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RECRUITING
NCT04054414
PHASE2

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

Sponsor: Pharmazz, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2019-01-10

Completion Date

2026-07

Last Updated

2025-07-04

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (5)

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

Belagavi, India

Institute of Postgraduate Medical Education & Research and SSKM Hospital

Kolkata, India

King George's Medical University

Lucknow, India

Rahate Surgical Hospital & ICU

Nagpur, India

Indian Spinal Injury Centre

New Delhi, India