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

October 16, 2023 updated by: Pharmazz, Inc.

A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase III Clinical Study to Assess Efficacy of PMZ-1620 Along With Standard Treatment in Patients of Acute Ischemic Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The peptide Sovateltide (IRL-1620) is a highly selective ETB receptor agonist. There are hidden stem cells in the brain, which becomes active following injury to the brain. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the brain to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic activity and also increases cerebral blood flow when administered following ischemia. It was discovered that in rat model of ischemic stroke, sovateltide, significantly improved survival, reduces neurological and motor function deficit while effectively decreasing infarct volume, edema and oxidative stress. The convincing results of preclinical efficacy studies of Sovateltide in ischemic stroke and its safety affirmation from phase I and phase II clinical studies encouraged us to investigate its efficacy in human patients of ischemic stroke. In the present prospective, multicentric, randomized, double-blind, parallel, saline-controlled phase II clinical study; the investigators plan to evaluate the efficacy of Sovateltide therapy along with standard supportive care in patients of acute ischemic stroke.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Amravati, India, 444606
        • Radiant Superspeciality Hospital
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research
      • Guntur, India, 522001
        • Lalitha Superspecialities Hospital
      • Ludhiana, India, 141421
        • Sidhu Hospital Pvt. Ltd.
      • Ludhiana, India, 141001
        • Dayanand Medical College & Hospital
      • Ludhiana, India, 141008
        • Department of Neurology, Christian Medical College and Hospital
      • Nagpur, India, 440008
        • New Era Hospital & Research Institute
      • Nashik, India, 422005
        • Chopda Medicare & Research Centre
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110070
        • Indian Spinal Injury Centre
    • Uttar Pradesh
      • Agra, Uttar Pradesh, India, 282002
        • Pushpanjali Hospital & Research Centre Pvt. Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult males or females Aged 18 years through 78 years (have not had their 79th birthday).
  2. Patient or Legally Authorized Representative willing to give informed Consent before study procedure.
  3. Stroke is ischemic in origin and radiologically confirmed Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
  4. Cerebral ischemic stroke patients presenting upto 24 hours after onset of symptoms with mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score >5 (NIHSS Level of Consciousness (1A) score must be < 2). This also includes patients who had ischemic stroke in the past and are completely recovered from earlier episode before having new or fresh stroke.
  5. Patient is < 24 hours from time of stroke onset when the first dose of PMZ-1620 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self- reported to be normal.
  6. Reasonable expectation of availability to receive the full PMZ-1620 course of therapy, and to be available for subsequent follow-up visits.

Exclusion Criteria:

  1. Patients receiving endovascular therapy or is a candidate for any surgical intervention for treatment of stroke which may include but not limited to endovascular techniques.
  2. Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥ 2).
  3. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, acute or chronic subdural hematoma on the baseline CT or MRI scan.
  4. Known pregnancy.
  5. Confounding pre-existing neurological or psychiatric disease.
  6. Concurrent participation in any other therapeutic clinical trial.
  7. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which PMZ-1620 therapy would be contraindicated or might cause harm to the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal Saline + Standard of care
Patients will receive the best available standard of care. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization.
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.
Other Names:
  • Vehicle
Experimental: PMZ-1620 (sovateltide) + Standard of care
Patients will receive the best available standard of care. In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight).
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.
Other Names:
  • PMZ-1620

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in National Institute of Health Stroke Scale (NIHSS)
Time Frame: 90 days
Neurological outcome as assessed by National Institute of Health Stroke Scale (NIHSS) score post randomization. NIHSS is 42 point scale where 0 is the best and 42 is the worst outcome.
90 days
Change in modified Rankin Scale (mRS)
Time Frame: 90 days
Neurological outcome as assessed by modified Rankin Scale (mRS) score post randomization. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.
90 days
Change in Barthel index [BI]
Time Frame: 90 days
Overall clinical outcome as assessed by Barthel index [BI] scores) at 3 months post randomization. BI is a 10 item scale with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.
90 days
Change in the proportion of ischemic stroke patients with NIHSS score <6
Time Frame: 90 days
Change in the proportion of ischemic stroke patients with National Institute of Health Stroke Scale (NIHSS) score <6 at day 6, 1 month and 3 months. NIHSS is 42 point scale where 0 is the best and 42 is the worst outcome.
90 days
Change in the proportion of ischemic stroke patients with mRS score <2
Time Frame: 90 days
Change in the proportion of ischemic stroke patients with modified Rankin Scale (mRS) score <2 at day 6, 1 month and 3 months. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.
90 days
Change in the proportion of ischemic stroke patients with Barthel index (BI) score >60
Time Frame: 90 days
Change in the proportion of ischemic stroke patients with Barthel index (BI) score >60 at day 6, 1 month and 3 months. BI is a 10 item scale with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality-of-life as assessed by EuroQol-EQ-5D
Time Frame: 90 days
Quality-of-life as assessed by EuroQol-EQ-5D will be determined at 1 month and 3 months post randomization. EuroQol-EQ-5D is a concise, generic instrument that could be used to measure, compare and value health status across disease areas. It is a five dimension instrument with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.
90 days
Change in Stroke-Specific Quality of Life (SSQOL)
Time Frame: 90 days
Stroke-Specific Quality of Life (SSQOL) will be assessed at 1 month and 3 months post randomization. SSQOL is composed of 49 items with scores ranging from 49 to 245, where a score of 245 is the best and 49 is the worst outcome.
90 days
Incidence in recurrence of ischemic stroke
Time Frame: 90 days
Incidence of recurrent ischemic stroke within 1 month and 3 months post-randomization, as assessed by Questionnaire to Validate Stroke-Free Status
90 days
Incidence of mortality
Time Frame: 90 days
Incidence of mortality within 3 months post-randomization
90 days
Incidence of Intra-Cerebral Hemorrhage (ICH)
Time Frame: 30 hours
Incidence of symptomatic Intra Cerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization
30 hours
Incidence of PMZ-1620 related adverse events
Time Frame: 90 days
Another objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmazz, Inc.

Investigators

  • Study Chair: Anil Gulati, MD, PhD, Chairman and CEO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2019

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMZ-1620/CT-3.1/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will be communicated and published as manuscript

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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