A Prospective, Multicentric, Randomized, Double Blind, Saline Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Patients of Acute Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Incidence of PMZ-1620 related adverse events
研究概览
简要总结
This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury.
详细描述
Trauma is projected to be third largest killer in the developing world by 2020, with a large number of these injuries comprising of traumatic spinal cord injury. People with spinal cord injuries (SCI) are two to five times more susceptible to die than people without an injury. More than 80% cases of SCIs occur among young people between the ages of 20 and 45 years and majority of sufferers are male. In developed countries, the incidence of spinal injuries varies from 20 to 50 per million. Every year about 250,000 to 500,000 number of SCI cases are reported.
There are hidden stem cells in the brain, which becomes active following injury to the spinal cord. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the spinal cord to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic and anti-oxidant activity.
Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females aged between 18 and 75 years inclusive
- •Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR)
- •Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (excludes patients who are on ventilator)
- •ISNCSCI Impairment Scale Grade "B," "C" or "D" based upon first ISNCSCI evaluation after arrival to the hospital is classified as motor or sensory incomplete
- •Willing and able to comply with the study Protocol
- •Women must be of non-childbearing potential or surgically sterile or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
- •Able to receive the Investigational Drug within 48 hours of injury
- •Neurological Level of Injury between C5-C8, T1-T12, L1-L5 and S1-S5 based upon first ISNCSCI evaluation after arrival to the hospital
- •Patient with incomplete/partial damage/transaction as shown by CT or MRI scan
- •Patients with any other chronic conditions, who are stable with appropriate treatment
排除标准
- •Previous history related to spinal cord disease
- •Patient on ventilator or requires ventilator
- •Patient with pathological fracture of vertebral column
- •Impairment Scale Grade "A" based upon first ISNCSCI assessment and classified as complete injury
- •One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination
- •Concomitant head injury with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)
- •Females who are breastfeeding or have a positive urine pregnancy test
- •Body mass index (BMI) of ≥35 kg/m2 at screening
- •Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
- •Patient having rheumatoid arthritis
- •The participant has a clinically significant cardiovascular disorder or an abnormal electrocardiogram (ECG) at the discretion of the investigator
- •Pre-existent neurologic disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorder with hallucinations/delusions/schizophrenia)
- •Patients who are currently participating in a clinical trial with an investigational drug or investigational device
- •Patients who, in the opinion of the investigator, are otherwise unsuitable for this study
研究组 & 干预措施
Normal Saline
Patients will receive the best available standard of care. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization.
干预措施: Normal Saline along with standard treatment (Drug)
PMZ-1620
Patients will receive the best available standard of care. In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight).
干预措施: PMZ-1620 along with standard treatment (Drug)
结局指标
主要结局
Incidence of PMZ-1620 related adverse events
时间窗: 90 days
The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.
Number of patients not receiving full treatment
时间窗: 90 days
Tolerability will be determined by the number of patients that do not receive all the 9 doses of PMZ-1620.
次要结局
- Changes in clinical progression of International Standards for Neurological Classification of spinal cord injury (ISNCSCI)(90 days)
- Changes in walking index for spinal cord injury (WISCI) score(90 days)
- Changes in Spinal Cord Independence Measure (SCIM) score(90 days)
- Changes in MRI/CT(90 days)
- Changes in electromyography (EMG)(90 days)