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NCT05691244 · ClinicalTrials.gov registry record · Phase 3
Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
A Phase 3 study of Acute Ischemic Stroke and Cerebral Stroke, sponsored by Pharmazz.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
- 20
- Study locations
NCT05691244 is a Phase 3 study of Acute Ischemic Stroke and Cerebral Stroke that is actively recruiting participants, run by Pharmazz. The registered enrollment target is 514 participants, above the 331-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT05691244, a Phase 3 study of Acute Ischemic Stroke and Cerebral Stroke, is actively recruiting participants, sponsored by Pharmazz.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 514 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Drug: Normal Saline
- DRUG Sovateltide
Study Locations (20)
California
- Mercy Medical Group - Carmichael
- St. John's Regional Medical Center - Oxnard
Texas
- Houston Medical Neurological Institute - Houston
- Memorial Hermann Hospital - Houston
Other
- Universitätsklinikum Essen AöR - Essen
- Universitätsklinikum Schleswig-Holstein AöR - Lübeck
Barcelona
- Hospital Germans Trias i Pujol - Badalona
- Hospital Universitari Vall d'Hebron - Barcelona
Arizona
- The University of Arizona - College of Medicine - Tuscon
Missouri
- SSM Health Neurosciences - Bridgeton
Ohio
- OSU Wexner Medical Center - Columbus
Pennsylvania
- UPMC Presbyterian Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2025-07-24 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05691244
The ClinicalTrials.gov registry entry for NCT05691244 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 331-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (55% higher). The listed sponsor is Pharmazz, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which Drug: Normal Saline is the first listed.
NCT05691244 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT05691244 about?
NCT05691244 is a clinical study titled "Assess the Safety and 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 th...
What is the current status of trial NCT05691244?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2025-07-24. Estimated completion is 2026-11.
What conditions does trial NCT05691244 study?
This clinical trial studies the following conditions: Acute Ischemic Stroke, Cerebral Stroke.
What interventions are being tested in trial NCT05691244?
The interventions under investigation include: Drug: Normal Saline (DRUG), Sovateltide (DRUG).
Who is sponsoring clinical trial NCT05691244?
This trial is sponsored by Pharmazz, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05691244 being conducted?
This trial has 20 study locations across Arizona, California, Missouri, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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