Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Acute Cerebral Ischemia
About this trial
This is an interventional treatment trial for Acute Cerebral Ischemia focused on measuring Stroke, Endothelin, Endothelin B Receptors, Ischemia, IRL 1620, Sovateltide, Neural progenitors
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Guntur Medical College and Government General Hospital
- Lalitha Super Specialities Hospital Pvt. Ltd.
- Radiant Superspeciality Hospital
- Government Medical College and attached Hospitals
- KG Hospital and Post Graduate Medical Institute
- Maharani Laxmibai Medical College
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sovateltide (Tyvalzi™) + Standard treatment
Normal Saline (Dose: Equal volume) + Standard Treatment
A total of 80 patients will be enrolled in the experimental arm. Three doses of sovateltide (each dose of 0.3 μg/kg body weight) will be given as an IV bolus in each patient (randomly assigned to this group) over one minute at an interval of 3 ± 1 hours on day 1, day 3, and day 6 (total dose/day: 0.9 μg/kg body weight). All patients will receive standard stroke treatment as provided by the specific hospital setup. Patients will be closely monitored for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.
A total of 80 patients will be enrolled in this arm. Three doses of an equal volume of normal saline will be administered as an IV bolus in each patient (randomly assigned to this group) over one minute at an interval of 3 ± 1 hours on day 1, day 3, and day 6. All patients will receive standard stroke treatment as provided by the specific hospital setup. Patients will be closely monitored for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.