{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T23:23:56Z","timestamp":1771457036734,"version":"3.50.1"},"reference-count":45,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2021,1,16]],"date-time":"2021-01-16T00:00:00Z","timestamp":1610755200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Duchenne Parent Project, Italy","award":["000"],"award-info":[{"award-number":["000"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brain Sciences"],"abstract":"<jats:p>Flavocoxid is a blended extract containing baicalin and catechin with potent antioxidant and anti-inflammatory properties due to the inhibition of the cyclooxygenase (COX) and 5-lipoxygenase (5-LOX) enzymes, nuclear factor-\u03baB (NF-\u03baB), tumor necrosis factor (TNF)-alpha, and the mitogen-activated protein kinases (MAPKs) pathways. This phase 1\/2 study was designed to assess the safety and tolerability of flavocoxid in patients with Duchenne muscular dystrophy (DMD). Thirty-four patients were recruited: 17 were treated with flavocoxid at an oral dose of 250 or 500 mg, according to body weight, for one year; 17 did not receive flavocoxid and served as controls. The treatment was well tolerated and nobody dropped out. Flavocoxid induced a significant reduction in serum interleukin (IL)-1 beta and TNF-alpha only in the group of DMD boys on add-on therapy (flavocoxid added to steroids for at least six months). The decrease in IL-1 beta was higher in younger boys. The serum H2O2 concentrations significantly decreased in patients treated with flavocoxid alone with a secondary reduction of serum glutathione peroxidase (GPx) levels, especially in younger boys. The exploratory outcome measures failed to show significant effects but there was a trend showing that the younger boys who received treatment were faster at performing the Gowers\u2019 maneuver, while the older boys who received treatment were faster at doing the 10-m walk test (10MWT). Therefore, a double-blind, placebo-controlled study for at least two\/three years is warranted to verify flavocoxid as a steroid substitute or as add-on therapy to steroids.<\/jats:p>","DOI":"10.3390\/brainsci11010115","type":"journal-article","created":{"date-parts":[[2021,1,18]],"date-time":"2021-01-18T05:17:34Z","timestamp":1610947054000},"page":"115","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A Phase 1\/2 Study of Flavocoxid, an Oral NF-\u03baB Inhibitor, in Duchenne Muscular Dystrophy"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4190-8042","authenticated-orcid":false,"given":"Gian Luca","family":"Vita","sequence":"first","affiliation":[{"name":"Nemo Sud Clinical Centre for Neuromuscular Disorders, Messina University Hospital, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7408-5989","authenticated-orcid":false,"given":"Maria","family":"Sframeli","sequence":"additional","affiliation":[{"name":"Nemo Sud Clinical Centre for Neuromuscular Disorders, Messina University Hospital, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norma","family":"Licata","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandra","family":"Bitto","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Romeo","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca","family":"Frisone","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annamaria","family":"Ciranni","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4187-2265","authenticated-orcid":false,"given":"Giovanni","family":"Pallio","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Federica","family":"Mannino","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M\u2019Hammed","family":"Aguennouz","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"},{"name":"Faculty of Medicine, Mohammed VI University of Health Sciences, Cheikh Khalifa Ibn Zayed Hospital, Bd. Mohammed Ta\u00efeb Naciri, Commune Hay Hassani, Casablanca 82 403, Morocco"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2543-6356","authenticated-orcid":false,"given":"Carmelo","family":"Rodolico","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Squadrito","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Toscano","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sonia","family":"Messina","sequence":"additional","affiliation":[{"name":"Nemo Sud Clinical Centre for Neuromuscular Disorders, Messina University Hospital, Via C. Valeria 1, 98125 Messina, Italy"},{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. Valeria 1, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5204-7826","authenticated-orcid":false,"given":"Giuseppe","family":"Vita","sequence":"additional","affiliation":[{"name":"Nemo Sud Clinical Centre for Neuromuscular Disorders, Messina University Hospital, Via C. Valeria 1, 98125 Messina, Italy"},{"name":"Department of Clinical and Experimental Medicine, University of Messina, Via C. 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