PubMed | University of Ulm, b Neurological Outpatient Clinic for Parkinson Disease and Deep Brain Stimulation, UCB Pharma, University of Cologne and c Kepler University Hospital
Type: Journal Article | Journal: Postgraduate medicine | Year: 2016
To evaluate Parkinsons disease (PD)-associated pain as perceived by the patients (subjective characterization), and how this may change following initiation of rotigotine transdermal patch.SP1058 was a non-interventional study conducted in routine clinical practice in Germany and Austria in patients experiencing PD-associated pain (per the physicians assessment). Data were collected at baseline (ie, before rotigotine initiation) and at a routine visit after 25days (-3days 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 Parkinsons Disease Rating Scale (UPDRS) II, III, and II+III scores, and Parkinsons 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.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.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.