The first data to show that Neupro® (rotigotine transdermal system) significantly improved wellbeing and daily activities that are often impaired by pain related to Restless Legs Syndrome (RLS) were presented this week at the 14th International Congress of Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina. Additional data from an open-label extension study showed that the efficacy of rotigotine remained stable over five years of follow up with over a third of patients remaining symptom free during that time and 96% categorized as "very much improved" or "much improved."
"Pain has been reported by up to 60% of RLS patients. These new data showed that by improving the core symptoms of RLS, rotigotine provided relief from pain and significantly improved patient wellbeing and daily activities impaired due to RLS-related pain. Therefore these data may be relevant for RLS patients with painful symptoms that are not currently being treated effectively," said Professor Ralf Kohnen, University of Erlangen- Nurembourg, Germany.
In the 6-month, double-blind study, 458 patients with moderate to severe RLS were randomised to receive either placebo or rotigotine (1,2,3 mg/24hrs) by transdermal administration. Patient impairment of daily activities due to pain was assessed using Item 8 of the Quality of Life Questionnaire for RLS patients (QoL-RLS; additional exploratory endpoint). At baseline, 456 patients (99.6%) were assessed and 433 patients (94.5%) were assessed at the end of the maintenance period.
At each visit, patients were asked to what degree pain in their arms or legs impaired their wellbeing or normal daytime activities on a scale of 0-5 points ("not at all" to "extremely"). The mean value for pain decreased from 2.41 to 1.85 in the placebo group, and from 2.61 to 1.39 in the rotigotine group.
Additionally, at baseline, 55.6% of the placebo group reported moderate to extreme pain, compared with 61.9% of patients in the rotigotine group. At the end of maintenance, these figures had changed to 38.2% and 22.9%, respectively.