Restless Legs Syndrome (RLS) is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs.
Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.
The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.
Mirapexin®, Sifrol®, Pexola®, Mirapex® (pramipexole)
Indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS).
On 10 November 2006, the U.S. Food and Drug Administration (FDA) has approved pramipexole, a non-ergot dopamine agonist, for the treatment of moderate to severe primary Restless Legs Syndrome (RLS).
In 2006, Pramipexole, a non-ergot dopamine agonist, has been approved for the symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS) in the USA, throughout the European Union and other countries such as Australia, Brazil, Canada, Mexico, followed 2010 by approval in Japan.
Pramipexole (known in Europe under the trade names Mirapexin® and Sifrol® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson Disease, as monotherapy or in combination with levodopa.
Despite many years of research and increased disease recognition, RLS still remains underdiagnosed or misdiagnosed to this day. RLS may be diagnosed with positive answers to the following criteria, which were developed by participants in the RLS Diagnosis & Epidemiology workshop at the National Institutes of Health in collaboration with members of the International Restless Legs Syndrome Study Group (IRLSSG).
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