A Prospective, Multicentric, Randomized, Double Blind, Saline Controlled Phase IIClinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy along withStandard Supportive Care in Patients of Acute Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Number of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is 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 with ASCI. Total 40 patients will be enrolled in this study. The enrolment period of the study will be approximately 12 months and total duration of the study will be approximately 15 months.For an individual patient, duration of the study will be 3 months (85-95 days), including 4 study visits: visit 1/Day 1 to Day 6 (screening/baseline/treatment visit), visit 2b/Day 30±5 (assessment visit), visit 3/Day 60±5 (assessment visit) and visit 4/End of Study/Day 90±5 (assessment and follow-up visit). Besides above visits, first 8 patients enrolled in this study will be evaluated for safety at Day 15 (visit 2a/Day 15±2 (assessment visit)). At visit 1, day 1, patients will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria:
Group 1: PMZ-1620 + Standard of care
Group 2: Normal Saline + Standard of care
Three doses of PMZ-1620 (each dose of 0.3μg/kg body weight) or Normal Saline (equal volume) will be administered as an IV bolus over one minute at an interval of 3±1 hours on Day 1, 3 and 6. There will be total of 9 doses over 3 days (0.9μg/kg body weight/day). In both treatment groups, patients will be provided the standard of care. Each patient will be monitored closely throughout his/her admission for the qualifying SCI and will be followed for 3 months from randomization. Each patient will be assessed for safety and efficacy parameters over 3 months from randomization at a clinic visit.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females aged between 18 to 75 years, both inclusive
- •Able to give consent for participation on their own or through their Legally Authorized Representative (LAR) 3.Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards
- •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
- •Female subject is either: a.
- •Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation,bilateral oophorectomy or hysterectomy) or, b.
- •If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, OR A vasectomised partner OR abstinence
- •Able to receive the Investigational Product 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 have a positive urine pregnancy test.
- •Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
- •Patient having rheumatoid arthritis
- •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.
- •Patients who are currently participating in a clinical trial with an investigational product or investigational device
- •Patients who, in the opinion of the investigator, are otherwise unsuitable for this study.
结局指标
主要结局
Number of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 03 Month
次要结局
- Statistically relevant changes in WISCI II Score(From baseline to 1, 2 and 3 months after treatment)
- Statistically relevant changes in clinical progression of ASCI as measured by ISNCSCI(scoring)
- Statistically relevant changes in SCIM score(From baseline to 1, 2 and 3 months after treatment)
- Statistically relevant changes in MRI/CT(From baseline and three months after treatment)
- Statistically relevant changes in EMG(From baseline and three months after treatment)