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Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke

NCT04047563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2023-10-18

No results posted yet for this study

Summary

In the present prospective, multicentric, randomized, double-blind, parallel, saline-controlled phase II clinical study; the investigators plan to evaluate the efficacy of sovateltide (IRL-1620 or PMZ-1620) therapy along with standard supportive care in patients of acute ischemic stroke.

Conditions

  • Cerebral Ischemia
  • Cerebral Infarction
  • Stroke, Acute

Interventions

DRUG

Normal Saline 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. In this arm normal saline along with standard treatment will be given for active comparison.

DRUG

PMZ-1620 (sovateltide) 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.

Sponsors & Collaborators

  • Pharmazz, Inc.

    lead INDUSTRY

Principal Investigators

  • Anil Gulati, MD, PhD · Chairman and CEO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-10
Primary Completion
2022-02-10
Completion
2022-02-10

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04047563 on ClinicalTrials.gov