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- Check4 days agoChange DetectedThe study has expanded to include 50 locations, and the website has been updated to version 2.10.0, replacing the previous version 2.9.7.SummaryDifference0.3%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Placebo Comparator : Placebo Drug vehicle only Drug : Placebo Placebo Comparator: Placebo Other Names: Drug vehicle only Experimental : Nerinetide (NA-1), 2.6 mg/kg Drug : Nerinetide (NA-1), 2.6 mg/kg Single intravenous infusion of nerinetide over 10 ± 1 minutes Other Names: NA-1 Primary Outcome Measures Outcome Measure Measure Description Time Frame Number of Subjects With mRS Score of 0 to 2 Overall number of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS. The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death. 90 Days Secondary Outcome Measures Outcome Measure Measure Description Time Frame Number of Subjects With NIHSS Score of 0 to 2 Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating. The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. 90 Days or the last rating Mortality Rate Mortality rate, as defined by event rate (%) for mortality over the 90-day study period 90 Days Keywords Provided by NoNO Inc. Acute Ischemic Stroke Endovascular Thrombectomy Neuroprotection Tat-NR2B9c NA-1 Nerinetide Additional Relevant MeSH Terms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Stroke Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Study Documents Provided by NoNO Inc. Study Protocol [ PDF , 1.18MB, 2019-02-19 ] Statistical Analysis Plan [ PDF , 0.52MB, 2019-05-09 ] Revision: v2.9.1'SummaryDifference14%
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