Health Condition 1: I635- Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
Conditions
Interventions
Intervention1: Sovateltide injection containing 30 µg
: Sovateltide(Sovateltide + Standard treatment), It is a lyophilized product Sovateltide injection containing 30 µg of Sovateltide in a 5.0 mL
Sponsors
Pharmazz India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males or females aged 18 years through 78 years (have not had their 79th birthday). 2. Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure. 3. 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. 4. 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 5. The patient is 6. Reasonable expectation of availability to receive the full Sovateltide course of therapy and to be available for subsequent follow-up visits.
Exclusion criteria
Exclusion criteria: 1.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. 2. 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 more than or equal to 2). 3. 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. 5. Confounding pre-existing neurological or psychiatric disease. 6. Concurrent participation in any other therapeutic clinical trial. 7.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any adverse events (AEs) or serious adverse events (SAEs)Timepoint: within 90 days post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of cerebral ischemic stroke patients with a change in modified Rankin Scale (mRS) score of more than & equal to 2Timepoint: at day 90 post-randomization;The proportion of cerebral ischemic stroke patients with a change in National Institute of Health Stroke Scale (NIHSS) score more than & equal to 6Timepoint: at day 90 post-randomization;The proportion of cerebral ischemic stroke patients with a Barthel index (BI) score more than & equal to 60Timepoint: at day 90 post-randomization;Change in NIHSSTimepoint: at day 90 post-randomization;Change in mRSTimepoint: at day 90 post-randomization;Change in BITimepoint: at day 90 post-randomization;Change in Quality-of-life as assessed by EuroQol-EQ-5DTimepoint: at day 90 post-randomization;Change in Stroke-Specific Quality of Life (SSQOL)Timepoint: at day 90 post randomization;The proportion of patients with recurrent cerebral ischemic strokeTimepoint: within 90 days post randomization,;Number of deathsTimepoint: within 90 days post-randomization;proportion of patients with radiographic or symptomatic Intra Cerebral Hemorrhage (ICH)Timepoint: within 24 (± 6) hours of randomization;Change in Montreal Cognitive Assessment (MoCA) scoreTimepoint: at day 90 post-randomization;Compare Alberta Stroke Program Early CT (ASPECT) Score for stroke severity & identify sites of ischemic lesions.Timepoint: at baseline | — |
Countries
India
Contacts
Public ContactDr Dharmesh Shah
Pharmazz India Private Limited
Outcome results
None listed