A Phase 3 interventional study of Normal Saline along with standard treatment and PMZ-1620 (sovateltide) along with standard treatment in Cerebral Ischemia, Cerebral Infarction and Stroke, Acute, sponsored by Pharmazz, Inc.. Completed at 11 sites in India. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Pharmazz, Inc. · Phase 3, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 158 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Pharmazz, Inc. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive the best available standard of care. 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.
Drug: Normal Saline along with standard treatment
Patients will receive the best available standard of care. 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).
Drug: PMZ-1620 (sovateltide) along with standard treatment
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.
Also known as: Vehicle
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.
Also known as: PMZ-1620
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.
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
Plan to share: No — Results will be communicated and published as manuscript
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pharmazz, Inc.