Status:
COMPLETED
Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke
Lead Sponsor:
Pharmazz, Inc.
Conditions:
Cerebral Ischemia
Cerebral Infarction
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
In the present prospective, multicentric, randomized, double-blind, parallel, saline-controlled phase II clinical study; the investigators plan to evaluate the efficacy of sovateltide (IRL-1620 or PMZ...
Detailed Description
The peptide Sovateltide (IRL-1620) is a highly selective ETB receptor agonist. There are hidden stem cells in the brain, which becomes active following injury to the brain. Intravenous administration ...
Eligibility Criteria
Inclusion
- Adult males or females Aged 18 years through 78 years (have not had their 79th birthday).
- Patient or Legally Authorized Representative willing to give informed Consent before study procedure.
- Stroke is ischemic in origin and radiologically confirmed Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
- Cerebral ischemic stroke patients presenting upto 24 hours after onset of symptoms with mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score \>5 (NIHSS Level of Consciousness (1A) score must be \< 2). This also includes patients who had ischemic stroke in the past and are completely recovered from earlier episode before having new or fresh stroke.
- Patient is \< 24 hours from time of stroke onset when the first dose of PMZ-1620 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self- reported to be normal.
- Reasonable expectation of availability to receive the full PMZ-1620 course of therapy, and to be available for subsequent follow-up visits.
Exclusion
- Patients receiving endovascular therapy or is a candidate for any surgical intervention for treatment of stroke which may include but not limited to endovascular techniques.
- Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥ 2).
- Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, acute or chronic subdural hematoma on the baseline CT or MRI scan.
- Known pregnancy.
- Confounding pre-existing neurological or psychiatric disease.
- Concurrent participation in any other therapeutic clinical trial.
- Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which PMZ-1620 therapy would be contraindicated or might cause harm to the patient.
Key Trial Info
Start Date :
November 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04047563
Start Date
November 10 2019
End Date
February 10 2022
Last Update
October 18 2023
Active Locations (11)
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1
Pushpanjali Hospital & Research Centre Pvt. Ltd
Agra, Uttar Pradesh, India, 282002
2
Radiant Superspeciality Hospital
Amravati, India, 444606
3
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012
4
Lalitha Superspecialities Hospital
Guntur, India, 522001