A prospective, multicentric, randomized, double-blind, parallel, phase IV study to assess the safety and efficacy of TycamzziTM (sovateltide) in patients with acute cerebral ischemic stroke
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 13
- 主要终点
- Any adverse events (AEs) or serious adverse events (SAEs)
研究概览
简要总结
This is a prospective, multicentric, randomized, double-blind, parallel, phase IV study to assess the safety and efficacy of TycamzziTM (sovateltide) in patients with acute cerebral ischemic stroke. A total of 160 patients (80 in each treatment arm) will be enrolled in the study. This protocol is designed to assess a novel first-in-class treatment for use in critical care and life-threatening condition of cerebral ischemic stroke with an unmet need and is of national interest. 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 3 study visits: visit 1/Day 1 (screening, randomization, baseline measurements, and treatment), Day 2 (measurements), Days 3 and 6 (measurements and treatment), visit 2/telephonic visit (Day 30 ±5), and visit 3/end of the study (Day 90 ± 7). At visit 1, a total of 160 patients will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria:
Group 1: TycamzziTM (sovateltide)+ Standard treatment
Group 2: Normal Saline (Dose: Equal volume) + Standard treatment
Sovateltide or Normal Saline will be administered as an intravenous (IV) bolus over one minute within 24 hours after the onset of stroke. In the Sovateltide group, three doses of Sovateltide (each dose of 0.3 mcg/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 stroke treatment. Standard treatment to be provided to the patients shall be the one used in the particular hospital setup. Each patient will be monitored closely for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.
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) before enrolment.
- •No hemorrhage as proved by cerebral CT/MRI scan.
- •Cerebral ischemic stroke patients presenting within 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 includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke.
- •The patient is <24 hours from the time of stroke onset when the first dose of Sovateltide therapy is administered.
- •Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self-reported to be normal.
- •Reasonable expectation of availability to receive the full Sovateltide course of therapy and to be available for subsequent follow-up visits.
排除标准
- •1.Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.
- •Patients classified as comatose are defined as a patient who requires 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, an 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.
- •7.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 Sovateltide therapy would be contraindicated or might cause harm to the patient.
结局指标
主要结局
Any adverse events (AEs) or serious adverse events (SAEs)
时间窗: within 90 days post-randomization
次要结局
- The proportion of cerebral ischemic stroke patients with a change in modified Rankin Scale (mRS) score of more than & equal to 2(at day 90 post-randomization)
- The proportion of cerebral ischemic stroke patients with a change in National Institute of Health Stroke Scale (NIHSS) score more than & equal to 6(at day 90 post-randomization)
- The proportion of cerebral ischemic stroke patients with a Barthel index (BI) score more than & equal to 60(at day 90 post-randomization)
- Change in NIHSS(at day 90 post-randomization)
- Change in mRS(at day 90 post-randomization)
- Change in BI(at day 90 post-randomization)
- Change in Quality-of-life as assessed by EuroQol-EQ-5D(at day 90 post-randomization)
- Change in Stroke-Specific Quality of Life (SSQOL)(at day 90 post randomization)
- The proportion of patients with recurrent cerebral ischemic stroke(within 90 days post randomization,)
- Number of deaths(within 90 days post-randomization)
- proportion of patients with radiographic or symptomatic Intra Cerebral Hemorrhage (ICH)(within 24 (± 6) hours of randomization)
- Change in Montreal Cognitive Assessment (MoCA) score(at day 90 post-randomization)
- Compare Alberta Stroke Program Early CT (ASPECT) Score for stroke severity & identify sites of ischemic lesions.(at baseline)