Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke
Condition: Cerebral Ischemia; Cerebral Infarction; Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Brain Ischemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      In the present prospective, multicentric, randomized, double-blind, parallel,
      saline-controlled phase II clinical study; the investigators plan to evaluate the efficacy of
      sovateltide (IRL-1620 or PMZ-1620) therapy along with standard supportive care in patients of
      acute ischemic stroke.
    

Detailed description: 
      The peptide Sovateltide (IRL-1620) is a highly selective ETB receptor agonist. There are
      hidden stem cells in the brain, which becomes active following injury to the brain.
      Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal
      progenitor cells in the brain to repair the damage by formation of new mature neurons and
      blood vessels. In addition, PMZ-1620 has anti-apoptotic activity and also increases cerebral
      blood flow when administered following ischemia. It was discovered that in rat model of
      ischemic stroke, sovateltide, significantly improved survival, reduces neurological and motor
      function deficit while effectively decreasing infarct volume, edema and oxidative stress. The
      convincing results of preclinical efficacy studies of Sovateltide in ischemic stroke and its
      safety affirmation from phase I and phase II clinical studies encouraged us to investigate
      its efficacy in human patients of ischemic stroke. In the present prospective, multicentric,
      randomized, double-blind, parallel, saline-controlled phase II clinical study; the
      investigators plan to evaluate the efficacy of Sovateltide therapy along with standard
      supportive care in patients of acute ischemic stroke.
    

Intervention name(s): Normal Saline along with standard treatment; PMZ-1620 (sovateltide) along with standard treatment
Intervention type(s): Drug; Drug
Intervention description(s): PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. In this arm normal saline along with standard treatment will be given for active comparison.; PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.
Other intervention name(s): Vehicle; PMZ-1620
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight).
In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization.
In both treatment groups, subjects will be provided the best available standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endothelin; Neurogenesis; Neural progenitor cells