A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Intravenous NA-1 Initiated by Paramedics in the Field for Acute Cerebral Ischemia Within Three Hours of Symptom Onset
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- NoNO Inc.
- 入组人数
- 532
- 试验地点
- 4
- 主要终点
- Modified Rankin Scale (mRS) scale
研究概览
简要总结
The purpose of this study is to determine whether nerinetide (NA-1) is effective in reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.
详细描述
Nerinetide (NA-1) is being developed as an emergency drug aimed at reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.
The primary objective is to determine the efficacy of nerinetide in reducing global disability in patients with acute stroke. The secondary objectives are to determine the efficacy of nerinetide in reducing functional dependence, reducing mortality rate, reducing worsening of stroke, improving neurological outcome and improving activities of daily living.
The leading safety objectives are to determine the effect of administering a target dose of 2.60 mg/kg (up to a maximum dose of 270 mg) IV infusion of nerinetide within three hours of symptom onset by paramedics in the field on serious adverse events and 90-day mortality.
This trial is a multicenter, randomized, double-blind, placebo-controlled, single dose study initiated prehospital in the ambulance. It is being conducted using Emergency Medical Services (EMS) in Canada. Subjects with suspected acute stroke will be identified in the field by trained paramedics using the approved stroke protocol in use by the local EMS system, and further screened for eligibility and approval by an on-call trial physician. The paramedics will administer the study drug. Upon arrival at the emergency department, subjects will receive standard-of-care.
An Independent Data Monitoring Committee will perform safety reviews of the clinical data.
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
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provisional diagnosis of acute stroke as identified by paramedics using the local stroke triage tool
- •Respiratory rate 12-24 breaths per minute
- •Oxygen saturation ≥ 90% on room air
- •Systolic blood pressure < 90 or > 220 mmHg
- •Weight 45-120 kg
- •Last seen in usual state of health less than 3 hours before anticipated study drug initiation
- •Independently ambulatory with or without devices prior to event
- •LAMS score of 2-5 for at least 15 minutes and remains 2-5 at time of randomization
排除标准
- •Lack of IV access
- •Canadian Triage and Acuity Scale Level 1 and/or uncorrected airway, breathing or significant circulatory problem
- •Blood sugar < 3 mmol/L (< 55 mg/dL)
- •Seizure at onset of symptoms or observed by paramedic
- •Glasgow coma score of <10
- •Major head trauma in the last three months
- •Recent stroke in the last three months
- •Known or presumptive signs of pregnancy or breastfeeding
- •Long term care facility resident
- •Known advance directive to not resuscitate
- •Known participation in a clinical trial with an investigational drug or device within 30 days preceding this trial
- •Pre-existing neurologic, psychiatric, or advanced systemic condition that would preclude obtaining the neurological or functional outcome evaluations
研究组 & 干预措施
Nerinetide (NA-1)
2.60 mg/kg of nerinetide (up to a maximum dose of 270 mg) administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
干预措施: Nerinetide (NA-1) (Drug)
Placebo
Placebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS) scale
时间窗: 90 days
The percentage of responders, using a sliding dichotomy on the mRS
次要结局
- Mortality rate(90 Days)
- mRS shift analysis(90 Days or the last rating)
- Worsening of stroke rate(90 Days)
- National Institutes of Health Stroke Scale (NIHSS)(90 Days or the last rating)
- Barthel Index(90 Days or the last rating)