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RECRUITING

NCT05691244

PHASE3

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

Sponsor: Pharmazz, Inc.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

514

Start Date

2025-07-24

Completion Date

2026-11

Last Updated

2026-06-24

Healthy Volunteers

Conditions

Acute Ischemic Stroke Cerebral Stroke

Interventions

DRUG

Drug: Normal Saline

Normal saline to be used as vehicle in the phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.

DRUG

Sovateltide

Phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.

Inclusion Criteria: A patient will be eligible for inclusion in the study if he/she fulfills the following criteria: 1. Adult males or females aged 18 - 80 years of age. 2. Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures. 3. 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. 4. 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. 5. 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. 6. Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits. Exclusion Criteria: A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria: 1. Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques. 2. Patients classified as comatose are defined as a patient who requires 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 (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan. 4. Known pregnancy and lactating women. 5. Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study. 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 sovateltide therapy would be contraindicated or might cause harm to the patient.

Locations (54)

The University of Arizona - College of Medicine

Tucson, Arizona, United States

Mercy Medical Group

Carmichael, California, United States

St. John's Regional Medical Center

Oxnard, California, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

SSM Health Neurosciences

Bridgeton, Missouri, United States

Hackensack University Medical Center at Paramus

Paramus, New Jersey, United States

Guilford Neurologic Associates Inc

Greensboro, North Carolina, United States

OSU Wexner Medical Center

Columbus, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

CHI Memorial Neuroscience Institute

Chattanooga, Tennessee, United States

Houston Medical Neurological Institute

Houston, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

Klinikum Altenburger Land GmbH

Altenburg, Altenburg, Germany

Universitaetsklinikum Goettingen

Göttingen, Lower Saxony, Germany

Klinikum der Stadt Ludwigshafen gGmbh

Rhein, Ludwigshafen Am, Germany

Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik

Minden, North Rhine-Westphalia, Germany

Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151

Recklinghausen, Recklinghausen, Germany

Charite-Universitaetsmedizin Berlin

Berlin, State of Berlin, Germany

RHON-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum Essen AöR

Essen, Germany

Universitätsklinikum Schleswig-Holstein AöR

Lübeck, Germany

University Hospital Tuebingen

Tübingen, Germany

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, Castille-La Mancha, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Madrid, Spain

Hospital Clínico Universitario Virgen de Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Hospital Universitari Joan XXIII

Tarragona, Tarragona, Spain

Instituto de Investigación Biomédica de A Coruña

A Coruña, Spain

Hospital Universitario Infanta Cristina (HUB)

Badajoz, Spain

Hospital Universitario de Cruces

Barakaldo, Spain

Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta

Girona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Medical Imbrain S.L.

Melilla, Spain

Hospital Clinico Universitario de Santiago

Santiago, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Fairfield General Hospital

Bury, Bury, United Kingdom

National Hospital for Neurology & Neurosurgery

London, London, United Kingdom

King's College Hospital NHS Foundation Trust

London, London, United Kingdom

St. George's University Hospitals

London, London, United Kingdom

University Hospital Southampton

Southampton, Southampton, United Kingdom

New Cross Hospital - Royal Wolverhampton NHS Trust

Wolverhampton, Wolverhampton, United Kingdom

London North West University Healthcare NHS Trust - Northwick Park Hospital

Harrow, United Kingdom

Hospitals NHS Foundation Trust - Royal Victoria Infirmary RVI

Newcastle, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Clinical Research Directory

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (54)