Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
ID05691244

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

Led by Pharmazz, Inc. · Updated on 2025-12-30

514

Participants Needed

42

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating sovateltide, a drug that targets ETB receptors, as a potential treatment for acute cerebral ischemic stroke, a serious condition caused by a blocked blood vessel in the brain. This type of stroke leads to brain tissue damage due to lack of oxygen and is more common than hemorrhagic stroke. Previous studies in animals and early human trials have shown sovateltide may help protect and repair brain cells, encouraging further research in a phase III clinical trial across multiple countries. The study compares sovateltide with a placebo (normal saline) alongside standard care for stroke patients. Participants receive three intravenous bolus doses of sovateltide or placebo over one minute each, spaced every 3 hours on day 1, with repeated dosing on days 3 and 6. The treatment starts within 24 hours after stroke symptoms begin. This randomized, double-blind trial aims to assess safety and how well sovateltide improves recovery compared to placebo. Participants will be closely monitored over 90 days, with evaluations including neurological function using scales like the modified Rankin Scale, National Institute of Health Stroke Scale, and Barthel Index. Quality of life and cognitive function will also be assessed at multiple points. Researchers will track any adverse events, recurrent strokes, and mortality. The study requires patients to be available for full treatment and follow-up to measure sovateltide's effects comprehensively.

CONDITIONS

Brief Title

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Consent obtained according to national laws and ethics requirements
  • Ischemic stroke diagnosed clinically and confirmed by CT or MRI with no hemorrhage
  • Stroke patients presenting within 24 hours of symptom onset with NIHSS score between 8 and less than 20 and low consciousness impairment
  • Stroke onset time less than 24 hours before first dose administration
  • Expected availability for full treatment and follow-up visits
Not Eligible

You will not qualify if you...

  • Receiving or candidate for endovascular therapy or surgical intervention for stroke
  • Comatose patients requiring repeated or strong painful stimulation to respond
  • Evidence of intracranial hemorrhage on baseline CT or MRI
  • Pregnant or breastfeeding women
  • History of neurological or psychiatric conditions that interfere with study evaluations
  • Participation in any other therapeutic clinical trial
  • Any major life-threatening or serious medical condition that affects study completion or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 days

Participants receive three doses of the study drug (either sovateltide or normal saline) as an IV bolus over one minute every 3 hours ± 1 hour on day 1. This dosing is repeated on days 3 and 6 post randomization.

3 dosing visits within 1 week

Follow-up

Duration - 90 days

Participants are monitored for safety and efficacy outcomes including neurological function and quality of life for up to 90 days post-randomization.

Visits at days 30, 60, and 90 post-randomization

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

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Research Team

A

Anil Gulati, MD, PhD

N

Neil Marwah, MD

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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Published Research Related To This Trial

Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase III Clinical Trial.

Anil Gulati, Sikandar Gokuldas Adwani, Pamidimukkala Vijaya...

https://pubmed.ncbi.nlm.nih.gov/39542995

Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke.

Anil Gulati, Nilesh Agrawal, Deepti Vibha...

https://pubmed.ncbi.nlm.nih.gov/33428177

Neuroprotective Effect of Sovateltide (IRL 1620, PMZ 1620) in a Neonatal Rat Model of Hypoxic-Ischemic Encephalopathy.

Michelle Davis Ramos, Seema Briyal, Preetha Prazad...

https://pubmed.ncbi.nlm.nih.gov/34826534

Sovateltide (IRL-1620) activates neuronal differentiation and prevents mitochondrial dysfunction in adult mammalian brains following stroke.

Amaresh K Ranjan, Seema Briyal, Anil Gulati

https://pubmed.ncbi.nlm.nih.gov/32728189

Sovateltide (IRL-1620) affects neuronal progenitors and prevents cerebral tissue damage after ischemic stroke.

Amaresh K Ranjan, Seema Briyal, Divya Khandekar...

https://pubmed.ncbi.nlm.nih.gov/32574518

Selective Endothelin-B Receptor Stimulation Increases Vascular Endothelial Growth Factor in the Rat Brain during Postnatal Development.

M G Leonard, P Prazad, B Puppala...

https://pubmed.ncbi.nlm.nih.gov/25806822

Endothelin receptor type B agonist, IRL-1620, prevents beta amyloid (Aβ) induced oxidative stress and cognitive impairment in normal and diabetic rats.

Seema Briyal, Cortney Shepard, Anil Gulati

https://pubmed.ncbi.nlm.nih.gov/24561065