A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous prasinezumab in early-stage Parkinson's disease (PADOVA): Rationale, design, and baseline data.

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Title: A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous prasinezumab in early-stage Parkinson's disease (PADOVA): Rationale, design, and baseline data.
Authors: Nikolcheva T; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland. Electronic address: tania.nikolcheva@roche.com., Pagano G; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland; University of Exeter Medical School, London, UK., Pross N; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Simuni T; Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Marek K; Institute for Neurodegenerative Disorders, New Haven, CT, USA., Postuma RB; Department of Neurology, McGill University, and Montreal Neurological Institute, Montreal, Canada., Pavese N; Clinical Ageing Research Unit, Newcastle University, Newcastle upon Tyne, UK., Stocchi F; University San Raffaele Roma and the Institute for Research and Medical Care, IRCCS San Raffaele Pisana, Rome, Italy., Seppi K; Department of Neurology, Medical University Innsbruck, Innsbruck, Austria., Monnet A; Product Development Data Science, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Shariati N; Product Development Data Science, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Ricci B; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Rutten-Jacobs L; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Respondek G; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Kustermann T; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Taylor KI; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Trundell D; Product Development Data Science, Roche Products Ltd, UK., Fontoura P; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Doody R; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland; Genentech USA Inc., San Francisco, USA., Svoboda H; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland; Roche Diagnostics GmbH, Penzberg, Germany., Bonni A; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Corporate Authors: PADOVA Investigators and Prasinezumab Study Group
Source: Parkinsonism & related disorders [Parkinsonism Relat Disord] 2025 Mar; Vol. 132, pp. 107257. Date of Electronic Publication: 2024 Dec 29.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: Elsevier Science Country of Publication: England NLM ID: 9513583 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-5126 (Electronic) Linking ISSN: 13538020 NLM ISO Abbreviation: Parkinsonism Relat Disord Subsets: MEDLINE
Database: MEDLINE Ultimate
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PubType: Academic Journal
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  Data: A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous prasinezumab in early-stage Parkinson's disease (PADOVA): Rationale, design, and baseline data.
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  Data: <searchLink fieldCode="AU" term="%22Nikolcheva+T%22">Nikolcheva T</searchLink>; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland. Electronic address: tania.nikolcheva@roche.com.<br /><searchLink fieldCode="AU" term="%22Pagano+G%22">Pagano G</searchLink>; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland; University of Exeter Medical School, London, UK.<br /><searchLink fieldCode="AU" term="%22Pross+N%22">Pross N</searchLink>; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Simuni+T%22">Simuni T</searchLink>; Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.<br /><searchLink fieldCode="AU" term="%22Marek+K%22">Marek K</searchLink>; Institute for Neurodegenerative Disorders, New Haven, CT, USA.<br /><searchLink fieldCode="AU" term="%22Postuma+RB%22">Postuma RB</searchLink>; Department of Neurology, McGill University, and Montreal Neurological Institute, Montreal, Canada.<br /><searchLink fieldCode="AU" term="%22Pavese+N%22">Pavese N</searchLink>; Clinical Ageing Research Unit, Newcastle University, Newcastle upon Tyne, UK.<br /><searchLink fieldCode="AU" term="%22Stocchi+F%22">Stocchi F</searchLink>; University San Raffaele Roma and the Institute for Research and Medical Care, IRCCS San Raffaele Pisana, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Seppi+K%22">Seppi K</searchLink>; Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.<br /><searchLink fieldCode="AU" term="%22Monnet+A%22">Monnet A</searchLink>; Product Development Data Science, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Shariati+N%22">Shariati N</searchLink>; Product Development Data Science, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Ricci+B%22">Ricci B</searchLink>; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Rutten-Jacobs+L%22">Rutten-Jacobs L</searchLink>; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Respondek+G%22">Respondek G</searchLink>; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Kustermann+T%22">Kustermann T</searchLink>; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Taylor+KI%22">Taylor KI</searchLink>; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Trundell+D%22">Trundell D</searchLink>; Product Development Data Science, Roche Products Ltd, UK.<br /><searchLink fieldCode="AU" term="%22Fontoura+P%22">Fontoura P</searchLink>; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Doody+R%22">Doody R</searchLink>; Product Development Neurology, F. Hoffmann-La Roche Ltd, Basel, Switzerland; Genentech USA Inc., San Francisco, USA.<br /><searchLink fieldCode="AU" term="%22Svoboda+H%22">Svoboda H</searchLink>; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland; Roche Diagnostics GmbH, Penzberg, Germany.<br /><searchLink fieldCode="AU" term="%22Bonni+A%22">Bonni A</searchLink>; Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
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  Data: <searchLink fieldCode="CA" term="%22PADOVA+Investigators+and+Prasinezumab+Study+Group%22">PADOVA Investigators and Prasinezumab Study Group</searchLink>
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  Data: <searchLink fieldCode="JN" term="%229513583%22">Parkinsonism & related disorders</searchLink> [Parkinsonism Relat Disord] 2025 Mar; Vol. 132, pp. 107257. <i>Date of Electronic Publication: </i>2024 Dec 29.
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  Data: Journal Article; Clinical Trial Protocol
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Science%22">Elsevier Science </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>9513583 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1873-5126 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2213538020%22">13538020 </searchLink><i>NLM ISO Abbreviation: </i>Parkinsonism Relat Disord <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=39798255
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        Value: 10.1016/j.parkreldis.2024.107257
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        Text: English
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