Primary objective of the multinational, double-blind, placebo-controlled trial is to evaluate the efficacy of eculizumab ⦠Eculizumab has recently been approved for use in NMO in both the US and Europe. A clinical trial of eculizumab for patients with refractory NMO is currently recruiting patients , following the report of successful results from Pittock et al. A study to evaluate the safety and efficacy of Eculizumab in patients with relapsing NMO Clinical Trial is currently Not Recruiting at University of Pennsylvania (UPenn), Philadelphia, PA US Clinical Trials Registry; Clinical Trials Nct Page; A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) A significant effect on the time to first adjudicated On-trial Relapse was observed for eculizumab compared with placebo (relative risk reduction 94%; hazard ratio ⦠1. Intervention Name: eculizumab. Patient has given written informed consent Key Exclusion Criteria: 1. During the development of eculizumab, there has been a change in classification of the designated orphan condition. The most frequently reported adverse reactions in the NMOSD placebo- controlled trial (â¥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion 6.1) To report SUSPECTED ADVERSE ⦠In a recently reported investigator initiated trial, eculizumab reduced the annualized relapse rate (ARR) in a highly relapsing NMO patient population from a median of 3 relapses per year to zero relapses per year (p < 0.0001). In the PREVENT trial, people with NMOSD (also called NMO) and AQP4-IgG experienced a 94% reduction in relapse risk with eculizumab (Soliris) compared with placebo. Experimental: Eculizumab. clinical trial (â¥10%) is: musculoskeletal pain (6.1). Oxford and Liverpool are the two centres for this trial. The Prevention of Relapses and Evaluation of Eculizumab in NMOSD Treatment (PREVENT) study was a multinational, double-blind, parallel-group Phase 3 time-to-event study that assessed the efficacy and safety of Soliris ® (eculizumab) compared to placebo for the treatment of patients with anti-aquaporin-4 (AQP4) ⦠In this phase 3 double-blind trial, patients with NMO-SD and AQP4 seropositivity, with an EDSS score of 7.0 or less, were randomly assigned (2:1) treatment with eculizumab (IV, every week for the first four doses, followed by ⦠In the PREVENT clinical trial of Soliris ® (eculizumab) 143 adults with anti-AQP4 antibody-positive NMOSD enrolled (96 received Soliris, 47 received placebo) The duration of the trial was 3 years; Immunosuppressive therapies were allowed, though some people only received Soliris Economics. The trial was stopped after 23 of the 24 prespecified adjudicated relapses, as decided by an independent panel, given that it wasnât known when the last event would occur. A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) Alexion Pharmaceuticals 26 June 2019 First Received: June 20, 2013 | Last Updated: June 26, 2019 A clinical trial of eculizumab for patients with refractory NMO is currently recruiting patients 6, following the report of successful results from Pittock et al. Here, we report the case of a patient with NMO and tuberculosis, treated with eculizumab. Most Read. As of 2014 there was insufficient evidence to show that eculizumab therapy improves life expectancy for people with paroxysmal nocturnal hemoglobinuria, and the cost-effectiveness was poor. This study is add-on design, so patients will be able to continue with other NMO therapy. Alexion Pharmaceuticals today announced the initiation of a single, multinational, placebo-controlled trial to evaluate the safety and efficacy of eculizumab in patients... | January 21, 2021 A maximum of 132 patients will be enrolled in the ECU-NMO-301 trial. US-based Alexion Pharmaceuticals has started a single, multinational, placebo-controlled trial designed to assess the safety and efficacy of eculizumab (Soliris) Alexion begins multinational registration trials of eculizumab to treat NMO and MG | Pharma Advancement Time Frame: From first dose to study completion (maximum of 4 ⦠Trial closed and results pending. 7. Biological: eculizumab; Arms, Groups and Cohorts. A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) The primary objective of the study is to assess the efficacy and safety of eculizumab In NMO, though there have yet to be any approved monoclonal antibodies, rituximab, anti-complement C5 (eculizumab), anti-IL-6 receptor (tocilizumab), anti-CD19 (inebilizumab) and non-pathogenic anti-aquaporin 4 (aquaporumab) have been suggested to be effective, and some of these are now under clinical trials. indication: treatment of neuromyelitis optica (NMO) . Consequently, eculizumab may prove to be a therapeutic tool for other severe inflammatory disorders 5, including neuromyelitis optica (NMO). Eculizumab, a complement inhibitor, works by inhibiting the C5 protein in the terminal part of the complement cascade. The primary endpoint for Study ECU-NMO-301 was the time to first on-trial relapse as adjudicated by an independent committee who were blinded to treatment. International update: Global Covid cases pass 91.6 million â concerns raised over vaccine efficacy; Novavaxâs South African Phase IIb COVID-19 vaccine trial likely to reveal results within next fortnight, source says In the phase III clinical trial, eculizumab i s administered by intravenous (IV) infusion at 900mg weekly for the first 4 weeks, and then 1,200mg every 2 weeks thereafter. Clinical Trial Outcome Measures Primary Measures. Patients who complete the ECU-NMO-301 trial may potentially enter this extension trial. The pivotal phase III PREVENT trial, in patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica (NMO), met its primary endpoint of time to first adjudicated on-trial relapse, demonstrating that treatment with eculizumab reduced the risk of NMO relapse by 94.2% compared with placebo (p < 0.0001). . Eculizumab is a terminal complement inhibitor. Patients who enrolled in PREVENT will have 2 to 1 chance of receiving eculizumab versus placebo. Patient completed the ECU-NMO-301 trial 2. Participation eligibility Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Eculizumab was approved by the FDA for AQP4+ NMO in 2019, based on the results of the PREVENT trial. Biological: eculizumab; Inclusion criteria. US-based Alexion Pharmaceuticals has started a single, multinational, placebo-controlled trial designed to assess the safety and efficacy of eculizumab (Soliris) in patients with relapsing neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug; Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial This is an international trial. In summary, Eculizumab has been studied in a previous phase 2 trial in patients with relapsing NMO. Cite this: Anti-CD19 MAb Trial Halted Early forBenefit in NMO - Medscape - ⦠This phase 3 registrational trial is intended to confirm the safety and efficacy of eculizumab in the treatment of relapsing NMO. Evaluate the long-term safety of eculizumab in patients with relapsing NMO. In the phase 3 randomized, double-blind placebo controlled PREVENT trial, patients with NMOSD who were anti-AQP4 antibody positive were treated with eculizumab or a placebo. neuromyelitis optica(NMO). A Double Blind Trial to Evaluate the Safety and Efficacy of Eculizumab in Relapsing NMO Patients (PREVENT Study) Rochester, MN The primary objective of the study is to assess the efficacy and safety of eculizumab treatment as compared to placebo in relapsing NMO patients using a time to first relapse study design. Eculizumab intravenous infusion every two weeks. Phase 3 double blind trial to evaluate the safety and efficacy of eculizumab in relapsing NMO patients (PREVENT Study, Alexion Pharmaceuticals). The patients who completed the trial could enter an extension trial and receive open-label treatment with eculizumab. The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO. Arm Group Label: Eculizumab Other Name: Soliris Eligibility: Criteria: Key Inclusion Criteria: 1. This is an extension trial to the ECU-NMO-301 trial. Patient completed the ECU-NMO-301 trial; Patient has given written informed consent; Exclusion criteria. CHESHIRE, Conn.--(BUSINESS WIRE)-- Alexion Pharmaceuticals (Nasdaq:ALXN) today announced the initiation of a single, multinational, placebo-controlled trial to evaluate the safety and efficacy of eculizumab (Soliris ®) in patients with relapsing neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic ⦠Eculizumab is not approved for the treatment of NMO; it is considered to be experimental for use in patients with NMO. The report was approved by the Ethics Committee of Universidade Metropolitana ⦠Eculizumab inhibits the terminal complement protein C5, impeding the complement cascade at this point. Eculizumab is licensed in the EU for treatment of paroxysmal nocturnal currently haemoglobinuria and atypical haemolytic uremic ⦠Eculizumab, a humanized monoclonal antibody against the terminal complement component 5, was shown to significantly reduce the risk of NMOSD relapse in a Phase III placebo-controlled trial. On 21 Dec 2018, Alexion Europe SAS submitted an ODD amendment to align the designated orph an indication to the current classification, i.e. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial â¦
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