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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
158
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.
Pushpanjali Hospital & Research Centre Pvt. Ltd
Agra, Uttar Pradesh, India
Radiant Superspeciality Hospital
Amravati, India
Post Graduate Institute of Medical Education and Research
Chandigarh, India
Change in National Institute of Health Stroke Scale (NIHSS)
Neurological outcome as assessed by National Institute of Health Stroke Scale (NIHSS) score post randomization. NIHSS is 42 point scale where 0 is the best and 42 is the worst outcome.
Time frame: 90 days
Change in modified Rankin Scale (mRS)
Neurological outcome as assessed by modified Rankin Scale (mRS) score post randomization. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.
Time frame: 90 days
Change in Barthel index [BI]
Overall clinical outcome as assessed by Barthel index \[BI\] scores) at 3 months post randomization. BI is a 10 item scale with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.
Time frame: 90 days
Change in the proportion of ischemic stroke patients with NIHSS score <6
Change in the proportion of ischemic stroke patients with National Institute of Health Stroke Scale (NIHSS) score \<6 at day 6, 1 month and 3 months. NIHSS is 42 point scale where 0 is the best and 42 is the worst outcome.
Time frame: 90 days
Change in the proportion of ischemic stroke patients with mRS score <2
Change in the proportion of ischemic stroke patients with modified Rankin Scale (mRS) score \<2 at day 6, 1 month and 3 months. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.
Time frame: 90 days
Change in the proportion of ischemic stroke patients with Barthel index (BI) score >60
Change in the proportion of ischemic stroke patients with Barthel index (BI) score \>60 at day 6, 1 month and 3 months. BI is a 10 item scale with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.
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Lalitha Superspecialities Hospital
Guntur, India
Dayanand Medical College & Hospital
Ludhiana, India
Department of Neurology, Christian Medical College and Hospital
Ludhiana, India
Sidhu Hospital Pvt. Ltd.
Ludhiana, India
New Era Hospital & Research Institute
Nagpur, India
Chopda Medicare & Research Centre
Nashik, India
All India Institute of Medical Sciences
New Delhi, India
...and 1 more locations
Time frame: 90 days
Change in Quality-of-life as assessed by EuroQol-EQ-5D
Quality-of-life as assessed by EuroQol-EQ-5D will be determined at 1 month and 3 months post randomization. EuroQol-EQ-5D is a concise, generic instrument that could be used to measure, compare and value health status across disease areas. It is a five dimension instrument with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.
Time frame: 90 days
Change in Stroke-Specific Quality of Life (SSQOL)
Stroke-Specific Quality of Life (SSQOL) will be assessed at 1 month and 3 months post randomization. SSQOL is composed of 49 items with scores ranging from 49 to 245, where a score of 245 is the best and 49 is the worst outcome.
Time frame: 90 days
Incidence in recurrence of ischemic stroke
Incidence of recurrent ischemic stroke within 1 month and 3 months post-randomization, as assessed by Questionnaire to Validate Stroke-Free Status
Time frame: 90 days
Incidence of mortality
Incidence of mortality within 3 months post-randomization
Time frame: 90 days
Incidence of Intra-Cerebral Hemorrhage (ICH)
Incidence of symptomatic Intra Cerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization
Time frame: 30 hours
Incidence of PMZ-1620 related adverse events
Another objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.
Time frame: 90 days