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.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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