Actively Recruiting
Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Led by Pharmazz, Inc. · Updated on 2025-12-31
160
Participants Needed
6
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, randomized, double-blind, parallel, phase IV study designed to evaluate the safety and efficacy of sovateltide (PMZ-1620, IRL-1620) as a potential treatment for cerebral ischemic stroke.
CONDITIONS
Official Title
Study to 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 years through 78 years (have not had their 79th birthday)
- Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure
- Stroke is ischemic in origin and radiologically confirmed by CT scan or MRI before enrollment with no hemorrhage
- Cerebral ischemic stroke patients presenting within 24 hours after symptom onset with mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score greater than 5 (NIHSS Level of Consciousness (1A) score less than 2)
- The patient is less than 24 hours from stroke onset when the first dose of Sovateltide is given
- Reasonable expectation to complete full Sovateltide therapy and attend follow-up visits
You will not qualify if you...
- Patients receiving or candidates for endovascular therapy or surgical intervention for stroke treatment
- Patients classified as comatose needing repeated or strong stimulation to move (NIHSS Level of Consciousness (1A) score 2 or higher)
- Evidence of intracranial hemorrhage or hematoma on baseline CT or MRI scan
- Known pregnancy
- Pre-existing neurological or psychiatric diseases that could affect outcomes
- Participation in any other therapeutic clinical trial
- Other major life-threatening or serious medical conditions preventing study completion or posing risk with Sovateltide therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Guntur Medical College and Government General Hospital
Guntur, Andhra Pradesh, India, 522001
Actively Recruiting
2
Lalitha Super Specialities Hospital Pvt. Ltd.
Guntur, Andhra Pradesh, India, 522001
Actively Recruiting
3
Radiant Superspeciality Hospital
Amravati, Maharashtra, India, 444606
Actively Recruiting
4
Government Medical College and attached Hospitals
Kota, Rajasthan, India, 324001
Actively Recruiting
5
KG Hospital and Post Graduate Medical Institute
Coimbatore, Tamil Nadu, India, 641018
Actively Recruiting
6
Maharani Laxmibai Medical College
Jhānsi, Uttar Pradesh, India, 284128
Actively Recruiting
Research Team
D
Dharmesh Shah, Dr.
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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