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Title of Journal: J Neural Transm

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Abbravation: Journal of Neural Transmission

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Publisher

Springer Vienna

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DOI

10.1016/j.alit.2016.12.003

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ISSN

1435-1463

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The PROMESAprotocol progression rate of multiple

Authors: Johannes Levin Sylvia Maaß Madeleine Schuberth Gesine Respondek Friedemann Paul Ullrich Mansmann Wolfgang H Oertel Stefan Lorenzl Florian Krismer Klaus Seppi Werner Poewe Gregor Wenning The PROMESA study group Armin Giese Kai Bötzel Günter Höglinger
Publish Date: 2016/01/25
Volume: 123, Issue: 4, Pages: 439-445
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Abstract

Formation of toxic αsynuclein oligomers appears to be a key underlying pathological mechanism of synucleinopathies such as Parkinson’s disease or multiple system atrophy MSA Given that Epigallocatechingallate has been shown to inhibit αsynuclein aggregation it might represent a causal treatment option Therefore we set out to evaluate the safety tolerability and a potential diseasemodifying effect of Epigallocatechingallate in patients with MSA after 48 weeks of treatment Power calculation was performed on existing natural history data on the progression of the Unified MSA Rating Scale as primary readout parameter To assess the efficacy of Epigallocatechingallate versus placebo regarding the reduction of disease progression measured during the study period 80  power 5  p level 50  effect size 36 patients per group are needed Considering a dropout rate of 20  a total of 86 patients will be recruited in this multicentre study These data provide a solid rationale to investigate whether supplementation of Epigallocatechingallate can delay the progression of the MSArelated disabilityThis study was funded by the ParkinsonFonds Deutschland gGmbH deutsche Parkinson Vereinigung Deutsche Stiftung Neurologie Arthur ArnsteinStiftung Berlin Bischof Dr Karl Golser Stiftung LüneburgStiftung für Parkinsonforschung Deutsches Zentrum für Neurodegenerative Erkrankungen DZNE Standort MünchenD Berg MD Site PI Universitätsklinikum Tübingen J Claßen MD Site PI Universitätsklinikum Leipzig G Ebersbach MD Site PI Kliniken Beelitz GmbH K Eggert MD Site PI Universitätsklinikum Marburg G Höglinger MD Site PI Universitätsklinikum München TU J Kassubek MD Site PI Universitätsklinikum Ulm J Levin MD Site PI Universitätsklinikum München LMU A Lipp MD Site PI Universitätsklinikum Charité Berlin M Löhle MD Site PI Universitätsklinikum Dresden B Mollenhauer MD Site PI ParacelsusElenaKlinik Kassel A Münchau MD Site PI Universitätsklinikum SchleswigHolstein Campus Lübeck M Südmeyer MD Site PI Universitätsklinikum Düsseldorf C Blankenstein MD head of PROMESAmonitoring MSZ Universitätsklinikum München TU C Eberhardt head of PROMESAclinical supplies Universitätsklinikum Charité Berlin B ErtlWagner MD head of PROMESAneuroimaging LMU München A Giese MD head of PROMESAneuropathology LMU München H Heise PhD head of PROMESAproject management Universitätsklinikum München LMU I Ricard PhD head of PROMESAdata management Universitätsklinikum München LMU S Zedler PhD head of PROMESAsafety management Universitätsklinikum München LMU K Bötzel MD S Lorenzl MD J Schwarz MD F Paul MD A Gerbes MD PROMESAdata safety monitoring committee Universitätsklinikum München LMU Klinik Haag Universitätsklinikum Charité Berlin

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