Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke (NCT05691244)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (8 items).
Location: The University of Arizona - College of Medicine — Tucson, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria:
- 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.
- 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).
- 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.
- Known pregnancy and lactating women.
- 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.
- Concurrent participation in any other therapeutic clinical trial.
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (54 Sites)
- The University of Arizona - College of Medicine — Tucson, Arizona
- Mercy Medical Group — Carmichael, California
- St. John's Regional Medical Center — Oxnard, California
- Sarasota Memorial Hospital — Sarasota, Florida
- Wellstar Kennestone Hospital — Marietta, Georgia
- SSM Health Neurosciences — Bridgeton, Missouri
- Hackensack University Medical Center at Paramus — Paramus, New Jersey
- Guilford Neurologic Associates Inc — Greensboro, North Carolina
- OSU Wexner Medical Center — Columbus, Ohio
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania
- UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania
- CHI Memorial Neuroscience Institute — Chattanooga, Tennessee
- Houston Medical Neurological Institute — Houston, Texas
- Memorial Hermann Hospital — Houston, Texas
- Klinikum Altenburger Land GmbH — Altenburg, Altenburg
- Universitaetsklinikum Goettingen — Göttingen, Lower Saxony
- Klinikum der Stadt Ludwigshafen gGmbh — Rhein, Ludwigshafen Am
- Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik — Minden, North Rhine-Westphalia
- Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151 — Recklinghausen, Recklinghausen
- Charite-Universitaetsmedizin Berlin — Berlin, State of Berlin
- RHON-KLINIKUM Campus Bad Neustadt — Bad Neustadt an der Saale,
- Universitaetsklinikum Erlangen — Erlangen,
- Universitätsklinikum Essen AöR — Essen,
- Universitätsklinikum Schleswig-Holstein AöR — Lübeck,
- University Hospital Tuebingen — Tübingen,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.