A Multicentric, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke.

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ A patient will be eligible for inclusion in the study if he/she fulfills the following criteria:

• Adult males or females aged 18 - 80 years of age.

• Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.

• A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.

• Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and \<20, NIHSS Level of Consciousness (1A) score \<2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.

• The patient is \<24 hours from the time of stroke onset when the first dose of sovateltide is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self- reported to be normal.

• Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits.

Locations
United States
Arizona
The University of Arizona - College of Medicine
NOT_YET_RECRUITING
Tuscon
California
St. John's Regional Medical Center
RECRUITING
Oxnard
Florida
Intercoastal Medical Group
NOT_YET_RECRUITING
Sarasota
Missouri
SSM Health Neurosciences
NOT_YET_RECRUITING
Bridgeton
North Carolina
Guilford Neurologic Associates
NOT_YET_RECRUITING
Greensboro
New Jersey
Hackensack University Medical Center
NOT_YET_RECRUITING
Paramus
Ohio
OSU Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
UPMC Presbyterian Hospital
NOT_YET_RECRUITING
Pittsburgh
Tennessee
CHI Memorial Neuroscience Institute
RECRUITING
Chattanooga
Texas
Houston Methodist Hospital Neurological Institute
NOT_YET_RECRUITING
Houston
Other Locations
Germany
Klinikum Altenburger Land GmbH
RECRUITING
Altenburg
Rhon-Klinikum Campus Bad Neustadt
NOT_YET_RECRUITING
Bad Neustadt A.d. Saale
Charite-Universitaetsmedizin Berlin
RECRUITING
Berlin
Universitätsklinikum Essen
NOT_YET_RECRUITING
Essen
Universitätsklinikum Essen AöR
RECRUITING
Essen
Universitaetsklinikum Goettingen
RECRUITING
Göttingen
Universitätsklinikum Schleswig-Holstein AöR
RECRUITING
Lübeck
Knappschaft Kliniken Vest GmbH
NOT_YET_RECRUITING
Recklinghausen
Universitatsklinikum Tubingen
NOT_YET_RECRUITING
Tübingen
Spain
Instituto de Investigación Biomédica de A Coruña
RECRUITING
A Coruña
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Anil Gulati, MD, PhD
anil.gulati@pharmazz.com
6307806087
Backup
Neil Marwah, MD
neil.marwah@pharmazz.com
6307806087
Time Frame
Start Date: 2025-07-24
Estimated Completion Date: 2026-11
Participants
Target number of participants: 514
Treatments
Active_comparator: Normal Saline + Standard of care
Normal saline will be used as a comparator. It will be available in a 5.0 mL vial. Three doses will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.
Experimental: Sovateltide + Standard of care
The test product is sovateltide. It is available as a lyophilized injection containing 30 µg of sovateltide in a 5.0 mL vial. Three doses of 0.3 μg/kg will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.
Related Therapeutic Areas
Sponsors
Leads: Pharmazz, Inc.

This content was sourced from clinicaltrials.gov