Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase IV Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Pharmazz, Inc.
160 participants
Jan 8, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) before enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
- Cerebral ischemic stroke patients presenting within 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 includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke.
- The patient is <24 hours from the time of stroke onset when the first dose of Sovateltide therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self-reported to be normal.
- Reasonable expectation of availability to receive the full Sovateltide course of therapy and to be available for subsequent follow-up visits.
Exclusion Criteria6
- Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.
- Patients classified as comatose are defined as a patient who requires 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, an acute or chronic subdural hematoma on the baseline CT or MRI scan 4. 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 Sovateltide therapy would be contraindicated or might cause harm to the patient.
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Interventions
Sovateltide (Tyvalzi™) is a highly selective ETB receptor agonist (Ki values are 0.016 and 1900 nM at ETB and ETA receptors, respectively). It is being developed as a first-in-class neuronal progenitor cell therapy for acute cerebral ischemic stroke. Sovateltide has demonstrated a significant neuroprotection following cerebral ischemia in animal models, while in a clinical phase I trial it was found safe and well-tolerated in healthy human volunteers (CTRI/2016/11/007509). A phase II study (NCT04046484) in 40 patients with cerebral ischemic stroke has demonstrated its superior efficacy with a significant improvement compared to the standard of care and widens the critical time window from 4 hours to 24 hours. A phase III study (NCT04047563) has also been recently completed in 158 patients with cerebral ischemic stroke, demonstrating significant improvement compared to the standard of care.
Three doses of Normal Saline (0.9% NaCl solution) with a volume equal to the volume of sovateltide will be administered as an IV bolus over one minute, at an interval of 3 hours ± 1 hour on day 1. The dose will be repeated on day 3 and day 6 post-randomization. All the patients in the Normal Saline group will continue receiving standard treatment.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05955326