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
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.
• 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