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

Pharmazz India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年11月21日

试验速览

暂无简介。

•1. Adult males or females aged between 18 to 75 years, both inclusive
•2. 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
•4. 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
•5. Willing and able to comply with the study Protocol
•6. 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
•7. Able to receive the Investigational Product within 48 hours of injury
•8. Neurological Level of Injury between C5-C8, T1-T12, L1- L5 and S1-S5 based upon first ISNCSCI evaluation after arrival to the hospital
•9. Patient with incomplete/partial damage/transaction as shown by CT or MRI scan
•10. Patients with any other chronic conditions, who are stable with appropriate treatment

•1. Previous history related to spinal cord disease
•2. Patient on ventilator or requires ventilator
•3. Patient with pathological fracture of vertebral column
•4. Impairment Scale Grade A based upon first ISNCSCI assessment and classified as complete injury
•5. One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination
•6. 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)
•7. Females who have a positive urine pregnancy test.
•8. Body mass index (BMI) of >=35 kg/m2 at screening
•9. Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
•10. Patient having rheumatoid arthritis
•11. Clinically significant cardiovascular disorder or an abnormal electrocardiogram (ECG) at the discretion of the investigator
•12. Pre-existent neurologic disorder which would preclude accurate evaluation and follow-up.
•13. Patients who are currently participating in a clinical trial with an investigational product or investigational device
•14. Patients who, in the opinion of the investigator, are otherwise unsuitable for this study

发起方