Results from the clinical trial programme conducted in RLS (restless legs syndrome) also known as Ekbom's syndrome, demonstrate that ropinirole is found effective in improving the symptoms and consequences of RLS.

Presented this week at the 8th Congress of the European Federation of Neurological Societies, the phase III data demonstrate ropinirole improved quantity and quality of sleep as early as one week after treatment initiation with continued efficacy more than 36 weeks. RLS, the fourth leading cause of insomnia, affects an estimated 10 - 15 per cent of the general adult population, the GlaxoSmithKline said in a press release.

RLS, a complicated and distressing neurological movement disorder characterised by painful or uncomfortable sensations in the legs, can have a profound impact on sleep and quality of life.

Data from four clinical trials assessed the benefit of ropinirole in improving RLS symptoms such as periodic leg movements, sleep deprivation and quality of life, and all four trials demonstrated significant improvement in treating RLS. For purposes of this analysis, where appropriate, data were pooled across trials. Researchers conducted three 12-week trials in which 818 patients were randomized to receive ropinirole or placebo. In a separate trial 206 patients were observed over a 36-week period. Patients in the 36-week study received ropinirole during an initial 24-week single-blind phase; those patients meeting criteria for treatment continuation then entered a double-blind phase. Patients in the continuation trial were randomized to ropinirole or placebo for an additional 12 weeks.

Significantly greater improvement in motor symptoms, sleep and health-related quality of life at 12 weeks was reported for ropinirole compared with placebo. In the longer-term study, patients showed improvements during the initial 24-week ropinirole phase and during the second 12-week phase (when ropinirole was replaced with placebo in half of the group). The response was better maintained for patients continuing ropinirole, the release says.

Patients showed marked improvements in International Restless Legs Scale (IRLS) scores, Clinical Global Impression-Improvement (CGI-I) scale scores, sleep, and quality-of-life parameters at week one. Ropinirole significantly improved the four most clinically relevant areas for RLS as measured by the Medical Outcomes Study sleep scale (MOS) - sleep disturbance, sleep quantity, sleep adequacy and daytime somnolence - at 12 weeks. Similar or greater improvements were observed at 24 weeks and were maintained to 36 weeks in patients who received ropinirole treatment for all measurements, including IRLS, CGI-I, MOS.

"RLS can have a significant negative impact on quality of life for patients due to the inability to fall or stay asleep and unpleasant sensory symptoms when relaxing. Chronic sleep deprivation can adversely affect your ability to concentrate, work, drive, take part in social activities, or enjoy recreational pastimes," said P Tidswell - one of the lead investigators. "Data show that ropinirole is highly effective in reducing sleep disturbance, promoting sleep, and improving quality of life. The initial onset of action was rapid, and the benefits of ropinirole were maintained in the longer term," he added.

Treatment differences in favour of ropinirole were also significant as measured by the restless legs syndrome quality of life survey (RLSQoL) and SF-36 scores (a survey assessing physical and mental health in the categories of vitality, physical role, social functioning and mental health). Benefits were better maintained in patients continuing to receive ropinirole than for those taking placebo.