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

Acute Spinal Cord Injury Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT04054414
• Study type: Interventional
• Source: Pharmazz, Inc.
• Contact: Manish S Lavhale
• Phone: +91 9873847397
• Email: manish.lavhale@pharmazz.com
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2019
• Completion date: July 2024