USE OF ROTIGOTINE FOR TREATING THE RESTLESS LEG SYNDROME
This invention relates to the use of rotigotine for the effective treatment of Restless Leg Syndrome (RLS) as well as to a rotigotine-containing transepicutaneous pharmaceutical composition, provided in particular in the form of an acrylate- or silicone-based Transdermal Therapeutic System (US) having a surface area of 2.5 to 20 cm 2 and containing 0.1 to 3.15 mg/cm 2 rotigotine as its active component against the Restless Leg Syndrome, said system leading in the human Restless Leg Syndrome condition to an improvement, compared to a placebo treatment, by 2 or more units on the International Restless Leg Syndrome Study Group (IRLSSG) scale after administration over a period of eight days.
1 - 24 . (canceled)
25 . A method of treating RLS in a patient who is experiencing augmentation or who has experienced augmentation, the method comprising
transepicutaneously administering to the patient rotigotine in a daily dosage amount of 0.5 to 10 mg effective to provide in at least 8 days an improvement of about 2 or more units on the IRLSSG scale, as compared to a placebo treatment,
wherein occurrence of augmentation in the patient is reduced, and
wherein the rotigotine is administered in monotherapy.
26 . The method of claim 25 , wherein the administration is by a transdermal therapeutic system (TTS) having a surface area of 2.5 to 20 cm 2 and containing 0.1 to 3.15 mg/cm 2 of rotigotine.
27 . The method of claim 26 , wherein the TTS is a silicone-based transdermal therapeutic system.
28 . The method of claim 26 , wherein the TTS is periodically removed and replaced by another TTS.
29 . The method of claim 25 , wherein the rotigotine is administered in an amount of 1 to 5 mg per day.
30 . In a method using a dopamine agonist for long-term therapy for a subject suffering from RLS, said subject being augmentation-prone under long-term dopamine agonist therapy, the improvement comprising
transepicutaneously administering rotigotine to the subject in a daily dosage amount of 0.5 to 10 mg effective to provide in at least 8 days an improvement of about 2 or more units on the IRLSSG scale, as compared to a placebo treatment.