Actively Recruiting
Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Led by Pharmazz, Inc. · Updated on 2025-12-30
514
Participants Needed
42
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females aged 18 - 80 years
- Consent obtained according to national laws and ethics committee requirements
- Ischemic stroke diagnosis confirmed clinically and/or by CT or MRI scan, with no hemorrhage
- Stroke symptoms started within 24 hours before treatment, with NIHSS score between 8 and less than 20 and Level of Consciousness score less than 2
- Pre-stroke mRS score of 0-2 if previously had stroke
- Ability and expectation to complete full therapy and follow-up visits
You will not qualify if you...
- Receiving or candidate for endovascular therapy or surgical intervention for stroke
- Comatose patients requiring strong or painful stimulation to respond (NIHSS Level of Consciousness score 2 or higher)
- Evidence of intracranial hemorrhage on baseline CT or MRI
- Known pregnancy or lactation
- History of neurological or psychiatric conditions that interfere with assessments or study participation
- Participation in another therapeutic clinical trial
- Presence of other major life-threatening or serious medical conditions preventing study completion or safe treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
The University of Arizona - College of Medicine
Tuscon, Arizona, United States, 85719
Actively Recruiting
2
Mercy Medical Group
Carmichael, California, United States, 95608
Actively Recruiting
3
St. John's Regional Medical Center
Oxnard, California, United States, 93030
Actively Recruiting
4
SSM Health Neurosciences
Bridgeton, Missouri, United States, 63044
Actively Recruiting
5
OSU Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
6
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
7
CHI Memorial Neuroscience Institute
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
8
Houston Medical Neurological Institute
Houston, Texas, United States, 77030
Actively Recruiting
9
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Actively Recruiting
10
Klinikum Altenburger Land GmbH
Altenburg, Altenburg, Germany, 04600
Actively Recruiting
11
Universitaetsklinikum Goettingen
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
12
Klinikum der Stadt Ludwigshafen gGmbh
Rhein, Ludwigshafen Am, Germany, 67063
Actively Recruiting
13
Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik
Minden, North Rhine-Westphalia, Germany, 32427
Actively Recruiting
14
Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151
Recklinghausen, Recklinghausen, Germany, 45657
Actively Recruiting
15
Charite-Universitaetsmedizin Berlin
Berlin, State of Berlin, Germany, 12203
Actively Recruiting
16
Universitätsklinikum Essen AöR
Essen, Germany, 45147
Actively Recruiting
17
Universitätsklinikum Schleswig-Holstein AöR
Lübeck, Germany, 23538
Actively Recruiting
18
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
19
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
20
Complejo Hospitalario Universitario de Albacete
Albacete, Castille-La Mancha, Spain, 2006
Actively Recruiting
21
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
22
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Madrid, Spain, 28222
Actively Recruiting
23
Hospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
24
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain, 41009
Actively Recruiting
25
Hospital Universitari Joan XXIII
Tarragona, Tarragona, Spain, 43005
Actively Recruiting
26
Instituto de Investigación Biomédica de A Coruña
A Coruña, Spain, 15006
Actively Recruiting
27
Hospital Universitario Infanta Cristina (HUB)
Badajoz, Spain, 06080
Actively Recruiting
28
Hospital Universitario de Cruces
Barakaldo, Spain, 48903
Actively Recruiting
29
Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta
Girona, Spain, 17007
Actively Recruiting
30
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
31
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
32
Hospital Clinico Universitario de Santiago
Santiago, Spain, 15706
Actively Recruiting
33
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
34
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
35
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Actively Recruiting
36
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
37
Fairfield General Hospital
Bury, Bury, United Kingdom, BL9 7TD
Actively Recruiting
38
National Hospital for Neurology & Neurosurgery
London, London, United Kingdom, NW1 2BU
Actively Recruiting
39
King's College Hospital NHS Foundation Trust
London, London, United Kingdom, SE5 9RS
Actively Recruiting
40
University Hospital Southampton
Southampton, Southampton, United Kingdom, SO16 6YD
Actively Recruiting
41
New Cross Hospital - Royal Wolverhampton NHS Trust
Wolverhampton, Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
42
Hospitals NHS Foundation Trust - Royal Victoria Infirmary RVI
Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
Research Team
A
Anil Gulati, MD, PhD
CONTACT
N
Neil Marwah, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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