The European @entity4531 ( @entity4531 ) Study Group performed the first multi-center, long-term study systematically evaluating @entity4531 augmentation under levodopa treatment. This prospective, open-label 6-month study was conducted in six European countries and included 65 @entity1 (85% treatment naive) with idiopathic @entity4531 . Levodopa was flexibly up-titrated to a maximum dose of 600 mg/day. Presence of augmentation was diagnosed independently by two international experts using established criteria. In addition to the augmentation severity rating scale (ASRS), changes in @entity4531 severity (International @entity4531 severity rating scale (IRLS), clinical global impression (CGI)) were analyzed. Sixty @entity1 provided evaluable data, 35 completed the trial and 25 dropped out. Augmentation occurred in 60% (36/60) of @entity1 , causing 11.7% (7/60) to drop out. Median time to occurrence of augmentation was 71 days. The mean maximum dose of levodopa was 311 mg/day (SD: 105). @entity1 with augmentation compared to those without were significantly more likely to be on higher doses of levodopa (> or =300 mg, 83 vs. 54%, P = 0.03) and to show less improvement of symptom severity (IRLS, P = 0.039). Augmentation was common with levodopa, but could be tolerated by most @entity1 during this 6-month trial. @entity1 should be followed over longer periods to determine if dropout rates increase with time.

Progressive development of augmentation during long-term treatment with levodopa in XXXX : results of a prospective multi-center study.

@entity1 :: ('9606', 'Species') :: ['patients', 'Patients'] @entity4531 :: ('MESH:D012148', 'Disease') :: ['Restless Legs Syndrome', 'RLS']
@entity4531 :: (MESH:D012148,Disease) :: ['restless legs syndrome']
