How can the findings of an open-label trial be used to support regulatory submissions?

Apr 8, 2014 ... Multicentre, Randomised, Open-Label Trial To Compare Efficacy And Tolerance Of Prednisone And IVIG In Patients With CIDP On A One Year Follow Up ... Mar 8, 2021 ... The findings show that treating COVID-19 patients with an injection of 100 milligrams of anakinra for ten days may be an effective approach because the drug ... In an open-label trial the identity of treatment is known to all. The double-blind trial is the optimal approach. This requires that the treatments to be ... Conclusions: These data suggest that ligands for the gamma subtype of PPARs may represent a novel therapy for ulcerative colitis. A double blind, placebo- ... Acthar® Gel (repository corticotropin injection) is FDA-approved for treatment of acute episodes or exacerbation of PsA, but no clinical trials have ... Search Clinical Trials ; GOG-3112 (DESTINY-Ovarian01) · A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Versus ... Nov 2, 2023 ... Interim Analyses from the Beacon Trial: A Phase 2, Randomized, Open-Label Trial of Bitopertin in Erythropoietic Protoporphyria. Gayle Ross ... The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure ... Triheptanoin dramatically reduced by 90% the number of non-epileptic paroxysmal manifestations over 2 months in GLUT1-DS and improved patient's brain energy ... Nov 9, 2023 ... Conclusions. These findings suggest that prescribed medical cannabis may have minimal acute impact on cognitive function among patients with ...