NCT04962503已完成2 期
A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Due to Distal [M2 Segment and Beyond] Arterial Large Vessel Occlusion (LVO) or Perforator Occlusion and Who Are Ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Changes in Volume of Infarct
研究概览
简要总结
The primary study objective is to assess the safety of afamelanotide while the secondary objective is to assess whether the therapy affects the size of the penumbra, by increasing blood flow, restoring oxygen supply to the brain, and reducing the amount of cerebral oedema (fluid) which is seen as a result of the stroke. Positive findings would indicate that the drug is able to support brain tissue-at-risk and provide overall neuroprotection and benefit to stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with a diagnosis of first AIS due to distal [M2 segment and beyond] occlusion or perforator occlusion
- •Perfusion abnormalities observed on Computed Tomography Perfusion (CTP)
- •Mild to moderate stroke severity
- •Pre-stroke mRS <4
- •Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission).
排除标准
- •Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS
- •Intervention by endovascular thrombectomy (EVT)
- •Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator's Brochure
- •Any evidence of hepatic (defined as three times standard range) or renal impairment (defined as estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m²)
- •Any other medical condition which may interfere with the study protocol
- •Female who is pregnant (confirmed by positive serum beta human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating
- •Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy
- •Unable to undergo MRI brain evaluation
- •Not suitable for trial participation according to judgment of the Principal Investigator (PI)
- •Patients starting afamelanotide 24 hours or more from ictus.
研究组 & 干预措施
Afamelanotide
Experimental
干预措施: Afamelanotide (Drug)
结局指标
主要结局
Changes in Volume of Infarct
时间窗: From Day 0 to Day 3 and Day 0 to Day 9
次要结局
- Changes of Neurological Function as Measured by the National Institutional Health Stroke Scale (NIHSS).(From baseline to Day 42)
- Changes of Daily Activities as Measured by the Modified Rankin Scale (mRS)(From baseline to Day 42)
研究者
研究点 (1)
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