EUCTR2015-005033-53-CZ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 Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage - 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 or MRA) and repaired by neurosurgical clipping or endovascular coiling
- •3. Subarachnoid hemorrhage on computed tomography (CT) scan (pre-repair) 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 know 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 control 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 249
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
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. Intracranial pressure >30 mm Hg lasting >4 hours anytime during the Prerandomization Phase
- •5. Substantial intraventricular hemorrhage
- •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 Prerandomization 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 required prior to randomization
- •10. Symptoms or electrocardiogram 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/Independent Ethics Committee
- •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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