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ABSTRACT
Objectives: To evaluate Parkinson’s disease (PD)-associated pain as perceived by the patients (subjective characterization), and how this may change following initiation of rotigotine transdermal patch.
Methods: SP1058 was a non-interventional study conducted in routine clinical practice in Germany and Austria in patients experiencing PD-associated pain (per the physician’s assessment). Data were collected at baseline (ie, before rotigotine initiation) and at a routine visit after ≥25 days (–3 days allowed) of treatment on a maintenance dose of rotigotine (end of study [EoS]). Pain perception was assessed using the 12-item Pain Description List of the validated German Pain Questionnaire (each item ranked 0 = ‘not true’ to 3 = ‘very true’). Primary effectiveness variable: change from baseline to EoS in the sum score of the 4 ‘affective dimension’ items of the Pain Description List. Secondary effectiveness variables: change from baseline to EoS in Unified Parkinson’s Disease Rating Scale (UPDRS) II, III, and II+III scores, and Parkinson’s Disease Questionnaire (PDQ-8) total score (PD-related quality-of-life). Other variables included scores of the eight ‘sensory dimension’ items of the Pain Description List.
Results: Of 93 enrolled patients (mean [SD] age: 71.1 [9.0] years; male: 48 [52%]), 77 (83%) completed the study, and 70 comprised the full analysis set. The mean (SD) change from baseline in the sum score of the four ‘affective dimension’ items was –1.3 (2.8) indicating a numerical improvement (baseline: 3.9 [3.4]). In the ‘sensory dimension’, pain was mostly perceived as ‘pulling’ at baseline (49/70 [70%]); ‘largely true’/‘very true’). Numerical improvements were observed in all UPDRS scores (mean [SD] change in UPDRS II+III: −5.3 [10.5]; baseline: 36.0 [15.9]), and in PDQ-8 total score (−2.0 [4.8]; baseline: 10.7 [5.9]). Adverse drug reactions were consistent with dopaminergic stimulation and transdermal administration.
Conclusion: The perception of the ‘affective dimension’ of PD-associated pain numerically improved in patients treated with rotigotine. ClinicalTrials.gov identifier: NCT01606670; https://clinicaltrials.gov/ct2/show/NCT01606670?term=NCT01606670&rank=1
Acknowledgments
The authors thank the patients and their caregivers in addition to the investigators and their teams who contributed to this study. The authors acknowledge Karolina Rzeniewicz PhD (Evidence Scientific Solutions, London, UK) for writing assistance, which was funded by UCB Pharma, Brussels, Belgium, and Cédric Laloyaux PhD CMPP (Strategic Publication Lead Neurology, UCB Pharma, Brussels, Belgium) for publication coordination. The authors also acknowledge Elisabeth Dohin MD (UCB Pharma, Brussels, Belgium) and Mahnaz Asgharnejad PharmD (UCB Pharma, Raleigh, NC, USA) for scientific and medical input into the data analyses and interpretation, and Dr Johannes Schwarz (Haag Hospital and Technical University of Munich) for his participation in the study and in the drafting of the manuscript. The data presented here were previously presented at Kongress der Deutschen Gesellschaft für Neurologie mit Fortbildungsakademie (DGN), 23–26 September, 2015, Düsseldorf, Germany; Poster IP006.
Declaration of interest
L Timmermann received personal fees for consulting services from Medtronic Inc., Boston Scientific, Sapiens, St. Jude Medical, GE Medical, UCB Pharma, and Archimedes Pharma; and received personal honoraria for speakers’ activities from Teva Pharma, UCB Pharma, Desitin, Medtronic, Boston Scientific, Abbott, GE Medical, Archimedes, and Bayer. The employer of L Timmermann, not L Timmermann personally, received financial support from: DFG, Federal Ministry of Education and Research, Manfred and Ursula Müller Foundation, Klüh Foundation, Hoffnungsbaum e.V., NBIA Disorders Association USA, Cologne Fortune, Medtronic, German Parkinson Association, Archimedes Pharma, Abbott, Bayer, UCB Pharma, Zur Rose Pharma, and Teva. C Oehlwein received personal honoraria for speakers’ activities from UCB Pharma, Medtronic, St. Jude Medical, and Desitin, and personal fees for consulting services from Medtronic and St. Jude Medical. The employer of C Oehlwein received financial support from MSD, UCB Pharma, Lundbeck, Meda Pharma, Lilly, Desitin, Teva, and Novartis; G Ransmayr received personal fees for advisory boards and consulting services from AbbVie, UCB Pharma, Biogen, Genzyme, Novartis, Merck Serono, and GE Medical. J Kassubek received personal honoraria for consulting services and speakers’ activities from UCB Pharma, Teva Pharmaceuticals, Medtronic, Zambon, Desitin, AbbVie, Boehringer Ingelheim, GlaxoSmithKline, Merz Pharmaceuticals, and Hoffmann-La Roche. E Will, H Schroeder, H Fröhlich, and L Bauer are employed by UCB Pharma. T Lauterbach is a former employee of UCB Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
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Notes
1 Hallucination and hallucination visual were analyzed as two separate ADR categories by MedDRA Preferred Term (one patient each).
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Notes on contributors
Lars Timmermann
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Christian Oehlwein
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Gerhard Ransmayr
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Holger Fröhlich
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Edgar Will
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Hanna Schroeder
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Thomas Lauterbach
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Lars Bauer
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.
Jan Kassubek
L Timmermann, C Oehlwein, G Ransmayr, E Will, H Schroeder, T Lauterbach, L Bauer, and J Kassubek were involved in the design of the study and interpretation of the results. L Timmermann was also involved in the design of post hoc analyses. L Timmermann, C Oehlwein, G Ransmayr, and J Kassubek were study investigators and contributed to data collection. E Will, T Lauterbach, and L Bauer were involved in data analysis. H Schroeder performed the data analysis. H Fröhlich designed and performed post hoc analysis of pain patterns. All authors were involved in review and critique of the manuscript. All authors approved the final version of the manuscript.