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

PMZ-1620/CLINICAL-2.3/2017

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.

2019-01-10

2024-06-01

2024-07-01

Recruiting

Early phase I

40

Inclusion Criteria: 1. Adult males or females aged between 18 and 75 years inclusive 2. Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR) 3. Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (excludes patients who are on ventilator) 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. 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 7. Able to receive the Investigational Drug 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 Exclusion Criteria: 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 are breastfeeding or 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. The participant has a 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 (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorder with hallucinations/delusions/schizophrenia) 13. Patients who are currently participating in a clinical trial with an investigational drug or investigational device 14. Patients who, in the opinion of the investigator, are otherwise unsuitable for this study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).\n\nIn 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.\n\nIn both treatment groups, subjects will be provided the best available standard of care.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-07-11