A Proof of Concept Study to Evaluate Administration of CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AegisCN LLC
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- CN-105 safety assessment
研究概览
简要总结
A multicenter, open-label phase 2a trial of CN-105 in patients with supratentorial intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of symptom onset. Eligible participants (approximately 60) will receive CN-105 administered intravenously (IV) for a 30-minute infusion every 6 hours for up to a maximum of 3 days (13 doses) or until discharge (if earlier than 3 days). Participants will be monitored daily throughout the Treatment phase of the study (up to a maximum of 5 days) and will receive standard-of-care treatment for the duration of the study. Additional protocol assessments will be required during the Treatment phase. After discharge from the hospital, participants will enter a 3-month Follow-up phase, with a clinic visit at 30 days and a follow-up telephone interview with telephone-validated Modified Rankin Scale (mRS) at 90 days after first dose of study agent.
Funding Source - FDA OOPD
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has given written informed consent to participate in the study in accordance with required regulations; if a participant is not capable of providing informed consent, written consent must be obtained from the participant's legally authorized representative (LAR).
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Is male or female, age 30 to 80 years, inclusive.
- •Has a confirmed diagnosis of spontaneous supratentorial ICH.
- •Able to receive first dose of study drug ≤ 12 hours after onset of ICH symptoms, such as alteration in level of consciousness, severe headache, nausea, vomiting, seizure, and/or focal neurological deficits, or last-known well time.
- •Has an interpretable and measurable diagnostic CT scan.
- •Has a Glasgow Coma Scale (GCS) score ≥ 5 on presentation
- •Has a National Institutes of Health Stroke Scale (NIHSS) score ≥
- •Has systolic BP (SBP) < 200 mm Hg at enrollment.
排除标准
- •Is pregnant or lactating.
- •Has a temperature greater than 38.5°C at Screening.
- •Has ICH resulting from trauma.
- •Has infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy).
- •Has primary intraventricular hemorrhage deemed to be at high risk for obstructive hydrocephalus, or extra-axial (ie, subarachnoid or subdural) extension of hemorrhage.
- •Has radiographic evidence of underlying tumor.
- •Has an unstable mass or evolving intracerebral compartment syndrome.
- •Has a ruptured aneurysm, arteriovenous malformation, or vascular anomaly.
- •Has a platelet count < 100,000/mL.
- •Has an international normalized ratio (INR) < 1.6 or irreversible coagulopathy either due to medical condition or detected before screening.
- •In the opinion of the investigator is unstable and would benefit from supportive care rather than supportive care plus CN-
- •In the opinion of the investigator has any contraindication to the planned study assessments, including CT and MRI.
- •Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which, in the opinion of the investigator, unacceptably increases the individual's risk by participating in the study.
- •Concomitant enrollment in another interventional study.
研究组 & 干预措施
CN-105
All eligible subjects will receive study drug, CN-105
干预措施: CN-105 (Drug)
结局指标
主要结局
CN-105 safety assessment
时间窗: 90 days
Number and severity of AEs throughout the duration of the study
Mortality
时间窗: 90 days
record 90-day mortality
In-hospital neurological deterioration
时间窗: 30 days
Increase of National Institutes of Health Stroke Scale (NIHSS), \> 2 from baseline, persisting more than 24 hours, and unrelated to sedation.
次要结局
- Improvement in 30-day mortality(30 days)
- Improvement in 30-day functional outcomes(30 days)