"Edaravone" from_date:2012

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Edaravone Oral Suspension (Radicava) - Amyotrophic lateral sclerosis Return to Article DetailsEdaravone Oral Suspension (Radicava)

Edaravone Oral Suspension (Radicava) - Amyotrophic lateral sclerosis Return to Article DetailsEdaravone Oral Suspension (Radicava)

AMX0035 and Oral Edaravone for Amyotrophic Lateral Sclerosis ©Institute for Clinical and Economic Review, 2022 AMX0035 and Oral Edaravone for Amyotrophic Lateral Sclerosis Final Evidence Report September 13, 2022 Prepared for ©Institute for Clinical and Economic Review, 2022 Page i Final Evidence Report – Amyotrophic Lateral Sclerosis DATE OF PUBLICATION: September 13, 2022 How to cite this document: Makam AN, Suh K, Nikitin D, Carlson JJ, Richardson M, Mohammed R, McKenna A, Pearson SD, Rind DM. AMX0035 and Oral Edaravone for ALS; Final Evidence Report. Institute for Clinical and Economic Review, September 13, 2022. https://icer.org/assessment/amyotrophic-lateral-sclerosis-2022/#timeline Anil Makam served as the lead author for the report and wrote the background

Combined Selective Endovascular Brain Hypothermia with Edaravone Dexborneol versus Edaravone Dexborneol Alone for Endovascular Treatment in Acute Ischemic Stroke (SHE): Protocol for A Multicenter, Single-Blind, Randomized Controlled Study. Introduction Selective endovascular brain hypothermia has been proposed as a potential neuroprotective strategy, however, its effectiveness is still not well established. The primary objective of this trial is to investigate the efficacy and safety of selective endovascular brain hypothermia with Edaravone Dexborneol for endovascular treatment in acute ischemic stroke (AIS). Methods The SHE study is a multi-center, single-blind, randomized controlled clinical trial. Patients with acute anterior circulation ischemic stroke who received endovascular treatment

Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial Sublingual edaravone dexborneol, which can rapidly diffuse and be absorbed through the oral mucosa after sublingual exposure, is a multitarget brain cytoprotection composed of antioxidant and anti-inflammatory ingredients edaravone and dexborneol. To investigate the efficacy and safety of sublingual edaravone dexborneol on 90-day functional outcome in patients with acute ischemic stroke (AIS). This was a double-blind, placebo-controlled, multicenter, parallel-group, phase 3 randomized clinical trial conducted from June 28, 2021, to August 10, 2022, with 90-day follow-up. Participants were recruited from 33 centers in China. Patients randomly assigned to treatment groups were

Edaravone (Radicava) - for the treatment of amyotrophic lateral sclerosis Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here: 1

Association between edaravone use and activities of daily living in older patients with atherothrombotic stroke: an observational study using Japanese real-world data. Edaravone is marketed in nine countries, although only Japan has approved edaravone for improvement of neurological symptom, disability of activities of daily living (ADL), and functional disability associated with acute stroke . This study aimed to elucidate the association of edaravone use with ADL using real-world data of older patients with atherothrombotic stroke. This retrospective observational research using the Medical Data Vision database in Japan included patients aged 65 years and older who had acute ischemic stroke of the atherothrombotic subtype. Primary outcome was ADL improvement defined as change in Barthel Index

Cost-effectiveness of edaravone dexborneol versus dl-3-n-butylphthalide for the treatment of acute ischemic stroke: a Chinese health care perspective. Edaravone dexborneol and dl-3-n-butylphthalide are two innovative brain cytoprotective drugs from China that have been approved and widely prescribed for acute ischemic stroke, and the cost of the two drugs are partially paid by the Chinese medical insurance system. This study aimed to investigate and compare the cost-effectiveness of edaravone dexborneol versus dl-3-n-butylphthalide for acute ischemic stroke from the Chinese healthcare system's perspective. A model combining a short-term decision tree model with 90 days and a long-term Markov model with a life-time horizon (40 years) was developed to simulate the cost-effectiveness

Clinical study of Edaravone Dexborneol combined with Tirofiban in treatment of Acute Cerebral Infarction. To explore the clinical efficacy and safety of edaravone dexborneol combined with tirofiban in the treatment of acute cerebral infarction. This is a retrospective study. A total of 80 patients with acute cerebral infarction (ACI) treated in Cangzhou People's Hospital from March 2018 group(0.05); Vmin and Qmin levels increased in both groups, which was more obvious in the intervention group(0.05); CRP and IL-6 levels reduced in both groups, which was more remarkable in the intervention group(0.05). The incidences of relevant adverse drug reactions presented no differences between the two groups during treatment(0.05). Edaravone dexborneol combined with tirofiban in the treatment

Effects of edaravone dexborneol on functional outcome and inflammatory response in patients with acute ischemic stroke. Edaravone dexborneol has been reported as an effective neuroprotective agent in the treatment of acute ischemic stroke (AIS). This study aimed at investigating the impact of edaravone dexborneol on functional outcomes and systematic inflammatory response in AIS patient. All participants were recruited from the AISRNA study (registered 21/11/2019, NCT04175691 [ClinicalTrials.gov]) between January 2022 and December 2022. The AIS patients were divided into two groups based on whether they received the treatment of edaravone dexborneol (37.5 mg/12 hours, IV) within 48 h after stroke onset. Inflammatory response was determined by detecting levels of cytokines (interleukin-2 [IL-2

Influences of Butylphthalide Injection in Combination with Edaravone on Clinical Efficacy and Cytokines in Elderly Acute Cerebral Infarction Patients. Acute cerebral infarction threatens human health and life safety. The edaravone is a new antioxidant and hydroxyl radical scavenger, which is used in the treatment of cardiovascular diseases. However, long-term use of edaravone is prone to drug resistance, resulting in limited therapeutic effect. Butylphthalein can improve collateral circulation, protect the integrity of vascular endothelial cells, improve vasospasm, increase blood perfusion in the ischemic area of brain tissue, and promote the recovery of cerebral nerve function. To measure the influences of butylphthalide injection in combination with edaravone on clinical efficacy

Efficacy of Radicava® IV (intravenous edaravone) in subjects with differing trajectories of disease progression in amyotrophic lateral sclerosis: Use of a novel statistical approach for post hoc analysis of a pivotal phase 3 clinical trial. Subjects with amyotrophic lateral sclerosis (ALS) treated with Radicava® (edaravone) IV (intravenous; Mitsubishi Tanabe Pharma America [MTPA], hereafter "MTPA IV edaravone") in Study MCI186-19 had a significantly slower physical functional decline vs placebo-treated subjects as measured by the revised ALS Functional Rating Scale (ALSFRS-R) and analyzed by the linear mixed model for repeated measures (MMRM). This Study 19 post hoc analysis of MTPA IV edaravone-treated and placebo-treated subjects evaluated linear and nonlinear latent class mixed models

Edaravone (Radicava) - To treat patients with amyotrophic lateral sclerosis (ALS) Radicava (edaravone) Injection * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDARadicava (edaravone) Injection * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print RadicavaCompany: Mitsubishi Tanabe Pharma Development America, Inc.Application

Retracted: Edaravone Combined with Clopidogrel Is Beneficial to Improve Efficacy, Neurological Impairment, and Life Function in Acute Cerebral Infarction Patients. [This retracts the article DOI: 10.1155/2021/8030521.].

Efficacy of Butylphthalide in Combination with Edaravone in the Treatment of Acute Ischemic Stroke and the Effect on Serum Inflammatory Factors. To investigate the efficacy of butylphthalide combined with edaravone in the treatment of acute ischemic stroke and the effect on serum inflammatory factors. One hundred and sixty patients with acute ischemic stroke who attended the neurovascular intervention department of our hospital from May 2020 to June 2022 were enrolled as study subjects for prospective analysis and were equally divided into a control group and an experimental group using the random number table method, with 80 cases in each group. The control group was treated with edaravone injection, while the experimental group was treated with butylphthalide combined with edaravone

Edaravone Administered Orally and Via Nasogastric Tube in Healthy Adults: A Comparative Bioavailability Phase 1 Study. Intravenous edaravone is used to treat patients with amyotrophic lateral sclerosis. This randomized, open-label, two-way crossover, single-dose phase 1 study compared the relative bioavailability of a newly developed edaravone oral suspension when administered orally and via a nasogastric tube (NGT) as a model of percutaneous endoscopic gastrostomy tube administration in healthy adult subjects. Thirty-six subjects were randomly assigned to one of two groups, with 18 per group. Blood was collected pre- and post-dose for pharmacokinetic assessments; safety was evaluated. Plasma concentration-time profiles of unchanged edaravone were similar between administration routes

Efficacy and safety of short-term edaravone or nerve growth factor add-on therapy for alcohol-related brain damage: A multi-centre randomised control trial. To measure the therapeutic effect of an anti-oxidant, edaravone (EDV), or neurotrophic treatment with nerve growth factor (NGF) as an add-on treatment for alcohol-related brain damage (ARBD). Multi-centre, randomised, single-blinded ). During the follow-up to 24 weeks, EDV add-on treatment improved the composite score of executive cognitive function and DST-R score better than TAU (both P < 0.01). Craving for alcohol was relieved in all three groups. No severe adverse events were observed. The short-term addition of edaravone to supplementary therapy treatment for alcohol-related brain damage (ARBD) improved executive cognitive

Clinical Efficacy and Short-Term Prognosis of Butylphthalide and Sodium Chloride Injection Compared to Edaravone in the Treatment of Patients with Acute Stroke. Acute stroke is characterized by rapid progression, high mortality, and disability rates, making it a significant focus in clinical research. Brain-protective agents, such as butylphthalide and edaravone, have emerged as important therapeutic options for acute stroke. This study aimed to explore how butylphthalide and edaravone promote healing in acute stroke, drawing on relevant data, literature, clinical experience, and personal concepts. The study design involves a narrative review, which comprehensively explores the pathogenesis of stroke by referencing relevant data and literature. Clinical experience and personal insights were

The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis. Intravenous (IV) edaravone is a US Food and Drug Administration-approved treatment for amyotrophic lateral sclerosis (ALS), shown in clinical trials to slow physical functional decline. In this study we compared the effect of IV edaravone (edaravone-first group) versus placebo followed by IV edaravone (placebo-first group) on survival and additional milestone events. This work is a post hoc analysis of Study 19/MCI186-19, which was a randomized, placebo-controlled, phase 3 study investigating IV edaravone versus placebo. Study 19 and its 24-week extension have been described previously (NCT01492686). Edaravone-first