Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- NoNO Inc.
- 试验地点
- 12
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of a ruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting, or flowed diversion.
- •Patient should be Grade II-IV on the WFNS grading scale for SAH.
- •Male or female with a minimum age of 18 years on the day of enrolment.
- •Female subjects of childbearing potential: Negative pregnancy test.
- •Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing.
- •Body weight less than or equal to 180 kg.
- •Vital signs on admission:
- •Blood pressure between 80-180 mm Hg systolic/50-100 mm Hg diastolic;
- •Body temperature ≤ 38.5C.
- •Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.
排除标准
- •Prior SAH within 6 months of presentation.
- •Dissecting or mycotic brain aneurysm.
- •Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
- •Known history of life-threatening allergic reaction to any medication.
- •Chronic renal disease defined as a baseline serum creatinine > 150 µmol/L.
- •Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
- •Women who are breastfeeding.
- •Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
- •Pre-morbid (estimated) modified Rankin scale score of >
- •Previous major stroke.
- •Patients with known HIV infection.
- •Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- •Previous participation in the ENACT trial (e.g, to treat a prior aneurysm), participation in another trial involving NA-1 or prior receipt of NA-
- •Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 90 days.
研究组 & 干预措施
NA-1
20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier. Single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion.
干预措施: NA-1 (Drug)
Placebo
Single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 90 days
Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.
次要结局
- Mortality(90 days)
- National Institutes of Health Stroke Scale (NIHSS)(90 days)
- Modified Rankin Scale (mRS)(30-45 days)
- In-hospital length of stay(90 days)