Effect of RNS60 in amyotrophic lateral sclerosis: a phase II multicentre, randomized, double-blind, placebo-controlled trial
- Beghi E.
- Pupillo E.
- Bianchi E.
- Bonetto V.
- Luotti S.
- Pasetto L.
- Bendotti C.
- Tortarolo M.
- Sironi F.
- Camporeale L.
- Sherman A. V.
- Paganoni S.
- Scognamiglio A.
- De Marchi F.
- Bongioanni P.
- DelCarratore R.
- Caponnetto C.
- Diamanti L.
- Martinelli D.
- Calvo A.
- Filosto M.
- Padovani A.
- Piccinelli S.
- Ricci C.
- Dalla Giacoma S.
- DeAngelis N.
- Inghilleri M.
- Spataro R.
- LaBella V.
- Logroscino G.
- Lunetta C.
- Tarlarini C.
- Mandrioli J.
- Martinelli I.
- Simonini C.
- Zucchi E.
- Monsurro M. R.
- Ricciardi D.
- Trojsi F.
- Riva N.
- Filippi M.
- Simone I. L.
- Soraru G.
- Spera C.
- Florio L.
- Messina S.
- Russo M.
- Siciliano G.
- Conte A.
- Saddi M. V.
- Carboni N.
- Mazzini L.
- Enia G.
- Zucchella A.
- Pinzani L.
- De Giorgi L.
- Nicoletti C.
- Semprucci E.
- Davide Arippol E.
- Giussani G.
- Graziani M.
- Ferrari C.
- Cantello R.
- Bersano E.
- Dolciotti C.
- Masciandaro S. M.
- Da Prato I.
- Cabona C.
- Meo G.
- Ceroni M.
- Dal Fabbro B.
- Chio A.
- Moglia C.
- Manera U.
- Fuda G.
- Casale F.
- De Marco G.
- Salamone P.
- Giannini F.
- Bocci S.
- Ceccanti M.
- Cambieri C.
- Libonati L.
- Moret F.
- Frasca V.
- Coletti T.
- Tortelli R.
- Capozzo R.
- Gerardi F.
- Sansone V.
- Fini N.
- Gianferrari G.
- Gessani A.
- Falzone Y.
- Schito P.
- Pozzi L.
- Domi T.
- D'Errico E.
- Morea A.
- Milella G.
- Gizzi M.
- Paci F.
- Ferracchiato S.
- Zarrelli M.
- Desina N.
- Govoni A.
- Schirinzi E.
- Simoncini C.
- Sabatelli M.
- Bernardo D.
- Bisogni G.
- Piras G.
- Monne M.
- Manca E.
DOIAbstract
Background and purpose: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. RNS60 is an immunomodulatory and neuroprotective investigational product that has shown efficacy in animal models of ALS and other neurodegenerative diseases. Its administration has been safe and well tolerated in ALS subjects in previous early phase trials. Methods: This was a phase II, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial. Participants diagnosed with definite, probable or probable laboratory-supported ALS were assigned to receive RNS60 or placebo administered for 24 weeks intravenously (375 ml) once a week and via nebulization (4 ml/day) on non-infusion days, followed b...
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