A prospective, multicentric, randomized, double-blind, parallel, phase III clinical study to assess efficacy of PMZ-1620 along with standard treatment in patients of acute ischemic stroke.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 28
- 主要终点
- 1. Proportion of patients with NIHSS score (more than and equal to 6), mRS score (more than and equal to 2) and BI score (Less than and equal to 60)
研究概览
简要总结
This is a prospective, multicentric, randomized, double-blind, parallel, Phase III efficacy study of PMZ-1620 therapy along with standard treatment in patients with acute ischemic stroke. A minimum of 132 patients (66 in each treatment arm) are to be evaluated as per the protocol, considering a discontinuation rate of about 20 %, a total of 158 patients (79 in each treatment arm) will be enrolled in the study. The enrolment period of the study will be approximately 15 months and the total duration of the study will be approximately 18 months. For an individual patient, the duration of the study will be 3 months (90 days), including 5 study visits: visit 1/Day 1 (screening/baseline/treatment visit), visit 2 (Day 12 + 2), visit 3 (Day 30 + 5), visit 4/telephonic visit (Day 60 ± 7), and visit 5/End of Study (Day 90 ± 7). At visit 1, a total of 158 patients will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria:
Group 1: PMZ-1620 + Standard treatment
Group 2: Normal Saline (Dose: Equal volume) + Standard treatment
PMZ-1620 or Normal Saline will be administered as an intravenous (IV) bolus over one minute within the window of 24 hours after the onset of stroke. In the PMZ group, three doses of PMZ-1620 (each dose of 0.3 μg/kg body weight) will be administered as an IV bolus over one minute at an interval of 3 hours ± 1 hour on day 1, day 3, and day 6 (total dose/day: 0.9 µg/kg body weight). In the control group, three doses of an equal volume of normal saline will be administered as an IV bolus over one minute at an interval of 3 hours ± 1 hour on day 1, day 3, and day 6 post-randomization. In both treatment groups, patients will be provided the standard treatment for stroke. Standard treatment to be provided to the patients shall be the one used in the particular hospital setup. Each patient will be monitored closely throughout his/her hospitalization for the qualifying stroke and will be followed for 3 months from randomization. Each patient will be assessed for efficacy parameters over 3 months from randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 78.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females Aged 18 years through 78 years (have not had their 79th birthday).
- •Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure.
- •Stroke is ischemic in origin and radiologically confirmed Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment.
- •No hemorrhage as proved by cerebral CT/MRI scan.
- •Cerebral ischemic stroke patients presenting upto 24 hours after onset of symptoms with mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score >5 (NIHSS Level of Consciousness (1A) score must be < 2).
- •This also includes patients who had ischemic stroke in the past and are completely recovered from earlier episode before having new or fresh stroke.
- •Patient is < 24 hours from time of stroke onset when the first dose of PMZ-1620 therapy is administered.
- •Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self- reported to be normal
- •Reasonable expectation of availability to receive the full PMZ-1620 course of therapy, and to be available for subsequent follow-up visits.
排除标准
- •Patients receiving endovascular therapy or is a candidate for any surgical intervention for treatment of stroke which may include but not limited to endovascular techniques
- •Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score more than or equal to 2)
- •Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, acute or chronic subdural hematoma on the baseline CT or MRI scan.
- •Known pregnancy
- •Confounding pre-existing neurological or psychiatric disease
- •Concurrent participation in any other therapeutic clinical trial
- •Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which PMZ-1620 therapy would be contraindicated or might cause harm to the patient.
结局指标
主要结局
1. Proportion of patients with NIHSS score (more than and equal to 6), mRS score (more than and equal to 2) and BI score (Less than and equal to 60)
时间窗: 1. On day 6, day 12, 1 month and 3 months post randomization | 2. On day 6, day 12, 1 month and 3 months post randomization | 3. On day 6, 1 month and 3 months post randomization
2.Proportion of patients with change in NIHSS score (more than and equal to 6), mRS score (more than and equal to 2) and BI score (more than and equal to 40) from baseline
时间窗: 1. On day 6, day 12, 1 month and 3 months post randomization | 2. On day 6, day 12, 1 month and 3 months post randomization | 3. On day 6, 1 month and 3 months post randomization
3.Proportion of patients with overall clinical outcome as assessed by the global statistical test of NIHSS, mRS, and BI scores
时间窗: 1. On day 6, day 12, 1 month and 3 months post randomization | 2. On day 6, day 12, 1 month and 3 months post randomization | 3. On day 6, 1 month and 3 months post randomization
次要结局
- Change in Quality-of-life as assessed by EuroQol-EQ-5D.(At base line, 1 month, 2 months and 3 months post randomization)
- Proportion of patients with radiographic or symptomatic Intra-Cerebral Hemorrhage (ICH)(within 24 (± 6) hours of randomization.)
- Change in MoCA score of patients(At 1 month and 3 months post-randomization)
- Proportion of patients with incidence in recurrent ischemic stroke(within 1 month and 3 months)
- Number of deaths occurs(within 3 months of post-randomization)
- Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)(3 months)