Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Recruiting now · Phase 4
Conditions studied: Acute Cerebral Ischemia
In brief
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.
Key facts
- Study ID
- NCT05955326
- Run by
- Pharmazz, Inc.
- People needed
- 160
- Starts
- 2024-01-08
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Guntur Medical College and Government General Hospital — Guntur, Andhra Pradesh, India (enrolling)
- Lalitha Super Specialities Hospital Pvt. Ltd. — Guntur, Andhra Pradesh, India (enrolling)
- Radiant Superspeciality Hospital — Amravati, Maharashtra, India (enrolling)
- Government Medical College and attached Hospitals — Kota, Rajasthan, India (enrolling)
- KG Hospital and Post Graduate Medical Institute — Coimbatore, Tamil Nadu, India (enrolling)
- Maharani Laxmibai Medical College — Jhānsi, Uttar Pradesh, India (enrolling)
Full record on ClinicalTrials.gov
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