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PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury
Sponsor: Pharmazz, Inc.
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
Conditions
Interventions
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.
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