Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial.
Angelo Antonini,Lars Bauer,Elisabeth Dohin,Wolfgang H. Oertel,O. Rascol,Heinz Reichmann,Miriam Schmid,P. Singh,Eduard Tolosa,K. Ray Chaudhuri +9 more
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TLDR
This is the first randomized controlled trial to use the NMS Scale (NMSS) as a primary outcome to assess treatment effects on NMS in PD.Abstract:
Background and purpose
Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality of life. This is the first randomized controlled trial to use the NMS Scale (NMSS) as a primary outcome to assess treatment effects on NMS in PD.
Methods
In this double-blind trial (NCT01300819), patients with PD and a total NMSS score ≥40 were randomized (2:1) to rotigotine or placebo, titrated over 1–7 weeks to optimal dose (≤8 mg/24 h for patients not receiving levodopa, ≤16 mg/24 h for patients receiving levodopa), maintained for 12 weeks. The primary outcome was change in NMSS total score from baseline to end of maintenance. Secondary outcomes were the nine NMSS domains, Unified Parkinson's Disease Rating Scale (UPDRS) III (motor) and the 39-item Parkinson's Disease Questionnaire (PDQ-39).
Results
In total, 283/349 (81.1%) randomized patients completed the trial; 211 rotigotine and 122 placebo were included in the full analysis set. The NMSS total score decreased by 23 (rotigotine) and 19 (placebo) points; the treatment difference was not statistically significant (−3.58; 95% confidence interval −8.43, 1.26; P = 0.147). Numerically greater than placebo improvements were detected in the ‘mood/apathy’ and ‘miscellaneous’ NMSS domains (P < 0.05). Treatment differences in UPDRS III (−2.60; −4.27, −0.92; P = 0.002) and PDQ-39 (−2.79; −5.21, −0.37; P = 0.024) favoured rotigotine. Adverse events reported more frequently with rotigotine were nausea, application site reactions, somnolence and headache.
Conclusions
Rotigotine improvement in the multi-domain NMSS total score was not superior to placebo. A different sensitivity of individual NMSS domains to dopaminergic therapy and a large placebo effect may have contributed to these findings.read more
Citations
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Journal ArticleDOI
Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence-based medicine review
Klaus Seppi,K. Ray Chaudhuri,Miguel Coelho,Susan H. Fox,Regina Katzenschlager,Santiago Perez Lloret,Daniel Weintraub,Daniel Weintraub,Cristina Sampaio,Cristina Sampaio +9 more
TL;DR: To update evidence‐based medicine recommendations for treating nonmotor symptoms in Parkinson's disease, the World Health Organization (WHO) selected Austria as a preferred destination for research and clinical trials.
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Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry.
Angelo Antonini,Werner Poewe,K. Ray Chaudhuri,Robert Jech,Barbara A. Pickut,Zvezdan Pirtošek,József Attila Szász,Francesc Valldeoriola,Christian Winkler,Lars Bergmann,Ashley Yegin,Koray Onuk,David,Per Odin,Ene Amalia,Guy Arnold,Ovidiu Bajenaru,Bruno Bergmans,Kari Anne Bjørnarå,Jeff Blackie,Matthias Bode,Paul Bourgeois,Stephan Bohlhalter,Ioan Buraga,Pierre R. Burkhard,Philippe Busson,Matilde Calopa,Jesper Clausen,Erik H. Danielsen,Luc Defebvre,Valérie Delvaux,Sophie Dethy,Espen Dietrichs,Oriol De Fabregues,Ransmayr Gerhard,Graziano Gusmaroli,Kirsten Hahn,Björn Hauptmann,Tove Henriksen,Jorge Hernández-Vara,Anne Jeanjean,Michaela Kaiserová,Jan Kassubek,Thomas E. Kimber,Spyridon Konitsiotis,Rejko Krüger,Rejko Krüger,Jaime Kulisevsky,Jo Leenders,Christofer Lundqvist,F. Ory Magne,Pietro Marano,Ivan Milanov,Nicola Modugno,Anjum Misbahuddin,Martin Nevrly,Zikos Panayiotis,Kenn Freddy Pedersen,Stephen Wørlich Pedersen,Lacramioara Perju-Dumbrava,M.M. Ponsen,Bogdan Ovidiu Popescu,Michel Rijntjes,Víctor Puente,Christoph Redecker,Christoph Schrader,Mariachiara Sensi,Mihaela Simu,Cleanthe Spanaki,Alexander Storch,Anette Storstein,Volker Tomantschger,Chris van der Linden,T. van Laar,F. Viallet,Tatiana Witjas,Martin Wolz,Maurizio Zibetti,Michel Van Zandijcke +78 more
TL;DR: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months.
Journal ArticleDOI
A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain.
Olivier Rascol,Theresa A. Zesiewicz,K. Ray Chaudhuri,Mahnaz Asgharnejad,Erwin Surmann,Elisabeth Dohin,Sigrid Nilius,Lars Bauer +7 more
TL;DR: The results suggest rotigotine may improve PD‐associated pain; a large‐scale confirmatory study is needed.
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Imaging the Etiology of Apathy, Anxiety, and Depression in Parkinson's Disease: Implication for Treatment.
Stéphane Thobois,Stéphane Thobois,Stéphane Prange,Véronique Sgambato-Faure,Léon Tremblay,Emmanuel Broussolle,Emmanuel Broussolle +6 more
TL;DR: Functional imaging has shown that mesolimbic dopaminergic but also serotonergic lesions play a major role in the mechanisms of these three neuropsychiatric manifestations, which has direct therapeutic implications.
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Emotional manifestations of PD: Neurobiological basis.
Anna Castrioto,Stéphane Thobois,Stéphane Thobois,Sebastien Carnicella,Audrey Maillet,Paul Krack +5 more
TL;DR: The aim of this review is to focus on the emotional manifestations stemming from the neurodegenerative process itself, including depression, anxiety, apathy, and fatigue, which can all be part of the clinical spectrum of premotor disease and may be improved by medications targeting parkinsonian motor signs or psychiatric symptoms as the disease progresses.
References
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Journal ArticleDOI
Non-motor symptoms of Parkinson's disease: dopaminergic pathophysiology and treatment
TL;DR: The dopaminergic basis of the range of non-motor symptoms that occur in PD such as depression, apathy, sleep disorders (including rapid-eye movement sleep behaviour disorder), and erectile dysfunction are investigated.
Journal ArticleDOI
The PRIAMO study: A multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson's disease
Paolo Barone,Angelo Antonini,Carlo Colosimo,Roberto Marconi,Letterio Morgante,Tania P. Avarello,Eugenio Bottacchi,Antonino Cannas,Gabriella Ceravolo,Roberto Ceravolo,Giulio Cicarelli,Roberto M. Gaglio,Rosa M. Giglia,Francesco Iemolo,M. Manfredi,Giuseppe Meco,Alessandra Nicoletti,Massimo Pederzoli,Alfredo Petrone,Antonio Pisani,Francesco E. Pontieri,Rocco Quatrale,Silvia Ramat,Rosanna Scala,Giuseppe Volpe,Salvatore Zappulla,Anna Rita Bentivoglio,Fabrizio Stocchi,Giorgio Trianni,Paolo Del Dotto +29 more
TL;DR: A key role for NMS in the clinical frame of PD is supported and the need to address them specifically in clinical trials using dedicated scales is addressed.
Journal ArticleDOI
International multicenter pilot study of the first comprehensive self-completed nonmotor symptoms questionnaire for Parkinson's disease : The NMSQuest study
Kallol Ray Chaudhuri,Pablo Martinez-Martin,Anthony H.V. Schapira,Fabrizio Stocchi,Kapil D. Sethi,Per Odin,Richard G. Brown,W. C. Koller,Paolo Barone,Graeme Macphee,Linda Kelly,Martin Rabey,Doug MacMahon,Sue Thomas,William G. Ondo,David B. Rye,A Forbes,S. Tluk,Vandana Dhawan,A Bowron,Adrian J. Williams,C. W. Olanow +21 more
TL;DR: An international pilot study assessing feasibility, validity, and acceptability of a nonmotor questionnaire (NMSQuest) found NMS were highly significantly more prevalent across all disease stages and the number of symptoms correlated significantly with advancing disease and duration of disease.
Journal ArticleDOI
The metric properties of a novel non-motor symptoms scale for Parkinson's disease: Results from an international pilot study.
Kallol Ray Chaudhuri,Pablo Martinez-Martin,Richard G. Brown,Kapil D. Sethi,Fabrizio Stocchi,Per Odin,William G. Ondo,Kazuo Abe,Graeme Macphee,Doug MacMahon,Paolo Barone,Martin Rabey,A Forbes,Kieran Breen,S. Tluk,Y. Naidu,Warren Olanow,Adrian J. Williams,Sue Thomas,David B. Rye,Yoshio Tsuboi,Annette Hand,Anthony H.V. Schapira,Anthony H.V. Schapira +23 more
TL;DR: NMSS can be used to assess the frequency and severity of NMS in PD patients across all stages in conjunction with the recently validated non‐motor questionnaire.
Journal ArticleDOI
The impact of non-motor symptoms on health-related quality of life of patients with Parkinson's disease.
Pablo Martinez-Martin,Carmen Rodriguez-Blazquez,Monica M. Kurtis,K. Ray Chaudhuri,K. Ray Chaudhuri +4 more
TL;DR: The Non‐Motor Symptoms Scale (NMSS) was used to assess the impact of the non‐motor symptoms on HRQoL of Parkinson's disease patients.
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