficit, cancer, hematologic or coronary disease),
- •or chronic condition (e.g., liver disease, kidney disease or psychiatric
- •disorder), that, in the opinion of the investigator, may increase the risk
- •associated with study participation or IP administration, or may
- •interfere with the interpretation of study results
- •14. Subjects who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomization. Subjects participating in a non-interventional study that has no bearing on assessment of EG-1962 or enteral nimodipine may be enrolled per guidelines of the local Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
- •15. Known hypersensitivity to nimodipine or other dihydropyridine calcium channel antagonists, poly-D, L-lactide-co-glycolide (PLGA), or hyaluronic acid
研究者
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