By Thomas S. May
RHODES, GREECE -- June 22, 2007 -- Rotigotine, delivered transdermally, is at least as effective as another dopamine agonist, ropinirole, at improving sleep quality and early morning motor function in early Parkinson's disease (PD), according to a randomised, double-blind study presented here at the 17th Meeting of the European Neurological Society (ENS).
The study enrolled 51 patients with early stage PD, 25 of whom were randomly assigned to receive up to 8 mg/day of rotigotine in a transdermal patch, while another 26 were given up to 9 mg/day of ropinirole. None of the patients were taking levodopa.
Following an initial screening period lasting up to 28 days and a baseline period including two overnight stays, there was a titration period of up to 4 weeks for rotigotine and 6 weeks for ropinirole, plus a 4-week maintenance period, which included two overnight stays.
Early morning motor performance was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 before the administration of morning medication, and sleep quality was assessed using the Parkinson's Disease Sleep Scale (PDSS). Patients were also surveyed about their degree of satisfaction regarding the treatment received during the trial, compared to their previous treatment.
The investigators found that most participants experienced significant improvements in sleep quality, as well as early morning motor function. Specifically, there was an increase in PDSS sum score of 4.2±2.7 for the rotigotine group, and an increase of 1.8±2.6 for patients in the ropinirole group. UPDRS III scores decreased by 6.3±1.3 and 5.9±1.3 points for the rotigotine and ropinirole groups, respectively.
Adverse events were reported by 56% of rotigotine patients versus 65% of patients in the ropinirole group. Those events consisted mostly of nausea and skin irritation for rotigotine, and nausea, fatigue, and headache for ropinirole-treated subjects. All rotigotine-treated subjects with previous treatment for PD were "satisfied" or "very satisfied" with the treatment compared to the previous treatment, whereas only 9% of patients treated with ropinirole preferred the treatment received during the trial to their previous treatment.
Based on these results, the investigators concluded that, "the rotigotine transdermal patch led to clinically relevant improvement in early morning motor function and sleep quality in this trial."
Funding for the study was provided by Schwarz Pharma, the makers of rotigotine patch (Neupro®).
[Presentation title: Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-stage Parkinson's Disease. Abstract P495]
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