A Placebo Controlled, Double-blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Naloxone HCl IV in Patients With Stroke
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Percentage of subjects who have the modified Rankin Scale (mRS) score of 2 or less on Day 90
研究概览
简要总结
This clinical trial was planned for the purpose to re-evaluate the safety and efficacy of naloxone hydrochloride in ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage.
Eligible subjects will be randomized to the naloxone hydrochloride group or placebo group at 1:1 ratio.
Also, factors, such as disease subtype and severity, which might impact the efficacy endpoints will be used to stratify.
- Stratification factor: cerebral infarction (NIHSS 5-15 points or 16-20 points) or cerebral hemorrhage
Administration of investigational product should be started within 48 hours from the onset of symptoms.
Subject receive the investigational product 7 consecutive times (for 7 days) in a single dose of intravenous infusion for 24 hours.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are males or females aged ≥19 years
- •Patients with a stroke who can administer drugs for clinical trials within 48 hours from stroke onset
- •Patients with a NIHSS score of 5-20 or GCS score of 8-13 at screening assessment (In the case of cerebral infarction, the NIHSS is evaluated, and cerebral hemorrhage, the GCS is evaluated.)
- •Patients with a mRS(Modified Rankin Score) > 2 after stroke and immediately before randomization.
- •Patients who or whose representative voluntarily agrees to this study and has given a written informed consent.
排除标准
- •Subjects with medical history of hypersensitivity reaction to investigational product or ingredients.
- •Patients with non-narcotic central nerve inhibitors such as barbital drugs or respiratory depression caused by pathological causes.
- •Patients who have not passed the wash-out time after administration of opioid analgesics.
- •Subjects with Renal dysfunction whose creatine level is more than twice the normal upper limit in screening tests
- •Subjects with Liver dysfunction whose AST/ALT level is more than three times the normal upper limit in screening tests.
- •Subjects with Systolic blood pressure less than 90 mmHg or more than 220 mmHg during screening.
- •Patients with a mRS > 2 before stroke onset.
- •Patients with a history of epilepsy.
- •Patients with myocardial infarction within 1 month.
- •Pregnant or lactating women
- •Patients who have passed more than 48 hours since the onset of symptoms.
- •Subjects who received other therapeutic investigational product within the last 30 days.
- •Patients who transient ischemic attack.
- •Patients whose life expectancy is less than 3 months due to comorbidities other than stroke
- •Thrombolysis (including non-drug treatments such as thrombolytic drugs and mechanical procedures used in thrombolysis) or extraventricular drainage (surgical treatment) has been performed or is scheduled to be performed.
- •Thrombolytic agent used in thrombolysis[ex. Streptokinase, Alteplase, Anistreplase, Urokinase, Reteplase, Tenecteplase, Tissue-plasminogen activator (t-PA), Single-chain urokinase-type plasminogen activator (Scu-PA), Lanoteplase, Monteplase, Plasminogen activator inhibitors (PAI)]
- •Surgical treatment [ex. mechanical thrombectomy, external ventricular drainage (EVD), extralesional drainage (ELD), decompression], Subarachnoid hemorrhage (SH), Trauma patients [ex. SH coiling, traumatic intracranial hemorrhage (ICH)], Among patients with infarction, patients who need or are scheduled to perform Depressive craniomy.
- •Any condition that, in the opinion of the investigator, would inappropriate to participate in the clinical trial
研究组 & 干预措施
Naloxone hydrochloride 5.0mg/5ml
Naloxone hydrochloride 60mg (However, the dose may be appropriately increased or decreased according to the judgement of the investigator)
干预措施: Naloxone hydrochloride 5.0mg/5ml (Drug)
Placebo
Placebo 60ml (However, the dose may be appropriately increased or decreased according to the judgement of the investigator)
干预措施: Sodium Chloride 45mg/5ml (Drug)
结局指标
主要结局
Percentage of subjects who have the modified Rankin Scale (mRS) score of 2 or less on Day 90
时间窗: Day 90
Modified Rankin Scale is an index that evaluates the patient's global functional outcome according to the independence of daily life and the degree of need for help from others. It is evaluated in seven stages (0 to 6 points), from asymptomatic to death. The higher score means a worse outcome, and 3 to 6 points are considered to be poor functional outcome.
次要结局
- The change from baseline in Korean Mini-Mental State Examination(KMMSE) up to Day 90(Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90)
- The change from baseline in Modified Barthel Index (mBI) up to Day 90.(Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90)
- The change from baseline in National institutes of health stroke scale(NIHSS) up to Day 90(Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90)
- The change from baseline in Modified Rankin Score (mRS) up to Day 90(Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90)
- The change from baseline in Glasgow Coma Scale(GCS) up to Day 90(Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90)
- The change from baseline in EuroQol five dimensions questionnaire(EQ-5D) up to Day 90(Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90)
- The change from baseline in Global Deterioration Scale (GDS) up to Day 90(Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90)
- The odds ratio of the factors which contribute to a mRS score to be less than or equal to 2 on Day 90(Day 90)