Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke (NCT05691244)
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.
🩺 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: Review the eligibility criteria below.
Location: The University of Arizona - College of Medicine — Tucson, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (54 Sites)
Showing the first 25 of 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,
📞 Contact the Study Coordinator
Phone: (630) 780-6087
Email: anil.gulati@pharmazz.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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- Safety Of A Second Dose Of Tenecteplase In Selected Acute Ischemic Stroke Patients Not Responding To The First Dose — Houston, Texas
- Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke — Richmond, British Columbia
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Explore by condition: All Acute Ischemic Stroke clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.