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

Sovateltide/CT-4.1/2022

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.

2024-01-08

2025-04-01

2025-07-01

Recruiting

Early phase I

160

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Investigational product (IP) is Sovateltide. It is a lyophilized product, available as Sovateltide injection containing 30 μg of Sovateltide (IRL-1620) in a 5.0 mL vial. The investigational product will be provided by Pharmazz India Pvt. Ltd. Three doses of Sovateltide (each dose of 0.3 μg/kg body weight) will be administered as an IV bolus over one minute at 3 ± 1 hours interval on day 1. The dose will be repeated on day 3 and day 6 post-randomization. Sovateltide will be administered as an IV bolus dose over one minute within 24 hours of the stroke onset. All the patients in the Sovateltide group will continue receiving standard treatment. The reference product is Normal Saline therapy. Three doses of Normal Saline (Equal volume) 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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "In this double-blind study, the patient and all relevant personnel involved with the conduct and interpretation of the study (including the investigator, investigational site personnel, and the sponsor or designee's staff) will remain blinded to the identity of the Investigational Product (IP) assigned and the randomization codes. The final randomization list will be kept strictly confidential, filed securely by the independent biostatistician, and accessible only to authorized persons as per the sponsor's standard operating procedures until the completion of the study.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

2024-04-08