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Helps Restless Leg Syndrome
07 Sep 2004

Results from Largest Study Ever Conducted on Restless Legs Syndrome
Presented During 8th Congress of the European Federation of Neurological
Societies. Results from the largest and most comprehensive clinical
trial programme ever conducted in RLS (restless legs syndrome), also
known as Ekbom’s syndrome, demonstrate that ropinirole is effective in
improving the symptoms and consequences of RLS. 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.
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
percent of the general adult population. “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.”
Overview of Studies
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.
Ropinerole Shows Improvement in Quality of Life for RLS Patients
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.
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.
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.
Episodes of increased disease activity (augmentation) were reported by
only three (0.37 percent) patients across the four studies.
About RLS
RLS is characterised by an uncontrollable urge to move the legs and
painful or distressing sensations in the lower limbs that are sometimes
described by patients as creeping, crawling, burning or pulling.
These sensations occur during rest, often during the evening or at
night. Movement can provide temporary relief. Although the primary cause
of RLS remains unclear, there is evidence that the cause may be related
to abnormalities in the central dopamine system in the brain. Three
percent of the population experiences moderately to severely distressing
RLS symptoms at least two to three times per week and requires medical
help.
Researchers have concluded that RLS often runs in families. However,
anybody is at risk of developing RLS. While the prevalence of RLS
increases with age, it has a variable age of onset and can occur in
children. In patients with severe RLS, one-third to two-fifths have
their first symptoms before age 20, although the official diagnosis of
RLS is usually made much later.

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