🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05691244
Recruiting Phase 3

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

NCT05691244 · tracked via the Priya Life Science UK tracker
Sponsor
Pharmazz, Inc.
Phase
Phase 3
Started
2025-07-24
Last updated
2026-09-15

Condition(s) studied

Acute Ischemic StrokeCerebral Stroke

Investigational drug(s) / intervention(s)

Drug: Normal SalineSovateltide

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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
The University of Arizona - College of Medicine Tucson Arizona Recruiting
Mercy Medical Group Carmichael California Recruiting
St. John's Regional Medical Center Oxnard California Recruiting
Sarasota Memorial Hospital Sarasota Florida Recruiting
Wellstar Kennestone Hospital Marietta Georgia Recruiting
SSM Health Neurosciences Bridgeton Missouri Recruiting
Hackensack University Medical Center at Paramus Paramus New Jersey Recruiting
Guilford Neurologic Associates Inc Greensboro North Carolina Recruiting
OSU Wexner Medical Center Columbus Ohio Recruiting
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
UPMC Presbyterian Hospital Pittsburgh Pennsylvania Recruiting
CHI Memorial Neuroscience Institute Chattanooga Tennessee Recruiting
Houston Medical Neurological Institute Houston Texas Recruiting
Memorial Hermann Hospital Houston Texas Recruiting
Klinikum Altenburger Land GmbH Altenburg Altenburg Recruiting
Universitaetsklinikum Goettingen Göttingen Lower Saxony Recruiting
Klinikum der Stadt Ludwigshafen gGmbh Rhein Ludwigshafen Am Recruiting
Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik Minden North Rhine-Westphalia Recruiting
Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151 Recklinghausen Recklinghausen Recruiting
Charite-Universitaetsmedizin Berlin Berlin State of Berlin Recruiting
RHON-KLINIKUM Campus Bad Neustadt Bad Neustadt an der Saale Germany Recruiting
Universitaetsklinikum Erlangen Erlangen Germany Recruiting
Universitätsklinikum Essen AöR Essen Germany Recruiting
Universitätsklinikum Schleswig-Holstein AöR Lübeck Germany Recruiting
University Hospital Tuebingen Tübingen Germany Recruiting
Hospital Germans Trias i Pujol Badalona Barcelona Recruiting
Hospital Universitari Vall d'Hebron Barcelona Barcelona Recruiting
Complejo Hospitalario Universitario de Albacete Albacete Castille-La Mancha Recruiting
Hospital Universitario La Paz Madrid Madrid Recruiting
Hospital Universitario Puerta de Hierro Majadahonda Madrid Madrid Recruiting
Hospital Clínico Universitario Virgen de Arrixaca El Palmar Murcia Recruiting
Hospital Universitario Virgen Macarena Seville Sevilla Recruiting
Hospital Universitari Joan XXIII Tarragona Tarragona Recruiting
Instituto de Investigación Biomédica de A Coruña A Coruña Spain Recruiting
Hospital Universitario Infanta Cristina (HUB) Badajoz Spain Recruiting
Hospital Universitario de Cruces Barakaldo Spain Recruiting
Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta Girona Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Hospital Clinico San Carlos Madrid Spain Recruiting
Medical Imbrain S.L. Melilla Spain Recruiting

+ 14 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05691244 on ClinicalTrials.gov ↗ ← All trials in the UK