EUCTR2006-005491-40-DE进行中（未招募）不适用
A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 with Continuous Ultrasound Administration in Subjects with Acute Ischemic Stroke Receiving Treatment with Intravenous Tissue Plasminogen Activator
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1. Males or females 18 years of age or older.
- •2. Patients with a diagnosis of intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA), or distal basilar artery as demonstrated by US.
- •3. Patients with neurological deficit measurable by NIHSS score, and that in the opinion of the treating physician requires treatment with full dose IV tPA.
- •4. Patients with persisting arterial occlusion and without frank resolution of neurological symptoms at the time of diagnostic ultrasound imaging, who, in accordance with local
- •and federal guidelines for use, are eligible for intravenous tPA or have been receiving
- •intravenous tPA for up to 45 minutes
- •5. Provision of informed consent as demonstrated by the patient’s signature or by the signature of the patient’s authorized legal representative on the Informed Consent Form in accordance with all local and federal regulations.
- •6. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and federal regulations.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients presenting with any of the following will not be included in the trial:
- •1. Evidence of hemorrhage on non-contrast head CT or MRI scan;
- •2. Patients with primary intra-arterial thrombolysis.
- •3. Patients with known right-to-left cardiac shunts as determined from medical history or patient chart.
- •4. Patients with any known hypersensitivity to the test article or any other diagnostic agents or therapeutics to be used.
- •5. Patients without temporal insonation windows.
- •6. Female and pregnant or breast feeding.
- •7. Patients receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment.
- •8. Patients with any standard contraindication for intravenous tPA therapy.
- •9. Patients with moderate to severe COPD (baseline O2 saturation less than 80% on room air);
- •10. Significant concurrent medical/neurological conditions or deviation from normal laboratory test values at baseline that, in the opinion of the investigator, pose significant risk to the patient and warrant exclusion from the study.
研究者
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