To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/ @entity18776 in the treatment of @entity4531 ( @entity4531 ), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed @entity4531 @entity1 (7 @entity1 , 16 @entity1 ) received a combination of RR and SR levodopa. @entity1 were treated on average for 10 months with a mean daily dose of 203 +/- 101 mg of RR and of 185 +/- 93 mg of SR levodopa. The mean daily total dose was 388 +/- 162 mg levodopa. Efficacy was documented using @entity1 's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 @entity1 completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 +/- 1.9, 7-point scale), sleep latency was shortened (-131 +/- 152 minutes), and total sleep time lengthened (+ 190 +/- 136 minutes). Severity of @entity4531 at time of falling asleep (-6.5 +/- 3.4, 11-point scale) and during the night (-6.0 +/- 3.5) was markedly lower at the end of the extension but severity of @entity4531 during the day (+1.9 +/- 5.0) slightly increased. Of 13 dropouts, 8 @entity1 discontinued therapy because of worsening @entity4531 during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/ @entity18776 in @entity4531 @entity1 with late-night problems was efficacious and not limited by tolerability problems in 40% of @entity1 , whereas in the majority of @entity1 , aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period.

One-year treatment with standard and sustained-release levodopa: appropriate long-term treatment of XXXX ?

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients', 'patient', 'men'] @entity18776 :: ('MESH:D001545', 'Chemical') :: ['benserazide'] @entity4531 :: ('MESH:D012148', 'Disease') :: ['restless legs syndrome', 'RLS']
@entity4531 :: (MESH:D012148,Disease) :: ['restless legs syndrome']
