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Clinical Trials in India / NCT04054414
Recruiting Phase 2

PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury

NCT04054414 · tracked via the Priya Life Science India tracker
Sponsor
Pharmazz, Inc.
Phase
Phase 2
Started
2019-01-10
Last updated
2025-07-04

Condition(s) studied

Acute Spinal Cord Injury

Investigational drug(s) / intervention(s)

Normal Saline along with standard treatmentPMZ-1620 along with standard treatment

Normal Saline along with standard treatment: The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.

PMZ-1620 along with standard treatment: PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi India Not Yet Recruiting
Institute of Postgraduate Medical Education & Research and SSKM Hospital Kolkata India Recruiting
King George's Medical University Lucknow India Recruiting
Rahate Surgical Hospital & ICU Nagpur India Recruiting
Indian Spinal Injury Centre New Delhi India Recruiting

More Pharmazz, Inc. trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04054414 on ClinicalTrials.gov ↗ ← All trials in India