[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pharmazz, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":197},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,73,102,130,154,173],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100492369","phase-3-assess-the-safety-and-efficacy-of-sovateltide-in-patients-with-acute-cerebral-ischemic-stroke-100492369",false,"NCT05691244","Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke","A Multicentric, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke.","RESPECT-ETB","Inclusion Criteria:\n\nA patient will be eligible for inclusion in the study if he\u002Fshe fulfills the following criteria:\n\n1. Adult males or females aged 18 - 80 years of age.\n2. Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.\n3. A stroke is ischemic in origin that is diagnosed clinically and\u002For radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT\u002FMRI scan.\n4. Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and \\\u003C20, NIHSS Level of Consciousness (1A) score \\\u003C2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.\n5. The patient is \\\u003C24 hours from the time of stroke onset when the first dose of sovateltide 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.\n6. Reasonable expectation of availability to receive the full sovateltide\u002Fplacebo course of therapy and to be available for subsequent follow-up visits.\n\nExclusion Criteria:\n\nA patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria:\n\n1. 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.\n2. 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).\n3. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.\n4. Known pregnancy and lactating women.\n5. Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study.\n6. Concurrent participation in any other therapeutic clinical trial.\n7. 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.","ALL","18 Years","80 Years",{"count":21,"type":22},514,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.",[28,29],"Acute Ischemic Stroke","Cerebral Stroke",[31],"Endothelin B Receptors","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2025-07-24",{"date":40,"type":22},"2026-11",{"name":42,"class":43},"Pharmazz, Inc.","INDUSTRY",54,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100457781","phase-2-multicentric-randomized-study-to-assess-safety-and-efficacy-of-centhaquine-in-patients-with-ards-100457781","NCT05241067","Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in Patients With ARDS","A Multicentric, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Centhaquine as an Adjuvant to the Standard of Care in Patients With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS)","Inclusion Criteria:\n\nA subject will be eligible for inclusion in the study if he\u002Fshe fulfills the following criteria:\n\n1. Adult male or female aged 18 years or older\n2. Hospitalized in the ICU diagnosed with moderate to severe ARDS having a PaO2\u002FFiO2 ratio of \\\u003C 200 mmHg or the SPO2\u002FFiO2 ratio of ≤ 235( if SPO2 ≤ 97 %) with PEEP ≥ 5 cm H20 include the patient receiving invasive \u002Fnon-invasive ventilation (NIV\u002FCPAP).\n3. The first dose of the study drug should be administered within 48 hours of confirming moderate to severe ARDS.\n4. Requires vasopressor support\n5. Written informed consent\n\nExclusion Criteria:\n\nA subject will not be eligible for inclusion in this study if he\u002Fshe meets any of the following exclusion criteria:\n\n1. Receiving or expected to receive extracorporeal membrane oxygenation or high-frequency oscillatory ventilation\n2. Confirmed pregnancy\n3. Breast feeding\n4. Participating in another interventional study\n5. Requires or having the renal replacement therapy\n6. Hepatic failure (Child-Pugh scores B and C)",{"count":53,"type":22},80,[55],"PHASE2","Acute respiratory distress syndrome (ARDS) is a life-threatening condition with a diffuse, inflammatory form of lung injury, causing pulmonary infiltration and respiratory failure leading to poor oxygenation. It is a rapidly progressive form of respiratory failure and accounts for approximately 10% of admissions to the intensive care unit (ICU) and has a high mortality (40%) in severe cases. Globally, approximately 3 million ARDS cases are reported each year, with around 200,000 cases seen in the United States.\n\nThe etiology of ARDS could be pulmonary or extra-pulmonary. Patients with ARDS have symptoms like difficulty in breathing, shortness of breath, and cyanosis, and they may require assisted breathing\u002Fventilatory support\u002Fextracorporeal membrane oxygenation. About 25% of ARDS patients need mechanical ventilation to support breathing; however, a ventilator-induced lung injury (VILI) is known to further exacerbate ARDS in many of them. In recent decades, numerous efforts have been made to develop therapies for treating\u002Fmanaging ARDS. Unfortunately, they have been largely unsuccessful or inconclusive, and at present, no effective pharmacological therapy for ARDS is available. Hence, development of better therapeutics for ARDS is an unmet need.\n\nCenthaquine is a first-in-class resuscitative agent for hypovolemic shock approved for marketing in India. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects (CTRI\u002F2014\u002F06\u002F004647). Results from multicentric, randomized, double-blind, parallel, controlled clinical phase II (CTRI\u002F2017\u002F03\u002F008184) and phase III (CTRI\u002F2019\u002F01\u002F017196) studies conducted in India indicate that centhaquine is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. A total of 155 patients with hypovolemic shock have been studied in the combined phase II and III trials, while a multicentric phase IV study (NCT05956418) in 400 patients with hypovolemic shock is currently being conducted in India. The outcomes of the completed trials indicate that centhaquine is safe and reduces mortality significantly (P=0.0271) compared to standard treatment of hypovolemic shock. In the phase II and III studies, ARDS and MODS were evaluated as secondary endpoints. Centhaquine provided hemodynamic stability and significantly reduced ARDS and multiple organ dysfunction score (MODS) in patients enrolled in these trials, which suggests that centhaquine has potential beyond treating hypovolemic shock and could be useful for ARDS treatment. Centhaquine is likely to provide hemodynamic stability, improve tissue oxygenation, reduce pulmonary edema, reduce ARDS score, and reduce MODS in patients with ARDS.",[58],"Acute Respiratory Distress Syndrome (ARDS)",[60,61,62,63],"ARDS","Resuscitation","Centhaquine","Hypoxia","NOT_YET_RECRUITING","2026-04-09",{"date":67,"type":36},"2026-04-14",{"date":69,"type":22},"2026-05",{"date":71,"type":22},"2026-12-31",{"name":42,"class":43},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100512743","phase-4-a-study-to-assess-the-safety-and-efficacy-of-centhaquine-in-hypovolemic-shock-patients-100512743","NCT05956418","A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients","A Prospective, Multi-centric, Open-labeled, Phase-IV Study to Assess Safety and Efficacy of LYFAQUIN™ (Centhaquine Citrate) as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Treatment of Shock","Inclusion Criteria\n\n• Adult hypovolemic shock patients aged 18 years or older admitted to the emergency room or ICU with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment. Blood Lactate level indicative of hypovolemic shock (\\>2.0 mmol\u002FL).\n\nExclusion Criteria\n\n* Development of any other terminal illness not associated with hypovolemic shock during the study duration.\n* Patient with altered consciousness not due to hypovolemic shock and comatose patient. • Known pregnancy.\n* Cardiopulmonary resuscitation (CPR) before enrollment.\n* Presence of a do not resuscitate order.\n* Patient is participating in another interventional study.\n* Patients with systemic diseases which were already present before having trauma, such as sepsis, cancer, chronic renal failure, liver failure, decompensated heart failure, or AIDS.",{"count":81,"type":22},400,[83],"PHASE4","This is a prospective, multi-centric, open-labeled, phase-IV clinical study to evaluate the safety and efficacy of centhaquine citrate (LYFAQUIN™), a first-in-class drug for treating hypovolemic shock, a life-threatening condition caused by severe blood or fluid loss. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. It has demonstrated the ability to decrease blood lactate levels, increase mean arterial pressure, enhance cardiac output, and reduce mortality rates. The increase in cardiac output during resuscitation is primarily attributed to an augmentation in stroke volume. Centhaquine exerts its effects by acting on the venous α2B-adrenergic receptors, which enhances venous return to the heart. Additionally, it produces arterial dilation by targeting central α2A-adrenergic receptors, thereby reducing sympathetic activity and systemic vascular resistance.",[86],"Hypovolemic Shock",[88,89,90,91,61,62,92],"Shock","Hypovolemia","Hemorrhage","Blood Pressure","Adrenergic","2025-12-26",{"date":95,"type":36},"2025-12-31",{"date":97,"type":36},"2021-08-13",{"date":99,"type":22},"2026-08",{"name":42,"class":43},17,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100512659","phase-4-study-to-assess-the-safety-and-efficacy-of-sovateltide-in-patients-with-acute-cerebral-ischemic-stroke-100512659","NCT05955326","Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke","A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase IV Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke","Inclusion Criteria:\n\n* Adult males or females aged 18 years through 78 years (have not had their 79th birthday)\n* Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure.\n* 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\u002FMRI scan.\n* 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 \\\u003C 2). This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke.\n* The patient is \\\u003C24 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.\n* Reasonable expectation of availability to receive the full Sovateltide course of therapy and to be available for subsequent follow-up visits.\n\nExclusion Criteria:\n\n* 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.\n* 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).\n* 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.\n* Confounding pre-existing neurological or psychiatric disease.\n* Concurrent participation in any other therapeutic clinical trial.\n* 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.","78 Years",{"count":111,"type":22},160,[83],"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.",[115],"Acute Cerebral Ischemia",[117,118,31,119,120,121,122],"Stroke","Endothelin","Ischemia","IRL 1620","Sovateltide","Neural progenitors",{"date":95,"type":36},{"date":125,"type":36},"2024-01-08",{"date":127,"type":22},"2026-03",{"name":42,"class":43},6,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100478774","phase-2-assess-safety-and-efficacy-of-sovateltide-in-hypoxic-ischemic-encephalopathy-100478774","NCT05514340","Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates","Inclusion Criteria:\n\n1. Either sex with ≥ 36 weeks of gestational age\n2. Receiving supportive management for perinatal asphyxia\n3. Perinatal depression, based on at least one of the following:\n\n   * Apgar score of \\\u003C5 at 10 minutes\n   * Need for resuscitation (chest compressions or mechanical ventilation) at birth\n   * pH \\\u003C7.00 or base deficit ≥ 16 mmol\u002Fliter in the cord or arterial blood within 60 minutes of birth\n   * Moderate\u002Fsevere encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.\n4. Informed consent by one of the parents or a legal representative\n\nExclusion Criteria:\n\n1. Gestational age \\\u003C36 weeks\n2. Admitted to hospital 12-hours after birth\n3. A genetic or congenital condition that affects neuronal development\n4. TORCH infection\n5. Neonatal sepsis\n6. Complex congenital heart disease\n7. Severe dysmorphic feature\n8. Microcephaly (head circumference \\\u003C 2 Standard Deviations below mean for gestational age)",{"count":138,"type":22},40,[55],"Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a \"Treatment for hypoxic-ischemic encephalopathy in neonates,\" which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.",[142,143,144],"Hypoxic-Ischemic Encephalopathy","Neonatal Asphyxia","Neonatal Encephalopathy",[142,146,144],"Cerebral Asphyxia",{"date":95,"type":36},{"date":149,"type":36},"2023-09-06",{"date":151,"type":22},"2026-12",{"name":42,"class":43},4,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100458558","phase-3-a-study-to-assess-safety-and-efficacy-of-centhaquine-as-a-resuscitative-agent-100458558","NCT05251181","A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent","A Multi-Centric, Randomized, Double-Blind, Placebo-controlled, Phase-III Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent to be Used as an Adjuvant to Standard Treatment of Hypovolemic Shock","Inclusion Criteria:\n\nA subject will be eligible for inclusion in the study if he\u002Fshe fulfils the following criteria:\n\n1. Adult males or females aged 18 years or older.\n2. Subjects with hypovolemic shock admitted to the hospital with systolic blood pressure ≤ 90 mm Hg at presentation, Mean Arterial Pressor (MAP) ≤ 65 mm Hg and continue to receive standard treatment of shock (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the subject shall be the one used in that hospital.\n3. Blood lactate level indicative of hypovolemic shock with lactate level more than 2 mmol\u002FL.\n\nExclusion Criteria:\n\nA subject will not be eligible for inclusion in this study if he\u002Fshe meets any of the following exclusion criteria:\n\n1. Subject with illness clinically defined as septic shock (Procalcitonin plasma levels of ≥0.5 ng\u002FmL) or cardiogenic shock or neurogenic shock.\n2. Subject for whom an etiology for hypovolemic shock cannot be determined on initial evaluation.\n3. Hypovolemic shock due to traumatic brain injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.\n4. Patient with altered consciousness not due to hypovolemic shock.\n5. Subject with confirmed pregnancy.\n6. Cardiopulmonary resuscitation (CPR) before randomization.\n7. Presence of a do not resuscitate order.\n8. Patient is participating in another interventional study.\n9. Patients with systemic diseases which were already present before having trauma, such as: cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS.",{"count":162,"type":22},430,[25],"This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest. Shock is a life-threatening condition of circulatory failure. It is a state of cellular and tissue hypoxia due to reduced oxygen delivery and\u002For increased oxygen consumption or inadequate oxygen utilization. Shock most commonly occurs when there is circulatory failure leading to reduced tissue perfusion. There are four types of shock: distributive, cardiogenic, hypovolemic, and obstructive. However, these are not exclusive, and many patients with circulatory failure have a combination of more than one form of shock (multifactorial shock).",[86],{"date":167,"type":36},"2025-12-30",{"date":169,"type":22},"2026-02",{"date":171,"type":22},"2027-10",{"name":42,"class":43},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100366680","phase-2-pmz-1620-sovateltide-in-patients-of-acute-spinal-cord-injury-100366680","NCT04054414","PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury","A Prospective, Multicentric, Randomized, Double Blind, Saline Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Patients of Acute Spinal Cord Injury","Inclusion Criteria:\n\n1. Adult males or females aged between 18 and 75 years inclusive\n2. Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR)\n3. Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (excludes patients who are on ventilator)\n4. ISNCSCI Impairment Scale Grade \"B,\" \"C\" or \"D\" based upon first ISNCSCI evaluation after arrival to the hospital is classified as motor or sensory incomplete\n5. Willing and able to comply with the study Protocol\n6. Women must be of non-childbearing potential or surgically sterile or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control\n7. Able to receive the Investigational Drug within 48 hours of injury\n8. Neurological Level of Injury between C5-C8, T1-T12, L1-L5 and S1-S5 based upon first ISNCSCI evaluation after arrival to the hospital\n9. Patient with incomplete\u002Fpartial damage\u002Ftransaction as shown by CT or MRI scan\n10. Patients with any other chronic conditions, who are stable with appropriate treatment\n\nExclusion Criteria:\n\n1. Previous history related to spinal cord disease\n2. Patient on ventilator or requires ventilator\n3. Patient with pathological fracture of vertebral column\n4. Impairment Scale Grade \"A\" based upon first ISNCSCI assessment and classified as complete injury\n5. One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination\n6. Concomitant head injury with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)\n7. Females who are breastfeeding or have a positive urine pregnancy test\n8. Body mass index (BMI) of ≥35 kg\u002Fm2 at screening\n9. Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs\n10. Patient having rheumatoid arthritis\n11. The participant has a clinically significant cardiovascular disorder or an abnormal electrocardiogram (ECG) at the discretion of the investigator\n12. Pre-existent neurologic disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorder with hallucinations\u002Fdelusions\u002Fschizophrenia)\n13. Patients who are currently participating in a clinical trial with an investigational drug or investigational device\n14. Patients who, in the opinion of the investigator, are otherwise unsuitable for this study","75 Years",{"count":138,"type":22},[55],"This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury.",[185],"Acute Spinal Cord Injury",[118,187],"Neurogenesis","2025-07-01",{"date":190,"type":36},"2025-07-04",{"date":192,"type":36},"2019-01-10",{"date":194,"type":22},"2026-07",{"name":42,"class":43},5,""]