- Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke — Recruiting • Phase III • Cardiology / Cardiovascular • NCT05691244.
- What is being tested: Sovateltide, a neuroprotective agent designed to protect brain tissue during acute ischaemic stroke and potentially promote neural repair in the recovery phase.
- Patient eligibility overview: Adults presenting with acute cerebral ischaemic stroke within a defined timeframe from symptom onset, meeting specific neurological and imaging criteria to ensure appropriate patient selection for intervention efficacy assessment.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects.…
- : A patient will be eligible for inclusion in the study if he/she fulfills the following criteria:
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.