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

Launched by PHARMAZZ, INC. · Jan 11, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment called sovateltide for patients who have experienced an acute ischemic stroke, which is a type of stroke caused by a blockage in blood flow to the brain. The trial aims to assess how safe and effective sovateltide is when given alongside standard care for stroke patients. Previous studies have shown promising results for sovateltide in improving patients' recovery, and researchers want to see if these benefits can be replicated in the United States.

To be eligible for this trial, participants must be adults aged 18 to 80 who have had a confirmed ischemic stroke within the last 24 hours and have a specific level of stroke severity. They should be able to provide consent for themselves or have a representative do so. Participants will receive sovateltide treatment and will be monitored for safety and effectiveness. It's important to note that individuals who are severely affected by their stroke, pregnant or breastfeeding, or have certain other medical conditions may not be able to take part in this study. If you or someone you know is interested in this trial, it could be a chance to contribute to research that may help improve stroke care in the future.

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Eligibility criteria

• Inclusion Criteria:
• A patient will be eligible for inclusion in the study if he/she fulfills the following criteria:
• • 1. Adult males or females aged 18 - 80 years of age.
• • 2. Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.
• • 3. A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
• • 4. Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and \<20, NIHSS Level of Consciousness (1A) score \<2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.
• • 5. The patient is \<24 hours from the time of stroke onset when the first dose of sovateltide 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.
• • 6. Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits.
• Exclusion Criteria:
• A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria:
• • 1. 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.
• • 2. 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).
• • 3. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
• • 4. Known pregnancy and lactating women.
• • 5. Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study.
• • 6. Concurrent participation in any other therapeutic clinical trial.
• • 7. 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.