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

Last updated: July 1, 2025
Sponsor: Pharmazz, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Spinal Cord Injuries

Treatment

Normal Saline along with standard treatment

PMZ-1620 along with standard treatment

Clinical Study ID

NCT04054414
PMZ-1620/CLINICAL-2.3/2017
CTRI/2018/12/016667
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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 LegallyAcceptable Representative (LAR)

  3. Able to cooperate in the completion of a standardized neurological examination byISNCSCI standards (excludes patients who are on ventilator)

  4. ISNCSCI Impairment Scale Grade "B," "C" or "D" based upon first ISNCSCI evaluationafter 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 useadequate birth control; men who are sexually active will also be required to useadequate 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 firstISNCSCI 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 appropriatetreatment

Exclusion

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 ascomplete injury

  5. One or more upper extremity muscle groups un-testable during baseline ISNCSCIexamination

  6. Concomitant head injury with a clinically significant abnormality on a head CT (headCT required only for patients suspected to have a brain injury at the discretion ofthe 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 ofimmunosuppressive or cancer chemotherapeutic drugs

  10. Patient having rheumatoid arthritis

  11. The participant has a clinically significant cardiovascular disorder or an abnormalelectrocardiogram (ECG) at the discretion of the investigator

  12. Pre-existent neurologic disorder which would preclude accurate evaluation andfollow-up (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorderwith hallucinations/delusions/schizophrenia)

  13. Patients who are currently participating in a clinical trial with an investigationaldrug or investigational device

  14. Patients who, in the opinion of the investigator, are otherwise unsuitable for thisstudy

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Normal Saline along with standard treatment
Phase: 2
Study Start date:
January 10, 2019
Estimated Completion Date:
July 31, 2026

Study Description

Trauma is projected to be third largest killer in the developing world by 2020, with a large number of these injuries comprising of traumatic spinal cord injury. People with spinal cord injuries (SCI) are two to five times more susceptible to die than people without an injury. More than 80% cases of SCIs occur among young people between the ages of 20 and 45 years and majority of sufferers are male. In developed countries, the incidence of spinal injuries varies from 20 to 50 per million. Every year about 250,000 to 500,000 number of SCI cases are reported.

There are hidden stem cells in the brain, which becomes active following injury to the spinal cord. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the spinal cord to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic and anti-oxidant activity.

Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration.

Connect with a study center

  • KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre

    Belgaum, 590010
    India

    Site Not Available

  • Institute of Postgraduate Medical Education & Research and SSKM Hospital

    Kolkata, 700020
    India

    Active - Recruiting

  • King George's Medical University

    Lucknow, 226018
    India

    Active - Recruiting

  • Rahate Surgical Hospital & ICU

    Nagpur, 440008
    India

    Active - Recruiting

  • Indian Spinal Injury Centre

    New Delhi, 110070
    India

    Active - Recruiting

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