{"id":5581,"date":"2021-03-09T07:30:00","date_gmt":"2021-03-09T07:30:00","guid":{"rendered":"https:\/\/irlab.se\/de-forsta-europeiska-patienterna-har-doserats-i-irlabs-fas-iib-iii-studie-med-mesdopetam\/"},"modified":"2021-03-09T07:30:00","modified_gmt":"2021-03-09T07:30:00","slug":"de-forsta-europeiska-patienterna-har-doserats-i-irlabs-fas-iib-iii-studie-med-mesdopetam","status":"publish","type":"post","link":"https:\/\/irlab.se\/sv\/de-forsta-europeiska-patienterna-har-doserats-i-irlabs-fas-iib-iii-studie-med-mesdopetam\/","title":{"rendered":"De f\u00f6rsta europeiska patienterna har doserats i IRLAB:s Fas IIb\/III-studie med mesdopetam"},"content":{"rendered":"<p><span><span><span>&nbsp;<\/span><\/span><\/span><span><span><span><span><span><span>\u201dDen kliniska Fas IIb\/III-studien p\u00e5g\u00e5r nu p\u00e5 tv\u00e5 kontinenter, b\u00e5de i USA och i Europa. Det \u00e4r gl\u00e4djande att europeiska kliniker nu har b\u00f6rjat rekrytera och behandla patienter i denna multinationella studie och att rekryteringshastigheten bibeh\u00e5lls. Fler l\u00e4nder kommer att f\u00f6lja under de kommande m\u00e5naderna,\u201d s\u00e4ger Nicholas Waters, VD p\u00e5 IRLAB.<\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p><span><span><span><span><span><span>Mesdopetam utv\u00e4rderas nu i en internationell klinisk Fas IIb\/III-studie f\u00f6r behandling av levodopa-inducerade dyskinesier vid Parkinsons sjukdom, PD-LIDs. Den p\u00e5g\u00e5ende studien \u00e4r randomiserad, dubbelblind och placebo-kontrollerad och syftar till att utv\u00e4rdera effekten av behandlingen i patienter med Parkinsons sjukdom som \u00e4r drabbade av dagliga besv\u00e4rande dyskinesier. Det prim\u00e4ra utfallsm\u00e5ttet \u00e4r f\u00f6r\u00e4ndringen av den totala tid av dagen patienten har god r\u00f6relsef\u00f6rm\u00e5ga utan besv\u00e4rande dyskinesier (\u201cgood ON\u201d), m\u00e4tt med patientdagbok. Studien \u00e4r planerad att inkludera cirka 140 patienter f\u00f6rdelade p\u00e5 fyra grupper med cirka 35 patienter i varje grupp, tre grupper med olika dosniv\u00e5er av mesdopetam och en placebogrupp. Varje patient kommer att behandlas under tre m\u00e5nader. Strategin f\u00f6r den kliniska Fas IIb\/III-studien har utvecklats i samarbete med regulatoriska och kliniska experter baserat p\u00e5 resultaten fr\u00e5n IRLAB:s framg\u00e5ngsrika studier med mesdopetam i Fas I, Fas Ib och Fas IIa. <\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p><span><span><span>Patientrekryteringen f\u00f6r Fas IIb\/III-studien initierades i USA efter att IRLAB erh\u00f6ll ett IND-godk\u00e4nnande av den amerikanska l\u00e4kemedelsmyndigheten FDA i november 2020. Det f\u00f6rsta motsvarande myndighetsgodk\u00e4nnandet i Europa erh\u00f6lls i februari 2021. De parallella ans\u00f6kningsprocesserna till regulatoriska myndigheter och etikkommitt\u00e9er i samtliga utvalda europeiska l\u00e4nder samt Israel har slutf\u00f6rts enligt plan. <\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>IRLAB (Nasdaq Stockholm: IRLAB A) meddelade idag att de f\u00f6rsta europeiska patienterna har doserats i den kliniska Fas IIb\/III-studien med mesdopetam. Regulatoriska myndigheter runt om Europa har godk\u00e4nt studien och Polen \u00e4r det f\u00f6rsta europeiska landet d\u00e4r behandling med mesdopetam har inletts.<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-5581","post","type-post","status-publish","format-standard","hentry","category-pressmeddelande-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>De f\u00f6rsta europeiska patienterna har doserats i IRLAB:s Fas IIb\/III-studie med mesdopetam - IRLAB<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/irlab.se\/sv\/de-forsta-europeiska-patienterna-har-doserats-i-irlabs-fas-iib-iii-studie-med-mesdopetam\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"De f\u00f6rsta europeiska patienterna har doserats i IRLAB:s Fas IIb\/III-studie med mesdopetam - IRLAB\" \/>\n<meta property=\"og:description\" content=\"IRLAB (Nasdaq Stockholm: IRLAB A) meddelade idag att de f\u00f6rsta europeiska patienterna har doserats i den kliniska Fas IIb\/III-studien med mesdopetam. 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